Quality Control Technician
San Diego Metro Area, CA
- Must have experience in a regulated environment, GMP documentation, NCMRs.
- NGS is a plus but it isn t a must have if they don t have it either.
- A background in QC is ideal but manufacturing background could work as well.
- Candidates with an R&D background will not be considered
- Requires knowledge and skills normally acquired through the successful completion of a BS Degree in a scientific discipline.
- 5+ years of experience in a GMP regulated industry or equivalent combination of education and experience.
- Educates department staff.
- Successfully generates, implements, preserves and enriches department Standard Operating Procedures (SOPs), acceptance criteria, etc., for products tested.
- Effectively and economically proofs raw materials, in process and final product and generates testing data.
- Releases products to Quality Assurance for final approval.
- Ensures that all customer complaints and inquiries are resolved.
- Conducts and maintains the real time stability study testing.
- Maintains inventory materials used in quality control.
- Evaluates price, quality and availability of raw materials used by the department.
- Cooperates and communicates with external and internal customers.
- Working knowledge of medical device quality and regulatory requirements including QSR and ISO quality system standards and the IVD Directive.
- Working knowledge of a production environment, including use of SOPs, batch records, ERP systems and purchasing specifications.
- Ability to follow Standard Operating Procedures (SOPs).
- Proficient in Microsoft Office Suite (Outlook, Word, Excel and Powerpoint).
- Working knowledge of the use of Adobe Acrobat, Illustrator, and Photoshop.
- Attention to detail.
- Ability to work independently as well as in a team environment.
- Excellent communication skills with the ability to train employees.