Description:
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.

EDUCATION/EXPERIENCE

• High school diploma or GED preferred
• Previous experience in records management in a GMP/GLP environment for pharmaceuticals and/or medical devices beneficial, but not required

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 capable of sustained concentration over printed and/or electronic materials for several hours at a time
  The pay range for this position is $45,000 to $53,000 per year. The base pay offered will take into account internal equity and also may vary depending on the candidate’s job-related knowledge, skills, and experience among other factors. This position will be eligible for medical, dental, vision, life insurance, 401k, and other benefits.
  Pacific BioLabs is an equal opportunity employer committed to diversity and inclusion. We are pleased to consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other legally protected factors

• 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
  Requirements: