Quality Associate I - Supplier Quality Management

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.

 

 

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:

• Bachelor’s degree (preferred science field), or Associate’s 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, you’ll be eligible for[1]:

• 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 Insuranc