QA Sr. Associate, Investigation Reviewer

Employer
Pfizer
Location
Sanford, North Carolina, United States
Posted
Oct 15, 2020
Ref
4794156
Required Education
Associate 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 Pfizer's clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

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

How You Will Achieve It
  • Review and approve QARs by performing the following as appropriate to the discrepancy:
  • Review supporting documentation including batch documentation testing results, training records, calibration records, level I and II policies, 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 discrepancies that impact product.
  • Support lead investigator to identify root causes of the GMP discrepancy by participating in M1s
  • Support proposed CAPAs to identified problems.
  • Assess the impact of discrepancies on products or processes and recommend product disposition.
  • Ensure clear and concise summaries of investigations, product impact assessments, and commitments
  • Participate in cross-functional team reviews to resolve Investigation issues.
  • Ensure that all SOP mandated timelines are followed.


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

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


Qualifications

Must-Have

3-5 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field

0 -3years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field

Some expertise in performing or reviewing different types of Investigations (ER/QAR, LIRs, Complaints and EHS) required.

PREFERRED QUALIFICATIONS

Experience with relevant QTS modules and QRM practitioner preferred.

Experience with RAAC/LIRs is preferred.

Experience in performing M1s

  • Last Date to Apply for Job: 29 October, 2020
  • Eligible for Employee Referral Bonus


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