Quality Control Analyst Regulated Studies (Research, Regulations and Compliance - Galveston) Experience Quality Control experience specific to data/product review/release

About the position

The primary responsibility of the Quality Control (QC) Analyst is to ensure technical data, scientific observations, and associated documentation of activities associated with the conduct of regulated scientific studies adhere to a defined set of quality criteria to satisfy compliance requirements. The QC Analyst works independently to prioritize, coordinate, organize, tabulate, review, manage, and track project activities to assure records are accurate and complete pursuant to studies conducted under the direction of, in whole or in part, the Institutional Office of Regulated Nonclinical Studies (ORNcS).

Responsibilities

• Schedule and manage QC activities to assure contract deliverables and milestones are met.
• Coordinate and manage activities between Study Directors, Veterinarians, and the Quality Assurance Unit (QAU).
• Assure data entries follow good documentation practices to ensure data quality and integrity.
• Comprehend regulatory compliance requirements per the Code of Federal Regulations, Food & Drug Administration (FDA) Good Laboratory Practice for Nonclinical laboratory Studies (21 CFR Part 58) and the FDA Animal Rule.
• Maintain current knowledge of applicable standards, trends, practices and Agency regulations and guidance documents.
• Identify deviations from study protocols and written standard operating procedures and communicate to the Study Director.
• Assist in deviation investigations when appropriate, and organization of deviation documentation.
• Identify high risk areas and develop and/or participate in mitigation activities to reduce potential compliance risks.
• Perform document/data verification activities for regulated studies.
• Assist Management, Study Directors, and QAU to ensure programs are efficient and in compliance with governmental regulations, quality agreements, study protocols, and applicable policies and standard operating procedures.
• Report findings in accordance with ORNcS Standard Operating Procedures (SOPs).
• Organize and lead meetings with study staff to identify documentation gaps or errors and provide education and/or direction for making corrections in accordance with good documentation.
• Perform QC review of laboratory study files, scientific datasets, technical forms, workbooks, records, and high visibility reports to assure that calculations, content, reference, are technically correct and complete for submission for QA audit.
• Review equipment records, training records, and other study associated documentation for accuracy and completeness.
• Organize and/or tabulate scientific data.
• Verify calculations and data tables.
• Compile scientific data in FDA Standard for Exchange of Nonclinical Data (SEND) format.
• Compile/Identify QC findings for reporting.
• Communicate insufficiencies to the Study Director and/or other appropriate personnel.
• Liaise between the Study Director and the QAU as appropriate.
• Prepare and organize study binders.
• Organize protocol and SOP deviations.
• Prepare, update, and maintain activity logs.
• Review SOPs to assure required formatting.
• Participate in SOP development, including writing, reviewing, and training.
• Participate in pre-study and departmental meetings.
• Serve as a liaison between scientific, veterinary, and regulatory teams.
• Prepare and track reports, including follow-up responses.
• Participate and assist QAU in the hosting of sponsor and Agency inspections.
• Assist in the organization and transfer of documents to ORNcS Records Retention.
• Support educational activities, including collaborative partnerships.
• Perform activities in accordance with Standard Operating Procedures (SOPs).
• Apply scientific knowledge and regulatory expertise in executing assignments and assisting other supported teams.

Requirements

• Bachelor's Degree (B.S./B.A.) or equivalent combination of education and experience relevant to the role.
• One year experience in research, clinical, environmental, or equivalent laboratory.

Nice-to-haves

• Bachelor's degree in chemistry, biology, microbiology, molecular biology, biological science, clinical laboratory science, or public health.
• 3-5 years' experience in research, clinical, environmental, or equivalent laboratory.
• Working knowledge of (A)BSL3/4 laboratory environments.
• Working knowledge of FDA 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies.
• Working knowledge of FDA 21 CFR Part 11, Electronic Signatures.