Bio-Technician - Quality & Regulatory Assurance Security Clearance

Position: Bio-Technician - Quality & Regulatory Assurance with Security Clearance
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. We currently have an exciting opportunity for a Bio-Technician at Diazyme Laboratories Inc.

located in Poway, CA. This person will join a multidisciplinary Research and Development, Quality and Regulatory team focused on Medical Device (IVD) product manufacturing.

DUTIES & RESPONSIBILITIES:

* Under general direction, performs laboratory experiments, analyzes data and writes scientific reports.

* Maintains, processes and complies a variety of confidential and sensitive electronic and hard copy records.

* Participates in research and development project meetings, assists in writing of operating procedures, safety guidelines, and technical documents.

* May function in a mentorship role to less experienced professional staff.

* Perform laboratory experiments, analyze and present data, write scientific report documents for various research and development projects.
* May participate in continuous improvement projects and prepare reports as requested.

* Maintains and updates a variety of confidential and sensitive electronic and/or hard copy records.

* Works in a safe manner in accordance with established operating procedures and practices.

* Maintains strict confidentiality of sensitive information.

* Other duties as assigned or required.

* 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.

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 associates degree in in biology, biochemistry, chemistry, immunology or related discipline and three or more years of related experience working in an academic or industrial setting.
Equivalent professional experience in an academic or industrial life science laboratory may be substituted in lieu of education.

* Bachelor's degree is preferred

* Requires a complete understanding of life science theories, principles and concepts as well as a working knowledge of laboratory protocols, and regulatory and safety requirements.

* Ability to perform laboratory experiments, analyze and interpret data and develop solutions to a variety of complex problems

* Excellent interpersonal, verbal and written communication skills to explain complex information and effectively communicate with all levels of employees and management.

* Ability to maintain confidentiality of sensitive information.

* Ability to contribute to the development of new processes.

* Ability to use office/scientific software and knowledge of basic computer operations and applications.

* Ability to work both independently and in a team environment as a leader is essential as is the ability to work extended hours as required.