Job description

Job Title: QA Specialist I

Location: Hayward CA 94545

Duration: 10 Months

Job Type: Contract

Pay Rate: $35 - $40/hr

Work Type: Onsite

Description:

*Key Responsibilities*

• Support two integral QMS processes that are led from the Hayward Compliance group to ensure the site is cGMP
• compliant, and aligned with global requirements.

Global Document Gap Assessment Process:

• Create quality records in Trackwise and assign to SMEs to assess whether any gap remediation is necessary
• Monitor closure of gap assessments to ensure records do not go overdue
• Assess gap assessments for completeness and approve extensions and closure, if justified.

Risk Register Process:

• Assist with facilitation of the Risk Register process
• Monitor and drive closure of risk Action Plans and drive closure
• Author quarterly reports that are uploaded into the Hayward Document Management System (DMS)
• Provide updates as needed (e.g. Site Quality Council slides)

*Key Requirements*

• 1-3 years experience in GMP role (preferably Quality or QA) in Pharma or Biologics
• Experience with leading a project or team
• Highly skilled in Word and Excel
• Excellent written and verbal communication skills
• Comfortable working in a diverse, cross-functional team
• Ability to work on-site
• Preferred to have Six Sigma certification (white, green, black)
• Preferred experience with Trackwise, DMS, and/or MS Teams
• Preferred experience in Drug Substance Biologics
• Preferred knowledge of ICH Q7; 21 CFR 11; Eudralex vol 4 part II, annex 2, annex 11, annex 13

TekWissen® Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.

Job Type: Contract

Salary: $35.00 - $40.00 per hour

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Hayward, CA 94545: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• How many years of experience you have in Drug Substance Biologics in the background of GMP?
• How many years of experience do you have with Trackwise, DMS or MS Teams?
• Do you have knowledge in ICH Q7; 21 CFR 11; Eudralex vol 4 part II, annex 2, annex 11, annex 13?
• Do you have experience leading a project or team?

Work Location: One location

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