Respond to quality events and complete related documentation
Determine immediate physical containment and remediation
Assist in identifying, assessing, and containing defects
Conduct ASP's and manage the rework process
Provide rework instructions
Review documentation and perform auditing of manufacturing and packaging processes for cGMP compliance

High school diploma or GED required, preference for advanced education
Minimum of 2 years experience in an FDA regulated industry preferred, 6 months required
Understanding of and ability to apply cGMPs
Working knowledge of SOPs
Strong analytical skills
Excellent oral and written communication skills
Strong interpersonal skills
Ability to work independently against multiple deadlines
Understanding of equipment operation and manufacturing/packaging processes

QA Tech – 2nd

Key skills