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Pfizer Quality Systems Specialist 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

The Quality Systems Specialist will join the Quality Systems (QS) team to support site change controls associated with validated manufacturing processes and methods to support manufacturing of biotherapeutic drug substance at the Pfizer Global Supply (PGS) site in Andover, MA. This role is responsible for independently managing the interdependencies between the site change control process and regulatory change management system. Also, as a member of Quality Systems, the candidate will be responsible for providing support to maintenance of the site change control program as well as other quality systems to ensure the site quality systems are maintained in a compliant state.

Role Responsibilities

  • Review and approve site change control records including performing regulatory impact assessments to applicable change records

  • Manage the interdependencies between site change management process and regulatory change management system by working directly with regulatory department to complete regulatory assessments for site change records, create regulatory change management records, and monitor Board of Health approvals to ensure site change records are current

  • Provide support to project teams on change control strategy and related compliance issues to ensure compliance with company policies and government regulations

  • Support front line decision making for site change records and regulatory change management

  • Author the change control chapter for the US Annual Product Quality Reports for commercial products manufactured at the Andover site

  • Provide support to the ownership and maintenance of the site change control program

  • Review and approve investigations, commitments and procedures as they relate to quality systems

  • Participate in continuous improvement initiatives both at site and network level

  • Provide support to both internal and external site inspections

  • Provide customer support to change control end users

  • Partner with other Pfizer sites to determine interdependencies as they regard to change control

Qualifications

Must-Have

  • Bachelor's Degree in science discipline or other relevant field with 4+ years of relevant experience in a regulated GMP environment OR MS in science discipline or other relevant field with 2+ years of experience in a regulated GMP environment

  • Proficient QA/QS compliance as it relates to biopharmaceutical manufacturing

  • Knowledge of GMP regulations/guidances (21 CFR Parts 11, 210 &211; EC Annex 15; ICH 7) as they pertain to the pharmaceutical/biopharmaceutical industry

  • A team player with excellent interpersonal, organizational, and communications skills (verbal and written)

  • Must be able to handle a diverse and dynamic workload

  • Must be self-motivated, engaged and able to perform moderately complex tasks independently

  • Requires no supervision for routine assignments and recognizes when management involvement is necessary

  • Strong problem-solving skills

Nice-to-Have

  • A broad understanding of Biopharmaceutical Sciences processes and Quality Systems

  • Knowledge of DMAIC process, lean principles and quality risk management

  • Knowledge of regulatory change management including common board of health reportability requirements

  • Knowledge of validation lifecycle and how it correlates to change control

  • Experience with TrackWise, Documentum systems

PHYSICAL/MENTAL REQUIREMENTS

This position will spend significant time in an office type setting as well as attending cross functional meetings.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Typically, a standard Monday through Friday work schedule, primarily work from home during current pandemic with potential to transition to office setting, little to no travel required

Additional Job Details:

  • Last Date to Apply for Job: 23 JUNE 2021

  • Eligible for Relocation Assistance: NO

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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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