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

• 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

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