Manufacturing Production Supervisor In-Processing Testing

  • Job Reference: 380938818-2
  • Date Posted: 25 September 2021
  • Recruiter: Cepheid
  • Location: Sunnyvale, California
  • Salary: On Application
  • Sector: Manufacturing Operations
  • Job Type: Permanent

Job Description

Job Description:

ESSENTIAL JOB RESPONSIBILITIES:

  • Manages the Consumables IPT 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 analytical methods. Works in conjunction with other departments to develop, qualify, and transfer testing analytical methods as applicable.
  • Ensures maintenance of testing 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 monitoring and review.
  • Identifies and implements improvement opportunities for established processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes.
  • Lead investigations for failures during testing; perform troubleshooting, process development or improvement activities.


TRAINING RESPONSIBILITIES:

  • Complete all assigned and required training satisfactorily and on time


MINIMUM REQUIREMENTS:

Education and Experience:

  • 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.

PREFERRED REQUIREMENTS:

  • Experience working in a GMP/ISO/FDA manufacturing environment
  • Experience using analytical scales, Pipettes and working with hazardous chemicals
  • Flexibility with the work schedule including modified shift times and weekends