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Job Description
As posted by the hiring company
Job Overview:
Job Summary
Diazyme, an affiliate of General Atomics, is a cGMP and ISO 13485 certified medical device manufacturer. Diazyme uses its proprietary enzyme and immunoassay technologies to develop diagnostic reagents which can be used on most automated chemistry analyzers in user-friendly formats. Products include test kits for diagnosis of cardiovascular disease, liver disease, cancer markers, renal disease, diabetes, sepsis and electrolytes.
Under general 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 for the product. Performs a variety of tests to aid in the maintenance and certification of test instruments and apparatus to ensure compliance with regulatory requirements. Monitors, verifies, and documents quality of product(s) in accordance with statistical, regulatory, company, or other approved control procedures.
Under general 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 for the product. Performs a variety of tests to aid in the maintenance and certification of test instruments and apparatus to ensure compliance with regulatory requirements. Monitors, verifies, and documents quality of product(s) in accordance with statistical, regulatory, company, or other approved control procedures.
DUTIES & RESPONSIBILITIES:
- Performs analysis of raw material, packaging material, in-process material, and finished products according to established procedures
- Prepares various reagents, solutions, instruments, and apparatus to support the testing activities.
- Cleans, tests and prepares various instruments and apparatus to ensure continued certification and compliance with regulatory requirements.
- Develops and analyzes a variety of 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 may present data at team meetings and management reviews.
- Completes and reviews various good manufacturing practices, safety, and regulatory required forms. Ensures all appropriate documentation is updated, reported and filed.
- May provide training, direction, and guidance to less experienced staff.
- Responsible for observing all laws, regulations, and other applicable obligations wherever and whenever business is conducted on behalf of the Company.
- Expected to work in a safe manner in accordance with established operating procedures and practices.
- Other duties as assigned or as 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 one or more year(s) 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 general understanding of quality procedures in a manufacturing environment as well as general knowledge of quality concepts and principles including the ability to read and understand engineering drawings and specifications.
- Must possess:
- The ability to identify and interpret data.
- Interpersonal, verbal and written communication skills to explain general information effectively with all levels of employees.
- Organization skills to maintain flow of work within the unit.
- The ability to establish priorities.
- The ability to maintain the confidentiality of sensitive information.
- General 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.
