Senior QA Associate, GLP #1234

San Diego Biotech Company
Job Location: 
San Diego, CA
Job Description: 

Job Summary
The successful candidate will assure GLP compliance with applicable regulatory requirements including audits, training programs and documentation review.

Primary Duties and Responsibilities
•Represents and interfaces with multiple departments and external providers to provide Good Laboratory Practices guidance in an effective manner.
•Develops, revises, and reviews Standard Operating Procedures.
•Performs internal GLP audits and or assists in the coordination of audits from outside parties.
•Addresses, resolves and mediates corrective actions in audit findings and prepares written reports as necessary; ensures training of internal staff as appropriate.
•Maintain QA CRO files.
•Trouble-shoots and takes the initiative on any QA-related issue for GLP compliance.
•Performs QA In-Study audits to ensures completeness and accuracy of information contained in all study documentation.
•Maintains the GLP archives; and participates in the implementation and maintenance of the document management system.
•Reviews protocols, study reports, and ensures that no deviations from approved protocols were made without proper authorization/documentation were performed in accordance with the GLP guidelines.
•Carry out job responsibilities and assignments safely and maintain a clean and safe work area.
•Other duties as may be necessary.


•Bachelor’s (BS) in the Life Sciences or related discipline.
•At least four to six years’ demonstrated experience in the GLP responsibilities listed above.
•Strong knowledge of GLP regulations and good documentation practices.
•Strong writing skills in protocols, SOPs and QA reports.
•Must have ability to listen, communicate effectively (both orally and in writing) and to interact with all levels within the organization. Excellent reasoning, interpersonal and organizational skills, and superior attention to detail.
•Extensive skills, knowledge and abilities with computers and software programs including Word, Excel, and document management programs.
•High attention to detail, and the ability to work in a fast-paced and team environment.

Career Paths
•Quality Assurance path
•Other Operations and Development opportunities are the primary career path

Special Considerations
•This job may necessitate working outside “regular” work hours.
•Some travel is required.
•While performing this role, the employee is frequently required to stand, walk, talk or hear, sit, use hands to finger, handle or feel, and reach with hands and arms. Specific vision abilities required by this job include close vision, color vision, and depth perception.
•While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, extreme cold, risk of electrical shock and risk of radiation. The noise level in the work environment is usually moderate.

Contact Information: 

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