Quality QMS Specialist

1 month ago

San Diego, United States Hydrogen Group Full time
  • Location: San Diego, CA (fully onsite)
  • Contract: 7-months
  • Pay rate: $45.00 - $55.00 per hour

Summary

· Join us as Quality QMS Specialist-Contract and you'll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people's lives.

· As the Quality QMS Specialist-Contractor, you will coordinate the day-to-day document control operations in compliance with procedures and applicable regulations and standards and participate in other tasks as necessary related to Quality Management Systems.

Responsibilities

· Coordinate with pertinent internal functional groups as needed to facilitate timely processing of new documents, document changes and change controls.

· Review internal documents prior to issuance to confirm aligns with Antares Pharma standards and works with document owners / change authors to resolve deficiencies.

· Support maintenance of QMS record storage, including preparation and documentation of records for transfer to off-sire location or disposal.

· Administrate the review of internal documents according to planned arrangements and external documents upon notification of update release.

· Provide copies of change controls, reports and other applicable documents to partners.

· Provide support to the continual improvement of document control and record management.

Qualifications

· Minimum of two years of college with minimum of 3 years experience in the medical device or pharmaceutical industry with document and change control management experience (a combination of education and experience may be considered)

· Strong computer skills. Proficient with Microsoft Office business software, particularly Microsoft Word, Excel and PowerPoint.

· Experience with eQMS software for document and record management. Familiarity with document control management using MasterControl a plus.

· Knowledge of GMP, ISO, QSR and other applicable international standards, regulations, directives and guidance.

· Familiarity with CAD software and reading technical drawings.

· Experience with document indexing structures, scanning and high-volume printing.

· Proven track record of communicating effectively, both orally and written.

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