- Location: Dayton, OH area
- Type: Direct Hire
- Job #36655
Quality Assurance Specialist
Astrix has an outstanding opportunity for an experienced Quality Assurance Specialist based onsite at our clients just outside Dayton, OH. This is a direct hire opportunity offering great benefits!
Under minimal supervision, utilizing in-depth knowledge and understanding of cGMP (current Good Manufacturing Practices), ISO (International Organization for Standardization) 9001, QA (Quality Assurance) and the company’s production capabilities, the incumbent, under direction of the QA Assistant Manager, is responsible for the implementation, maintenance, and continuous improvement of CIS’ QMS (Quality Management Systems).
- Responsible for batch record review.
- Responsible for release of raw materials and finished products.
- Primary coordinator of the CIS CAPA (Corrective Action and Preventative Action) program. This includes reviews of sufficient root cause analysis, review/approve CAPA and effectiveness plans, perform effectiveness check, etc.).
- Assist and/or perform internal audits.
- Assist with external audits, including supplier audits.
- Perform related QA functions in support of ISO and the cGMP QMSs to include but not limited to: batch release and data review, document writing/revision, closing deviations, investigating OOS (Out of Specification) results, room clearances, non-conformance and training.
- Perform equipment qualification protocol reviews and approvals.
- Author annual product reviews (APRs) for APIs and related products.
- Perform any related work as required.
- Bachelor’s Degree in chemistry or related field of study preferred; equivalent applicable industry experience may be substituted for the degree requirement.
- Minimum 4-7 years of experience in a GMP setting.
- Knowledge and/or experience with ISO 9001, 21 CFR 212 and/or ICH Q7 is preferred.
- Excellent interpersonal, verbal and written communication skills are required.
- Attention to detail, organizational skills, ability to multitask and follow tasks through to completion. Work independently and in a team environment.
- Work is performed primarily in an administrative office environment; however, some work is performed in an industrial plant environment.
Offers a competitive salary and a comprehensive benefit program including generous paid time off, health insurance with 100% company paid deductibles, Long Term Incentives and 6% matching 401K plan. Also eligible for a 10% bonus of your yearly salary.