Quality Assurance Technician

Sotera Health.com

Office

Denmark

Full Time

Objective of the function

Coordinate and undertake quality assurance tasks within defined procedures and as directed by the Quality Manager (QAM)

Responsibilities/Duties

Quality Management

Document control – Creation and review of facility- and laboratory documents as part the Document Change Request.
Retrieve of obsolete copies.
Maintaining and improving the QMS
Handle external calibrations ensuring that calibrated equipment is used at any time.
Handling of NC, DEV and CAPA’s according to procedures
Preparing and negotiation of Quality Agreements with our customer
Elaborating PQR related to the irradiation process as part of the customer PQR.
Responsible for handling temperature logger and perform temperature mappings.
Be an active part in Quality and optimization-projects at the site.
Work according to QMS requirements
Work in alignment with Sterigenics Code of Conduct
Ad hoc tasks according to department task list

QC Release / Approval

Laboratory reports
Reports on laboratory qualifications
Batch review for release (facility and laboratory)
Create certificates and invoices in E1
Calibration certificate review

Other

Handle PO’s for ordering of supplies and services

Authority:

The position is given the authority:

to release non-pharma products (facility) by signing certificates and approve laboratory tests by signing certificates and reports.
Verify external calibration reports/certificates
to purchase needs for the daily routine work. When it comes to new equipment and larger investments, the purchase will be conducted with the General Manager or Laboratory Manager
Investigate and report any deficiencies and CAPA’s to QA Manager
Monthly reporting in TQMR/E1 and to key customers

Requirements: Knowledge/Education and Training:

Technician, engineer, or other relevant scientific level of education
Quality Systems & standards
cGMP, GLP, ISO, FDA
Relevant QA experience (min 5 years) from Medical Device or Pharmaceutical industry
Familiar with ISO 9000, ISO 13485 and / or ISO 17025
Experience with validation of sterilization processes is an advance
Experience in auditing is an advance
Ability to understand complex issues and find the best / smartest solution
The ability to create good cooperation with colleagues and other stakeholders
Ability to plan and work according to deadlines
Ability to perform routine technical tasks to a consistently high standard
Experience in in English (reading, speaking, writing)

Experience: Skills: Contacts: Internal:

General Manager
Laboratory Manager
Operations Manager
QA Manager
QA Supervisor
QA Specialist
QC Coordinator
Technicians
Technical Supervisor
Business Support Supervisor
Production
Corporate QA
Customers
Suppliers

External: Deputy:

QA Supervisor
QA Manager

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies.
Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Learn more about Sotera Health at soterahealth.com.