Quality Assurance Specialist

About the role

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.

Responsibilities

• 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

Qualifications

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

Schedule

Full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Portage, MI are encouraged to apply.

Benefits

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays