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Danaher Corporation QC Supervisor in Newark, California

This Quality Control Supervisor position works to assure that operations at Cepheid meet client requirements and cGMP regulations via Quality Control staff. The QC Supervisor will ensure responsiveness to clients and overall client satisfaction. The successful individual is responsible for coordinating and implementing activities to attain strategic objectives within the department and looks to his or her direct supervisor or other peers within the industry for guidance. In addition, the QC Supervisor is able to establish goals and objectives, supervise work practices for their direct reports, will interpret and execute policies and procedures that typically affect organizational units. This position will interact with other departments and/or divisions within Cepheid.

ESSENTIAL JOB RESPONSIBILITIES:

  • Manages the Quality Control department daily work activities including: Team schedule, ensuring training, general guidance to direct reports and across functional groups, and serves as resource for technical / administrative problems.

  • Hires, trains, motivates, leads, develops and evaluates staff. Takes corrective action as necessary on a timely basis and in accordance with company policy.

  • Ensures Quality Control systems are compliant with corporate and site procedures, as well as industry standards.

  • Supports development of novel QC analytical methods. Works in conjunction with other departments to develop, qualify, and transfer QC analytical methods as applicable.

  • Ensures maintenance of QC equipment – qualification, calibration and maintenance.

  • Drafts, reviews, and approves Standard Operating Procedures (SOP), sampling plans, specifications, protocols and reports related to product/processes, equipment, method, validation. This includes deviation investigation and reporting.

  • Develops and implements statistical tools for Quality Systems monitoring and review.

  • Identifies and implements improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes.

  • Lead investigations for failures during Quality control testing; perform troubleshooting, process development or improvement activities.

MINIMUM REQUIREMENTS:

Education or Experience (in years):

  • High school degree with 8+ years of experience or Bachelor’s degree with 5+ years of experience OR Master’s degree with 3+ years of experience.

Knowledge and skills:

  • Experience with managing people and providing leadership.

  • Thorough knowledge of cGMP regulations related to Quality Control required.

  • Experience with analytical method, and Microbiology testing.

  • Proven track record in method validation / qualification and qualification of equipment / systems.

  • Experience with facility / laboratory expansions.

  • Experience in a QC support in high pace manufacturing setting.

12 hour shift (6am to 6pm)Week 1: 36 hours (3 days/week)

Week 2: 44 hours (4 days/week)

Total/Pay Period = 80 hours

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.

Operating Company: Cepheid

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