Quality Control Associate Bioanalytical Laboratory

POSITION SUMMARY:

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. 

DUTIES AND 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

EXPERIENCE AND QUALIFICATIONS:

• Associate’s degree in biology, chemistry, or other related scientific discipline, or equivalent work experience required

o Bachelor’s degree preferred

• 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. 

• Exposure to ligand-binding assays (ELISA, MSD) platforms preferred. 

KNOWLEDGE, SKILLS AND ABILITIES:

• 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 

PHYSICAL DEMANDS: 

• This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.

WORK ENVIRONMENT:

• This position is performed in a traditional office environment with periodic requirements to work with laboratory personnel in their designated work areas. 

COMPENSATION SUMMARY

The annual base salary for this position ranges from $45,500. to $66,000. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate’s knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success.

BENEFITS SUMMARY

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 disabil