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Qa Investigation Reviewer Jobs

Company

Pfizer
Address , Sanford, Nc
Employment type FULL_TIME
Salary
Expires 2023-07-18
Posted at 1 year ago
Job Description
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and 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 Pfizer Sanford, NC site is a complex multi-product, multi-host biotech manufacturing site that manufactures clinical and commercial Vaccine and Gene Therapy products.This position will support the Pfizer Sanford Quality Assurance department by performing Quality activities associated with Gene Therapy manufacturing operations.
You will be primarily responsible for performing the following Quality Assurance (QA) responsibilities: investigation review and approval and Corrective Action/Preventative Action (CAPA) approval. Additional responsibilities may include: batch disposition, manufacturing floor support including aseptic observations, change control approval, product and material release, complaints handling, Biological Product Deviation Reports (BPDR) issuance, Annual Product Record Reviews (APRR), and standard operating procedure and manufacturing batch record approval.
As a QA Investigation Reviewer, your knowledge and skills will contribute towards the goals and objectives of the team. Strong communication skills are required to facilitate explaining difficult issues and achieving consensus between teams.
The individual should be able to demonstrate the following:
  • Ability to follow written procedures and learn from hands-on training
  • Demonstrate knowledge of and adherence to EH&S safety requirements for site
  • Participates in activities/projects to support work group/project team goals
  • Organizes and provides written and/or oral presentations of work with minimal input
  • Ability to organize and track status of assigned actions across multiple production areas
  • Excellent written and verbal communication and interpersonal skills
  • Good foundation in general scientific practice and principles
  • Display knowledge in cGXP, manufacturing operations, batch disposition, and Aseptic principles and concepts
  • Approve SOPs, forms, protocols, investigations, change controls, and risk assessments (facilitator and/or team member).
How You Will Achieve It
  • Interface with other parts of the organization such as Global Quality Operations groups and Pfizer Research and Development groups.
  • Suggest improvements and conduct continuous improvement activities.
  • Act as a primary point of contact for the QA organization for investigation support and review
  • Act as SME for department to support site audits/inspections.
  • Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
  • Maintain regulatory compliance in accordance with current Good Manufacturing Practices {part of GxP} practices.
  • Provide Quality support on the shop floor by providing aseptic observations for drug product related processes (i.e. review in-process records, observe media fills, aseptic observation, airflow visualization review etc.).
  • Demonstrate good decision-making skills
  • Provide Quality Review and oversight of site cGXP documentation related to the operation of a gene therapy manufacturing facility to ensure compliance with global regulatory agencies and Pfizer Quality Standards.
  • Provide manufacturing floor support that may include weekends and first, and/or third shift hours on occasion. Assess the operations executed for adherence to regulatory requirements, Quality Agreement requirements and Pfizer expectations.
  • Demonstrate strong knowledge/understanding of the principles and concepts of aseptic technique and manufacturing operations.
  • Review and approve investigation and CAPA records to assure compliance with regulatory standards and regulatory filing.
Qualifications
Must-Have
  • HS or GED with 10 years of relevant experience in investigation or reviewing manufacturing and laboratory investigations roles in Pharma industry or;
  • Bachelor’s degree in Science with at least 5 years of experience in investigation or reviewing manufacturing and laboratory investigations roles in Pharma industry or;
  • Associate's degree in Science with 8 years of experience in investigation or reviewing manufacturing and laboratory investigations roles in Pharma industry or;
  • Experience in Quality platforms (e.g LIMS, QTS, eQMS, SAP, DMS)
  • Ph.D. with 0-2 years of experience in investigation or reviewing manufacturing and laboratory investigations roles in Pharma industry .
  • Master’s degree in Science with 3+ years of experience in investigation or reviewing manufacturing and laboratory investigations roles in Pharma industry or;
  • Must be able to work in a team environment within own team and interdepartmental teams
  • Proactive approach and strong critical thinking skills
  • Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
  • Excellent communication, decision-making and interpersonal skills
  • Good working knowledge of Microsoft Excel and Word
Nice-to-Have
  • Willing to lead by example and be a collaborative and active listener.
  • Previous experience with a startup facility and developing Quality Operations processes is beneficial.
  • Preferred experience with aseptic practices.
  • Experience with Drug Substance and Drug Product clinical/commercial manufacturing preferred.
  • Effectively manages stressful situations, able to focus on tasks
Physical or Mental Requirements
  • Requires working on shop floor and in an office setting.
  • Computer usage would be typical. Ability to stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, aseptically gown into manufacturing areas, and walk long distances.
Non-Standard Work Schedule, Travel or Environment Requirements
  • Work schedule is primarily first shift during weekdays but may include occasional weekend support and second, and/or third shift hours to support manufacturing operations activities.
  • Job requires majority on-site presence.
  • Limited travel for the position; no more than 5% traveling.
  • Ability to adhere to safe work practices and procedures such as aseptic gowning.
Other job details
  • Employee Referral Bonus eligible
  • Last day to apply: June 1st, 2023
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
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