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Pfizer QA Specialist III 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 support the QA activities related to Pfizer's Drug Substance manufacturing. You will ensure all activities are supported in a compliant manner. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

Yourknowledge 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 focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Independently support simple to moderate investigations in cross-functional work areas, providing sound quality assurance judgment to ensure product quality.

  • Review of executed Manufacturing Batch Records(MBRs)

  • Supports investigations and seeks guidance from management or senior members of the team as required.

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

  • Reviews and approves MBRs, protocols and reports, and authors, reviews and approves SOPs as appropriate (as required for support when necessary).

  • Provide Quality Review and oversight of site GMP documentation related to the support of Drug Substance Manufacturing 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 (and external sites/CMOs as necessary) to gather the input and background knowledge needed to complete assignments.

  • Anticipate issues and escalate to appropriate management attention immediately.

Qualifications

Must-Have

  • Bachelor's Degree required.

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

  • Experience in Quality administered systems

  • Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards

  • Proactive approach and strong critical thinking skills

  • Must be able to work in a team environment within own team and interdepartmental teams

  • Excellent communication and interpersonal skills

  • Good working knowledge of Microsoft Excel and Word

Nice-to-Have

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

  • Previous experience in QA strongly preferred.

  • Previous experience in QC, Manufacturing and/or Engineering preferred.

  • Skilled at the use of Enterprise systems including, but not limited to site Quality Tracking System (QTS), 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.

  • Must be able to support QA on the floor in the manufacturing area.

Work Location Assignment:Hybrid

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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