Boston Scientific Principal Quality Aseptic Specialist 

United States, Minnesota, Maple Grove 

943524571

About This Role:

In a fast-paced and dynamic environment, the Principal Quality Aseptic Specialist will be responsible for partnering with Production, Engineering, R&D, and Microbiology teams to prioritizing quality signals and improvement projects to ensure the manufacture and delivery of high-quality aseptic products and facilitate compliance with regulatory requirements.

Your Responsibilities Include:

• Own and drive deliverables related to site Contamination Control Strategy for Aseptic product manufacturing.
• Provide guidance and training to Operations team on aseptic processing, including development of internal training on key aspects related to aseptic manufacturing, cleanroom behaviors and aseptic processing in biological safety cabinets and isolator systems.
• On the floor support model to drive partnership with operations to enhance bio-decontamination prevention and control, monitor and support aseptic Process Simulations Media Fills.
• Oversee Extractible and leachable studies / Antimicrobial effectiveness testing / Elemental impurities.
• Manage technical queries from vendors and regulatory bodies and inform strategies concerning submission.
• Manage responses and closure of RFI’s from regulators by directing and coordinating site responses and authoring justifications where relevant.
• Support new product and process integrations with built in quality and strategies that align to production area.
• Maintain and enhance cross-functional and cross-site relationships.
• Provide guidance regarding technical strategies and approaches; work cross-functionally in identifying and resolving technical issues.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Monitor and ensure compliance with company policies and procedures (e.g., federal/country, and regulatory requirements).

Required Qualifications:

• Minimum of a bachelor's degree in scientific discipline with 10+ years of cGMP experience in a relevant Microbiological role preferably in an aseptic environment or supporting aseptic manufacturing
• Good working Knowledge of the US and EU GMP and Safety Compliance regulations, e.g., Annex 1
• Knowledge of Isolator formulation and filling systems and VHP decontamination, single use technology, primary packaging components (sing dose syringe, caps, sealed package)

Preferred Qualifications:

• Advanced technical degree preferred.
• Previous experience interacting with Regulatory agencies.
• Effective communication skills demonstrated track record of project management execution, and leadership experience.
• Medical device experience
  

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.