Bioanalytical QC Associate: Detail-Driven Data Reviewer

MSD; Gaithersburg (MD); On-site; USD 46,000 - 66,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company matching

Paid vacation

Paid holidays

Paid parental leave

Job summary

MSD is seeking a Quality Control Associate to support the Bioanalytical Laboratory, performing Quality Control review of study data and documentation to ensure accuracy and adherence to plans, protocols, and policies. The role requires attention to detail and collaboration with BPIs, coordinators, and lab staff in a GLP/GCLP environment.

With 1 year of QC experience in bioanalytical settings, you will follow SOPs and GDP while maintaining thorough records.

Qualifications

• 1 year of bioanalytical QC or GLP/GCLP environment required.
• Bachelor's degree preferred.
• Experience reviewing large bioanalytical data packages.
• Exposure to ELISA, MSD platforms preferred.

Responsibilities

• Perform QC review of study data, reports, logs, equipment records to identify errors and deviations.
• Communicate with BPIs, study coordinators, and lab personnel to resolve issues.
• Keep detailed records of findings and resolutions.
• Escalate unresolved issues to managers as necessary.
• Follow SOPs, GLP/GCLP (if applicable), GDP and statements of work.
• Review Out of Specification results for equipment and other investigations.
• Participate in study-related meetings as required.

Skills

Attention to detail

Organizational skills

Multi-tasking

Cross-functional communication

MS Office

SharePoint

GDP knowledge

Education

Associate degree

Bachelor's degree preferred

Tools

MS Office

SharePoint

Job description

MSD is seeking a Quality Control Associate to support the Bioanalytical Laboratory, performing Quality Control review of study data and documentation to ensure accuracy and adherence to plans, protocols, and policies. The role requires attention to detail and collaboration with BPIs, coordinators, and lab staff in a GLP/GCLP environment.

With 1 year of QC experience in bioanalytical settings, you will follow SOPs and GDP while maintaining thorough records.