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Quality Control Supervisor

Company: Renaissance Pharmaceuticals
Location: Lakewood
Posted on: June 14, 2019

Job Description:

OverviewOversee and coordinate the daily activities of the Quality Systems Chemistry Laboratory to ensure lab testing provide the highest quality analytical support for manufacturing while ensuring compliance with protocols, cGMPs and safety regulations. This QSCL conducts analytical testing of bulk testing, components, finished drug product and stability testing. The QC Supervisor interacts with other functional departments to ensure QSCL services are provided timely, efficiently and in compliance with all Renaissance and cGMP standards.Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.Responsibilities


  • Direct the work activities of the finished product / raw material and stability testing work groups to ensure that testing is executed in a timely and compliant manner.
  • Appropriately prioritize and delegate assignments and projects for self and team members. Keep management informed of status and issues.
  • Perform analytical data review when appropriate to meet regulatory and customer requirements and to ensure methods and procedures are being followed.
  • Conduct, review and/or approve laboratory investigations of product or manufacturing issues/analytical method issues/customer complaints.
  • Create and revise specifications, SOPs and other appropriate documents for QC operations.
  • Assure accurate and timely input of QC data to information systems: e.g.: ERP, databases, etc.
  • Prepare change control documents and specifications; attend change control meetings as required and coordinate training requirements for departmental changes.
  • Ensure documents associated with regulatory requirements are properly maintained.
  • Ensure all data is accurately generated using validated test methods and applicable SOP's in a cGMP environment.
  • Responsible for a thorough and accurate laboratory review and approval process to assure proper documentation and compliance with all Renaissance procedures, cGMP's , ICH guidelines and USP, Ph. Eur. compendia.
  • Review and approve laboratory data to ensure accuracy and completeness as required.
  • Act as primary point of contact for QC team members when problems or issues arise and facilitate resolution of issues.
  • Provide technical expertise to internal customers and other lab personnel.
  • Serve as liaison with support departments, external customers and vendors.
  • Maintain the necessary organizational and planning skills to effectively assign work schedules to ensure timely completion of all tasks necessary to provide responsive delivery of quality services to other functional areas.
  • Ensure SOP's and test methods are revised and implemented as necessary.
  • Identify, conduct and lead opportunities to continuously improve quality, cost and efficiency of processes in accordance with the strategic direction of the department to fulfill company and department goals and actively participate in cross functional teams for problem solving and continuous improvement.
  • Demonstrate technical competence including understanding of theory and interpretation all laboratory techniques. (i.e. chromatographic, spectroscopic physical and wet chemical)
  • Manage the laboratory instrumentation IQ/OQ/PQ and calibration program.
  • Assure Lab personnel are trained and qualified to perform job functions. Ensure personnel are successfully completing regulatory and job training requirements.
  • Monitor and coach performance of team members. Conduct annual performance reviews.

    QualificationsBachelor's degree in a Natural Science with a minimum of 5 years of relevant experience in the pharmaceutical industry. Additional education may be substituted for experience on a year per year basis. PI110324376

Keywords: Renaissance Pharmaceuticals, Lakewood , Quality Control Supervisor, Other , Lakewood, New Jersey

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