- Professional
- Office in Hercules
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 QC Reviewer. Responsibilities of the QC Reviewer include review and approval of data generated in the testing services departments, 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.
JOB RESPONSIBILITIES:
The QC 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 QC 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 $ $55,000 - $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.
Apply Now
