Quality Analyst I - Quality Batch Review

Simtrabps; Bloomington (IN); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 0%

Paid Holidays

Paid Time Off

Education Assistance Program

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions is seeking a Quality Analyst I to join the QA team in Bloomington, Indiana. You will review GMP batch records, reconcile discrepancies, and support timely release and disposition of products.

The role emphasizes collaboration with Production, QA, and regulatory bodies to maintain high quality and compliance standards. Requirements include a Bachelor's degree and experience in pharmaceutical quality or manufacturing, with proficiency in MS Word/Excel/Outlook and

Qualifications

• Bachelor's degree required or equivalent.
• Experience in Pharmaceutical Quality or Manufacturing preferred.
• Proficient with MS Word, Excel, Outlook and enterprise software (Veeva, D365, Trackwise).

Responsibilities

• Perform batch record review for GMP batches produced at Simtra for accuracy and compliance.
• Reconcile discrepancies with documentation and/or electronic systems.
• Foster collaboration between Quality Assurance, Production and other functions to ensure timely batch record review and release.
• Initiate deviation investigation reports.
• Participate in continuous improvement projects to enhance quality and efficiency.
• Perform final batch record review, product release and disposition of GMP batches.
• May interact with clients or regulatory agencies.

Skills

Quality Assurance

GMP

Documentation Control

Education

Bachelor's degree in related field

Tools

Microsoft Word

Excel

Outlook

Veeva

D365

Trackwise

Job description

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 teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence,fulfilling 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 Manager or Supervisor, QA Batch Review. They perform review of all quality documentation generated during filling or packaging 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 deviation 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 or Regulatory Agency interaction

The requirements

• Bachelors degree required
• Experience in Pharmaceutical Quality or Manufacturing preferred
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Veeva, D365, 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, you’ll be eligible for

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life 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
  • Short and Long-Term Disability Insurance
  • 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

[1] Current benefit offerings are in effect through 12/31/26

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.

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