Quality Associate II - Filling (2nd shift)

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.

 

 

The role:

The Quality Associate II is a member of the Quality Assurance Line Operations Team reporting directly to the Quality Line Operations (QALO) III. They maintain quality oversight of the manufacturing areas by working closely with manufacturing personnel and performing various checks during the 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 (SOPs). They facilitate training of new Quality Associates in QALO. 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. The role may also support CAPEX/expansion projects for manufacturing, representing Quality on cross-functional project implementation teams.

 

This position is on 2nd shift (Monday - Friday, 2:30pm - 11:30pm).

 

The responsibilities:

• Facilitates training qualifications and on-going support for associates, including activities such as aseptic intervention oversight, room inspections, oversight checklists, and equipment chart review
• Leads cross functional continuous improvement project teams utilizing Lean principles
• Serves as principal quality author for significant nonconformance (potential batch impact) reports
• Provides technical support and guidance to nonconformance authors
• Acts as team leader to shift associates in absence of supervisor
• Assists supervisor in maintenance of visual controls and accountability tools
• Ensures compliance with all federal, state, local and company-specific regulations related to quality of product and employee safety
• Reviews records to ensure they are complete, accurate and compliant with current Good Manufacturing Practices (cGMP) requirement, including batch records and other documents involved in the aseptic processing of drug product
• Reports errors, deficiencies, discrepancies and observations to management
• Performs Quality functions in classified areas, including checklists, and aseptic intervention oversight
• Initiates and reviews proposed standard operating procedure (SOP) revisions
• Works in collaboration with management team to prepare for internal and external audits and assists with timely closure of audit observations

 

Desired qualifications:

• BS degree (preferred science discipline) and 1 year of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or AS degree with at least 3 years of Pharmaceutical Quality/Manufacturing, or other GXP regulated industry experience, or no degree with at least 5 years Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience
• Working knowledge of FDA CFR 210,211 and other applic