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Quality Systems Specialist

3 months ago

Hercules, United States QuinTalent Inc Full time

Quality System Specialist I - Open to College Students in the field of Molecular Biology / Chemistry / BioTech

Work is for 15 hrs / week onsite at Hercules, CA - 6 months contract - May be extended ***

6 months, may be extended - pay is $28/hr.

The candidate will support our client's implementation of Design History File management within the new global eQMS system. The Quality System Specialist’s primary duties will include:

  • Collation of legacy on-market product DHF documentation identified to be transferred into the new eQMS by functional SMEs. This includes working with cross functional SMEs to define documentation meta data, ensure appropriate supporting documentation is included in document transfers, support completion of document transfer spreadsheets to support automated document migration from legacy systems and support verification activities post transfer.
  • Update documents (procedures, work instructions and templates) transferred from legacy document control system (local eQMS)
  • Work with global sustaining teams to evaluate legacy DHF files impacted by ongoing change control projects to determine if manual migration activities are required. If so, support manual migration by initiating document workflows.
  • Work with SMEs to update other QMS and DHF documentation as needed (per legacy DHF review activities) and coordinate review and approvals in eQMS as required.

How You'll Make An Impact:

  • Support a quality environment and mindset throughout the business by working closely with design and sustaining teams to support compliant and accurate product design history files (DHF) including ensuring accurate binder structures are established in the eQMS, ensure legacy files are accurately transferred and new and/or modified deliverables are complaint with internal procedures and external regulations and standards.
  • Ensuring updates to procedures, work instruction and templates into the new eQMS format are completed according to established project timelines.
  • Ability to work in an ever-shifting environment and possess a high level of patience to support cross functional teams with shifting priorities.
  • A self-started who can work independently and possesses a sense of ownership and accountability to the activities assigned to them.

What You Bring:

  • Bachelors in Biology / Chemistry or life science field - College Students local to Hercules, CA are welcome to apply
  • 0-1years experience in a regulated manufacturing industry or equivalent combination of education and experience.
  • Detail-oriented and ability to multitask.