We are currently seeking a Quality Specialist II for our Quality Assurance group in West Lafayette, IN. This position of Quality Assurance Specialist II is to perform cGMP review of lab operations to ensure appropriate reports/data/processes to conform with SOP’s and guidelines. Role serves as important function to maintain appropriate regulatory documentation.
- Perform QA audits of scientific reports/data to ensure cGMP compliance in preparation for release of the reports to the customer.
- Develop, implement, and revise procedures (SOPs, Methods, etc.) Conduct investigations and internal audits of quality systems.
- Review equipment and software qualification and validation protocols.
- Participate in client audits and regulatory inspections by escorting auditors and securing requested.
- Designs and plans audits of simple quality systems for review with QA Mgmt.
- Conducts employee training sessions as necessary documents and data.
Education and/or Experience:
- BS degree in chemistry or other related scientific field.
- Demonstrated proficiency in oral and written communication skills producing effective interaction with others at all levels.