Sr. QA Associate Validation

Pfizer • Groton, CT

305d • $80,300 - $133,900

About The Position

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.

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.

Nice To Haves

• 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).

Responsibilities

• 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.

Benefits

• 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.
• Health benefits to include medical, prescription drug, dental and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree