Quality Analyst I - Batch Review @ Simtra BioPharma Solutions
Your Application Journey
Email Hiring Manager
Job Details
About Quality Analyst I - Batch Review
Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies to bring sterile injectable products to market. Operating in Bloomington, Indiana, US and Halle/Westfalen, Germany, Simtra offers a variety of delivery systems including pre-filled syringes, liquid/lyophilized vials, and more.
The Role
The Quality Analyst I is a member of the Quality Assurance Team reporting to the Quality Supervisor, Batch Review. The role involves reviewing all quality documentation generated during filling operations and communicating effectively with customer support departments.
Responsibilities
- Review batch records for GMP batches ensuring accuracy and compliance.
- Reconcile documentation discrepancies with internal guidelines and electronic systems.
- Collaborate with Quality Assurance, Production, and support functions for timely reviews.
- Initiate nonconformance investigation reports.
- Participate in continuous improvement projects to enhance operations and quality.
- Perform final batch record review and product release/disposition.
- Handle client interactions as required.
Desired Qualifications
- Bachelor's degree required.
- Experience in pharmaceutical quality or manufacturing preferred.
- Proficiency with Microsoft Word, Excel, Outlook and enterprise software (e.g., JDE, BPLM, Pilgrim, Trackwise).
Physical / Safety Requirements
Overtime work including nights and weekends may be required. The role involves continual use of hands and fingers, and may require standing for long periods.
Benefits
Eligible benefits include medical & dental coverage, flexible spending accounts, life and AD&D insurance, retirement savings with 401(k) match, paid time off, parental leave, educational assistance, and many more. Onsite amenities include a workout facility, cafeteria, and credit union.
Equal Employment Opportunity & Data Privacy
Simtra is an equal opportunity employer committed to diversity and data privacy. For more details, visit the Simtra Recruitment Platform Global Privacy Policy.
Key skills/competency
- cGMP
- Quality Assurance
- Batch Review
- Compliance
- Documentation
- Continuous Improvement
- Regulatory
- Pharmaceutical
- Manufacturing
- Communication
How to Get Hired at Simtra BioPharma Solutions
🎯 Tips for Getting Hired
- Customize resume: Highlight GMP quality review experience.
- Research Simtra: Understand their products and culture.
- Prepare examples: Showcase problem-solving in batch reviews.
- Practice software skills: Demonstrate proficiency in enterprise tools.