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 — which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement  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 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 by working closely with manufacturing personnel and performing various checks during manufacturing processes. They also assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Simtra Standard Operating Procedures.

This position strives for continuous improvement of processes and contributes to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

• Ensures compliance with all worldwide regulatory agency requirements and company-specific regulations related to quality of product and employee safety.
• In-process review of records to ensure they are complete, accurate and compliant with current Good Manufacturing Practices (cGMP) requirements. Records include batch records and other documents involved in the aseptic processing of drug product.
• Reports errors, deficiencies, discrepancies and observations to management. May stop operations when product safety is or may be compromised.
• Performs Quality functions in classified areas, including production oversight, manufacturing process assessments, and aseptic intervention oversight.
• Works in collaboration with management teams to prepare for internal and external audits. Assists with timely closure of audit observations and CAPAs.
• Initiates and authors Nonconformance Reports and corrective and preventative action responses.
• Conducts bi-annual inspections of classified areas in preparation for facility shutdown periods.
• Initiates standard operating procedure (SOP) revisions as needed to support continuous improvement.
• Ensures that SOPs are current and effective and that staff performs routine tasks according to SOP through direct observation.

• Bachelor’s degree (preferred science discipline), or 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 and the ability to use enterprise software (examples include: JDE, SAP, Maximo, Track Wise,…