Quality Associate II - Trainer

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 - Trainer is a member of the Quality Assurance Line Operations Team reporting directly to the Quality Manager. They manage the training and compliance program for Quality Assurance Line Operations personnel. Additionally, The Quality Associate II - Trainer is expected to maintain quality oversight of the manufacturing areas by working closely with quality and manufacturing personnel; performing oversight during the manufacturing processes. They also assess regulatory and quality risks in procedures, training material, activities, and processes according to regulatory agency rules, guidelines, Simtra Standard Operating Procedures, and industry best practices. This position strives for continuous improvement of the training program, monitoring of industry best practices and regulatory requirements, and contributes to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product. This position reports on the weekend shift.

The responsibilities :

• Manages the training and qualification program for Quality Assurance Line Operations personnel (ex. gowning, aseptic technique, quality oversight, chart review, etc.)
• Supports continuous improvement of the training program, monitoring of industry best practices and regulatory requirements.
• Responsible for maintenance of visual controls of the quality training program.
• Provides on-going support and continued learning for Quality personnel, including activities such as aseptic intervention oversight, room inspections, oversight checklists, and equipment chart review.
• Ability to author Significant Nonconformance (potential batch impact) Reports and provide support to nonconformance authors
• Acts as team leader to shift associates in absence of supervisor
• 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) requirements. Records include batch records and other documents involved in the aseptic processing of drug products.
• Reports errors, deficiencies, discrepancies and observations to management. May stop operations when product safety is or may be compromised.
• Reviews proposed document revisions, including Standard Operating Procedures (SOPs), forms, batch records, and deploys appropriate training to Quality personnel.
• Works in collaboration with management team to prepare for internal and external audits. Assists with timely closure of audit observations.
• Provides Quality support / oversight of major CapEx / expansion projects including onboarding of new filling lines, and integration of new equipment / technology into existing processes to ensure appropriate procedures, training, and curriculum updates are conducted.

Desired qualifications :

Physical / Safety Requirements :

In return, you'll be eligible for [1] :

Medical & Dental Coverage

Spouse Life Insurance

Paid Holidays

Voluntary Insurance Benefits

Vision Coverage

Workout Facility

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 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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