Responsible for day-to-day activities in support of the Documentation Center. This position will work under the direction of the Quality Associate. PRIMARY DUTIES AND RESPONSIBILITIES:
Qualifications: EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
- Perform final documented review of completed batch paperwork prior to shipment and final review of all other GMP documentation.
- Documentation responsibilities include the initiation of SOP changes, processing new and revised SOP's, maintaining Preventive Maintenance and Critical Systems documentation.
- Provide support to management during all regulatory inspections.
- Assist in training of new staff on Good Documentation Practices.
- Perform other responsibilities as assigned.
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
- 2-3 years related experience in manufacturing, quality or related experience.
- Ability to work independently, ability to work well within a team, and willing to work overtime as needed to meet demands of Center.
- Must have demonstrated strength in written and verbal communication, organization skills, and detailed orientation.
- Knowledge of manufacturing and quality documentation, procedures, and systems as related.
- Computer related skills (word processing, spreadsheets) are required.