Quality Assurance Specialist
On-siteLocation, Northern Cape, South Africa
Job Summary
Perform quality checks during manufacturing, filling, and packaging activities, including weight checks, seal integrity, line clearance verification, and label reconciliation. Document inspection activities in accordance with Good Documentation Practices and assist in batch record review for completeness. Support QA oversight of equipment setup, participate in deviation documentation, and aid in SOP preparation. Escalate compliance issues to senior staff and support regulatory inspections. Work Mon-Fri 7:00AM-4:30PM at the Johnson City, TN plant with occasional on-call availability for critical shifts. Requires standing, walking, and occasional lifting of 30 lbs.
Required Qualifications
- High School Diploma or equivalent
- Associate degree in a scientific or technical discipline
- 0–2 years of experience in Quality Assurance, Manufacturing, or a regulated industry (pharmaceutical/biotechnology)
- Basic understanding of cGMP and regulatory requirements for pharmaceutical production
- Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
- Strong attention to detail, communication, and organizational skills
- Ability to follow procedures, take direction, and work collaboratively in a team environment
- Must be available to respond to critical shift issues outside of scheduled hours on an as-needed basis
- Occasional lifting of up to 30 lbs
Desired Qualifications
- Associate degree in a scientific or technical discipline preferred
- Minimum 0–2 years of experience in Quality Assurance, Manufacturing, or a regulated industry (pharmaceutical/biotechnology preferred)
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