Microbiology Services Quality Control Specialist
San Francisco Bay Area, CA Microbiology Services
Job Type
Full-time, Part-time
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 Control Specialist in the Microbiology Services department. Responsibilities of the Microbiology Services Quality Control Specialist include design, coordination, and implementation of quality standards in support of regulated testing. The Microbiology Services Quality Control Specialist will perform peer review of microbiology testing data. 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 Microbiology 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 development, method validation, release testing and stability testing. The purpose of the Microbiology 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 Microbiology Services Quality Control Specialist will report to the Director of Microbiology Services, but will have a dotted-line report to the Associate VP of Quality Assurance. This secondary reporting line ensures QC and data review activities adhere to standards established by QA, and also provides opportunities for collaboration and cross-training of QC personnel across testing departments.


JOB RESPONSIBILITIES:

The Microbiology Services Quality Control Specialist 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), Protocols, and trending reports in accordance with Company SOPs and regulatory requirements.


Major Responsibilities of the Microbiology Services Quality Control Specialist include:

  • Review study documentation for accuracy, clarity, and compliance with protocols, test procedures, Standard Operating Procedures (SOPs), and applicable regulations
  • Ensure Analyst’s training was current at the time of testing
  • Determine whether equipment was within period of qualification
  • Review electronic data to ensure result is correct
  • Verify that method was applied properly
  • Ensure laboratory records reflect good documentation practices
  • Identify deviations from protocols or approved, written procedures
  • Initiate alert and documentation process for identified excursions from protocols, test procedures, and specified acceptance criteria
  • Review logbooks
Requirements

EDUCATION/EXPERIENCE

  • Bachelor’s degree in Microbiology or related field preferred
  • Certificate in Quality Assurance is a plus
  • 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 would be beneficial

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