Quality Assurance Specialist I/II at Pacific BioLabs

Hercules, California, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Jan, 26

Salary

90000.0

Posted On

15 Oct, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Regulatory Compliance, Documentation, Interpersonal Relations, Teamwork, Organizational Skills, Communication Skills, Listening Skills, Scientific Principles, GMP, GLP, ISO, Client Audits, OOS Investigations, Deviation Reporting, Internal Audits

Industry

research

Description

Description Pacific BioLabs is an independent CRO providing cGMP/GLP testing in toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology. We are currently seeking energetic scientists and professionals to support our clients in the pharmaceutical, biotech, and medical device fields. Join us in our mission to improve public health through science! Pacific BioLabs has immediate opening for full time Quality Assurance Specialist I/II in the Quality Assurance Department. The QS Specialist is responsible for assisting management with the maintenance of the Quality Systems. The QA Specialistmust be sensitive to the demanding regulatory compliance requirements attending to the operation of a pharmaceutical testing laboratory. This job also requires the ability to demonstrate a high commitment to interpersonal relations. Work must be performed in compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Quality System Regulations (QSR), ISO quality management system requirements, and other necessary regulatory requirements (e.g. OSHA, EPA, CDC, USDA, OLAW, etc.) as required by the task at hand, as well as any additional duties as assigned by the Chief Quality Officer. PRIMARY RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO Ensure that all client requests for information pertaining to laboratory services are met in a timely and effective manner Assist in the documentation and resolution of client complaints Issue laboratory reports in a timely manner Assist in the review and approval of method transfer and validation reports Host client audits of the laboratory Play a role in departmental or company-wide projects designed to improve the internal efficiency and overall quality of work performed at the laboratory Play a role in creating and maintaining an atmosphere of teamwork throughout the laboratory Provide support in the maintenance of Quality Assurance processes, such as OOS investigations, deviation reporting, vendor approval, internal audits, trending, CAPA, and other quality systems as directed by Quality management Maintain thorough knowledge and understanding of all general SOPs pertaining to the laboratory Maintain thorough knowledge and understanding of GMP/GLP/ISO requirements as these pertain to work performed in the laboratory Assist in the process for preparation and review of department SOPs, worksheets, and data forms when appropriate Requirements QUALIFICATIONS Associate or B.S. in Chemistry, Biology, Microbiology, or equivalent experience required. Minimum of 1-2 years of experience preferably in Life Sciences and/or IT supporting cGMP Operations. Thorough knowledge of scientific principles required. Must be able to work with a diverse group of individuals. Must have a solid grasp of the fundamentals and importance of teamwork. Excellent organizational skills Strong communication skills Good listening skills. Knowledge of pharmaceutical and/or medical device regulatory requirements expected (GLP, GMP, GCP). The pay range for this position is $55,000 to $90,000 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.

Responsibilities

The Quality Assurance Specialist is responsible for assisting management with the maintenance of the Quality Systems and ensuring compliance with regulatory requirements. This role includes documentation of client complaints, issuing laboratory reports, and hosting client audits.