Quality Analyst II - Quality Batch Review/Disposition

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical & Dental Coverage

Flexible Spending Accounts

Life and AD&D Insurance

401(k) Retirement Savings Plan with 1:

Time Off Program

Education Assistance Program

Employee Assistance Program

Employee Ownership Plan

Job summary

Simtra BioPharma Solutions in Bloomington, IN seeks a Quality Analyst II to join the QA team. The role focuses on reviewing batch records and releasing GMP batches, coordinating with support functions to meet internal and contractual timelines.

You will mentor less experienced staff, drive continuous improvement projects, and ensure compliance with regulatory requirements. This is a hands-on QA position with opportunities for cross-functional collaboration and career growth.

Qualifications

• Bachelor’s degree in a science field with a minimum of 2 year Pharmaceutical Quality or Manufacturing experience, or Bachelor’s degree in non-science field with at least 5 years of Pharmaceutical Quality or Manufacturing experience.
• Master’s degree in a science field with a minimum of 1 year Pharmaceutical Quality or Manufacturing experience, or Master’s degree in non-science field with at least 5 years of Pharmaceutical Quality or Manufacturing experience.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, Trackwise, etc.)

Responsibilities

• Perform batch record review and final product release / disposition 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.
• Plan, organize, evaluate, and communicate applicable activities of designated QA batch review functions, including Quality metrics reporting.
• Initiate and Author batch record related Deviations.
• Perform verification of Hold System activities.
• Reconcile controlled forms in the Veeva system.
• Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions to ensure on-time Quality review of batch records in order to achieve internal targets and contractual commitments for batch release.
• Participate in raised client issue resolution (conference calls, responding to batch record observations)
• Subject Matter Expert for Batch Release procedures and presenting performed batch records during client and regulatory audits as required.
• Mentor and train less experienced Batch Review/Release personnel
• Lead continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction.

Skills

Quality Assurance

Documentation review

Interdepartmental communication

Mentoring

Continuous improvement

Education

Bachelor’s degree in science

Bachelor’s degree in non-science with 5+ years

Master’s degree in science

Master’s degree in non-science with 5 years

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

D365

Veeva

Trackwise

Job description

Quality Analyst II - Quality Batch Review/Disposition

Bloomington, Indiana, United States

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.

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 II is a member of the Quality Assurance Team (QA) reporting directly to the Quality Manager or Supervisor, Quality Batch Review and Batch Release. They perform review of all quality documentation generated during filling and/or packaging operations. They must communicate effectively with customer support departments to coordinate batch review and release activities to meet internal commitments and contractual commitments. They provide leadership and guidance to analysts with less experience and create an environment where teamwork, productivity, safety, identity, strength, purity and quality are reflected in the finished product.

The responsibilities:

• Perform batch record review and final product release / disposition 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.
• Plan, organize, evaluate, and communicate applicable activities of designated QA batch review functions, including Quality metrics reporting.
• Initiate and Author batch record related Deviations.
• Perform verification of Hold System activities.
• Reconcile controlled forms in the Veeva system.
• Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions to ensure on-time Quality review of batch records in order to achieve internal targets and contractual commitments for batch release.
• Participate in raised client issue resolution (conference calls, responding to batch record observations)
• Subject Matter Expert for Batch Release procedures and presenting performed batch records during client and regulatory audits as required.
• Mentor and train less experienced Batch Review/Release personnel
• Lead continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction.

The requirements:

• Bachelor’s degree in a science field with a minimum of 2 year Pharmaceutical Quality or Manufacturing experience, or Bachelor’s degree in non-science field with at least 5 years of Pharmaceutical Quality or Manufacturing experience.
• Master’s degree in a science field with a minimum of 1 year Pharmaceutical Quality or Manufacturing experience, or Master’s degree in non-science field with at least 5 years of Pharmaceutical Quality or Manufacturing experience.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, Trackwise, etc.)

Physical / Safety Requirements

• Must wear appropriate personal protective equipment as applicable
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long periods of time, but may involve walking or standing for periods of time.

In return, you’ll be eligible for[1]:

• 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.

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.