Sr. QA Associate – Validation

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

As a Sr. QA Associate – Validation, the successful candidate will play an integral part in the QA oversight of Validation and Qualification activities conducted within the Pfizer Groton, CT site as well as provide remote support for our RCMF operation in Ringaskiddy Ireland. 
This Operations Quality role within the Pharmaceutical Sciences Operations Quality (PSOQ) organization will offer the opportunity to collaborate with key business lines across the Pharmaceutical Sciences Small Molecule (PSSM) network in support of new technology and small molecule therapies.
 

In this role, you will:

• Provide validation and qualification guidance to customers for equipment and computerized systems related to solid dosage manufacturing, API manufacturing, laboratory instrumentation and related utilities (e.g., water, nitrogen, etc.).
• Review and approval of validation system life cycle documents including Validation Plans, IQ/OQ/PQ, vendor assessments, design documents, reports, procedures and periodic reviews.  
• Support projects and contribute to validation strategy.
• Participate and support quality investigations including root cause analysis, Pfizer Human Performance assessments, and approval of investigation reports.
• Review and approve change controls, quality investigations, and corrective/preventive actions.
• Participate in the development of procedures which increase efficiency while maintaining high quality standards
• Provide support to internal audits (e.g. RQA) & regulatory inspections (e.g. FDA, HPRA) as needed.
•  Support special projects, teams and global initiatives.

• Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree in chemistry, Engineering, Biology, or other relevant STEM field is required, or equivalent relevant experience 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
• Awareness of U.S. current Good Manufacturing Practices (GMP) and EU GMPs with respect to manufacturing and testing requirements for clinical supplies used in phase 1 through 4 clinical trials as demonstrated by work experience
• Strong critical thinking skills
• Ability to work effectively within own team and interdepartmental teams
• Proactive approach to problem-solving

Bonus Points If You Have (Preferred Requirements)

• Knowledge of cGMP’s related to equipment and computer system validation/qualification.
• Knowledgeable of PharmSci GMP business line functions.
• Experience in quality investigation techniques
• Experience with Quality Risk Management (QRM)
• Previous quality assurance experience is preferred
• Hands-on knowledge of systems such as GDMS, eQMS, QTS, and EAMS.
• Experience with advanced data analytics/visualizations (e.g., Spotfire, Tableau, MS Power Business Intelligence)

  
 

PHYSICAL/MENTAL REQUIREMENTS

Not applicable.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

This position may require infrequent travel to Pharm Sci sites in the PSSM network

Work Location Assignment: Hybrid

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.