Location: Miami, Florida, United States
Compensation: $55,000 to $60,000
We are seeking a QA Technical Supervisor.
Responsibilities of this position include, but are not limited to:
1. Supervising and coordinating activities of QA Inspectors who perform Quality Assurance tasks such as sampling, inspections, and tests designed to ensure manufactured products are in compliance with internal SOP’s, Safety initiatives, Company policies, FDA and DEA regulations.
2. Document all work performed, ensuring accuracy and thoroughness.
3. Inform management of any deviations from established standards.
4. Demonstrate ability to learn and perform activities of workers supervised.
5. Monitor manufacturing and QA areas for compliance with internal SOPs and FDA GMP regulations.
6. Ensure that all work activity is documented accurately… and is in compliance with requirements.
7. Ensure samples are processed and distributed to different departments in a timely manner.
8. Review records for GMP compliance, accuracy and thoroughness.
9. Investigate failures and deviations in manufacturing operations and initiate corrective action.
10. Issue SICODs and perform/document investigations pertaining to SICODs when required.
11. Inform management of problems, failures and deviations from established internal and regulatory requirements.
12. Maintain QA Inspector Training SOP Matrix and all associated training documentation.
13. Direct all training activities for the department.
14. Assist management in the development, execution, and monitoring progress towards departmental goals/objectives.
15. Prepare and conduct staff performance appraisals, development plans, and disciplinary activities as warranted.
16. Draft and revise departmental SOPs, forms and documents.
17. Update procedures to reflect new or changed products, processes, equipment, policies, FDA regulations, customer demands, etc. and to ensure they are current.
18. Assist in Validation Projects. Provide status/monthly reports to management.
19. Maintain QA Alert Notice log.
20. Delegation of QA Manager for final QA disposition on QA Alert Notices.
21. Demonstrate initiative required to generate ideas for improved process efficiency / continuous improvements within general procedural guidelines.
Responsible for assisting management in monitoring and periodic reporting of monthly/quarterly metrics and quality indicators, including but not limited to QA Alerts, QAI related activities, sampling failures, deviations, etc.
Assist management in driving and providing support in troubleshooting.
