What are the responsibilities and job description for the Quality Assurance Specialist position at Select Source International?
Job Title: QA Specialist II (Not an IT Role)
Location: Austin, TX 78759
Duration: 11 Months contract
Shift: Wednesday to Saturday (8.00 AM to 6.00 PM)
- HOURS Wednesday thru Saturday 8 am to 6 pm (10 hours a day) HOWEVER, must be able to train for 6 to 8 weeks on Monday thru Friday 9 am to 5 pm. Employee must be able to work onsite during these hours. Please be sure your candidates know this!
- 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 non-conformances 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.
- Top 3 Skills 1) ability to follow procedures 2) strong attention to detail 3) strong understanding of med device quality docs. Manager will consider candidates who are willing to relocate at their own expense.
