26 Jul
QA Manager
California, Tustin , 92780 Tustin USA

Vacancy expired!

QA Manager 1163079 Job Scope & Purpose: Our Boston-based biotech client has an exciting Donor Operations Center in the Irvine area and is looking for a QA Manager to join the team! The Quality Assurance Manager will work closely with operational teams to support the collection of donor derived products. You will be involved in the quality support of collection facility personnel as well as engaged in the review of batch records to ensure the appropriate release of donor material to serve at risk populations. Please note this role is an on-site position in Tustin, CA. This is an exciting opportunity for anyone who excels at active, and creative problem solving. While this is a GMP environment, it is not your typical experience, our clients' program requires a unique opportunity to apply GMP principles to an area as yet unregulated by the FDA. Their unique product provides the opportunity to grow within a cutting edge GMP program, setting the benchmark for a new industry. Primary Job Responsibilities:

  • Provides quality guidance, support and reviews for a Donation Collection Facility and Donation Operation's projects and programs, ensuring follow up activities are completed and in compliance with requirements.
  • Perform detailed batch record reviews and participate in Donor Review Committees.
  • Perform initiation, investigation, and corrective action monitoring for deviations and CAPAs related to donation collection facilities or other assigned Donor Program areas.
  • Perform record retention and archival tasks, including but not limited to deviations, CAPAs, change control documents, batch records and logbooks.
  • May participate in development, review and training of Donor Program processes/procedures.
  • Other duties as assigned including providing support to other quality groups as needed.
  • Occasional travel may be required to Donation Collection Facilities.
Primary job Requirements:
  • 6+ years of QA experience, and a degree in life sciences
  • Experience in batch records or GMP auditing is required, as well as in investigation and corrective action assessment for deviations and CAPAs.
  • Strong verbal and written communication are essential, as well as strong interpersonal skills as we work across department lines to ensure we can support donation activities, and the needs of the company overall.
  • ASQ Certified Quality Auditor (CQA) a plus.
About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™ Stratacuity 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. Stratacuity 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 us. Code:TechOpsEEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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 or

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