Quality Associate - Filling; 3rd Shift

Simtra Bio Pharma 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 – all of which are directly injected into patients worldwide. We emphasize quality and continuous improvement, holding ourselves to the highest regulatory standards.

While our primary focus is cGMP manufacturing, we also provide support services such as 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 expectations of customers.
• Make it TOGETHER – we work as one, respecting each voice and tapping into our unique strengths across teams to solve problems in new ways.
• Make it RIGHT – we hold ourselves to a high standard of excellence, fulfilling 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 by taking on challenges to improve patient health.

The Quality Associate I is a member of the Quality Assurance Line Operations Team, reporting directly to the Quality Line Operations Lead. They maintain quality oversight of the manufacturing areas, working closely with manufacturing personnel and performing checks during manufacturing processes. They also assess regulatory and quality risks in activities and processes according to regulatory agency rules, guidelines and Simtra Standard Operating Procedures, striving for continuous improvement and creating an environment that reflects safety, identity, strength, purity and quality in the finished product.

• Ensure compliance with all worldwide regulatory agency requirements and company‑specific regulations related to product quality and employee safety.
• Conduct in‑process reviews of records to ensure they are complete, accurate and compliant with cGMP requirements. Records include batch records and other documents used in aseptic processing of drug product.
• Report errors, deficiencies, discrepancies and observations to management; may stop operations when product safety is or may be compromised.
• Perform quality functions in classified areas, including production oversight, manufacturing process assessments and aseptic intervention oversight.
• Work with management teams to prepare for internal and external audits, assist with timely closure of audit observations and CAPAs.
• Initiate and author Nonconformance Reports and corrective and preventative action responses.
• Conduct bi‑annual inspections of classified areas in preparation for facility shutdown periods.
• Initiate SOP revisions as needed to support continuous improvement.
• Ensure SOPs are current and effective and that staff performs routine tasks according to SOP through direct observation.

• Bachelor’s degree (preferred in a science discipline), or an Associate’s degree with at least 1 year of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or no degree with at least 2 years Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience.
• Computer proficiency in Microsoft Word, Excel and Outlook; ability to use enterprise software (examples: JDE, SAP, Maximo, Track Wise).

• Must wear appropriate PPE as required for various manufacturing areas.
• Must be able to gown qualify for Grade A/B areas.
• Duties may require overtime work, including scheduled weekend shifts.
• Use of hands and fingers to manipulate office equipment is required.
• Position…