QA Specialist
3 weeks ago
- This position will support 3rd party for medical devices, device history records and mostly will handle Batch Records.
- Must have Bachelor’s degree preferably in STEM Engineering / Science degrees are best fits.
- Must have a minimum of 3 years of experience in a medical device or pharma regulated environment, preferably in manufacturing.
- HEAVY Documentation role doing batch review, quality doc approvals Documentation exp. on Resume review of quality documents batch release experience or lab notebook (design, manufacturing or release).
- Experience in nonconformances and CAPA is a plus.
- Must have strong attention to detail. Must know and be able to follow procedures, review document requirements and determine if acceptable for procedure and if not escalate.
- Internship, co-ops and schooling will not be considered.
- Masters degrees will not supplant any years of experience so must still come with minimum 3 years of experience.
- Ability to follow procedures
- Strong attention to detail
- Strong understanding of med device quality docs.
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