USA - Documentation Specialist I (Manufacturing/Quality)

Job title: Documentation Specialist I

Location: Pearl River, NY (Onsite)
Schedule: Monday - Friday; 7:30 AM - 4:00 PM
Pay Rate Max: $37 per hour

Sanofi's contingent workforce program, FLEXT Direct, is seeking a Documentation Specialist I for a 6-month contract.

We are seeking a highly detail-oriented and motivated professional to join our quality assurance team in a dynamic pharmaceutical or biotechnology manufacturing environment. This role plays a critical part in ensuring that all manufacturing batch records are thoroughly reviewed and compliant with regulatory requirements, while also serving as a key resource for coaching and guiding shopfloor technicians on Good Documentation Practices (GDP). The ideal candidate will bring a strong sense of urgency, exceptional interpersonal skills, and a commitment to maintaining the highest standards of drug substance safety, efficacy, and quality. This position offers the opportunity to contribute meaningfully to process improvements, deviation investigations, and corrective action initiatives that directly impact product quality and patient safety.

Responsibilities:
- Track and review manufacturing batch records to ensure compliance with regulatory requirements
- Follow up with Manufacturing Technicians to ensure corrections are completed in a timely manner
- Maintain error tracking metrics to identify and address repeated violations of GDP
- Coach shopfloor technicians on GDP principles and best practices as applicable
- Identify and escalate GDP issues that could affect the safety, efficacy, and quality of drug substance
- Review batch record structure and recommend simplifications to minimize errors as applicable
- Ensure batch record review cycle times are met consistently
- Participate in deviation investigations and CAPA creation as applicable

Skills:
- Strong experience with CAPA processes, batch record review, and technical writing
- Proficiency in using documentation and quality management systems to locate errors and manage change action requirements
- Familiarity with ERP systems and electronic documentation platforms
- Knowledge of quality systems and GDP requirements within a pharmaceutical or biotechnology setting
- Excellent attention to detail with the ability to work quickly and accurately under pressure
- Strong interpersonal and information-gathering skills with the ability to work effectively in a team environment
- Preferred experience with manufacturing GDP practices
- Preferred experience handling deviation investigations

Experience:
- Pharmaceutical or biotechnology industry experience is required
- Experience with CAPA processes, batch record review, and technical writing is required
- Experience using documentation systems and quality management platforms is required

Qualifications:
- High School Diploma with a minimum of 5 years of relevant experience, or
- Associate's Degree with a minimum of 3 years of relevant experience, or
- Bachelor's Degree with a minimum of 1 year of relevant experience, including final batch record review

Joining this team means becoming an integral part of a mission-driven organization where your contributions directly support the production of safe and effective therapies for patients. You will have the opportunity to grow your expertise in quality assurance, collaborate with cross-functional teams, and make a tangible impact on manufacturing excellence in a fast-paced and rewarding environment.

Salary : $37