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Quality Assurance Manager in Hayward, CA at Apex Life Sciences

Date Posted: 12/3/2018

Job Snapshot

Job Description

This position has primary responsibility for managing the company’s quality systems and assuring compliance with it. The Quality Assurance Manager has the authority to provide direction and guidance to others in the company, for their development, implementation, and maintenance of the details of the quality system. The Quality Assurance Manager is the primary representative of company during inspections and audits by regulatory agencies or customers.

Skills, Knowledge, and Attributes:

  • Working knowledge of basic laboratory techniques in microbiology, cell biology, and biochemistry.
  • Experience using laboratory software for instrument control and data collection and analysis.
  • Familiarity with formal quality systems such as CGMP’s or ISO, preferred but no required.
  • Ability to judge a product’s fitness for its intended use based on the original R&D specifications, compliance with quality standards, and acceptability to customers.
  • Familiarity with failure investigation and analysis, followed by corrective and preventive action and quality improvement.
  • Ability to schedule and perform maintenance and calibration of scientific equipment, using outside services where appropriate.
  • Experience representing the company during regulatory or customer audits, both on-site and written.
  • Skilled in the preparation, improvement, review, and approval of documentation for manufacturing and quality control.
  • Familiarity with the preparation of published documents such as C of A’s and MSDS’s and responsibility for posting/distribution of these documents.
  • Excellent interpersonal and time management skills. Ability to supervise QA technicians and work across departmental lines, both formally and informally.
  • Excellent communication skills, oral and written, with a good working knowledge of Microsoft Office.
  • Experience using company-wide Quality Control software, such as part of an ERP system.
  • The position involves daily interaction with manufacturing, QC testing, laboratory R&D, software R&D, and upper management, as well as hands-on work with laboratory testing and software validation.

Position Requirements:

  • Minimum requirement for this position is a Bachelor’s degree in Biology, preferably Microbiology or Biochemistry.
  • Minimum 4 years experience in quality control in a regulated QA environment, along with experience in a research or clinical laboratory with emphasis in biochemistry and cell biology / microbiology.


EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.