QA Investigation Reviewer Lead

Employer
Pfizer
Location
Sanford, North Carolina
Posted
Sep 27, 2021
Ref
4825195
Required Education
Bachelors Degree
Position Type
Full time

ROLE SUMMARY

Provides QA leadership and oversight for GTx investigations. Performs investigation review and participates on teams investigating manufacturing or laboratory deviations.  Supports determination of product impact, identification of root cause and appropriate CAPA.  Ensures  investigation results and conclusions are documented, consistent and supported by data. Provides training and mentoring for other colleagues. Provides leadership for metric review and program improvements. Perform all duties in compliance with site and corporate cGMP, safety, environmental and human resource policies and procedures.

ROLE RESPONSIBILITIES

Review and approve investigations by performing the following:

  • Review supporting documentation including batch documentation, testing results, training records, calibration records, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents in support of the investigation
  • Interact and coordinate with appropriate personnel including manufacturing, clinical, QA/QC, regulatory, technical services, etc.
  • Communicate immediately with Quality management for all GMP deviations that impact product.
  • Support lead investigator to identify root causes of the GMP deviation by participating in Method 1s
  • Support identification of proposed CAPAs
  • Assess the impact of deviations on products or processes and recommend product disposition.
  • Ensure clear and concise summaries of investigations, product impact assessments, and commitments
  • Ensure that all procedurally defined timelines are followed.

Ensures timely completion of investigation commitments.  This includes verification that all drafting and revision of change controls, standard operating procedures, testing specifications, batch documentation, training documentation, validation/technical documentation, work orders, purchase orders, and others meet the intent of the CAPAs.

Maintains regulatory compliance by initiating investigations as needed and ensuring that all colleagues document all deviations and resulting changes, whether process, equipment, or procedural, per regulatory and company policies.

BASIC QUALIFICATIONS

  • Minimum 8 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
  • Minimum 5 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field
  • 0-1 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a PhD in Science/related field
  • Some expertise in performing or reviewing Investigations (ER/QAR, LIRs, Complaints and/or EHS) required.

PREFERRED QUALIFICATIONS

Experience with relevant QTS modules and QRM practitioner preferred.

  
PHYSICAL/MENTAL REQUIREMENTS

Ability to stand for 1 hour at a time, sit for 2 to 3 hours at a time. Require working in an office setting where sitting and computer usage would be typical. 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Limited travel for the position; no more than 10% traveling.

Other Job Details:

  • Last Date to Apply for Job: 10/12/21
  • Relocation support available

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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