The QA Coordinator is a support role. The qualified individual will perform reviews of GMP documents used for manufacturing processes completed in the Charles City, Iowa facility. These documents are reviewed for completeness and accuracy, compliance with internal procedures, environmental monitoring, and material usage data. The coordinator records relevant manufacturing/ testing data in the SAP system. The coordinator will communicate with a cross functional audience within the manufacturing envelope to facilitate timely completion of this process.
Ensures cGMP compliance within the site’s quality systems
- Perform assigned batch record reviews
- Documentation review
- Data collection for site Metrics
- Support role for all areas of Quality
- Database review for support of release
- Participate in the preparation for and execution of foreign and domestic regulatory agency inspections.
Education and Experience:
- Minimum of AA degree required
- Excellent verbal and written communication skills, fluent in English.
- Proficient with the following software programs: Word, Excel, PowerPoint, and Access.
- Excellent organizational skills and strong ability to multi-task.
- Willingness to positively embrace change and flexibility in adjusting to changing priorities.
- Previous experience with the governing regulations and understanding of how those regulations apply to the business.
- Skills promoting organization, teamwork, innovative thinking, attention to detail and quality.
- Strong attention to detail, ability to work well independently and as part of a team, and to work effectively with people at all levels within the organization.
- Ability to sit or stand for extended periods of time at a workstation.
- Ability to work in manufacturing environment with varying temperatures and ability to wear company supplied garments.
- Must be able to walk or stand for long periods of time.
- Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently.
- Must be able to work scheduled 40 hours with the ability to work overtime as needed.
- Frequent lifting and carrying of 5 to 25 lbs.
- Regular reaching, bending, stooping, and twisting.
- Repetitive motion and substantial movement of the wrists, hands, and/or fingers.