Job Description

The Bioanalytical Quality Associate is responsible for verifying adherence to laboratory policies and procedures which influence the quality of the laboratory’s services. Additionally, this position acts as a technical reviewer of all Bioanalytical Study Reports and Study Files prior to customer delivery, plans and executes internal audits of the laboratory operations, supports resolution of audit findings, and provides recommendations to management for continuous quality improvements.

DUTIES AND RESPONSIBILITIES

• Perform technical reviews of sample testing Study Reports and Study Files.
  • QC review of Report contents such as project details, analytical data, result specifications, and conclusions.
  • QC review of adherence to data transfer specifications (DTS), as applicable.
• Examine Study files for completeness, report findings and recommendations to the Bioanalytical Principal Investigator (BPI) and laboratory management.
  • Collaborate with BPI to oversee resolution of all findings and facilitate required documentation and closure (deviation, variance, CAPA, etc.).
  • Provide management with monthly summary of technical reviews, audit findings, and deviations.
• Manage archiving activities for study records and data, in accordance with established standard operating procedures.
• Plan and oversee internal audits of the laboratory processes, Good Laboratory Practices/Good Clinical Laboratory Practices (GLP/GCLP) studies, training files, competency assessments, and archives.
  • Hold audit de-briefings to cover gaps and audit findings
  • Manage the resolution and closure of gaps and audit findings
• Manage process for continuous improvement initiatives
  • Act as subject matter expert (SME) for laboratory documentation change orders and training initiatives
  • Provide recommendations for LIMS workflow improvements, based on audit findings
• Ensure laboratory facility and equipment are suitable and in compliance with required operating conditions
  • Oversee functional responsibilities of lab designees (maintenance activities and documentation).
  • Supervise scheduled calibrations, equipment maintenance and qualifications (IQ/OQ/PQ).
  • Administer the OCEASoft monitoring system for Bioanalytical assets.
  • Communicate with management regarding inadequacies and resolution plans for equipment failures or facility issues
• Utilize self-reliance in understanding and adhering to laboratory safety precautions and proper use of personal protective equipment.

EXPERIENCE AND QUALIFICATIONS

• Bachelor’s degree in health or science related field.
• Five years’ minimum experience in a Quality role, preferably in a GLP laboratory/cGMP environment
• Professional Quality Certification (e.g., ASQ, ASCP) is a plus.
• Experience with protein-based immunoassays, running antibody-based assays, developing reagents and product development is desirable.
• Training and experience in a Biosafety Level 2 (BSL-2) laboratory is preferred.

KNOWLEDGE, SKILLS AND ABILITIES

• Strong scientific fundamentals and analytical background.
• Demonstrate understanding and verification of scientific text and data.
• Awareness of GLP, FDA Guidance for Industry, and CLIA regulations.
• Ability to initiate projects and to work independently, as well as a part of a team including technical and clinical subject matter experts.
• Strong organizational and project management skills with the ability to organize multiple tasks and set priorities under deadlines with minimal supervision.
• Proficiency in MS Office suite; familiarity with electronic file management using SharePoint (end user minimum) and MS Excel is necessary.

PHYSICAL DEMANDS

• • Some work may be performed in the laboratory
• • Ability to lift up to 25 lbs.

WORK ENVIRONMENT

• Standard office environment
• Biosafety Level 2 laboratory

COMPENSATION SUMMARY

The annual base salary for this position ranges from $78,100 to $116,200. 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 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.

EEO STATEMENT

MSD is an Equal Opportunity Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO statement, please visit here Meso Scale Diagnostics uses E-Verifyto validate the work eligibility of candidates.