Senior Specialist, Quality Control - Microbiology


Senior Specialist, Quality Control - Microbiology
Brisbane, CA

The Senior Specialist, Quality Control - Microbiology will perform QC activities associated with the GMP production and testing of the Companys products. Such products include recombinant Adeno-associated Viral Vectors (rAAV), gene-modified T cells and hematopoietic stem cells. The QC Specialist will be responsible for microbiology testing, method qualification and verification activities.

Responsibilities:
  • Serves as Subject Matter Expert for internal or external matters. Participates in inspection readiness activities and significantly involved in inspections by regulatory agencies
  • Responsible for authoring QC Micro related protocols, and reports for the purposes of method qualification/verification
  • Assist with preparing SOPs, results summaries, assay/equipment qualification and validation protocols, reports and other documentation
  • Ensures all issues/documentation associated with each process in assigned area have been resolved and approved are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures
  • Maintain QC laboratory equipment, systems and inventory for GMP compliant testing
  • Keep accurate and complete records per cGMP and compile trending reports as required
  • Other duties as assigned

Qualifications:
  • Minimum BS in Biology with a focus in Microbiology, Molecular, Cellular Biology or Virology. Masters degree preferred.
  • 5+ years of quality control microbiology experience in the pharmaceutical industry providing guidance to Manufacturing Operations, QA, and other cGMP areas is required.
  • Demonstrated in-depth experience of performing QC functions associated with the GMP production and testing of biologic products in an industry setting
  • Direct experience in microbiological method qualifications in accordance with USP/EP/JP guidelines
  • Knowledge of and the ability to implement CFR, USP, and ICH requirements.
  • Understand regulatory guidelines for microbiological test methods and translate guidelines into effective experimental designs.
  • Understanding of Microbiological assays such as Bioburden, Endotoxin (LAL), Growth Promotion, Sterility, Mycoplasma.
  • Experience tracking and trending Microbiological data, with the ability to identify and report aberrant results to manager and conduct or assist in laboratory investigations.
  • Strong Independent judgement, decision-making capability and ability to think conceptually and understand impact of decisions critical
  • Capability to establish good relationships with others who have different values, cultural styles and perspectives
  • Sound understanding and demonstrated application of statistical methods/tools
  • Excellent interpersonal, written and oral communication skills
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment
  • Physical requirements: work on your feet for several hours in a clean room environment
  • Travel requirements: Less than 10%

Job Details

Job Type: Direct Placement
Location: Brisbane, CA
Job ID: 21-10225
Date Updated: September 24, 2021