Document Control Specialist

*** The candidate must not be allergic to penicillin or cephalosporin drugs ***

The Quality Document Technician is responsible for various assignments supporting quality systems and ensuring that required documents are created and organized for use in manufacturing and for releasing products.

• Makes detailed observations, analyzes data, and interprets results.
• Create, verify, and distribute quality documentation required for manufacturing.
• Support Document Center Technicians with standard office work and for batch release.
• Maintains department equipment and inventory levels for controlled materials.
• Identifies process improvements and escalates to Quality Supervision and/or Management.
• Ability to work independently and as part of a team in a fast-paced environment.

• Basic science, math, and computer skills (including Microsoft Word and Excel) are required.
• Good writing, verbal communication, and problem-solving skills are required.
• Ability to work in a team environment and make independent decisions based on procedural and regulatory requirements.
• It is desirable for the candidate to have experience with the requirements of current Good Manufacturing & Documentation Practices (GMP & GDP) in pharma manufacturing facilities.
• The candidate must be able to work flexible hours in a dynamic environment with minimal direct supervision.
• The ability to work on some weekends is required.
• Will work in both Drug Delivery and Penicillin facilities as needed.
• Overtime may be required to meet the production schedule.
• 6 months of experience in manufacturing/quality preferred
• HS Diploma or equivalent is required
• Be able to work flexible hours in a dynamic environment with minimal direct supervision. Ability to work some Saturdays is required.