QA Senior Specialist

Employer
Pfizer
Location
Andover, Massachusetts
Posted
Oct 07, 2021
Ref
4821851
Required Education
Bachelors Degree
Position Type
Full time
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 QC support activities (method transfers, protocols, reports, lab investigations, change controls. other activities as needed) for both Drug Product and Drug Substance. You may also be involved in Quality Agreements as needed. Your expertise will help in identifying deviations from established standards, in the testing of drug product and drug substance support. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

It is your problem solving skills that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
  • Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the Department.
  • Lead and drive continuous improvement activities.
  • Support the development of country quality strategic initiatives based on risk and business needs, in close collaboration with key stakeholders.
  • Lead continuous inspection readiness for Quality Assurance.
  • Drive effective management of quality issues and Corrective Action Plan (CAPAs) and make decisions that may involve complex quality and technical issues.
  • Ensure appropriate networking and sharing of best practices with Corporate Compliance colleagues and with other compliance functions in other Pfizer affiliates or in the market.
  • Participate in internal Good Manufacturing Practices (cGMP) audits and support regulatory inspections or corporate audit activities.
  • Communicate with and influence internal and external customers across site and department boundaries to ensure compliant and aligned resolution of project related issues and investigations.
  • Ensure appropriate internal networking to develop and maintain close and effective business partner relationship with internal colleagues.

Qualifications

Must-Have
  • Bachelor's Degree required
  • 10+ years of relevant experience required
  • Pharmaceutical manufacturing/Quality experience
  • Current Good Manufacturing Practices experience with compliance issues resulting from cGMP deviations or product defects, regulations as related to vendor management programs and other industry quality systems and processes
  • Proactive approach and strong critical thinking skills
  • Strong collaboration, relationship management, and interpersonal skills
  • Excellent written and verbal communication
  • Advanced computer skills in MS Office applications and good knowledge of enterprise systems, such as PDM, Quality Tracking System Trackwise, Documentum platforms

Nice-to-Have

  • Biology, Chemistry, Engineering, or related Technical Physical Science field of study preferred
  • Master's degree
  • Experience in Quality Systems in pharmaceutical, medical device, or combination product industry

Other Job Details:

  • Eligible for Relocation Assistance: YES

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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