Quality Assurance Manager

1 week ago


West Nyack, New York, United States gonzer Full time
Job Title: Quality Control Supervisor

Job Summary:

L.J Gonzer Associates is 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:

  • 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 where needed.
  • Guide and enforce all cGMPs for all shift personnel.
  • Assist with investigations from respective shifts.
  • Attend meetings/conference calls with or on behalf of the QC Inspection manager.
  • Provide daily shift summary reports 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 escalate QC Inspection issues to QC/QA management.
  • Have the authority to make and execute decisions related to the production lines.

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.
  • Team-oriented and self-motivated.


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