Senior Associate QA
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 are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.Role Summary
The Senior Associate QA is part of the Pfizer Global Biotherapeutics Quality Organization and will partner closely with quality, manufacturing and laboratory lines. On-site support is required for this role.
This role is responsible for providing QA support to GMP drug product manufacturing and testing operations to enable the disposition of biologic clinical trial materials. This will include the review of batch records (master and executed), investigations (manufacturing and lab), change controls, CAPAs, SOPs, test methods, laboratory data, and other GMP documentation to ensure compliance with procedures and global board of Health regulations. Candidate will also participate in the QA observation of our drug product medial fill program. Candidate will also support the release of raw materials utilized, minimally, in drug product manufacturing.
This role requires a moderate level of understanding of the regulations pertaining to GMP manufacturing and testing. Additionally, this role will require the candidate to independently manage their work while delivering and positively interacting with our customers. On top of current experience, the candidate shall possess the capabilities to learn and expand their knowledge moving forward. Experience in the use of digital systems (e.g. document, inventory, laboratory, investigation, electronic batch records) is helpful. Experience with sterile drug product regulations is preferred.
- Review and approve GMP documents such as batch records (master and executed), investigations (manufacturing and lab), change controls, CAPAs, SOPs, test methods, laboratory data to ensure compliance with global board of Health regulations.
- Perform disposition of clinical drug product and related materials from the Andover Liquid Dose Manufacturing Facility (AN-LDM).
- Participate in the QA observation of our drug product medial fill program.
- Participate in the release of raw materials utilized in manufacturing as needed.
- Support the site relative to a constant state of inspection readiness. Participate in audits relative to this role as needed.
- Ability to resolve moderately complex issues and escalate appropriately.
- Ability to present to peers/management locally and virtually inclusive of communicating with other Pfizer Sites.
- May participate in quality risk management activities.
- May lead or participate on special projects, limited duration teams, and local or global initiatives such as continuous improvement teams for Quality Assurance.
- Able to seek out and assess internal and external compliance with applicable regulations.
- As a Pfizer colleague, responsible for knowing, understanding and acting in accordance with Pfizer’s values.
- The successful candidate will possess strong interpersonal, teamwork, and collaboration skills.
- Contribute to quality assurance management team initiatives and objectives.
- Bachelor's Degree required.
- 5+ years of relevant experience within a GMP environment required.
- Team player with strong interpersonal, organizational, and communications skills are a must.
- Candidate must be self-motivated, engaged and able to perform moderately complex tasks independently.
- Biopharma industry experience, including a good understanding of FDA and international regulatory requirements for Aseptic drug product manufacturing and testing preferred.
- A microbiological background is desirable.
- Science, Engineering, or Technical field of study preferred.
- Mental agility to multi-task a broad scope of different types of quality assurance work.
- Ability to independently problem solve and make recommendations for solutions.
- Role is primarily office setting. Traveling outside between buildings on Andover Pfizer campus is required.
- Role includes leading and/or participating in WebEx meetings and frequent use of Microsoft Applications (e.g. MS Teams).
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.
- It is not anticipated that this role will require business travel but it would be minimal if needed.
Other Job Details:
- Eligible for Relocation Assistance: NO
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer 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 EligibilityPfizer 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.Quality Assurance and Control#LI-PFE