Quality Documentation Specialist [United States]


 

Tenure: 90 Days (Parental Leave)

Location: Irvine, CA

The position title is QA analyst, in the area of quality assurance with oversight of operation and quality at the Bioscience Laboratories Irvine (BLI) facility.

Job Details:

This position is responsible for one or more of the following duties or activities:

  • Technical writing and authoring GMP reports including but not limited to:
  • Standard Operation Procedures (SOP)
  • Audit/inspection responses
  • Laboratory investigations
  • Documentation control support for site functional teams, including but not limited to quality assurance, quality control, manufacturing, validation and facilities.
  • Logbook issuance
  • Controlled copy issuance
  • Drafting, reviewing and approving Document Control Requests.
  • Administration of the site’s electronic document repository (One Vault).
  • Management of the site’s physical document control repository.
  • Filing of controlled records
  • Managing the controlled document check-in/check-out process.

General responsibilities:

  • Adhere to client EHS policies and procedures.
  • Remain current on assigned procedures.
  • Perform activities per effective procedures and in accordance to cGMPs and safe practices.

Job Type: Contract

Pay: $40.00 - $45.00 per hour

Experience level:

  • 3 years

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Work setting:

  • In-person

Ability to commute/relocate:

  • Irvine, CA 92602: Reliably commute or planning to relocate before starting work (Required)

Education:

  • Bachelor's (Preferred)

Experience:

  • Quality assurance: 3 years (Preferred)
  • Document management systems: 3 years (Preferred)
  • electronic document repository (One Vault): 2 years (Preferred)
  • Technical writing and authoring GMP reports: 3 years (Preferred)
  • pharma or biotech or medical device industry: 3 years (Preferred)

Work Location: In person

Speak with the employer
+91 9754872074

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