Quality Assurance Specialist

Eurofins; Portage (MI); On-site; USD 55,000 - 85,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with company match

Paid vacation and holidays

Life and disability insurance

Job summary

Eurofins USA BioPharma Services in Portage, MI is seeking a quality assurance professional to ensure GMP/GLP compliance and to support QA operations across laboratories. The role emphasizes accurate investigations, CAPA review, and collaboration with clients and staff.

The ideal candidate will have a chemistry/biology-related degree and at least two years in QA, with strong documentation and communication skills. Full-time schedule with comprehensive benefits is offered.

Qualifications

• Bachelor's degree in chemistry, biology, biochemistry, or related degree concentration with laboratory experience.
• At least two years of related industry experience including Quality Assurance responsibilities.
• Position is full-time, Monday - Friday 8:00am - 5:00pm.
• Excellent full-time benefits including medical, dental, and vision options, life and disability insurance, 401(k) with company match, paid vacation and holidays.

Responsibilities

• Applies GMP/GLP in all areas of responsibility.
• Applies the highest quality standard in all areas of responsibility.
• Demonstrates strong client service skills, teamwork, and collaboration.
• Proactively plans and multitasks to maximize productivity.
• Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration.
• Use opportunities to contribute to continuous quality and process improvement of QA department and of the laboratories.
• Demonstrate understanding of QAU operations and functions.
• Demonstrate skill in using the computer to access information, perform job functions (e.g., spreadsheets, power point), and prepare documents.
• Perform investigation writing and review including thorough root cause analysis and CAPA review - Perform internal audits and walk through inspections.
• Review procedures, methods and protocols - Release analytical reports.
• Assist in hosting client audits.
• Provide information/entries for monthly/quarterly quality reports to management.
• Conducts all activities in a safe and efficient manner.
• Communicates effectively with clients and staff members.
• Performs other duties as assigned.
• Investigation review.
• Stability QA for protocols

Skills

GMP/GLP knowledge

Quality Assurance

CAPA

Root cause analysis

Investigation writing

Audit support

Documentation

Client service skills

Multi-tasking

Education

Bachelor's degree in chemistry, biology, biochemistry, or related degree concentration

Tools

Microsoft Office

Spreadsheets

PowerPoint

Job description

• Applies GMP/GLP in all areas of responsibility, as appropriate
• Applies the highest quality standard in all areas of responsibility
• Demonstrates and promotes the company vision - Regular attendance and punctuality
• Applies the highest quality standard in all areas of responsibility
• Demonstrates strong client service skills, teamwork, and collaboration
• Proactively plans and multitasks to maximize productivity
• Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
• Use opportunities to contribute to continuous quality and process improvement of QA department and of the laboratories
• Demonstrate understanding of QAU operations and functions
• Demonstrate skill in using the computer to access information, perform job functions (e.g., spreadsheets, power point), and prepare documents
• Perform investigation writing and review including thorough root cause analysis and CAPA review - Perform internal audits and walk through inspections
• Review procedures, methods and protocols - Release analytical reports
• Assist in hosting client audits
• Provide information/entries for monthly/quarterly quality reports to management
• Conducts all activities in a safe and efficient manner
• Communicates effectively with clients and staff members
• Performs other duties as assigned
• Investigation review
• Stability QA for protocols

The ideal candidate would be/have:

• Motivated to be accurate and produce high quality work, with minimal supervision
• Planning, organization, and work management (multi-tasking) and follow-up skills
• Work at maximum efficiency; quality orientation; high attention to detail; meticulous work habits;
• Communicate effectively, both orally and in writing; good judgement, decision making, and problem solving; initiative and innovation abilities;
• Good computer, office equipment, and typing skills;
• Accept changes in schedules and versatility of workload and a willingness to adjust to corporate needs; work overtime if necessary;
• Professional in appearance, conduct, and company representation;
• Logical thinking process; follow and give detailed verbal and written instructions; clear understanding of priorities

Basic Minimum Qualifications:

• Bachelor's degree in chemistry, biology, biochemistry, or related degree concentration and some laboratory experience;
• At least two years related industry experience including some Quality Assurance responsibilities

Position is full-time, Monday - Friday 8:00am - 5:00pm.

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.