Quality Control Technician

Job Summary Diazyme, an affiliate of General Atomics, is a cGMP and ISO 13485 certified medical device manufacturer. Diazyme uses its proprietary enzyme technologies to develop diagnostic reagents which can be used on most automated chemistry analyzers in user-friendly formats. Their products include test kits for diagnosis of cardiovascular disease, liver disease, cancer markers, renal disease, diabetes, and electrolytes.

Under limited supervision, this position is responsible for performing analysis of raw material, packaging material, in-process material, and finished products according to established procedures to determine conformance to accepted specifications. The role involves conducting tests to maintain and certify test instruments and apparatus for regulatory compliance, monitoring and documenting product quality following approved control procedures, and maintaining, analyzing, and developing various records and reports. The individual may represent the organization to outside customers and vendors and provide direction and guidance to less experienced staff.

DUTIES & RESPONSIBILITIES:

• Conducts complex analysis of raw material, packaging material, in-process material, and finished products following established procedures.
• Prepares reagents, solutions, instruments, and apparatus for testing activities.
• Cleans, tests, and prepares instruments and apparatus to ensure certification and regulatory compliance.
• Develops and analyzes confidential and sensitive electronic and/or hard copy records, reports, and files.
• Participates in the development of test protocols, quality control documentation, and record keeping.
• Prepares reports and presents data at team meetings and management reviews.
• Completes and reviews good manufacturing practices, safety, and regulatory forms, ensuring proper documentation is updated, reported, and filed.
• Provides training, direction, and guidance to less experienced staff.
• Observes all laws, regulations, and applicable obligations while conducting business on behalf of the company.
• Works safely following established operating procedures and practices.
• Performs other duties as assigned or required.

We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply.

Job Qualifications:

• Typically requires an associate's degree or trade school certification along with three or more years of experience working as a quality technician in a manufacturing environment. May substitute equivalent experience as a quality technician in lieu of education.
• Requires a detailed understanding of quality procedures in a manufacturing environment as well as detailed knowledge of quality concepts and principles including the ability to read and understand moderately complex engineering drawings and specifications.
• Must possess:
  1. the ability to identify, analyze and interpret data;
  2. interpersonal, verbal and written communication skills to explain detailed information effectively with all levels of employees including management and outside customers and vendors;
  3. organization skills to maintain flow of work within the unit;
  4. the ability to establish priorities;
  5. the ability to maintain the confidentiality of sensitive information; and,
  6. detailed knowledge of computer operations and applications and word processing and spreadsheets.
• Must be able to work both independently and in a team environment and be able to work extended hours as required.

Salary:$52,020 - $77,325