QC Technician III-Molecular Diagnostics
Our client, a industry pioneer with over 20 years of experience developing and manufacturing diagnostic products and reagents, is seeking a Quality Control Technician III.
Summary: The QCTIII is responsible for assuring that only quality products are released for distribution and to ensure that products are tested to meet the applicable government regulations and industry standards. This position is also responsible for resolving customer inquiries and complaints.
- Trains department employees.
- Effectively creates, implements, maintains and improves department Standard Operating Procedures (SOPs), acceptance criteria, etc., for products tested.
- Effectively and efficiently tests 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 respectfully communicates with external customers and internal customers.
- Other duties, as assigned.
- 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.
- Working knowledge of polymerase chain reactions, gel electrophoresis, capillary electrophoresis, DNA/RNA isolation and purification, cDNA synthesis, and Next Generation Sequencing.
- 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.
- Ability to manage multiple projects and changing priorities.
- Demonstrated Ability to learn and take on new challenges.