Senior QA Specialist I

Pfizer • Andover, MA

10d • $99,200 - $165,400 • Hybrid

About The Position

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. What You Will Achieve You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s commercial batches of drugs. You will ensure that product and process match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards in the manufacturing and packaging of products. As a QA Specialist III, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will make complex issues easier to understand and build stronger alignment between teams. It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

Requirements

• Applicant must have a high school diploma with at least 10 years experience, or an Associate’s degree with at least 8 years experience or a Bachelor’s degree required and at least 4 years of experience or a Master’s degree with at least 2 years experience, PhD with 0+ years of experience in GMP Pharmaceutical or Medical Device Manufacturing environment or relevant regulatory experience (i.e. Board of Health) required.
• Must be able to be present at the Andover site routinely as required.
• This position requires permanent work authorization in the United States.

Nice To Haves

• Biology, Chemistry, Engineering, or related Technical Physical Science field of study preferred.
• Previous experience in QA strongly preferred.
• Previous experience in Manufacturing and/or QC preferred.
• Skilled at the use of Enterprise systems including, but not limited to: Site Quality management System (QMS), Laboratory Information Management System (LIMS), SAP and Pfizer document repositories.
• Experience with quality aspects of start-up of a manufacturing facility is helpful but not required.

Responsibilities

• Review and approve laboratory and manufacturing incidents and investigations.
• Collaborate in development and implementation of CAPA.
• Provide Quality Review and oversight of site cGXP documentation related to the support of manufacturing and Site/Engineering activities to ensure compliance with global regulatory agencies and Pfizer quality standards.
• Collaborate/independently engage with a wide range of co-workers, customers and management within PGS to gather the input and background knowledge needed to complete assignments.
• Anticipate issues and escalate to appropriate management attention immediately.
• Provide ongoing Site-based Ops support activities, on teams, in forums & support to site customers.
• Exercises judgment in resolving moderate to complex quality issues.
• Plans and executes work independently and consult with supervisor as needed, providing a recommendation for a solution.
• Know and apply technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.

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
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior