Quality Analyst I Quality Batch Review
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Job Location:
Bloomington, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
06-11-2025
Vacancies:
1 Vacancy
Job Summary
Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington Indiana US and Halle/Westfalen Germany we offer a wide range of delivery systems including pre-filled syringes liquid/lyophilized vials diluents for reconstitution powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules cytotoxics highly potent compounds diluents for reconstitution and vaccines which are all directly injected into patients worldwide. As such there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing we offer many support services including formulation and development lyophilization optimization global regulatory support and secondary packaging. Our teams are driven to help clients scale innovate and bring life-changing medicines to patients worldwide.
Why join Team Simtra Because we:
Make it HAPPEN We bring a growth mindset to every opportunity developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER We work as one respecting each voice and tapping into our unique strengths across teamsso we can solve problems in new ways.
Make it RIGHT We hold ourselves to a high standard of excellencefulfilling our commitments to the customer their patients and our team members.
Make it COUNT We take pride in our day-to-day work knowing the impact we make taking on challenges big and small to improve patient health.
The role:
The Quality Analyst I is a member of the Quality Assurance Team (QA) reporting directly to the Quality Supervisor Batch Review. They perform review of all quality documentation generated during filling operations and effectively communicate with customer support departments.
The responsibilities:
- Perform batch record review for GMP batches produced at Simtra for accuracy and compliance to procedures based on regulatory requirements and internal guidelines etc.
- Reconcile discrepancies with documentation and/or electronic systems as appropriate.
- Facilitate an environment of partnership and communication between Quality Assurance Production and other support functions to ensure timely Quality review of batch records in order to achieve internal targets and contractual commitments for batch release.
- Initiates nonconformance investigation reports.
- Participate in continuous improvement projects to improve department operations increase efficiency solve problems generate cost savings improve quality and increase employee and customer satisfaction.
- Perform final batch record review product release / disposition of GMP batches produced at Simtra
- May require client interaction
Desired qualifications:
- Bachelors degree required
- Experience in pharmaceutical quality or pharmaceutical manufacturing preferred
- Computer proficiency in Microsoft Word Excel and Outlook and the ability to use enterprise software (examples include: JDE BPLM Pilgrim Trackwise etc.)
Physical / Safety Requirements
- Duties may require overtime work including nights and weekends
- Use of hands and fingers to manipulate office equipment is required
- Position may require standing for long periods of time.
In return youll be eligible for1:
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- Short and Long-Term Disability Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Holidays
- Paid Time Off
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance Program
- Employee Assistance Program
- Community and Volunteer Service Program
- Employee Ownership Plan
- Additional Benefits
- Voluntary Insurance Benefits
- Vision Coverage
- Accident
- Critical Illness
- Hospital Indemnity Insurance
- Identity Theft Protection
- Legal and more
- Onsite Campus Amenities
- Workout Facility
- Cafeteria
- Credit Union
- Voluntary Insurance Benefits
1 Current benefit offerings are in effect through 12/31/25
Disclaimer
This job description is intended to provide the minimum knowledge skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.
Data Privacy
To learn more about Simtras approach to data privacy please review the Simtra Recruitment Platform Global Privacy Policy: Experience:
IC
Key Skills
- Gas Chromatography
- Laboratory Experience
- Archival Standards
- ELISA
- Test Cases
- Analytical Chemistry
- Quality Assurance
- Spectroscopy
- Quality Control
- cGMP
- Selenium
- Western Blot
About Company
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