Quality Control Associate Bioanalytical Laboratory

MSD Careers • Gaithersburg, MD

2d

About The Position

The Quality Control Associate provides support to the Bioanalytical Laboratory (BAL) staff for sample testing studies, including those performed under applicable elements of Good Laboratory Practices (GLP) and/or Good Clinical Laboratory Practices (GCLP), under direct supervision. This includes, but is not limited to, performing Quality Control review of study data and all laboratory and study-related documentation for accuracy and adherence to applicable plans, protocols, and policies.

Requirements

• Associate’s degree in biology, chemistry, or other related scientific discipline, or equivalent work experience required
• Minimum of 1 year of experience in bioanalytical QC or sample testing in a GLP and/or GCLP environment is required; experience in a contract research organization is highly preferred
• Experience reviewing large, complex bioanalytical data packages strongly preferred.
• Exceptional attention to detail with demonstrated commitment to excellence and performance
• Excellent organizational skills with the ability to prioritize workload and meet strict deadlines with an appropriate sense of urgency.
• Ability to multi-task and work productively in a demanding environment with changing priorities
• Basic understanding of PK, ADA, NAb, serology, and biomarker assays.
• Knowledge of GDP (ALCOA+) requirements
• Strong cross-functional communication skills both verbally and in writing, with the ability to collaborate effectively with other teams and departments
• Ability to receive, understand, and follow verbal and written directions
• Proficiency in MS Office suite; familiarity with electronic file management using SharePoint
• This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.

Nice To Haves

• Bachelor’s degree 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 and works with bioanalytical principal investigators (BPIs), study coordinators, and lab personnel to resolve any identified issues and ensures all issues are resolved in a timely manner.
• Keeps detailed records of findings and their resolution.
• Escalates unresolved issues to managers, as necessary.
• Performs all study-related activities according to the appropriate Standard Operating Procedures (SOPs), GLP/GCLP (if applicable), Good Documentation Practices (GDP), and statements of work.
• Participates in reviewing Out of Specification results for equipment and other investigations
• Participates in study related meetings as required

Benefits

• At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits.
• We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance.
• Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program.
• Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 251-500 employees