Senior QA Specialist I

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts 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.

How You Will Achieve It

• Ability to work in a fast-paced environment and be able and willing to juggle priorities as required.

• Review and approve laboratory and manufacturing incidents and investigations. Collaborate in development and implementation of CAPA .

• As needed, 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.

Qualifications

Must-Have

•  Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience 

• Experience in GMP Pharmaceutical or Medical Device Manufacturing environment or relevant regulatory experience (i.e. Board of Health) required.

Nice-to-Have

• 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.

PHYSICAL/MENTAL REQUIREMENTS

Must be able to be present at the Andover site routinely as required.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

The position is first shift Monday through Friday.  Some occasional off-hours (night/weekend/holiday) support may be required to support staff an