What are the responsibilities and job description for the USA - Documentation Specialist I (Manufacturing/Quality) 1st Shift (contract) position at Sanofi?
Job Summary
Join Sanofi's contingent workforce program, FLEXT Direct, as a Documentation Specialist II for a 12-month contract. As a Production Specialist, you will play a crucial role in ensuring that all production activities are scheduled efficiently and that documentation processes adhere to cGMPs. Your responsibilities will include reviewing manufacturing batch production records for compliance, managing document submission timelines, creating manufacturing schedules, and supporting various departments with documentation needs.
Responsibilities
Education:
Preferred Experience
Bachelors Degree with 1–3 years of experience preferred
Prior experience in document control, production support, or quality assurance roles is advantageous. Familiarity with Good Manufacturing Practices (GMP), FDA regulations, or ISO standards is a plus.
This position offers an exciting opportunity to contribute significantly to Sanofi's contingent workforce program by ensuring efficient production scheduling and meticulous documentation practices. Join us in this dynamic role where your attention to detail and organizational skills will make a meaningful impact.
Join Sanofi's contingent workforce program, FLEXT Direct, as a Documentation Specialist II for a 12-month contract. As a Production Specialist, you will play a crucial role in ensuring that all production activities are scheduled efficiently and that documentation processes adhere to cGMPs. Your responsibilities will include reviewing manufacturing batch production records for compliance, managing document submission timelines, creating manufacturing schedules, and supporting various departments with documentation needs.
Responsibilities
- Review manufacturing batch production records (BPR) for compliance with internal specifications and cGMPs.
- Scan and copy documents before submission to QA.
- Manage cycle time for document review and submission.
- Create manufacturing schedules based on production volumes.
- Collaborate with different departments to review the production schedule.
- Ensure documentation aligns with cGMP regulations and ISO 13485 guidelines.
- Print and issue Batch Records, Protocols, and Labels for production.
- Draft and review specifications, batch records, and standard operating procedures.
- Complete Athena-related transactions as necessary.
- Initiate CAPAs (Corrective and Preventive Actions) and NCRs (Non-Conformance Reports) when required.
- Support QA with document updates as needed.
- Monitor batch record errors trends and provide metrics to manufacturing management.
- Assist in documentation improvement projects.
- Perform data entry tasks accurately.
- Track KPIs for the department when necessary.
- Lead the team in support functions when required.
- Ability to work independently while managing multiple tasks concurrently.
- Strong attention to detail and accuracy in document review and processing.
- Proficiency in Microsoft Office Suite (Excel and Word), Adobe Acrobat, and document management systems.
- Excellent written and verbal communication skills.
- Outstanding organizational and time management abilities.
Education:
- High School Diploma or GED with 8-10 years of experience preferred
Preferred Experience
Bachelors Degree with 1–3 years of experience preferred
Prior experience in document control, production support, or quality assurance roles is advantageous. Familiarity with Good Manufacturing Practices (GMP), FDA regulations, or ISO standards is a plus.
This position offers an exciting opportunity to contribute significantly to Sanofi's contingent workforce program by ensuring efficient production scheduling and meticulous documentation practices. Join us in this dynamic role where your attention to detail and organizational skills will make a meaningful impact.
