Location: Austin, TX
Duration: 8 Months
Description:
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:
Ability to follow procedures
strong attention to detail
strong understanding of med device quality docs.
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.