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You will be updated with latest job alerts via emailUse Your Power for Purpose
Every day Pfizers unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative always putting the patient first. Whether you are involved in development maintenance compliance or research analysis your contribution directly impacts patients.
What You Will Achieve
The Pfizer Sanford NC site is a complex multi-product biotech manufacturing site that manufactures clinical and commercial vaccine and mAb products. This position will support the Pfizer Sanford Quality Operations department by performing Quality activities associated with Microbial Control of the Sanford facility. It is your dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Supporting investigations reporting on microflora present in the facility and developing and driving implementation of continuous improvement activities associated with contamination and environmental control
Performing GMP tasks associated with maintaining compliant manufacturing areas and operations through sampling analyzing interpreting and trending results
Contributing to the development and execution of Microbial Control site strategy by providing technical support for complex projects to ensure compliance to the strategy as well as Pfizer Quality Standards and BOH requirements
Driving implementation of site strategy initiatives and work collaboratively to enforce aseptic behaviors and techniques across site
Providing technical expertise related to aseptic techniques contamination control strategy environmental monitoring program and other areas related to the impact of microorganisms on site manufacturing processes
Preparing reports and/or exercise administrative control in support of the site Microbial Control program
Acting as a designee for Microbial Control Lead
Acting as an Aseptic Behavior Program Coach (including conducting observations and ensuring adherence to aseptic behavior expectations)
Supporting media fill program strategy and airflow visualization review
Leading continuous improvement projects
Acting safely and following all EH&S safety requirements for site
Authoring SOPs forms protocols investigations and risk assessments (as a facilitator and/or team member)
Supporting regulatory agency inspections
Interacting with Production Quality Operations and other Sanford site departments. Depending on specific assigned tasks/activities interacting with other Pfizer PGS sites Pfizer research and development groups and contract laboratories.
Here Is What You Need (Minimum Requirements)
Applicant must have a Bachelors degree with at least 2 years of experience; OR a Masters degree with 0 years of experience; OR an Associates degree with 6 years of experience; OR a High school diploma (or equivalent) and 8 years of relevant experience
Strong knowledge and experience with microbiology microbial control of pharmaceutical manufacturing facilities aseptic practices environmental and utilities monitoring and trending and Quality Risk Management.
Strong knowledge of Microsoft Office applications specifically Word PowerPoint and Excel.
Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards
Good working knowledge of Microsoft Excel and Word
Ability to prioritize track and report status of assigned actions across multiple production areas
Bonus Points If You Have (Preferred Requirements)
Experience with the Mobile Data Acquisition application (MODA-EM) Global Quality Tracking System (TrackWise); and Laboratory Information Management System (LIMS)
Manufacturing quality or engineering experience in the biotech or pharmaceutical industry.
Experience leading continuous improvement projects
Knowledge in the application of statistical tools root cause analysis and/or six sigma methodologies
Physical/Mental Requirements
Ability to develop professional relationships to work effectively within own team and interdepartmental teams
Ability to follow written procedures and learn from hands-on training
Strong organizational skills and attention to detail
Non-Standard Work Schedule Travel or Environment Requirements
Other Job Details:
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 providers 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. This position requires permanent work authorization in the United States.
Required Experience:
Senior IC
Full-Time