Quality Associate I - Supplier Quality Management

Simtra BioPharma Solutions (Simtra) is a worldclass 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 prefilled syringes liquid/lyophilized vials diluents for reconstitution powderfilled 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 lifechanging 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 daytoday work knowing the impact we make taking on challenges big and small to improve patient health.

This role:

The Quality Associate I Supplier Quality Management (SQM) will administrate and collaborate with the management of the supplier lifecycle. This role will be responsible to collect and analyze supplier data to verify the consistency of the existing process and the highlighting any trends if applicable. This role will also collaborate with other Supplier Quality functions to ensure compliance with current local and global procedures. This position reports to the Senior Manager Supplier Quality.

This role is expected to be hybrid with onsite requirements on a weekly basis in Bloomington Indiana

The responsibilities:

• Administrate the SQM documentation within the eQMS system and Simtra SQM SharePoint.
• Collaborate with Supplier Auditors in the Quality Agreement maintenance.
• Collect and analyze SQM system metrics.
• Collaborate on the creation of metric presentations for Management Meetings.
• Administrate the New Supplier process
• Collaborate on the Supplier Review/Requalification process.
• Collaborate on the Supplier Change Notification process.

Desire qualifications:

• Bachelors degree (preferred science field) or Associates degree with at least three years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience or high school diploma/GED with at least six years Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience
• Ability to understand cGMPs and other regulatory and international guidelines applicable to the life science industry.
• Computer proficiency in Microsoft Word Excel and Outlook and the ability to use enterprise software (examples include: JDE Trackwise Veeva etc.
• Data collection experience desirable

Physical / Safety Requirements:

• Duties may require overtime work including nights and weekends
• Position requires sitting for long hours but may involve walking or standing for 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 LongTerm 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

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.

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