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.
- 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)
- 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