Quality Assurance Assistant

Pacific Biolabs•Hercules, CA

20d•$45,000 - $53,000

About The Position

Pacific BioLabs is an independent CRO providing cGMP/GLP testing in toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology. We are currently hiring to support our clients in the pharmaceutical, biotech, and medical device fields. Join us in our mission to improve public health through science! PBL has an immediate opening for a Quality Assurance Assistant in the Quality Assurance department. The primary duty of the Quality Assurance Assistant will be duties associated with archival of documents and laboratory records for regulated testing of pharmaceuticals, biopharmaceuticals, and medical devices. The Quality Assurance Assistant will be responsible for the overall archive process from organizing, filing retrieving and disposition of records. Types of records include, but are not limited to, GLP and GMP study data, records, reports, equipment, and facility records in paper and electronic form. The role includes maintaining an accurate inventory of all items in the archive.

Requirements

High school diploma or GED preferred
ESSENTIAL SKILLS
Excellent organizational skills
A record of high productivity
Strong communication skills
Computer skills
Job requires mobile use of hands and arms
Must be able to lift 50 pounds in a safe manner
Must be capable of working at a desk and computer terminal for up to four hours at a time and for up to eight hours on a given day
Must be capable of sustained concentration over printed and/or electronic materials for several hours at a time

Nice To Haves

Previous experience in records management in a GMP/GLP environment for pharmaceuticals and/or medical devices beneficial, but not required

Responsibilities

Acting as the site archivist for all GLP records according to 21 CFR Part 58
Working closely with Study Directors in orderly storage and expedient retrieval of all GLP raw data, documentation, protocols, specimens, and interim and final reports
Organizing and filing of GMP paper and electronic documents
Maintaining storage inventory
Retrieving documents and coordinating off-site storage
Scanning paper documents and converting into the electronic domain, while ensuring the result is a Certified True Copy per regulatory standards
Following all applicable Policies and Standard Operating Procedures
Any other duties as assigned by Supervisor