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Job Runner

 
  • Category: Healthcare
  • Education: Bachelors Degree
  • Employment Length: fulltime
  • Source: Business
  • Ad #: 11956
 
Via: kellyjobsmnetwork Apply / More Info
 
Full Details

Quality Control (QC) Manager, Vista, CA

Position Overview:  Manage the company's quality activities to ensure accurate and timely compliance with the company's quality program.  Reporting to the Director of Quality, the Quality Control Manager is responsible for assisting and directing the activities of two QC associates in ensuring products and associated documentation are prepared in accordance with and meet the company's quality standards.  This includes adherence to, and expert knowledge of, the company's QMS policies, as well as GMP, and ISO 9001:2015 guidelines.  Assist QA Director with customer, FDA, and USDA audits.  This position is an exempt, full-time position.  Compensation is commensurate with experience. Benefits package, after 90-day probationary period, includes vacation and sick pay, full medical / dental / vision coverage and 401(k) with company match.

Essential Duties and Responsibilities:

  • Ensure timely and complete departmental checks of manufacturing batch records ensuring no omissions or inaccuracies are recorded and the record is prepared in accordance with company and GMP guidelines.
  • Evaluate departmental procedures and processes for accurate and efficient quality control checking of documentation and materials, including finished goods and raw materials in receiving.
  • Facilitate quality system improvement programs and initiatives.
  • Assist in the review of and approval of GMP documents such as executed batch records, validation protocols and reports, SOPs, and change controls to ensure compliance.
  • Manage departmental resources in accordance with company and Quality Director's goals.
  • Assist Quality Director as needed with preparation for and execution of audits.
  • Assist in management of risk assessments, complaints, CAPAs and NCMRs, perform trend analysis and maintain quality databases 

Job Requirements:

  • Bachelor's degree (B.S.) in Biology, Chemistry, or related science field.
  • Five (5) or more years of Quality Control (QC) experience in a life sciences company.
  • Two (2) or more years of experience in a QC Manager role required.
  • Good knowledge of applicable regulations and guidance documents for human blood products and medical devices, including ISO 9001; 2015, ISO 13485, FDA QSRs, European regulations, and USDA regulations for animal serum.
  • Excellent communication skills.
  • Excellent attention to detail, strong organizational skills.  Management experience required.
  • Computer literate with good working knowledge of Microsoft products (ERP experience is an added advantage)  

For immediate assistance, apply today!  Questions?  Call 714.971.0721 or 858.207.6311

 
Map: Vista CA
 
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