Senior Associate, QA Validation

Why Patients Need You

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

This role is responsible for providing quality assurance support to GMP facilities and equipment for our Pharmaceutical Sciences manufacturing and testing operations based at the Pfizer Andover, MA Site.  This will include supporting utility, manufacturing (cell bank, drug substance and drug product), laboratory and related computer systems to enable the disposition of biologic clinical trial materials.  This role is responsible for the review of all documentation related to validation, maintenance, and calibration activities.  This role will also have responsibility to review procedures, change controls, Investigations, and commitments.

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 requires a moderate level of understanding of the regulations pertaining to facilities and equipment used in GMP manufacturing and testing.  Additionally, this role will require the candidate to multi-task and 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 or quality support of digital systems (e.g. manufacturing control systems, Enterprise Asset Management Systems [EAMS], investigation and change control systems) 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. 

Role Responsibilities

• Provide Quality Assurance support for the Pharmaceutical Sciences validation program at the Andover, MA Pfizer site including utility, manufacturing, laboratory, and computer systems.
• Role includes validation documentation review and approval including specifications, protocols, testing documents, vendor assessments, summary reports, data integrity assessments as well as any supporting documentation associated with maintaining validated state.
• Provide QA support to the Pharmaceutical Sciences requalification program for all equipment and instrumentation used in Pharmaceutical Sciences cell bank, drug substance, and drug product manufacturing facilities as well as analytical and microbiological laboratories at the Andover Site.
• Review and approve change controls, investigations, commitments, and procedures.
• Provide quality support to the calibration of equipment including review of Out-Of-Tolerances.
• Participate in the onboarding of new equipment, instruments, and systems.
• Support and understand Data Integrity principles (ALCOA) as well as Electronic Record and Electronic Signatures (ERES) in support of our digital systems.
• Provide QA support to the Electronic Asset Management System (EAMS) including Work Order approval, as needed.
• Represents Quality Assurance by sitting on or providing validation-related support to local or global project teams when required.
• Provide quality support to process validation activities, as needed.
• Provide quality support to qualifying service providers (e.g. validation, calibration, maintenance), as needed.
• Support the site relative to a constant state of inspection readiness.  Participate in audits relative to this role, as needed.
• 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.
• Ability to make quality decisions to resolve moderately complex issues with minimal assistance from management.  Able to recognize when an issue is beyond their sphere of influence and escalates immediately. 
• Able to seek out and assess internal and external compliance with applicable regulations.
• Ability to present to peers/management locally and virtually inclusive of communicating with other Pfizer Sites.
• 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.
• Contributes to quality assurance management team initiatives and objectives.

Qualifications

Must-Have

• 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.

Nice-to-Have

• Biopharma industry experience, including a good understanding of Aseptic drug product manufacturing and testing preferred.
• Science, Engineering, or Technical field of study preferred.
• Mechanical or Chemical Engineering background is helpful.
• Understanding of FDA and international regulatory requirements as related to GMP facilities and equipment is desirable.
• Experience in biotherapeutic GMP manufacturing and/or laboratory operations or related engineering discipline 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. 
• 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

#LI-PFE

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 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.

Quality Assurance and Control

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