Quality Control Associate Bioanalytical Laboratory

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

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
• 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 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/AA STATEMENT

MSD is an Equal Opportunity/Affirmative Action 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, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO/AA and Pay Transparency statement, please visit here.

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