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QA Manager, Environmental Control and Aseptic Compliance

Company: Pfizer
Location: Sanford
Posted on: May 3, 2021

Job Description:


This role will be the Manager QA, Environmental Control and Aseptic Compliance in Sanford, NC.

This Individual Contributor position will support the Microbial Control group and will be responsible for Environmental Control and Aseptic Compliance activities associated with the manufacturing operations in Sanford Vaccines and Gene Therapy programs. Major responsibilities will include design and execution of the contamination control strategy, media fill program strategy, airflow visualization support and review, aseptic behavior program and training support.


The position will also be responsible for the following: PQS Adherence Oversight, understanding/applying emerging regulatory expectations, drafting responses for corporate/external inspections (e.g. MSQA, BOH inspections), planning and executing highly complex projects, conducting continuous improvement activities, interfacing with and representing the Sanford site in cross-departmental/cross-site/cross-network/cross-organization meetings/summits, and providing aseptic practice guidance/coaching.

Additional key responsibilities will be Quality Assurance approver of SOPs, protocols, investigations, risk assessments (facilitator and/or team member), etc. ensuring compliance with all current site, corporate and regulatory requirements.

Responsible for knowing, understanding and acting in accordance with Pfizer's values

System owner for the Pfizer Sanford Aseptic Behavior program (including scheduling, conducting observations, ensuring adherence to aseptic behavior expectations, metrics creation and tracking/reporting status; developing and driving continuous improvement).

System owner for the Pfizer Sanford Media Fill Program; validation master planning; defining worst-case conditions; intervention risk assessments.

System owner for the Pfizer Sanford Disinfectant Efficacy program; defining worst-case conditions, disinfectant selection, organism and surface evaluations

Providing regulatory surveillance for emerging regulatory requirements and providing oversight to ensure the area remains in compliance with site procedures, global regulatory agency requirements and Pfizer Quality Standards.

Facilitates/completes PQS assessments and leads gap remediations as needed.

Facilitates compliance gap assessments (RONA) and leads gap remediations as needed.

Coordinates and provides any Aseptic Behavior data for the Site Quality Review Team (SQRT) meetings.

Responsible for Aseptic Behavior/Practices education (defines training requirements, metrics, tracks and reports site status); provides guidance/coaching; curriculum development.

Assessing existing situations and suggesting improvements in the Quality Systems to increase compliance throughout the facility/laboratory. Plans and leads highly complex projects to ensure their timely completion.

Interfaces with other parts of the organization such as Global Compliance Division, Global Quality Operations groups, Regulatory Affairs, and Pfizer Research and development groups.


* 8 years minimum of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field is required, OR * 5 years minimum of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field is required, OR * Ph. D in Science/related field is required, prior manufacturing, quality or engineering experience in the biotech or pharmaceutical industry is preferred.


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.


Limited travel for the position; no more than 15% traveling.

Other Job Details:

* Last Date to Apply for Job: 5/10/2021 * Eligible for Relocation Package * 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


Keywords: Pfizer, Sanford , QA Manager, Environmental Control and Aseptic Compliance, Other , Sanford, Florida

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