57404BR
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 general supervision, this position is responsible for performing quality control testing of raw material, packaging material, in-process material, and finished products according to established procedures to determine conformance to accepted specifications. 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 for QC 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.
Job Category:
Quality
Experience Level:
Entry-Level (0-2 years)
Workstyle:
Onsite
Full-Time/Part-Time:
Full-Time Hourly
Pay Range Low:
48,500
Pay Range High:
72,125
Travel Percentage Required:
0% - 25%
Relocation Assistance Provided?:
No
US Citizenship Required?:
No
Clearance Required?:
No
General Atomics is committed to hiring and retaining a diverse workforce. We are an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, religious creed, ancestry, gender, pregnancy, sex, sexual orientation, transitioning status, gender identity, gender expression, national origin, age, genetic information, military and veteran status, marital status, medical condition, mental disability, physical disability, or any other basis protected by local, state, or federal law. In accordance with applicable federal law, General Atomics takes affirmative action to employ and advance the employment of qualified protected veterans and individuals with disabilities. We also prohibit compensation discrimination under all applicable laws. U.S. Citizenship is required for certain positions. To learn more, please review the EEOC’s "Know Your Rights: Workplace Discrimination is Illegal" poster.