Sr. QA Validation Associate, Gene Therapy

Employer
Pfizer
Location
Sanford, North Carolina
Posted
Jul 30, 2021
Ref
4819101
Required Education
Bachelors 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.

Initially this position will involve project support for the Gene Therapy Facility, Pfizer Sanford, NC Quality Operations department by performing Quality Assurance activities associated with the verification/validation of the facility and ensuring cGMP readiness. Once the facility has been handed over to the site, the role will transition to a Quality Verification/Validation role.

How You Will Achieve It
  • Provide Quality oversight and approval of verification/validation documentation as defined within the Project Verification Plan, including working with the other Quality Team members on ensuring the facility is cGMP ready during the Project Phase.

    Perform Quality Assurance activities associated with ensuring the facility is cGMP ready and operational. This includes review and approval of all Process, Cleaning, Equipment, Automation and Facilities documentation.
  • Responsible for knowing, understanding and acting in accordance with cGXPs and Pfizer’s values
  • Provide Quality Review/Oversight of cGXP documentation related to the operation of a Gene Therapy manufacturing facility/laboratory to ensure compliance with global regulatory agencies and Pfizer quality standards. 
  • Responsible for final authorization/approval/release of documentation/equipment/processes.
  • Assess existing situations and suggesting improvements in the Quality Systems to increase compliance throughout the facility.
  • Plans and leads projects to ensure their timely completion.
  • Organizes and provides written and/or oral presentations of work with minimal input. 
  • Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
  • Comprehensive understanding of {Current} Good Manufacturing Practices {part of GxP} guidelines outlined in Code of Federal Regulations.
  • Ensure compliance with latest Pfizer Quality Standards for validation and qualification activities.

Qualifications

Must-Have
  • Bachelor's Degree with 3+ years' experience.
  • 3-5 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field. Ideal candidate will have experience with validation, qualification and/or verification. Automation experience is desirable.
  • 2-5 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field. Ideal candidate will have experience with validation, qualification and/or verification. Automation experience is desirable.
  • Ability to stand for 1 hour at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets.Typical working schedule is Monday-Friday 8am-5pm. Limited travel for the position; no more than 15%. It may be necessary to work in areas that require aseptic gowning.
  • Strong verbal and written communication skills
  • Ability to work in a team environment and manage projects independently

Nice-to-Have
  • Master's degree
  • Relevant pharmaceutical experience.
  • Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems is required, as related to sterile products and medical devices

  

PHYSICAL/MENTAL REQUIREMENTS

Ability to stand for 1 hour at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Typical working schedule is Monday-Friday 8am-5pm. Limited travel for the position; no more than 15%. It may be necessary to work in areas that require aseptic gowning.

  • Last Date to Apply for Job: August 8, 2021
  • Referral Bonus Eligible
  • Relocation Support Available

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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