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Quality Assurance Manager

1 month ago


West Nyack, New York, United States Synerfac Full time

Job Summary
As a Quality Assurance Manager at Synerfac, you will be responsible for ensuring the quality of our products by overseeing the Quality Control process. This includes managing and maintaining the retain room for samples and batch records storage and retrieval, ensuring adequate QC inspector coverage, and coaching and counselling QC inspectors as necessary.

Key Responsibilities
Manage and maintain the retain room for samples and batch records storage and retrieval
Ensure adequate QC inspector coverage for Mon-Sat
Coach and counsel QC inspectors as necessary
Report problems and issue non-conforming reports and recommendations
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

Requirements
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