Quality Analyst - Batch Review

Simtrabps; Bloomington (IN); On-site; USD 50,000 - 70,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with Company Match

Education Assistance Program

Employee Ownership Plan

Job summary

Simtrabps in Bloomington, Indiana seeks a Quality Analyst I to join the Quality Assurance Team. The role focuses on performing quality documentation reviews to ensure compliance with regulatory standards and internal guidelines.

This position requires meticulous attention to detail and collaboration across teams. Ideal candidates hold a bachelor's degree, have experience in pharmaceutical manufacturing, and are proficient in Microsoft Office and relevant enterprise software.

Comprehensive benefits are offered including medical coverage, 401(k), and educational assistance.

Qualifications

• Bachelor's degree required.
• Experience in pharmaceutical quality or pharmaceutical manufacturing preferred.
• Computer proficiency in Microsoft Word, Excel, and Outlook necessary.

Responsibilities

• Perform batch record review for GMP batches for accuracy and compliance.
• Facilitate communication between Quality Assurance and Production.
• Initiate nonconformance investigation reports.
• Participate in continuous improvement projects.

Skills

Pharmaceutical quality experience

Attention to detail

Team collaboration

Data analysis

Education

Bachelor's degree

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

JDE

BPLM

Pilgrim

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?

• 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 Supervisor, Batch Review. They perform review of all quality documentation generated during filling operations and effectively communicate with customer support departments.

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.

Benefits

• 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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