Quality Assurance Associate

Pfizer, S.A. de C.V; Sanford (NC); On-site; USD 66,000 - 111,000; Full time

Job summary

A leading company in the pharmaceutical industry seeks a Manufacturing Quality Operations Associate at its Sanford, NC location. The role involves providing Quality Assurance support across various manufacturing modalities, ensuring compliance with regulatory expectations and safety protocols. Applicants should have relevant educational qualifications and be adept at working in a team-oriented environment to handle quality-related tasks effectively.

Benefits

401(k) with matching contributions

Paid vacation and personal days

Comprehensive health benefits

Bonus eligibility

Relocation assistance

Qualifications

• Knowledge of current Good Manufacturing Practices (cGMPs) required.
• Experience in a biopharmaceutical environment preferred.
• Ability to work efficiently in a team and manage tasks concurrently.

Responsibilities

• Provide Quality Assurance support to all modalities manufactured on site.
• Conduct compliance walkthroughs and perform batch record reviews.
• Assist in investigations of manufacturing events and support regulatory inspections.

Skills

Problem-solving

Judgment

Critical thinking

Communication

Teamwork

Education

Bachelor's degree

Associate's degree

High school diploma

Tools

SAP

gLIMS

Microsoft Office

Job description

• United States - North Carolina - Sanford

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Transforming Delivery of high quality products

Pfizer, We are one

PGS - Manufacture the Future

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.

What You Will Achieve

The Manufacturing Quality Operations Associate provides Quality Assurance (QA) support to all modalities manufactured on site including clinical, commercial, and contract manufacturing operations providing QA Floor oversight. The role ensures adherence to regulatory expectations, safety, and GxP (i.e., Current Good Manufacturing and Documentation Practices). Duties include, but are not limited to, Aseptic Observations, Acceptable Quality Limit (AQL) testing, line clearance approvals, alarms evaluation, on the floor triage, and on the floor real-time batch record review. The Associate will work cross-functionally with MQA Sr. Associates, manufacturing, and support groups to investigate manufacturing events, and support site internal and external regulatory inspections. The role is based at the Pfizer Sanford, NC Pfizer Global Supply (PGS) site.

In this role, you will:

The Manufacturing Quality Operations Associate support includes documentation review, facility walkthrough, support for activities such as review of in-process records, AQL, aseptic observations, compliance walkthroughs, smoke studies, media fills, alarms evaluation, Product Changeovers, etc.

Assess manufacturing operations/documentation to ensure proper execution and adherence to Procedures, Regulatory requirements, Safety, Quality Agreement requirements, and Pfizer Quality Standards (PQS) expectations.

Work cross-functionally with various business groups (i.e., Operations, Tech Ops, Automation, Compliance, Process Engineering, Investigators, etc.) on manufacturing events to identify root cause(s), aid in the completion of impact assessment, and identification of Corrective/Preventive Action (CAPA).

Aid in resolving manufacturing events, and provide opinion, guidance/path-forward. Consults with MQA Sr Associates and/or MQA Manager to align on decisions.

Support site regulatory inspections.

Facilitate internal & external meetings and provide training/presentations/updates/report-out to QA and Manufacturing colleagues on a regular basis.

Suggest Continuous Improvements (CI) initiatives to improve safety and processes and successfully utilize IMEX tools and the “one best way” philosophy.

Perform paper/electronic compound batch record review/disposition using computer software applications including, but not limited to: gLIMS, SAP, MES, AMPS, Batch Tracker.

Provide guidance/coaching to less experienced QA, Contingent Workers, and Manufacturing colleagues.

Assist with other MQA related tasks as needed.

Here Is What You Need (Minimum Requirements)

Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience

Fundamental knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs) used in the Pharmaceutical Industry. Knowledge of, and experience in a biopharmaceutical/pharmaceutical cGMP environment

Knowledge of electronic systems including Trackwise, PDOCs, SAP, gLIMS, AMPS, Microsoft Office.

Good judgment and correct decision making based on company procedures/standards, technical experience, and industry guidance / regulatory requirements

Strong critical thinking skills

Ability to work effectively within own team and interdepartmental teams

Proactive approach to problem-solving

Experience in the pharmaceutical industry and Quality administered systems

Sound knowledge of current Good Manufacturing Practices (part of GxP)

Effective written and oral communication skills

Bonus Points If You Have (Preferred Requirements)

Experience in quality administered systems

Strong organizational skills and attention to detail

Experience with regulatory compliance and documentation

Ability to mentor and review the work of other colleagues

Experience at a manufacturing site.

Experience in production batch record review, batch disposition, investigation of non-conformance, root cause analysis and change control management

Strong problem-solving skills

Ability to work independently and as part of a team

Excellent time management and multitasking abilities

PHYSICAL/MENTAL REQUIREMENTS

Role requires ability to gown into manufacturing areas, standing for several hours continuously.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Adhere to safe work practices and procedures such as aseptic gowning

Use Your Power for Purpose

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.

What You Will Achieve

The Manufacturing Quality Operations Associate provides Quality Assurance (QA) support to all modalities manufactured on site including clinical, commercial, and contract manufacturing operations providing QA Floor oversight. The role ensures adherence to regulatory expectations, safety, and GxP (i.e., Current Good Manufacturing and Documentation Practices). Duties include, but are not limited to, Aseptic Observations, Acceptable Quality Limit (AQL) testing, line clearance approvals, alarms evaluation, on the floor triage, and on the floor real-time batch record review. The Associate will work cross-functionally with MQA Sr. Associates, manufacturing, and support groups to investigate manufacturing events, and support site internal and external regulatory inspections. The role is based at the Pfizer Sanford, NC Pfizer Global Supply (PGS) site.

In this role, you will:

• The Manufacturing Quality Operations Associate support includes documentation review, facility walkthrough, support for activities such as review of in-process records, AQL, aseptic observations, compliance walkthroughs, smoke studies, media fills, alarms evaluation, Product Changeovers, etc.

• Assess manufacturing operations/documentation to ensure proper execution and adherence to Procedures, Regulatory requirements, Safety, Quality Agreement requirements, and Pfizer Quality Standards (PQS) expectations.

• Work cross-functionally with various business groups (i.e., Operations, Tech Ops, Automation, Compliance, Process Engineering, Investigators, etc.) on manufacturing events to identify root cause(s), aid in the completion of impact assessment, and identification of Corrective/Preventive Action (CAPA).

• Aid in resolving manufacturing events, and provide opinion, guidance/path-forward. Consults with MQA Sr Associates and/or MQA Manager to align on decisions.

• Support site regulatory inspections.

• Facilitate internal & external meetings and provide training/presentations/updates/report-out to QA and Manufacturing colleagues on a regular basis.

• Suggest Continuous Improvements (CI) initiatives to improve safety and processes and successfully utilize IMEX tools and the “one best way” philosophy.

• Perform paper/electronic compound batch record review/disposition using computer software applications including, but not limited to: gLIMS, SAP, MES, AMPS, Batch Tracker.

• Provide guidance/coaching to less experienced QA, Contingent Workers, and Manufacturing colleagues.

• Assist with other MQA related tasks as needed.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience

• Fundamental knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs) used in the Pharmaceutical Industry. Knowledge of, and experience in a biopharmaceutical/pharmaceutical cGMP environment

• Knowledge of electronic systems including Trackwise, PDOCs, SAP, gLIMS, AMPS, Microsoft Office.

• Good judgment and correct decision making based on company procedures/standards, technical experience, and industry guidance / regulatory requirements

• Strong critical thinking skills

• Ability to work effectively within own team and interdepartmental teams

• Proactive approach to problem-solving

• Experience in the pharmaceutical industry and Quality administered systems

• Sound knowledge of current Good Manufacturing Practices (part of GxP)

• Effective written and oral communication skills

Bonus Points If You Have (Preferred Requirements)

• Experience in quality administered systems

• Strong organizational skills and attention to detail

• Experience with regulatory compliance and documentation

• Ability to mentor and review the work of other colleagues

• Experience at a manufacturing site.

• Experience in production batch record review, batch disposition, investigation of non-conformance, root cause analysis and change control management

• Strong problem-solving skills

• Ability to work independently and as part of a team

• Excellent time management and multitasking abilities

PHYSICAL/MENTAL REQUIREMENTS

Role requires ability to gown into manufacturing areas, standing for several hours continuously.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Adhere to safe work practices and procedures such as aseptic gowning

Work Location Assignment:On Premise

The annual base salary for this position ranges from $66,500.00 to $110,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

Quality Assurance and Control#LI-PFE