QA Specialist II

Title: QA Specialist II
Location: Austin TX 78759
Duration: 12 months

Job Description:

• 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. Master's degrees will not supplant any years of experience so must still come with minimum 3 years of experience

• This position is Nonexempt. Hours over 40 will be paid at Time and a Half.
• Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices).
• BS degree or 3-7 years equivalent experience.

Top 3 Skills:
1) ability to follow procedures
2) strong attention to detail
3) strong understanding of med device quality docs.