This position is for Documentation support for the manufacturing department. The 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 very flexible work schedule is required for the candidate. Ability to accommodate production requirements that may require working extended day hours and weekends in peak time. Core Work hours are 10:00 PM to 6:30 AM however may change as needed. This role requires frequent work on weekends depending on production demands.
Ensure batch records are prepped for production per production schedule
Prepare additional batch record pages as needed
Perform quality review of Filling, Inspection, and Packaging batch records according to batch record review cycle time
Document batch record corrections in electronic correction log
Work with production to obtain corrections with 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 SAP phase confirmations, Close Work orders for completed batches using SAP system as per production plan.
Utilize visual management tool and Trackwise to track batch records
Complete corrections for returned records within the correction turnaround time
HS Diploma/GED or higher
Prior or related cGMP or Pharmaceutical experience preferred
Must have computer skills, good communication and comprehension skills, and high attention to detail
SAP knowledge is preferred
The ideal candidate must be customer-driven, outgoing, and a team player. The candidate should be organized and willing to learn from experienced personnel.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
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.
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.
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