Quality Inspector, QC, IQC, QA

Job Summary

The Quality Inspector role is to support manufacturing quality. Responsible for timely and effective GMP review of production records in order to maintain a continuous flow of records, and to manage and control materials used for the product realization including nonconforming materials. Responsible for Lot release testing.

• Maintain the effectiveness of Quality Management Systems to assure compliance with GMP:
  • Manufacturing site Policies and Procedures
  • ISO 13485 QMS, 21 CFR 820 QSR
  • Relevant global quality systems.
• Participates in the implementation of the Quality Management System.
• Perform manufacturing QC processes in a timely manner including lot release testing and testing related to validation, qualification.
• Calibration and maintenance of laboratory equipment and related systems, maintenance of laboratory equipment.
• Assist in the development of QC/QA procedures, Protocols, reports, create and maintain QC/QA documentation for new and existing products, processes, and equipment.
• Reviews, interprets, and evaluates analytical data, including raw data, of developmental, clinical, and commercial related products for accuracy and compliance within procedures and GxP requirements.
• Monitors stability studies of developmental, clinical, and commercial related products tested internal or contract laboratories.
• Analyze and evaluate preliminary testing data, initiate NCMR and other quality related tasks as appropriate.
• Assist supervisor/manager in maintaining the current laboratory and QC/QA activities.
• Contact point for instrumentation issues and providing training and troubleshooting support to the laboratory on new or existing instrumentation.
• Monitor and ensure compliance of all laboratory equipment and associated systems and provide training to technicians as required.
• Prepare, review & approve laboratory documentation related to laboratory instrumentation and systems (e.g. SOPs, validation protocols, reports etc.).
• Provide support to laboratory investigations involving laboratory systems including NCMR and deviation.
• Work with cross functional teams on new product transfer, qualification, validation, etc.
• Reviews, enters, and maintains stability data for developmental, clinical, and commercial products. Transfers analytical methods and qualification as applicable.
• Prepares and maintains QC/QA documentation, including protocols, reports, and test methods. Procures reference materials for contract analytical laboratories.
• Maintains and updates department documents required for regulatory compliance and assures testing requirements adherence to latest regulatory standards.
• Engage in managing the documentation Change Control Process including receiving / generating, identifying, distributing, tracking, and publishing Change Requests and Orders as applicable.
• Engage in filing, identification, archiving, storage, recovery and destruction of QC/QA Documentation and Records as needed.
• Review & Release of WIP Materials and Finished Goods for GMP this includes review of quality records for:
  • Good Documentation Practices/Data Integrity
  • Completeness of records
  • Accuracy of records
  • Lot/part/description accuracy
  • Materials and Finished Goods included, but not limited to:
    • Wafers
    • HPC
• Preparation, and performing a variety of routine and QC/QA tasks following cGMP regulations
• Work collaboratively with required functions as part of a cross functional team to investigate customer complaints and address them in a timely manner.
• Work collaboratively with cross functional teams as relevant and ensure that Change controls, deviations/investigations, CAPAs are initiated and executed as applicable in a timely manner.

Required

• Knowledge of GMP (21 CFR Part 820, and ISO 13485)
• Hands‑on knowledge of computer applications including use of the Internet, Word and Excel applications and presentation software such as Power Point
• Sound knowledge of cGMP and experience in a regulated industry
• Strong verbal and written communication skills
• Excellent organizational skills along with strong attention to detail

• HS degree is preferable or equivalent 2-3 years of experience in an FDA regulated industry (Biotech,…