Description
This Pharmaceutical company is looking for a QA specialist to be responsible for managing document control, CAPA and internal audit processes. This person will also be responsible for providing QA support to product development and manufacturing.Responsibilities:
- Coordinating CAPA process; perform review and closure of CAPA.
- Provides support to the change management program and document control activities. Coordinate internal audits.
- Track, trend, and report on assigned quality system metrics.
- Manage and maintain process deviation log and closures.
- Participate in the development of slides/data for Management Review.
- Conduct internal, external (supplier) and/or 3rd party audits.
- Participate in notified Body audits, regulatory inspections or 3rd party audits.
Provide support for regulatory filings.
Requirements:
- B.S. Degree in Molecular Biology or related field and 6 years of industry experience; in vitro diagnostic quality assurance preferred or
- A.S./High School Diploma plus 8 years of industry experience; in vitro diagnostic quality assurance preferred.
- A thorough understanding of GDP, GMP and FDA Quality System Regulations
- Quality engineering experience as well as experience with CLIA is a plus.
- Excellent problem solving and analytical skills
- Effective interpersonal and communication skills
To find out more about Real please visit www.realstaffing.com