Quality Analyst

Responsibilities

• Perform batch record review for GMP batches for accuracy and compliance to procedures
• Reconcile discrepancies with documentation and electronic systems
• Facilitate communication between Quality Assurance, Production, and support functions
• Initiate nonconformance investigation reports
• Participate in continuous improvement projects to increase efficiency and quality
• Perform final batch record review and product release/disposition of GMP batches
• Interact with clients as required

Requirements

• Bachelor's degree
• Proficiency in Microsoft Word, Excel, and Outlook
• Ability to use enterprise software (e.g., JDE, BPLM, Pilgrim, Trackwise)

Preferred Qualifications

• Experience in pharmaceutical quality or pharmaceutical manufacturing

Benefits

• Medical and Dental coverage
• 401(k) with company match
• Paid Time Off and Paid Holidays
• Paid Parental Leave
• Education Assistance Program
• Employee Ownership Plan
• Onsite amenities including workout facility and cafeteria

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) partnering with pharmaceutical and biotech companies to bring sterile injectable products to market.