Total 1,394 Quality Assurance / Control job vacancies in Parris Island, South Carolina

Administered by the Workforce Advancement Federation (WAF), the Career Conversion Programme (CCP) for Biomedical Manufacturing Executives is a premier talent development initiative designed to cultivate the next generation of skilled professionals for Singapore’s Biomedical manufacturing industry. This comprehensive 15-month programme features structured on-the-job training (OJT) provided at Novartis Singapore Pharmaceutical Manufacturing Pte Ltd (NSPM), facilitating the practical application of acquired knowledge and ensuring participants develop the essential competencies required for their roles.

Eligilibity for CCP:

• Singapore Citizen or Permanent Resident;

• Minimum 21 years old;

• Mid-Career Individual: Graduated, or completed National Service, whichever is later, for at least 2 years* prior at the point of application; or

• Fresh Graduate: Graduated, or completed National Service, whichever is later;

• Not in a similar job function prior to joining Career Conversion Programme (CCP);

• Have not attended the same programme – Career Conversion Programme (CCP) for Biomedical Manufacturing Executives / Professionals (Train-and-Place with Commitment to hire) – previously;

• Have not been funded under the same programme – Career Conversion Programme (CCP) for Biomedical Manufacturing Executives / Professionals (Train-and-Place with Commitment to hire) – previously.

• Should not be shareholders, immediate ex-employees of Novartis, or be related to shareholders of Novartis.

Successful candidates must be able to commence the program by March 2025.

Job Purpose

Responsible for providing quality oversight to ensure smooth manufacturing operation and new product launches/transfer in a compliant and timely manner. Support drug substance batch review and release in full gmp compliance to regulatory standards and ensures quality strategy/continuous improvement are executed in alignment to site objective/s.

Key Responsibilities

Operational

a. Provide Quality oversight to site operations/objectives

· Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance.

· Participate/Support meetings (as required) and team tiered process to monitor/detect/act on anomalies to key site quality KPIs and continuous improvement.

b. Review/ Release of Raw materials and manufactured materials

· Perform and be responsible in ensuring Batch record review and/or release (raw materials and manufactured materials – for authorized person only) is in full cGMP compliance to regulatory and Novartis Quality Standards

· Support the release team in batch release in ensuring batch release (manufactured materials – for authorized person only) is in full cGMP compliance to regulatory and Novartis Quality Standards.

c. Support exception investigations and change control activities

· Lead/support in ensuring a smooth manufacturing operations in production/QC/Logistics, in handling deviations/capa, change control, complaints, customer management, escalation, recall etc are in full cGMP compliance to regulatory and Novartis Quality Standards

d. Support OpEx improvement projects

· Support for end-to-end lifecycle management, timely review & escalation, stakeholder management to achieve agreed outcomes for projects assigned and areas under responsibility

e. New Product Introduction

· Support in ensuring success to new product launch/transfer and equipment/product lifecycle management are in full cGMP compliance to regulatory and Novartis Quality Standards e.g., Product Transfer, Equipment Qualification, Computerized System Validation, Shipping Validation, Cleaning Validation, , Process Validation, Ongoing Process Verification & etc

f. Customer Management

· Lead/support network/project governance meeting and team tiered process to monitor/detect/act on anomalies to project milestones, KPIs and continuous improvement.

· Support in preparing customers request documentation or requests

g. Documents review

· Provide support (Review/Approval) of GMP Record/Document in ensuring compliance to regulatory and Novartis Quality Standards

h. Inspections

· Provide support in ensuring inspection readiness. Support customer, internal Novartis and Health Authority audits.

i. Any other task/duties assigned by Line Manager

Requirements

· University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)

· Several years of experience in pharmaceutical quality control, quality assurance or production or relevant quality experience. Fresh graduates are welcome to apply.

· Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice

· New entrants to biopharmaceutical industry and should not be holding a bond obligation with any organisation

Administered by the Workforce Advancement Federation (WAF), the Career Conversion Programme (CCP) for Biomedical Manufacturing Executives is a premier talent development initiative designed to cultivate the next generation of skilled professionals for Singapore’s Biomedical manufacturing industry. This comprehensive 15-month programme features structured on-the-job training (OJT) provided at Novartis Singapore Pharmaceutical Manufacturing Pte Ltd (NSPM), facilitating the practical application of acquired knowledge and ensuring participants develop the essential competencies required for their roles.

Eligilibity for CCP:

• Singapore Citizen or Permanent Resident;

• Minimum 21 years old;

• Mid-Career Individual: Graduated, or completed National Service, whichever is later, for at least 2 years* prior at the point of application; or

• Fresh Graduate: Graduated, or completed National Service, whichever is later;

• Not in a similar job function prior to joining Career Conversion Programme (CCP);

• Have not attended the same programme – Career Conversion Programme (CCP) for Biomedical Manufacturing Executives / Professionals (Train-and-Place with Commitment to hire) – previously;

• Have not been funded under the same programme – Career Conversion Programme (CCP) for Biomedical Manufacturing Executives / Professionals (Train-and-Place with Commitment to hire) – previously.

• Should not be shareholders, immediate ex-employees of Novartis, or be related to shareholders of Novartis.

Successful candidates must be able to commence the program by March 2025.

Job Purpose

Support all activities establishing and maintaining Microbiology lab in BioProduction Operations QC. Ensure all microbiological testing of samples for production support and documented in accordance with written testing SOP’s and in accordance with local and/or international regulations.

Key Responsibilities

• Maintain QC Micro/EM laboratory in full cGMP-compliance.

• Track and execute individual training requirements to ensure completion on time including new methods and instrumentation.

• Ensure laboratory operations are in accordance to cGMP standards

• Perform microbiological testing and EM sampling in accordance current testing monographs/SOPs and in accordance with local/ international regulations.

• Ensures that testing completed in a timely manner based on plan.

• Support laboratory routine operations such as inventory management and house-keepings.

• Support the optimization of work flows in the QC Micro/EM Laboratory.

Requirements

•Minimum Diploma with 4 to 5 years of relevant working experience, preferably in a cGMP environment. Fresh graduates are welcome to apply.

• New entrants to biopharmaceutical industry and should not be holding a bond obligation with any organisation

• Related experience should be in GMP-regulated industries in Quality Control

• Background knowledge on analysis such as Bioburden and Endotoxin testing

• Preferrably a working knowledge of FDA and ex-USA regulatory requirements as well as industry quality management tools, standard, and quality systems.

• Assist in developing, implement, and maintain compliance policies, procedures, and governance structures.
• Ensure ongoing compliance monitoring and periodic audits to identify and address compliance issues.
• Assist in conducting risk assessments and recommend mitigation strategies for potential compliance issues.
• Maintain accurate and organized records of compliance-related activities and documentation.
• Assist in providing training and guidance to internal teams on compliance matters to foster a compliance-driven culture.
• Stay updated on regulatory changes and ensure timely updates to compliance policies and processes.
• Support internal teams during external audits or inspections by regulators.
• Collaborate with cross-functional teams to embed compliance across operations.
• Assist in setting up compliance processes and governance structures across brands.
• Handle any ad-hoc compliance-related tasks as required.
• 2–5 years of experience in a similar or related role.
• US exposure and legal background are a huge plus.

Job Responsibilities:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.

Responsibilities

• Prepare polymer additives for production usage.
• Carry out lab evaluation of finished products using testing equipment.
• Quality checks on finished products as well as production samples.
• Ensure proper documentations of results, equipment and consumables.
• Ensure proper sample management according to SOPs.
• Prepare test reports/Certificate of Analysis.
• Carry out safety and housekeeping activities in the department.
• Any other duties as and when required to be done by Quality Manager.

Requirements

• Possess at least ITE/Diploma in Chemical Process Technology, Chemistry Chemical Engineering, Science & Technology, Polymer Science or equivalent.
• Fresh graduates are welcomed. Preferably 1 to 2 years of relevant experience in lab testing/chemical/ petrochemical industry.
• On-the-job training will be provided.
• Keen to learn and responsible.
• Good interpersonal and communication skills.
• Team player.
• Meticulous with an eye for accuracy.
• Proficient in MS Office.

Job Description:

• Ensure the machine is working correctly, and calibrating the machine to ensure proper measuring.
• Perform incoming, in-process and final inspection as per customer requirement.
• Maintain calibration record of measuring equipment.
• Document inspection results by completing reports and logs.
• Maintain safe and healthy working environment by following standards and procedures.
• Raise non-conformance report if necessary.

Job Requirements:

• NITEC/Higer NITEC in Precision Engineering.
• 2 -3 years of relevant QC experience in a manufacturing environment and knowledge.
• Able to interpret technical/mechanical drawings of geometrical dimensioning and tolerance.
• Able to perform CMM measurement; preferably with Wenzel or Zeiss.

Supervises a staff of Air Traffic Control Specialists that is responsible for carrying out air traffic control assignments within a geographic area.

Plans and assigns work to be accomplished by subordinate employees. Sets work priorities and schedules. Approves leave; gives advice, counsel, and instruction to employees on both work and administrative matters. Evaluates performance of employees and recommends performance ratings. Hears and resolves complaints from employees and refers group grievances and more serious unresolved complaints to a higher level manager. Identifies and arranges for developmental and other training needs of employees. Finds ways to improve production or increase the quality of the work directed. Adjusts staffing levels and work procedures to accommodate resource decisions made at higher levels. Recommends goals and objectives for the area and tracks accomplishments.

Communicates and reinforces diversity and EEO policies and programs in all areas of responsibility, including selections, training, and transfers. Supports and participates in the labor management partnership process, and fosters a work environment where all employees are treated in a fair and equitable manner.

The Operations Supervisor reports to the Operations Manager. Performance is evaluated upon the effectiveness with which assigned program objectives are achieved.

• YOU WILL/MAY:
• Ensure that regulated establishments produce a safe product by executing appropriate inspection methods, determining non-compliance with regulatory requirements, documenting noncompliance and initiating enforcement actions, where warranted.
• Verify that meat and poultry slaughter and/or processing establishment's Sanitation Standard Operating Procedures (SSOP) and Hazard Analysis and Critical Control Point (HACCP) Plans meet regulatory requirements.
• Execute Sanitation Standard Operating Procedures (SSOP) and Hazard Analysis and Critical Control Point (HACCP) Plans effectively to prevent unsanitary conditions and adulteration of product.
• Review records, observe plant operations and conduct hands-on verification to ensure compliance with regulatory requirements and prepare detailed documentation (Non-Compliance Records) of non-compliance with regulatory requirements.
• Determine when regulatory control action is necessary. You will assess whether the plant's corrective or preventative actions are acceptable and effective, if there are trends in noncompliance, or if an enforcement action is warranted.
• Conduct regulatory oversight activities inside plants in matters relating to other consumer protections (e.g., economic adulteration and misbranding).
• Have contact with plant managers, owners and others to explain legal and regulatory requirements, discuss operation of the plant's SSOP, HACCP plan and other food safety programs.
• Communicate and defend determinations on non-compliance issues and discuss plans for addressing non-compliance.
• Work with a variety of individuals to resolve problems, clarify differences of interpretation concerning HACCP and other food safety or consumer protection requirements.
• Advise other Agency inspectors, supervisors and officers on inspection and enforcement matters for which you are involved.
• Conduct various samplings, surveys and tests to obtain pertinent data on potential problem areas, industry trends, or other issues of current interest to the Agency.
• Be involved in performing health and safety verification sampling and tests for detection of specific microbes (e.g., salmonella, listeria, etc.), residues or contaminants.
• Assure that products approved for import are in full compliance with all applicable Federal regulations governing the importation of meat and poultry products.
• Authorize entry of all meat or poultry products considered to comply with Federal regulations or refuse entry of any products which violate any of the requirements for admission into this country.
• Coordinate with other Federal agencies (e.g., the Animal and Plant Health Inspection Service (APHIS) and U.S. Customs and Border Protection (CBP) on such matters as animal health restrictions and refused entry lots.

As an INTERNAL CONTROL ANALYST, GS-0501-11, you will:

This position is located in an Air National Guard (ANG) wing, Comptroller's Flight; The purpose of the position is to function as the Financial Management (FM) focal point for the Financial Improvement and Audit Readiness (FIAR) initiative, as well as, advise the Comptroller and Wing Commander in all matters relating to FM FIAR within the FM community. The incumbent will provide direction and leadership, under the Comptroller's authority, towards the planning, implementing and achievement of the FM FIAR initiative within the Wing. This work requires knowledge and skill in the application of related laws, regulations, precedents, methods, and techniques of budgeting.


.

• YOU WILL/MAY:
• Ensure that regulated establishments produce a safe product by executing appropriate inspection methods, determining non-compliance with regulatory requirements, documenting noncompliance and initiating enforcement actions, where warranted.
• Verify that meat and poultry slaughter and/or processing establishment's Sanitation Standard Operating Procedures (SSOP) and Hazard Analysis and Critical Control Point (HACCP) Plans meet regulatory requirements.
• Execute Sanitation Standard Operating Procedures (SSOP) and Hazard Analysis and Critical Control Point (HACCP) Plans effectively to prevent unsanitary conditions and adulteration of product.
• Review records, observe plant operations and conduct hands-on verification to ensure compliance with regulatory requirements and prepare detailed documentation (Non-Compliance Records) of non-compliance with regulatory requirements.
• Determine when regulatory control action is necessary. You will assess whether the plant's corrective or preventative actions are acceptable and effective, if there are trends in noncompliance, or if an enforcement action is warranted.
• Conduct regulatory oversight activities inside plants in matters relating to other consumer protections (e.g., economic adulteration and misbranding).
• Have contact with plant managers, owners and others to explain legal and regulatory requirements, discuss operation of the plant's SSOP, HACCP plan and other food safety programs.
• Communicate and defend determinations on non-compliance issues and discuss plans for addressing non-compliance.
• Work with a variety of individuals to resolve problems, clarify differences of interpretation concerning HACCP and other food safety or consumer protection requirements.
• Advise other Agency inspectors, supervisors and officers on inspection and enforcement matters for which you are involved.
• Conduct various samplings, surveys and tests to obtain pertinent data on potential problem areas, industry trends, or other issues of current interest to the Agency.
• Be involved in performing health and safety verification sampling and tests for detection of specific microbes (e.g., salmonella, listeria, etc.), residues or contaminants.
• Assure that products approved for import are in full compliance with all applicable Federal regulations governing the importation of meat and poultry products.
• Authorize entry of all meat or poultry products considered to comply with Federal regulations or refuse entry of any products which violate any of the requirements for admission into this country.
• Coordinate with other Federal agencies (e.g., the Animal and Plant Health Inspection Service (APHIS) and U.S. Customs and Border Protection (CBP) on such matters as animal health restrictions and refused entry lots.

• YOU WILL/MAY:
• Ensure that regulated establishments produce a safe product by executing appropriate inspection methods, determining non-compliance with regulatory requirements, documenting noncompliance and initiating enforcement actions, where warranted.
• Verify that meat and poultry slaughter and/or processing establishment's Sanitation Standard Operating Procedures (SSOP) and Hazard Analysis and Critical Control Point (HACCP) Plans meet regulatory requirements.
• Execute Sanitation Standard Operating Procedures (SSOP) and Hazard Analysis and Critical Control Point (HACCP) Plans effectively to prevent unsanitary conditions and adulteration of product.
• Review records, observe plant operations and conduct hands-on verification to ensure compliance with regulatory requirements and prepare detailed documentation (Non-Compliance Records) of non-compliance with regulatory requirements.
• Determine when regulatory control action is necessary. You will assess whether the plant's corrective or preventative actions are acceptable and effective, if there are trends in noncompliance, or if an enforcement action is warranted.
• Conduct regulatory oversight activities inside plants in matters relating to other consumer protections (e.g., economic adulteration and misbranding).
• Have contact with plant managers, owners and others to explain legal and regulatory requirements, discuss operation of the plant's SSOP, HACCP plan and other food safety programs.
• Communicate and defend determinations on non-compliance issues and discuss plans for addressing non-compliance.
• Work with a variety of individuals to resolve problems, clarify differences of interpretation concerning HACCP and other food safety or consumer protection requirements.
• Advise other Agency inspectors, supervisors and officers on inspection and enforcement matters for which you are involved.
• Conduct various samplings, surveys and tests to obtain pertinent data on potential problem areas, industry trends, or other issues of current interest to the Agency.
• Be involved in performing health and safety verification sampling and tests for detection of specific microbes (e.g., salmonella, listeria, etc.), residues or contaminants.
• Assure that products approved for import are in full compliance with all applicable Federal regulations governing the importation of meat and poultry products.
• Authorize entry of all meat or poultry products considered to comply with Federal regulations or refuse entry of any products which violate any of the requirements for admission into this country.
• Coordinate with other Federal agencies (e.g., the Animal and Plant Health Inspection Service (APHIS) and U.S. Customs and Border Protection (CBP) on such matters as animal health restrictions and refused entry lots.

• YOU WILL/MAY:
• Ensure that regulated establishments produce a safe product by executing appropriate inspection methods, determining non-compliance with regulatory requirements, documenting noncompliance and initiating enforcement actions, where warranted.
• Verify that meat and poultry slaughter and/or processing establishment's Sanitation Standard Operating Procedures (SSOP) and Hazard Analysis and Critical Control Point (HACCP) Plans meet regulatory requirements.
• Execute Sanitation Standard Operating Procedures (SSOP) and Hazard Analysis and Critical Control Point (HACCP) Plans effectively to prevent unsanitary conditions and adulteration of product.
• Review records, observe plant operations and conduct hands-on verification to ensure compliance with regulatory requirements and prepare detailed documentation (Non-Compliance Records) of non-compliance with regulatory requirements.
• Determine when regulatory control action is necessary. You will assess whether the plant's corrective or preventative actions are acceptable and effective, if there are trends in noncompliance, or if an enforcement action is warranted.
• Conduct regulatory oversight activities inside plants in matters relating to other consumer protections (e.g., economic adulteration and misbranding).
• Have contact with plant managers, owners and others to explain legal and regulatory requirements, discuss operation of the plant's SSOP, HACCP plan and other food safety programs.
• Communicate and defend determinations on non-compliance issues and discuss plans for addressing non-compliance.
• Work with a variety of individuals to resolve problems, clarify differences of interpretation concerning HACCP and other food safety or consumer protection requirements.
• Advise other Agency inspectors, supervisors and officers on inspection and enforcement matters for which you are involved.
• Conduct various samplings, surveys and tests to obtain pertinent data on potential problem areas, industry trends, or other issues of current interest to the Agency.
• Be involved in performing health and safety verification sampling and tests for detection of specific microbes (e.g., salmonella, listeria, etc.), residues or contaminants.
• Assure that products approved for import are in full compliance with all applicable Federal regulations governing the importation of meat and poultry products.
• Authorize entry of all meat or poultry products considered to comply with Federal regulations or refuse entry of any products which violate any of the requirements for admission into this country.
• Coordinate with other Federal agencies (e.g., the Animal and Plant Health Inspection Service (APHIS) and U.S. Customs and Border Protection (CBP) on such matters as animal health restrictions and refused entry lots.

• YOU WILL/MAY:
• Ensure that regulated establishments produce a safe product by executing appropriate inspection methods, determining non-compliance with regulatory requirements, documenting noncompliance and initiating enforcement actions, where warranted.
• Verify that meat and poultry slaughter and/or processing establishment's Sanitation Standard Operating Procedures (SSOP) and Hazard Analysis and Critical Control Point (HACCP) Plans meet regulatory requirements.
• Execute Sanitation Standard Operating Procedures (SSOP) and Hazard Analysis and Critical Control Point (HACCP) Plans effectively to prevent unsanitary conditions and adulteration of product.
• Review records, observe plant operations and conduct hands-on verification to ensure compliance with regulatory requirements and prepare detailed documentation (Non-Compliance Records) of non-compliance with regulatory requirements.
• Determine when regulatory control action is necessary. You will assess whether the plant's corrective or preventative actions are acceptable and effective, if there are trends in noncompliance, or if an enforcement action is warranted.
• Conduct regulatory oversight activities inside plants in matters relating to other consumer protections (e.g., economic adulteration and misbranding).
• Have contact with plant managers, owners and others to explain legal and regulatory requirements, discuss operation of the plant's SSOP, HACCP plan and other food safety programs.
• Communicate and defend determinations on non-compliance issues and discuss plans for addressing non-compliance.
• Work with a variety of individuals to resolve problems, clarify differences of interpretation concerning HACCP and other food safety or consumer protection requirements.
• Advise other Agency inspectors, supervisors and officers on inspection and enforcement matters for which you are involved.
• Conduct various samplings, surveys and tests to obtain pertinent data on potential problem areas, industry trends, or other issues of current interest to the Agency.
• Be involved in performing health and safety verification sampling and tests for detection of specific microbes (e.g., salmonella, listeria, etc.), residues or contaminants.
• Assure that products approved for import are in full compliance with all applicable Federal regulations governing the importation of meat and poultry products.
• Authorize entry of all meat or poultry products considered to comply with Federal regulations or refuse entry of any products which violate any of the requirements for admission into this country.
• Coordinate with other Federal agencies (e.g., the Animal and Plant Health Inspection Service (APHIS) and U.S. Customs and Border Protection (CBP) on such matters as animal health restrictions and refused entry lots.

• YOU WILL/MAY:
• Ensure that regulated establishments produce a safe product by executing appropriate inspection methods, determining non-compliance with regulatory requirements, documenting noncompliance and initiating enforcement actions, where warranted.
• Verify that meat and poultry slaughter and/or processing establishment's Sanitation Standard Operating Procedures (SSOP) and Hazard Analysis and Critical Control Point (HACCP) Plans meet regulatory requirements.
• Execute Sanitation Standard Operating Procedures (SSOP) and Hazard Analysis and Critical Control Point (HACCP) Plans effectively to prevent unsanitary conditions and adulteration of product.
• Review records, observe plant operations and conduct hands-on verification to ensure compliance with regulatory requirements and prepare detailed documentation (Non-Compliance Records) of non-compliance with regulatory requirements.
• Determine when regulatory control action is necessary. You will assess whether the plant's corrective or preventative actions are acceptable and effective, if there are trends in noncompliance, or if an enforcement action is warranted.
• Conduct regulatory oversight activities inside plants in matters relating to other consumer protections (e.g., economic adulteration and misbranding).
• Have contact with plant managers, owners and others to explain legal and regulatory requirements, discuss operation of the plant's SSOP, HACCP plan and other food safety programs.
• Communicate and defend determinations on non-compliance issues and discuss plans for addressing non-compliance.
• Work with a variety of individuals to resolve problems, clarify differences of interpretation concerning HACCP and other food safety or consumer protection requirements.
• Advise other Agency inspectors, supervisors and officers on inspection and enforcement matters for which you are involved.
• Conduct various samplings, surveys and tests to obtain pertinent data on potential problem areas, industry trends, or other issues of current interest to the Agency.
• Be involved in performing health and safety verification sampling and tests for detection of specific microbes (e.g., salmonella, listeria, etc.), residues or contaminants.
• Assure that products approved for import are in full compliance with all applicable Federal regulations governing the importation of meat and poultry products.
• Authorize entry of all meat or poultry products considered to comply with Federal regulations or refuse entry of any products which violate any of the requirements for admission into this country.
• Coordinate with other Federal agencies (e.g., the Animal and Plant Health Inspection Service (APHIS) and U.S. Customs and Border Protection (CBP) on such matters as animal health restrictions and refused entry lots.