Senior QMS Specialist in San Francisco, CA at GPAC

Date Posted: 4/15/2021

Job Snapshot

Job Description

A biotech company in the Bay area is hiring a highly motivated Senior QMS Specialist. They are a diagnostics company for cardiovascular rapid point-of-care and home testing products.

This role will provide Quality and Regulatory support to the manufacturing and R&D activities. They will be responsible for maintaining the QMS systems, specifically the NC/CAPA, change control, and internal audit programs. The role will also be key in employee training and assist with the safety program.

This position offers an excellent compensation and benefits package; apply now!

Senior QMS Specialist Responsibilities:

  • Execute and maintain the NC/CAPA system
  • Maintain QMS system
  • Provide support to the QMS activities within the company, specifically the Design Control process
  • Act as liaison and work with R&D and manufacturing regarding quality and compliance issues
  • Perform the internal audits and assist with management review
  • Maintain the Training Program
  • Write technical documents - procedures, protocols, reports, validations, etc.
  • Document/Change control
  • Materials Review Board
  • Work on multiple, simultaneous projects, which require the ability to manage time flexibly and interact with a variety of people

Senior QMS Specialist Requirements:

  • S degree in Life Sciences (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, etc.), Engineering or a technical field, M.S degree preferred
  • Certification a big plus, such as RAC from RAPS
  • Knowledge of and 5 years of experience with Quality Systems regulations including 21 CFR 820 and ISO 13485
  • 1 year of experience with the execution of quality systems like CAPA, NCMR, deviations and document control
  • 2 years of experience with QMS system and technical writing
  • High level of experience and understanding of GMP/GLP system requirements
  • Experience with medical device inspection and testing, bio-analytical knowledge for antibody testing/verification
  • Strong regulatory compliance and technical background, statistical knowledge and analytical skills
  • Excellent skills in organization, record keeping and oral and written communications
  • Strong interpersonal skills and multi-cultural awareness, able to negotiate and build consensus and to develop effective relationships through collaboration
  • Able to adapt to a fast-paced work environment and must have a strong work ethic to complete assignments with high quality under tight deadlines

For additional information on this opportunity, contact Miki Miller directly at 605.215.5248.
You can email me directly at: miki.miller@gogpac.com

All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.

GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States for the past 31 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.