Quality Client Representative

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 Representative is responsible for performing activities associated with management of the CAPA Quality System and works closely with Project Management to facilitate communication between Simtra and clients regarding critical quality-related events. The Quality Representative interacts directly with clients and provides exemplary customer service to both internal and external customers by focusing on quality and compliance. This position reports to the Manager I, CAPA/Complaints.

• Serve as a Quality Representative for the CAPA System, providing support to internal and external customers to ensure compliance with corporate and regulatory guidelines.
• Support day-to-day operation of CAPA related recurring meetings and CAPA Quality System.
• Train personnel on procedures and processes as they relate to the CAPA processes.
• Review and approve local CAPAs for closure, ensuring that all appropriate work has been performed and properly documented.
• Responsible for making and delivering accurate and timely quality decisions pertaining to the CAPA System and quality requests.
• Utilizes problem-solving tools to drive root cause analysis and appropriate corrective / preventative action.
• Escalate quality issues to impacted departmental Quality Manager and/or Quality Director as necessary for corrective action implementation.
• Authors and reviews CAPA investigations as needed to meet client delivery dates and expectations.
• Support CAPA System requests for external/client/internal audit activities.
• Track, trend, compile and report CAPA quality metrics as necessary.
• Support complaint investigations and review/approve level 1 complaint investigations as needed.
• Represents Quality in required client meetings.
• Understands Quality Systems, Regulatory, and Procedural requirements that govern the client/company relationship and product.
• Partners with Program Management, Technical Services, Quality Control, and Manufacturing to provide support, align facility representation, and provide consistent quality inform.
• Negotiate and provide guidance in the approval process of Quality Agreements.
• Lead continuous improvement activities to maximize business results.

• Bachelor's degree required, preferably in a science related field and a minimum 5 years of pharmaceutical industry experience OR a Master's degree and 3 years of pharmaceutical industry experience
• Familiar with quality operating procedures, quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality.
• Knowledge of worldwide regulatory requirements.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

• Duties may require overtime work, including nights and weekends
• Position may require sitting or standing for long hours of time.

[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…