Pfizer QA Specialist II in Andover, Massachusetts
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 clinical and commercial batches of drugs. You will make sure that product and process documents 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. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It The QA Specialist II demonstrates increasing knowledge of cGMPs and quality processes and procedures as well as a knowledge of scientific principles associated with activities supported by the quality role. This role supports Operations including batch record, investigation, and document review, and disposition activities. Resolve routine quality issues related to product manufacture and testing under limited guidance/coaching. Project work, as needed, will also be expected.
Provides ongoing site-based Ops support for both start up and ongoing product manufacturing.
Competently reviews batch record with increased complexity and associated simple deviations and simple analytical investigations. (Cal OOTs, RAAC, CIS and Events)
Able to resolve less challenging quality issues and independently make simple batch disposition decisions under limited guidance/coaching.
Able to review and approve documents in PDOCS with quality mindset.
Uses established QA procedures and methodologies to propose solutions for straight forward problems under limited guidance/coaching
Makes decisions that require knowledge of quality systems.
Represents QA on various Teams with direction from management.
Reviews and approves change controls for appropriateness, completeness and alignment with quality, validation and regulatory expectations.
Exercises judgment in resolving simple quality issues.
Able to review executed batch documentation for technical content within own subject area and reference to applicable GMPs and regulatory expectations, make value-added comments.
Manages own workload with minimum oversight by manager/peer.
Represents their quality records with Board of Health inspectors, with support of management, as needed.
Maintains inspection readiness and supports internal/external audits as needed.
- Bachelor's Degree in Biology, Chemistry, Engineering, or related Technical Physical Science with 2+ years of experience in GMP Pharmaceutical Manufacturing Environment required OR High School Diploma or Equivalent with 6 years of experience in GMP Pharmaceutical Manufacturing Environment required OR Master's Degree in Biology, Chemistry, Engineering, or related Technical Physical Science with 1+ years of experience in GMP Pharmaceutical Manufacturing Environment required.
Experience in writing and managing deviations.
Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management.
- Ability to gown into cGMP Manufacturing areas and adhere to governing gowning procedures as appropriate.
Non-Standard Work Schedule, Travel, or Environment Requirements
Position is first shift Monday through Friday. Some occasional off hour (night/weekend/holiday) support may be required to support staff and operations.
Other Job Details:
Eligible for Relocation Assistance: NO
Eligible for Employee Referral Bonus: YES
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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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