Documentation Coordinator II

Job Description
- Review and audit data and records generated by Manufacturing and Packaging Operations for processing a material or product batch
- Correct batch record errors; ensure all batch record components are present; reference and approve exception documents
- Ensure all in-process and release testing is complete and all Quality holds are released
- Interface with electronic databases/systems to interpret data pertinent for release to specific countries
- Ensure batch records are retained and filed securely
- Ensure Quality goals are met and practices/procedures comply with company policies and applicable regulations
- Interact with other departments, external customers, and regulatory agencies
- May release batch records in electronic systems per global/local/customer/regulatory requirements

Qualifications
- Minimum High School graduate; Bachelor’s or Associate’s degree desired
- 2+ years’ experience in Manufacturing, Quality or Engineering
- Minimum 5 years’ experience in a manufacturing/finishing environment is desired
- Knowledge of GMP regulations and standards affecting pharmaceutical products
- Good analytical skills and attention to detail
- Good interpersonal relations/communications skills; good verbal and written communication skills
- Must be available to work daily overtime, including weekends, as needed

Benefits
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees
- Eligible to participate in short-term incentive programs