Quality Assurance Specialist 2 - San Diego, CA | Biospace
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Quality Assurance Specialist 2

Biological Dynamics

Location:
San Diego, CA
Posted Date:
7/6/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
QA, Quality, Quality Assurance,

Job Description

Based in San Diego, CA, Biological Dynamics, Inc. (BioDyn) is a privately held molecular diagnostics company and a pioneer in the field of Alternating Current Electrokinetics (ACE)-based diagnostics.  At BioDyn, we are developing novel diagnostic solutions to screen, diagnose and manage high burden conditions, such as cancer. Our diverse team shares passion for improving patient care, a focus on cutting-edge technology, and a deep commitment to innovation, which shapes the future of our company and drives our innovative culture. To learn more about BioDyn, please visit our website, www.BiologicalDynamics.com, or feel free to view a TEDx Talk given by BioDyn’s Co-founder and CEO, Dr. Raj Krishnan, at https://www.youtube.com/watch?v=wMsOYqJ4ShA.

Of immediate need to BioDyn is a full-time Quality Assurance Specialist 2.   This role will be primarily responsible for document and change control, control of records, equipment calibration, monitoring and maintenance, and training management. This is a very busy role tasked with the handling of many repetitive administrative tasks.  The ideal candidate must possess strong organizational, time management and planning skills in order to manage and prioritize multiple tasks successfully.  In addition, the candidate must possess exceptionally high quality standards, detail orientation, and excellent oral and written communication skills.  The ability to work independently with limited supervision and exercise sound judgment will be critical to the individual’s success in this role.  

Key Responsibilities:

•   Maintain an effective document and record retention program;

•   Create, edit, and maintain procedural documentation including, but not limited to, department policies, procedures, and guidance documentation in the corporate quality system;

•   Coordinate the paper-based documentation system from document number assignments through processing documents, change orders, implementation, and training;

•   Work with internal customers to resolve document format issues such as fonts, tables, pictures, step numbers, template formats and even re-writing or writing the document for the internal customer;

•   Monitor change activities approval/implementation and be able to resolve issues of varying complexity;

•   Organize all quality records, physical and electronic versions;

•   Update quality system logs, linking them to documents and records;

•   Work with management to choose and implement an electronic documentation system;
•   Facilitate quality training to employees;

•   Execute and maintain equipment maintenance and calibration program;


•   Assist in supplier selection and monitor their performance on a regular basis;

•   Assist in non-conforming and corrective/preventative action processes;

•   Assist in developing quality systems & make recommendations for improvements to existing Quality systems;

•   Support internal and/or external audits in compliance with ISO 13485 and 21CFR820 requirements;

•   Serve as QA interface with limited responsibilities to other departments; and

•   Additional responsibilities as needed and assigned.

Requirements

•   Bachelors Degree in science or engineering discipline, or related field desired;

•   3 to 5 years of relevant QA experience in a scientific organization;

•   Experience with delivering training material to groups;

•   Experience with choosing and implementing an FDA and ISO 13485 compliant;

•   electronic document management system strongly preferred;

•   Experience with MS Office, MS Project, Visio and PowerPoint required;

•   Previous experience in a medical device/IVD environment, a plus;

•   Quality certification, a plus;

•   and maintain accurate records;

•   Strong organizational skills, time management and planning skills;

•   Ability to manage and prioritize multiple administrative tasks; and

•   Ability to work independently with limited supervision and exercise sound judgment within the defined procedures and practices to determine appropriate actions.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the individual may be required to occasionally lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects of a negligible weight frequently or continuously.  Sedentary work involves sitting the majority of time.

The successful candidate will join a dynamic, innovative team focused on developing cutting edge technologies in a fast-paced, collaborative environment. Biological Dynamics is an equal opportunity employer.  We offer a positive, diverse and exciting work environment with competitive compensation and benefits. To apply for this position please email your cover letter and resume.