Quality Specialist
San Francisco Bay Area, CA Quality Assurance
Job Type
Full-time, Part-time
Description

Pacific BioLabs is an independent CRO offering cGMP/GLP testing services in toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology. Founded in 1982, PBL is beginning a new chapter, applying significant investment and energy towards modernizing workflows, upgrading facilities and most importantly, enhancing our employee experience. We are looking for talented, energetic scientists and professionals to share in our passion for our mission to enhance public health through the testing services we provide to our pharma, biotech and medical device clients. If you are up for a challenge, come join our team!


PBL has an immediate opening for a Quality Specialist in the Quality Assurance department. The primary duty of the Quality Specialist is data review and inspection of testing activities (toxicology, microbiology, cytotoxicity, and analytical chemistry). Other responsibilities include performing investigations and assessments. The Quality Specialist operates in a team environment and consequently must perform activities with diplomacy and tact. The Quality Specialist role presents the employee with an opportunity to both learn the skills required to advance in the field of quality assurance and at the same time play a crucial role in the company’s long-term success. Local candidates preferred.


RESPONSIBILITIES FOR THE QUALITY SPECIALIST INCLUDE BUT ARE NOT LIMITED TO: 

  • Ensure that the company’s system for handling quality complaints is functioning in an efficient and timely manner
  • Ensure testing compliance is consistent with regulatory requirements and internal SOPs, methods, protocols, study plans, and/or other approved written procedures
  • Participate in quality improvement projects designed to improve the nature of Pacific BioLabs' customer service
  • Assist Senior Management in administering the company’s Quality Management efforts
  • Assist Study Directors and Testing Staff in meeting regulatory requirements
  • Assist Quality Management in quality follow-up procedures and/or corrective action
  • Assist in the review of data generated by technical departments as well as the Final Report/Report of Analysis
  • Perform electronic data and audit trail verification when appropriate
  • Assist in the review and approval of deviation notices and investigations generated by technical departments
  • Assist in the review and approval of unexpected/out of specification notices and investigations generated by technical departments
  • Assist in processing change controls
  • Assist in processing corrected, amended and/or reissued reports
  • Assist Quality Management in meeting regulatory requirements (GLP, GMP, QSR, etc.)
  • Monitor and ensure the process whereby testing requested by Pacific BioLabs’ client is subcontracted to other laboratories
  • Assist Quality Management in the review and approval process for company SOPs
  • Assist Quality Management in maintaining the company’s Form Control System
  • Compliance with GMP/GLP and ISO requirements
  • Compliance with USP, JP, EP, ICH, OECD, AAMI and/or other guidelines/regulations
  • Knowledge of and familiarity with all SOPs
  • Participate in staff meetings and training sessions
  • Other duties as assigned by Supervisor
Requirements

EDUCATION/EXPERIENCE

  •  B.S. in Science or Life Science field (or equivalent in training/experience) preferred

ESSENTIAL SKILLS

  • Critical thinking and problem-solving skills
  • Excellent organizational skills and ability to prioritize multiple tasks
  • Ability to obtain and assess objective evidence
  • Proficiency in Microsoft Office

Salary will be commensurate with education and experience. A benefits package including medical, dental and 401(k) is also offered.


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.


PM21