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Quality Assurance Associate

REF: VAC-116

  • Location:
  • Petaluma
  • Salary:
  • Competitive
  • Closing Date:
  • 31 Dec 2017
LGC provides a range of measurement products and services which underpin the safety, health and security of the public, including reference materials and proficiency testing, genomics solutions, services and instrumentation, and expert sample analysis and interpretation. Our customers are across a number of end markets including Pharmaceuticals, Agricultural Biotechnology, Food, Environment, Government and Academia. 

Job Summary:
This role is responsible for administrative and project based tasks within the Quality Assurance department. The Quality Assurance Associate role is pivotal in the daily functions of the Quality operation within a growing organization and meticulous attention to detail is a key to success in this role. The Quality Assurance Associate is primarily responsible for the Batch Record Review and Document Control processes at LGC Biosearch Technologies. This position is a full-time, non-exempt role that reports to Quality Management.

Key Responsibilities:
• Review of batch production records for completeness and release
• Review of analytical records and any supporting documentation to ensure compliance with cGMPs and LGC Biosearch policies and procedures
• Be well versed in the requirements of ISO 9001, ISO 13485, 21 CFR 820 and other applicable regulations
• Perform routine document control activities including creation and/or revision, processing, routing and review
• Work with various departments to set up appropriate documentation to improve efficiency and accuracy
• Assists in performing QC data review for batch record in-process and final QC approval
• Assist with internal Quality audits of internal departments, as necessary
• Assisting Quality Management with various projects, including but not limited to the trending of Quality Objective data and CAPA maintenance
• May be called upon to assist with the Supplier Qualification program
• Provide guidance and train others on Quality System and Quality Assurance procedures
• Perform additional tasks, as assigned

Skills and Abilities: 
•    Experience with Batch Record Review, Product Disposition and Document Control
•    Familiarity with ISO 9001:2008, ISO 13485:2003 and 21 CFR 820
•    Excellent people, verbal, and communication skills

•    AA, AS in Chemistry, Biochemistry, Biological Sciences or a similar scientific discipline or equivalent combination of education and experience
•    2-3 years’ experience in a diagnostics or medical device environment Preferred; Quality Assurance experience preferred

Computer Skills: 
Microsoft Office, Outlook, Word, and Excel, Powerpoint, Visio, Acrobat, and the ability to generate metrics, such as graphing tools.  Use of a web browser

Essential competencies and behaviors: 

•    Resonates and operates in line with LGC’s core value behaviors: Respect, Integrity, Passion, Curiosity and Brilliance

LGC Biosearch Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, age, status as a protected veteran, or status as a qualified individual with disability.

To apply, please use the following URL: