Senior QA Associate

Use Your Power for Purpose

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you participate in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

The Senior QA Associate is part of the Pfizer Biotherapeutics Quality team based at the Pfizer Andover, MA site. This role is responsible for providing quality assurance support to GMP facilities and equipment for our Pharmaceutical Sciences clinical manufacturing and testing operations.

Primary Responsibilities include:

Provide quality oversight for the Pharmaceutical Sciences validation program at Andover, MA site including utility, manufacturing, laboratory, and computer systems.

Review/Approve documentation pertaining to equipment and computer system validation lifecycles, inclusive of maintenance, calibration, vendor assessment, data integrity assessments, requalification, decommissioning, etc. .

Additionally, support internal and external audits as required.

The Senior QA Associate will also be responsible for reviewing/approving standard operating procedures, change controls, investigations, and commitments.

Document review and material release in support of clinical manufacturing operations.

Guide, lead/co-lead projects, and manage time to meet objectives.

Contribute to Quality Assurance by enhancing internal processes through various continuous improvement initiatives locally or global project teams when required.

Evaluate operations and/or procedures for compliance with regulations, Quality Agreements, and Pfizer standards.

Ensure continuous inspection readiness.

Manage quality issues and CAPAs, making complex decisions when needed.

Participate in cGMP audits and support regulatory or corporate inspections.

Manage quality aspects of equipment and computer systems lifecycle from onboarding to decommissioning.

Communicate and influence across site and department boundaries for compliant adherence.

Network internally to maintain effective business relationships with colleagues.

Ability to make quality decisions to resolve issues when choosing between multiple options.

Here Is What You Need (Minimum Requirements)

Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience

Pharmaceutical manufacturing/Quality experience.

Audit and BoH inspection experience.

Current Good Manufacturing Practices experience with compliance issues resulting from cGMP deviations.

Initiative-taking approach and strong critical thinking skills

Ability to perform moderately complex tasks independently.

Strong collaboration, relationship management, and people skills.

Excellent written and verbal communication.

Advanced computer skills in MS Office applications and good knowledge of enterprise systems.

Bonus Points If You Have (Preferred Requirements)

Experience in Quality Systems in pharmaceutical, medical device, or combination product industry.

Mechanical or Chemical engineering background and/or validation experience is helpful.

Experience and understanding of data integrity (DI) and electronic records and electronic signatures (ERES) as it pertains to computerized systems and equipment is helpful.

Physical/Mental Requirements

Mental agility to handle a large quantity and broad scope of different types of quality assurance work.

Ability to independently problem solve and make recommendations for solutions.

Change agility is required based upon speed and frequency of change in priorities.

Role is primarily office-sitting, standing, walking, and bending. Walking outside regularly across Andover Pfizer campus is required.

Role includes leading and/or participating in Microsoft Teams meetings and frequent use of Microsoft applications.

Non-Standard Work Schedule, Travel or Environment Requirements

Role is a standard daytime 40-hour work week.

Adherence to Pfizer safety practices is a must.

Work Location Assignment: On Premise

The annual base salary for this position ranges from $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% 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

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