Title:  Senior Quality Assurance and Control Associate (Compliance)

Division:  Molecular Virology and Microbiology
Schedule:  Monday - Friday, 8:00 a.m. - 5:00 p.m.
Work Location:  Texas Medical Center, Houston, TX
Salary Range:  $61,913 - $80,490
FLSA Status:  Exempt
Requisition ID:  4095
Job Purpose

The Senior Quality Assurance and Control Associate monitors research activities to ensure compliance with all relevant local, federal, and state regulatory and institutional policies while identifying protocol problems, reviewing study-related documents, and ensuring that appropriate corrections are made and documented for missing or incomplete data.

Job Duties
  • Maintains knowledge in FDA and OECD GLP regulations, GCP regulations as well as domestic and international guidance documents and CAP/CLIA requirements
  • Evaluates current laboratory practices. Recommends changes or modifications to laboratory procedures in order to facilitate compliance with GLP standards.
  • Conducts audits (protocol/plan, raw data and final report audits for accuracy and completeness, verifying that the final reports accurately reflect the raw data generated) and in-lab critical phase inspections of any GLP and/or GCP-regulated study performed at the laboratory for conformance to the final protocol/plan, SOPs, and relevant GLP/GCP/GCLP regulations.
  • Prepares written records of all inspections and audits. Submits findings to the study director and/or principal investigator (or laboratory supervisor, when appropriate) and management, indicating deviations from or conformance with applicable regulations, protocol/plan and SOPs.
  • Reports periodically to management regarding quality issues and status of inspection/audit activities.
  • Ensures SOPs, forms and other controlled documents are current and reflect laboratory processes and meet regulatory requirements.
  • Hosts client and regulatory inspections.
  • Assists in reviewing, writing and maintaining up-to-date SOPs and controlled documents for unit.
  • Updates the master schedule as required by GLPs.
Minimum Qualifications
  • Education Required: Bachelor's degree.
  • Experience Required: Four years of relevant experience.
Preferred Qualifications
  • Bachelor's degree in biology, chemistry or related field.
  • At least 4 years of experience in QA or QC, with focus on bioanalytical and/or analytical.
  • Familiarity with GLP, GCLP, regulated guidance and CAP/CLIA requirements.
  • Knowledge of regulations and guidance applicable to working as laboratory QA
  • Detail-oriented and highly organized
  • Effective oral and written communication skills
  • Excellent interpersonal skills
  • Computer skills: working knowledge of Internet, MS Word, Excel, Outlook, Powerpoint, Box and Dropbox
  • Ability to multitask and work under pressure of multiple projects and deadlines
  • Ability to effectively prioritize workload and manage changes in direction
  • Must be able to record and keep essential records for a regulated environment.





Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.