Quality Assurance Specialist II

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

• Provide Quality review of documentation to ensure compliance with global regulatory agencies and Pfizer quality standards.
• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Responsible for the review and approval of records related to site’s raw material program and supplier management program.
• Review and approve records to ensure that the information and documentation conforms to Pfizer policy and cGMP's.
• Create, review and approve deviations and consistently produce quality work.
• Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.
• Participate in Green/Black belt projects, Right First Time (RFT) Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.
• Suggest improvements and conduct continuous improvement activities.
• Lead/Participate in Quality Risk Management (QRM) assessments that gain approval through Site and Area Quality Operations (QO) Management.

Qualifications

Must-Have

• Bachelor's Degree with 2+ years of experience in GMP Pharmaceutical or Medical Device Manufacturing environment or relevant regulatory experience (i.e. Board of Health) required OR High School Diploma or Equivalent with 6 years of experience in GMP Pharmaceutical or Medical Device Manufacturing environment or relevant regulatory experience (i.e. Board of Health) required OR Master's Degree with 1+ years of experience in in GMP Pharmaceutical or Medical Device Manufacturing environment or relevant regulatory experience (i.e. Board of Health) required.

Nice-to-Have

• Field of study in Biology, Chemistry, Engineering, or related Technical Physical Science preferred.
• 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.

Physical/Mental Requirements

• 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:

• Last Day to Apply: 01 OCTOBER 2021
• Eligible for Relocation Assistance: NO

#LI-PFE  

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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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