Manufacturing Operations Batch Record Reviewer (Secondment 6 Months)

Pfizer

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profile Job Location:

Sanford, FL - USA

profile Monthly Salary: Not Disclosed
Posted on: Yesterday
Vacancies: 1 Vacancy

Job Summary

WHY PATIENTS NEED YOU

At Pfizer the impact you will have on improving patients lives is profound. You will play a crucial role in navigating and interpreting the growing regulatory demands to ensure optimal patient care. Your expertise and commitment are crucial in adapting to these changes and maintaining the highest standards of patient care. Join us in our mission to make a global impact on patient care.

WHAT YOU WILL ACHIEVE

The Manufacturing Batch Record Reviewer provides support to clinical commercial and contract manufacturing operations. The role ensures adherence to regulatory expectations safety and GxP (i.e. Current Good Manufacturing and Documentation Practices). Duties include but are not limited to batch record review (both paper and eBR) ensuring necessary corrections are obtained and batch record finalization is completed by lead time attainment requirements. The secondee will work cross-functionally with manufacturing groups to perform compound/intermediate and final product batch record reviews and support Quality Assurance final disposition.

HOW YOU WILL ACHIEVE IT

  • Perform compound/intermediate and final product batch record review using computer software applications including but not limited to: gLIMS SAP DeltaV AMPS MODA Batch Tracker.

  • Assess manufacturing operations/documentation to ensure proper execution and adherence to Procedures Regulatory requirements and Quality standard expectations.

  • Assist with other tasks as needed such as: correction completion batch tracker updates.

QUALIFICATIONS

Must-Have

  • Applicant must have a bachelors degree with 0 years of experience; ORan associates degree with 4 years of experience; OR a high schooldiploma (or equivalent) and 6 years of relevant experience.

  • Fundamental knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs) used in the Pharmaceutical Industry.

  • Knowledge of and experience in a biopharmaceutical/pharmaceutical cGMP environment.

  • Knowledge of electronic systems including SAP gLIMS DeltaV.

  • Good judgment and correct decision making based on company procedures/standards technical experience and industry guidance / regulatory requirements.

  • Collaboration skills and the ability to independently engage with a wide range of co-workers customers and management to gather input needed to complete assignments.

  • Familiarity with the companys product ranges and ensuring regulatory compliance.

OTHER JOB DETAILS

  • Last Date to Apply for Job:January 16 2026

  • Additional Location Information:NO

  • Eligible for Relocation Package NO

  • Secondment 6 months

  • If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for12 months or longer you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information.

  • There will be no change to your current work location.

  • Position is considered Flexible and colleagues are expected to comply with Log In For Your Day(LIFYD) requirements at site location (e.g. about 2.5 days a week in office).

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.

Pfizer endeavors to make to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing please email. This is to be used solely for accommodation requests with respect to the accessibility of our website online application process and/or interviewing. Requests for any other reason will not be returned.

Regulatory Affairs

WHY PATIENTS NEED YOUAt Pfizer the impact you will have on improving patients lives is profound. You will play a crucial role in navigating and interpreting the growing regulatory demands to ensure optimal patient care. Your expertise and commitment are crucial in adapting to these changes and maint...
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