Stability / Reference Standard Specialist

About the role

Eurofins USA PSS Insourcing Solutions is seeking a candidate to join our team. As a key member of the Quality Assurance department, you will play a crucial role in maintaining the integrity and accuracy of our stability studies and analytical samples.

Responsibilities

• Build and maintain stability studies in Lab Information Management System (LIMS)
• Manage label request program
• Manage inventory system
• Receive, store, forecast, submit, and deliver stability and analytical samples
• Understand and follow all relevant policies relating to this job including business, compliance, quality, environmental and safety expectations
• Support the development, registration and launch of new pharmaceutical products
• Support the client's work requests as needed
• Support domestic and international shipping of material
• Additional duties as needed

Qualifications

• Fundamental knowledge of cGMP compliance requirements
• Excellent communication (oral and written) and attention to detail
• Strong computer and organizational skills and experience with Microsoft Office
• Ability to work independently and as part of a team, have self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, prioritize multiple tasks, keep accurate records, follow instructions, and comply with company policies
• Must be able/authorized to handle Controlled Drugs or Controlled Substances under the guidance of DEA requirements

Minimum Qualifications

• Bachelor's degree
• 2 years professional experience

Additional Information

• Position is full-time, working Monday-Friday 8:00 a.m.-5:00p.m. overtime as needed
• Candidates currently living within a commutable distance of Indianapolis, IN are encouraged to apply
• 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
• Authorization to work in the United States indefinitely without restriction or sponsorship

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.