Seeking full-time Quality Control Chemist in Grafton WI
It is the responsibility of Quality Assurance to assure that all documentation, procedures and protocols comply with GMP and FDA guidelines. This position's responsibilities include but are not limited to implementing and enforcing compliance of all Standard Operating Procedures and FDA guidelines through training and audits.
- Understanding of Good Manufacturing and Laboratory Practices, FDA regulations, Quality System SOPs, and current compliance standards, including data integrity requirements.
- Ability to audit documents, procedures, and records for accuracy and continuity
- Strong written and verbal communication skills.
- Conducts batch record and test data review, and approves batches for release.
- Assist with the Material Supplier Evaluation Program.
- Assist in maintaining compliance of Environmental Monitoring, Equipment Calibration, and Equipment Maintenance Program.
- Issues Deviation, CAPA, and OOS investigations. Tracks investigations and outcome. Reviews and recommends approval of indicated actions to senior associates or quality management.
- Assist Document Control in review, filing, and issuance of documents.
- Conducts audits of all areas and assists with writing audit reports.
- Assists with customer/regulatory agency audits when necessary.
- Writes and reviews Annual Product Review reports.
- Writes protocols for Process Validation Protocols and assists with writing of Process Validation Reports
- Assists with customer inquiries and investigations of customer complaints.
- This position requires a B.S. degree and 5-8 years’ experience in pharmaceutical manufacturing or 8-10 years of equivalent experience.
If you or anyone you know is interested and qualified for this position, please send an updated resume to us ASAP for immediate consideration.