Quality Assurance Manager
2 days ago
At L.J Gonzer Associates, we are seeking a highly skilled Quality Control Supervisor to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in our production processes.
Key Responsibilities:- Oversee product inspection and in-process testing to ensure compliance with regulatory requirements.
- Manage and maintain the retention room for samples and batch records storage and retrieval.
- Ensure adequate QC inspector coverage for Monday to Saturday.
- Work overtime and adjust to production demands and schedule as needed.
- Ensure all inspections, paperwork, and sample collections are performed completely, accurately, and timely.
- Coach, counsel, and correct QC inspectors as necessary.
- Provide training, instructions, and corrective action.
- Report problems, issue non-conforming reports, and recommendations as needed.
- Guide and enforce all cGMPs for all shift personnel.
- Assist with investigations from respective shift.
- Attend meetings/conference calls with or on behalf of the QC Inspection manager.
- Provide daily shift summary report via email to site management.
- Generate and analyze metrics obtained from the QC Inspection department for inclusion in QA reports.
- Assist with site-wide GMP training as it pertains to QC Inspection.
- Timely escalation of QC Inspection issues to QC/QA management.
- Have the authority to make and execute decisions related to the production lines.
- Bachelor's degree in Applied Sciences or Engineering (Biology, Chemistry, Physics, or a related field).
- 5 to 8 years of experience in Quality Control (QC) or Quality Assurance (QA) supervision.
- Proven supervisory/management experience.
- Supplier quality experience preferred.
- Proficient in Quality Systems, including Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) in FDA-regulated industries.
- Strong problem-solving abilities: Identifies and resolves issues promptly, gathers and analyzes information effectively, and develops alternative solutions.
- Excellent interpersonal and communication skills, with the ability to engage effectively with internal and external clients.
- Strong leadership and process improvement skills.
- Adept at deviation management and investigation.
- Team-oriented and self-motivated.
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