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.
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.
Education Required: Bachelor's degree.
Experience Required: Four years of relevant experience.
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.
Baylor College of Medicine fosters diversity among its students, trainees, faculty and staff as a prerequisite to accomplishing our institutional mission, and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care.
- Diversity, respect, and inclusiveness create an environment that is conducive to academic excellence, and strengthens our institution by increasing talent, encouraging creativity, and ensuring a broader perspective.
- Diversity helps position Baylor to reduce disparities in health and healthcare access and to better address the needs of the community we serve.
- Baylor is committed to recruiting and retaining outstanding students, trainees, faculty and staff from diverse backgrounds by providing a welcoming, supportive learning environment for all members of the Baylor community.