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QC Supervisor

Company: Scientific Search
Location: Dayton
Posted on: November 22, 2021

Job Description:

Location: Near Warren, NJ

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We are looking to hire a Supervisor, Quality Control Laboratory. This key role is responsible for supervising the activities of the Quality Control Department ensuring that raw material and final products are tested on time and meeting all applicable procedures and specifications.

If you've got the necessary skills and experience to excel in this position, we want to hear from you! Apply today!

  • the Supervisor, Quality Control Laboratory, you will be responsible for ensuring the technical adequacy of activities performed at the QC Laboratory inclusive but not limited to: raw materials, in-process, final product and stability testing, )OS investigation, deviations, and NCMRs issuance, review and approval. Ensure that the Stability Program meets all the established time point testing requirements. Provide direction and guidance to the QC laboratory staff in the performance of daily laboratory operations such as testing, equipment maintenance and calibrations, supplies and reagents inventory and record keeping in conformance with applicable regulations. Serve as a subject matter expert, coach, and mentor to the other laboratory staff.
  • Provides direction to the laboratory staff in the performance of daily tasks. Ensures that department employees follow all applicable regulatory and safety requirements.
  • Reviews/approves as needed, laboratory records for completeness, technical accuracy, and acceptability of results and for conformance to written specifications, SOPs, and applicable regulations (inclusive but not limited to: FDA, Health Canada, ISO 13485, OSHA, etc.).
  • Schedules laboratory activities to meet production requirements.
  • Establishes the appropriate structure to support the on-market as well as special stability requirements in support of validation or other applicable study protocols. Prepares required protocols and procedures for stability studies as needed.
  • Ensures timely completion of out-of-specification records, root cause analyses, and deviations investigations.
  • Implements key performance metrics to monitor and improve the laboratory activities efficiencies and compliance.
  • Implements continuous improvements initiatives to increase laboratory efficiencies such as elimination of redundant tests, 5S, kanban, balanced workload, etc.
  • Manages employee training activities including appropriate training records.
  • Performs employee appraisals.
  • Timely identifies and documents, under the direction of Human Resources department, the need for any employee intervention inclusive of disciplinary actions.
  • Assists in the establishment of a succession planning process for laboratories key functions.
  • Assists with the preparation of department budget and keeps expenses within established limits.
  • Interacts cooperatively with coworkers, supervisors, or managers of other departments and receives direction well from superiors.
  • Performs other duties as assigned by the Associate Director, Quality Operations.
    We are looking for a Supervisor, Quality Control Laboratory with a blend of strong leadership and technical skills including day-to-day management of activities in line with corporate objectives and priorities, resource management inclusive of associate performance management, and strategy development related to the support role and the function this team provides.

    Specific Qualifications For This Role Include
    • Bachelor's degree in related industry (chemistry, biology, immunology, etc.)
    • 4 to 10 years related experience and/or training, including cGMP experience or experience in a regulated environment
    • Previous medical device and / or IVD experience, required
    • Supervisory experience in the field with effective managerial skills to lead and supervise a team
    • Working knowledge of 21 CFR820, ISO 13485, IVDD
    • Medical Technologist, ASCP SBB certification, BS Clinical Laboratory Sciences, preferred
    • Ability to influence others to perform their jobs effectively and to be responsible for making decisions and problem solving
    • Ability to focus on a goal and obtain a pre-determined result
    • Demonstrated proficiency with Microsoft Suite products
      For immediate consideration, email and mention Job#16059

      #ZR

Keywords: Scientific Search, Trenton , QC Supervisor, Other , Dayton, New Jersey

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