Analytical Services Quality Assurance Reviewer I/II

2 weeks ago

Hercules, United States Pacific BioLabs Full time
Job DescriptionJob Description
Description:

Pacific BioLabs is an independent CRO offering cGMP/GLP testing services in toxicology, biocompatibility, pharmacology, analytical chemistry, 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 Assurance Reviewer in the Analytical Services department. Responsibilities of the Quality Assurance Reviewer include review and approval of data generated in the Analytical services department, and the release of the report of analysis. The successful candidate will be responsible and thorough, with a willingness to apply their skills in a risk-managed approach to help Pacific BioLabs maintain the highest quality standards.


The Analytical Services Department provides testing for a variety of customer needs such as Research and Development, Pharmaceutical/Biotech Manufacturing, Medical Device commercialization, and Clinical Trial support. Service categories include method validation, release testing and stability testing. The purpose of the Analytical Services department is to provide results which ensure that our clients' end products will meet the pre-defined standards for safety, identity, strength, purity, and efficacy.


The Quality Assurance Reviewer will report to the Chief Quality Officer of PBL.


JOB RESPONSIBILITIES:

The Quality Assurance Reviewer will review test data as a subject matter expert, investigate deviation and out of specification occurrences, implement corrective actions, SOP revisions, creation and maintenance of On-the-Job Training records (OJTs), review protocols, and assist in trend reports in accordance with Company SOPs and regulatory requirements.


Major Responsibilities of the Quality Assurance Reviewer include:

  • Review study documentation for accuracy, clarity, and compliance with protocols, test procedures, Standard Operating Procedures (SOPs), compendial methods, and applicable regulations
  • Ensure Analyst's training was current at the time of testing
  • Determine whether equipment was within the period of qualification
  • Review electronic audit trails to ensure results are correct
  • Verify that method was applied properly
  • Ensure laboratory records reflect good documentation practices
  • Identify deviations from protocols or approved, written procedures
  • Review logbooks
Requirements:

EDUCATION/EXPERIENCE

  • Bachelor's degree in Analytical Chemistry or related field preferred
  • Previous experience in Quality Assurance, Quality Control, or testing for pharmaceuticals and/or medical devices preferred
  • Excellent data review and analysis skills
  • Solid organizational skills
  • Strong communication skills
  • Knowledge of pharmaceutical and/or medical device regulatory requirements expected (GLP, GMP, GCP)
  • Familiarity with standards such as ISO 17025, ISO 9001, ISO 13485 beneficial

The pay range for this position is $ $50,000 - $90,000. The base pay offered varies depending on the candidate's job-related knowledge, skills, and experience among other factors, including internal equity. 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.



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