Job Description

Comecer, an ATS company, develops and manufactures high-tech systems for Aseptic Processing and Containment in Pharmaceutical and Nuclear Medicine Industries, specializing in isolation technology solutions for regenerative medicine and tissue engineering.

Essential Job Duties

• Support colleagues in drafting and finalizing technical documents and the interpretation and application of legal, regulatory and project requirements
• Quality management of orders in relation to:
  • Specific validation (DQ)
  • Validation documentation
  • Process controls
• Develop inspection methods to analyze product quality
• Implement a working system to ensure conformity and accuracy in the production process
• Ensure products compliance with company and international quality standards
• Ensure that the product corresponds to the desired technical specifications and take corrective action to resolve non-conformities
• Plan and document control activities and inspections
• Other duties as required.
  

Qualifications

• Bachelor’s degree or post-secondary education in Quality Control, Engineering, Nuclear Medicine, or Microbiology.
• Technical or engineering experience required, aseptic processing and containment strongly preferred
• Previous experience in similar role required
• Knowledge of quality management systems and procedures
• Knowledge of methods to apply to resolve non-conformities
• Knowledge of regulations applicable to Comecer products and certification processes.
• Ability to work effectively with internal, cross-functional teams and customers according to deadlines and under pressure-filled conditions.
• Self-driven, attentive to detail, consistent, and process driven.
• Fluent in English, written and oral, fluent in Italian is an asset
• Excellent time-management skills and ability to efficiently coordinate multiple projects at a time.
• Proficient with Microsoft software tools including Outlook, Project, Word, Excel, and Power Point
• Must be eligible and able to travel domestically & internationally within 30 days from hire date and legally eligible to operate a vehicle, as this is an essential job function.
  

Benefits ATS Comecer USA offers:

• Medical, Dental, and Vision Insurance
• 401k matching
• 10 Paid Holidays
• Paid Vacation

To keep our employees safe:

• While Traveling for work
  • Travel Preparedness Kits (KN95 masks, hand sanitizer, sanitizing wipes, and disposable gloves)
• Onsite
  • Hand sanitizer dispensers placed throughout the facility
  • Require social distancing
  • Provide disposable gloves and respirators upon request
  • Conduct visitor health assessments

*Visa sponsorship is not available for this role