Our client, a industry pioneer with over 20 years of experience developing and manufacturing diagnostic products and reagents, is seeking a Quality Control and Technical Support Supervisor (SQC).
The Quality Control and Technical Support Supervisor (SQC) is responsible for assuring that only quality products are released for distribution. It is their job to ensure that products are tested to meet the applicable government regulations and industry standards.
The SQC is also responsible for resolving customer inquiries and complaints.
ESSENTIAL FUNCTIONS / JOB RESPONSIBILITIES
- Directs, manages, and trains employees working within the department.
- Effectively creates, implements, maintains and improves the Standard Operating Procedures (SOP), acceptance criteria, etc. for the department and products tested.
- Effectively and efficiently tests raw materials, in process and final product, and generates testing data.
- Releases products to QA for final approval.
- Ensures that all customer complaints and inquiries are resolved.
- Oversees investigations and documentation of customer complaints.
- 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.
- Participates in NCMRs, MRB and CAPAs.
SKILLS / KNOWLEDGE / ABILITIES
- Working knowledge of polymerase chain reactions, gel electrophoresis, capillary electrophoresis, Next-Generation Sequencing, DNA/RNA isolation and purification, DNA/RNA quantitation, and cDNA synthesis.
- Working knowledge with 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.
EDUCATION AND EXPERIENCE
- Requires knowledge and skills normally acquired through the successful completion of a BS Degree in a scientific discipline.
- 4+ years of experience in a GMP regulated industry or equivalent combination of education and experience.
- 2+ years of technical support or customer service experience.
- 2+ years of supervisory experience.