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Englewood Lab

Quality Control Supervisor

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeTotowa, NJ, USA

About the Job

Requirements

  • A minimum of a diploma or bachelor's degree in Life Sciences, Engineering, or a related profession.
  • Five or more years of industry or related experience in cosmetics, devices, food, or pharmaceuticals.
  • Data analysis and specification development skills.
  • Computer literacy and effective communication skills.

Responsibilities

  • Schedule Quality Control Inspectors for bulk manufacturing, production or assembly lines, and warehouse finished-goods auditing, including associated sample handling and in-process record review.
  • Investigate nonconformances, product complaints, and out-of-specification results; provide corrective and preventive actions and follow up within assigned areas.
  • Train and supervise document-review and batch-release personnel; issue certificates of conformance, certificates of manufacture, and certificates of analysis for finished goods; and maintain accurate approved, quarantined, and rejected product records.
  • Ensure compliance with standard operating procedures and applicable regulatory requirements, including FDA, EPA, OSHA, and ISO 13485:2003 requirements.
  • Review finished goods with the shipping department for formal release and compliance with customer requirements.
  • Work closely with Quality Assurance and Quality Systems on quality and compliance matters.
  • Maintain working knowledge of inspection requirements for components, raw materials, in-process and bulk materials, and finished goods.
  • Ensure Quality Control Inspectors review in-process manufacturing, production, and assembly activities for conformance to specifications, and follow up on out-of-specification results and nonconformances.
  • Participate in the in-process quality training program, both in-house and external.
  • Analyze the in-process inspection program periodically and make recommendations.
  • Assist in interpreting and developing customer specifications and assembly or packaging requirements.
  • Assist in establishing production and assembly inspection information sheets and required documentation.
  • Maintain and update the enterprise resource planning system and repositories of batch records, documents, and manufacturing and assembly in-process specifications.
  • Review batch records, worksheets, inspection documentation, and production-related records for completeness and correctness.
  • Review Quality Control inspection reports daily for correctness and completeness.
  • Facilitate on-site customer inspections by coordinating product availability and communicating disposition to Quality and Inventory Control; interface with customer distribution operations as needed.
  • Maintain awareness of and comply with safety regulations while performing job duties.
  • Ensure finished goods, bulk materials, raw materials, and components are maintained correctly in the warehouse and other holding areas.
  • Assist in reviewing and releasing finished products.
  • Perform supplier and vendor audits, mock recalls, and internal audits.
  • Perform additional duties or assignments as directed by the supervisor.

Desired Qualifications

  • Previous inspecting, auditing, or manufacturing experience is a plus.

About the Company

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