Job Description

• Understand and apply appropriate quality requirements to stability programs.
• Stability metrics reporting
• Serve as a single point of contact for tracking overall status of stability portfolio.
• Coordinate with Internal Process Teams to organize and track stability from time point pull through completion of data evaluation.
• Recognize and escalate quality and compliance gaps to supervision
• Provide feedback about stability process for continuous improvement.
• Assist in routing stability related documents in the document management system
• Track tasks and activities in Trackwise.
• Provide support during inspections as needed.

Qualifications

• BS in a data or science-related field or equivalent experience
• At least a year of Previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing
• Experience or knowledge of analytical data and data management
• Proficiency with data entry
• Proficiency with computer system applications, (Trackwise, Veeva, Sharepoint)
• Demonstrated strong written and verbal communications skills.
• Strong attention to detail and organizational skills
• Excellent interpersonal skills.

Additional Information

Position is Monday-Friday 8:00 am- 5:00 pm 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
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• Authorization to work in the United States indefinitely without restriction or sponsorship

Eurofins USA PSS Insourcing Solutions is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.