Bioanalytical Quality Associate

Responsibilities

• Perform technical QC reviews of Bioanalytical Study Reports and Study Files, ensuring accuracy in analytical data, result specifications, and conclusions.
• Verify adherence to data transfer specifications (DTS) and laboratory policies.
• Plan and execute internal audits of laboratory processes, GLP/GCLP studies, training files, and archives.
• Manage the resolution and closure of audit findings, deviations, and CAPAs in collaboration with the Bioanalytical Principal Investigator.
• Oversee laboratory facility and equipment compliance, including scheduled calibrations and maintenance (IQ/OQ/PQ).
• Manage archiving activities for study records and data in accordance with SOPs.
• Act as a subject matter expert for laboratory documentation change orders and continuous improvement initiatives.

Requirements

• Bachelor’s degree in a health or science-related field.
• Minimum of 5 years of experience in a Quality role, preferably within a GLP or cGMP environment.
• Strong knowledge of FDA Guidance for Industry and CLIA regulations.
• Proficiency in MS Office suite and experience with electronic file management via SharePoint.
• Strong organizational and project management skills with the ability to work independently.

Preferred Qualifications

• Professional Quality Certification (e.g., ASQ, ASCP).
• Experience with protein-based immunoassays, antibody-based assays, or reagent development.
• Training and experience working in a Biosafety Level 2 (BSL-2) laboratory.

Benefits

• Comprehensive medical, dental, and vision coverage.
• 401(k) plan with company matching.
• Paid vacation, sick leave, holidays, and parental leave.
• Company-paid short-term and long-term disability insurance.
• Additional perks including fitness club contributions and pet insurance.

About the Company

MSD is a leader in providing advanced bioanalytical services, dedicated to maintaining the highest standards of quality and regulatory compliance to support scientific discovery and clinical development.