• Job Description

  Req#: 4892549

  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 be responsible for evaluation, review and approval of validation master plan, protocols and reports. Your methodological approach will help us ensure compliance of our quality systems with company standards and government regulatory requirements.

  Yourproblem-solving ability will help us troubleshoot validation problems for equipment and performance processes and conduct statistical analysis of testing results and process anomalies. Your documentation skills will guide the writing, review and approval of for validation process documents and technical reports related to equipment, products and processes.

  As a Senior Associate, 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 facilitate in explaining difficult issues and establishing consensus between teams.

  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 Quality Assurance Validation Specialist III will join the Quality Assurance Validation group to support validation projects and oversight of the site validation program for the Quality Unit at the Andover, MA site. This group ensures the validated state of equipment, instruments, and systems supporting manufacturing of biotherapeutic drug substance is compliant with corporate policies and regulatory requirements. Documentation review includes validation protocols, test plans, change controls, summary reports, and project plans, along with a multitude of supporting documentation associated with maintenance of the validated state. Review and approval of investigations, commitments, SOPs, and maintenance work orders will also be performed.

  • Serve as Quality Assurance oversight for the validation program at the Andover, MA Pfizer site.
  • Primary focus on validation documentation review and approval including specifications, protocols, other testing documents, summary reports, higher level validation plans, program documentation and strategies.
  • Review and approval of change controls including assessment for validation impact and identification of appropriate testing to ensure maintenance of the validated state.
  • Provide support to project teams on compliance and technical issues related to validation to ensure compliance with company policies and government regulations.
  • Review and approve investigations, commitments, and procedures, and maintenance work orders as they relate to validation.
  • Exercises judgement in resolving simple to moderate quality validation issues.
  • Participate in continuous improvement initiatives.
  • Maintain a constant state is inspection readiness.
  • Skilled in the use of Enterprise systems including, but not limited to Quality Tracking System (QTS), Pfizer Document Repositories, Pfizer Equipment Maintenance System

  Qualifications

  Must Have

  • Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an associates degree with 6 years of experience OR a bachelors with at least 3 years of experience OR Masters with more than 1 year of experience.
  • Excellent attention to detail and working knowledge of Food and Drug Administration Regulations/Guidance, and Good Manufacturing Practices
  • Excellent organizational skills, and ability to handle changing deadlines
  • Strong communication with written and verbal skills
  • Working knowledge of Microsoft Office, especially Excel for evaluation of data

  Nice to Have

  • Proven relevant industry experience in either Quality Assurance or Validation engineering.
  • Combined experience in Quality Assurance or Validation Engineering / Engineering / Manufacturing / Laboratories preferred.
  • Knowledge of GMP regulations/guidance’s (21 CFR Parts 11, 210 & 211; EC Annex 15; ICH 7) as they pertain to the pharmaceutical / biopharmaceutical industry is preferred.

  PHYSICAL/MENTAL REQUIREMENTS

  • Detail oriented
  • Excellent communication skills, both oral and written
  • Excellent organizational skills
  • The candidate must be able to collaborate effectively with multidisciplinary project teams.
  • The candidate must be able to handle a diverse and dynamic workload.
  • Requires limited supervision for routine assignments and recognizes when management involvement is necessary.
  • Strong problem-solving skills.

  NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Typically, a standard 1st shift, Monday through Friday work schedule, office setting, little to no travel required.
  • Minimal off shift support needed if issues arise.

  
  Work Location Assignment: Flexible

  OTHER JOB DETAILS

  • Last Date to Apply for Job: September 4, 2023
  • Referral Bonus Eligibility: YES
  • Eligible for Relocation Package: NO

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

  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

  #LI-PFE

• About the company

  At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer.

Notice