KH/DG - Quality Assurance Manager in Hayward, CA at Apex Life Sciences

Date Posted: 8/8/2018

Job Snapshot

Job Description


 This position has primary responsibility for designing, implementing, documenting, and auditing 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.

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.

Ability to assure and oversee design control of both software and laboratory products, followed by design verification and product validation.

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 companywide Quality Control software, such as part of an ERP system.

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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 employeeservices@apexsystemsinc.com or 844-463-6178.

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 employeeservices@apexsystemsinc.com or 844-463-6178.