What are the responsibilities and job description for the Associate, QA Frontline (Overnight) position at TALENT Software Services?
Shift Details:
Alternate Wed, Thurs-Sat 1800-0700
Alternate Wed, Sun-Tues 1800-0700
Job details:
Skill Required:
Alternate Wed, Thurs-Sat 1800-0700
Alternate Wed, Sun-Tues 1800-0700
Job details:
- Provide on-the-floor QA oversight and support to manufacturing operations
- Review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations
- Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations
- Represent QA in support of deviations including active participation in Root Cause Analysis (RCA)
- Provide cGMP and compliance guidance to Manufacturing and Novato Technical Services (NTS) personnel
- Provide QA support including authoring, review, and approval of documents in Quality Management Systems in accordance with client's policies
- Perform area walkthroughs
- Perform other duties and projects as assigned by management
Skill Required:
- Prior batch record execution or review experience
- Prior experience in investigation, change control, other Quality Management Systems (QMS)
- Working knowledge of cGMPs
- Excellent written and verbal communication and interpersonal skills
- Must display strong analytical and problem-solving skills
- Manufacturing and Manufacturing Sciences experience preferred
