Bioanalytical QC Associate - Precision & GLP/GCLP Focus

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

Benefits offered by this job

Medical insurance

Dental coverage

Vision coverage

401(k) match

Paid time off

Paid holidays

Parental leave

Job summary

MSD in Gaithersburg, MD is seeking a Quality Control Associate for the Bioanalytical Laboratory to support GLP/GCLP study data review and documentation. You will perform QC reviews of study data, reports, logs, and equipment records under SOPs and GDP guidelines.

The role requires an Associate’s degree in biology or chemistry (or equivalent) and at least one year in bioanalytical QC in GLP/GCLP environments; familiarity with ELISA/MSD platforms is preferred.

Qualifications

• Associate's degree in biology, chemistry, or related scientific discipline, or equivalent work experience.
• Minimum of 1 year of experience in bioanalytical QC or sample testing in a GLP and/or GCLP environment is required; CRO experience preferred.
• Experience reviewing large, complex bioanalytical data packages strongly preferred.
• Exposure to ligand-binding assays (ELISA, MSD) platforms preferred.

Responsibilities

• Performs Quality Control review of study data, reports, logs, equipment records, and other laboratory documentation to identify errors and deviations.
• Communicates with investigators, study coordinators, and lab personnel to resolve issues in a timely manner.
• Keeps detailed records of findings and their resolution.
• Escalates unresolved issues to managers as necessary.
• Performs study activities according to SOPs, GLP/GCLP (if applicable), GDP, and statements of work.
• Participates in reviewing Out of Specification results for equipment and investigations.
• Participates in study meetings as required.

Skills

Attention to detail

Organizational skills

Cross-functional communication

Multitasking

GDP/ALCOA+ knowledge

Verbal/written communication

MS Office proficiency

Education

Associate's degree in biology, chemistry or related field

Tools

ELISA platforms

MSD platforms

SharePoint

Job description

MSD in Gaithersburg, MD is seeking a Quality Control Associate for the Bioanalytical Laboratory to support GLP/GCLP study data review and documentation. You will perform QC reviews of study data, reports, logs, and equipment records under SOPs and GDP guidelines.

The role requires an Associate’s degree in biology or chemistry (or equivalent) and at least one year in bioanalytical QC in GLP/GCLP environments; familiarity with ELISA/MSD platforms is preferred.