Batch Record Reviewer - Vaccines

Batch Record Reviewer – Vaccines

JOB OVERVIEW:

This position is for Documentation support for manufacturing department. Candidate will serve to perform routine batch record review tasks and batch record signing. Maintains all associated documentation for operations being performed. Applies acquired skills while performing the most complex tasks of the position, following established practices and procedures.

Based on production schedules, random and different start time scenarios may occur, so a flexible work schedule is required for the candidate. Ability to accommodate production requirements that may require to work extended day hours and weekends in peak time is required. Core Work hours are 2:00PM to 10:30PM Sunday through Thursday, however, schedule may vary as needed

KEY RESPONSIBILITIES:

• Performs batch record reviews based on business need, and effective procedures. Must be flexible to ensure records are requested for changing business volume and needs.

• Ensure batch records are prepped for production per production schedule

• Prepare additional batch record pages as needed

• Document batch record corrections in electronic correction log

• Work with production to obtain corrections within correction turnaround time

• Provide coaching to Operators on how to properly document production activities

• Identify and communicate to Management any deviations

• Assist in deviation investigation closure

• Enter and verify Shop Floor Data

• Complete PO confirmation and all other SAP phase confirmations

• Utilize visual management tool and Trackwise to track batch records

• Complete corrections for returned records within correction turnaround time

• Completes tasks and corresponding documentation as required by cGMP to ensure document completion.

• Prints new controlled forms and gathers the completed logbooks.

• Utilizes Standards to capture and Record batch record reviews.

• Help manage workload for review and scheduling of record reviews.

• Ensuring daily record review tasks are completed and corrections are addressed.

• Update all metrics and report as needed.

• All other duties as assigned by management.

JOB REQUIREMENTS:

• HS Diploma/GED or higher

• 3+ years of cGMP experience

• Pharmaceutical experience preferred

• Must have computer skills, good communication and comprehension skills, and high attention to detail

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.