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HPLC Supervisor, Quality Control

Company: Avid Bioservices
Location: Tustin
Posted on: June 10, 2021

Job Description:

Avid Bioservices Inc., located in Tustin CA, is a dedicated contract development and manufacturing organization ("CDMO") focused on development and CGMP manufacturing of biopharmaceuticals products derived from mammalian cell culture. Avid provides a comprehensive range of process development, high quality CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 28 years of experience producing monoclonal antibodies, enzymes, and recombinant proteins in batch, fed-batch, and perfusion modes, Avid's services include CGMP clinical and commercial product manufacturing, purification, release and stability testing as well as regulatory strategy, submission and support. Avid also provides a variety of process development activities, including cell culture and feed optimization, analytical methods development, and product characterization.

We are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch.

Summary/Objective:

The Quality Control Supervisor provides leadership and oversees the day to day operations of the Quality Control HPLC Finished Product and Stability Testing group. He or she will supervise the performance and development of direct reports to ensure organization and department goals are met. Must have strong technical skills and GMP experience. The Quality Control HPLC Supervisor will lead and support continuous improvement initiatives.

Essential Functions: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

  • Review analytical data, stability testing, draft and review of technical reports, SOPs or Test Methods (related to lab operations, method validation or creation, instrument qualification, procedure verification and validation).
  • Monitor progress of individuals and teams of QC analysts toward departmental goals.
  • Plan and create QC schedules to accommodate manufacturing support and client support.
  • Supervise analysts in their work assignments and identify needs for further training.
  • Ensure adherence to regulatory compliance and cGMPs.
  • Provide review and feedback including evaluations, and ensure correct billing of time and materials to clients.
  • Facilitate or coordinate training for QC personnel in areas of regulations and compliance.
  • Ensure thorough and proper documentation of activities in respective log books and complete reviews.
  • Perform instrument troubleshooting and train QC personnel in existing methods and instruments.
  • Responsible for thorough knowledge of cGMP and regulatory requirements and ensure compliance.

Supervisory Responsibilities:

Directs activities of functional areas through direct reports (QC Analysts).

Position Type/Expected Hours of Work:

This role is a full-time, exempt position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5 p.m. unless otherwise stated by Manager. Must be available to work holidays, weekends, or extended hours to support QC schedule.

Required Qualifications:

  • B.S. degree in Chemistry or Biology.
  • Minimum of 5 years of life science industry experience in a QC or analytical lab including 1 year of supervisory experience.
  • Experience with the following: analytical testing and equipment, writing reports/procedures/specifications, chromatography, aseptic techniques, assay validations, GMPs and regulatory audits.

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Avid Bioservices does not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or protected veteran status.

Keywords: Avid Bioservices, Tustin , HPLC Supervisor, Quality Control, Other , Tustin, California

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