Quality Assurance Engineer
Cook Medical is looking for a versatile Quality Assurance Engineer with a specific interest in GMP compliance for life science products.
We are an American-owned company manufacturing medical devices, cell-growth media as well as cell-therapy products for clinical trials. You will be part of a small team based in Denmark servicing other Cook companies within the cell-therapy area, e.g., with QP certification and distribution of investigational medicinal products for clinical sites in Europe.
The team works under a manufacturing and importation authorization from the Danish Medicines Agency and in an ISO 9001:2015-certified Quality Management System.
As a Quality Assurance Engineer, you will be responsible for ensuring appropriate cGXP documentation is generated, reviewed, approved and maintained. The maintenance of the Quality Management System will also be one of your main responsibilities.
The candidate with ongoing commitment to upgrading knowledge, job skills and abilities in addition to competences related to all duties and responsibilities will have the possibility to develop both personally and professionally and potentially become QP delegate over time.
Your responsibilities will be:
- Identify and/or assist in the resolution of potential or existing quality issues that may jeopardize patient safety, cGXP compliance or regulatory compliance
- Various quality assurance tasks such as review of quality records including batch records
- Create and update quality system documents such as policies and standard operating procedures
- Participate in risk management activities
- Review and determine the acceptability of nonconformances and corrective and preventive actions
- Perform trend analyses and evaluations
- Perform complaint investigations
- Perform internal auditing
- Assist in the coordination and compliance with requests of regulatory authorities during inspections
- Qualify and monitor suppliers and service providers
- Training of new personnel in both general and specific QA processes
- Perform assessment and reporting related to adverse events
- Administrative tasks related to pharmacovigilance
The person we are looking for shall be a team player, meticulous and with strong problem-solving skills and the ability to appreciate both the overall interaction and the specific activities of all processes within the quality management system. You must be able to work both collaboratively and independently with minimal supervision. You will be part of a dedicated team who has an informal and humorous tone and appreciates good workplace relationships.
You have an eye for detail and the ability to juggle multiple tasks and projects across the organization in a thorough and systematic way. We expect you to be an excellent team player with a positive attitude and committed approach to quality management. You have excellent communication skills at all levels and the desire to work in a global environment.
As a Quality Assurance Engineer, you are expected to have the following qualifications:
- A Master’s degree in life science
- Excellent and effective English written and oral communication skills A couple of years’ experience working with QA in a regulated industry, such as the pharmaceutical or medical device industry
- Preferably, experience of batch review
- Preferably, experience of risk assessment and deviation management
- Preferably, familiarity with EU rules and regulations for advanced-therapy medicinal products
Cook Medical has a healthy company culture with a strong common set of values. Responsible, competent and professional staff is our most important resource. We have a flat organizational structure and focus on open dialogue. Qualities such as determination, loyalty and humour are highly appreciated.
The staff of Cook Medical helps to uphold the company’s philosophy of developing innovative medical solutions to raise the quality of patient treatment worldwide - we make a difference every day.
Cook Medical offers a well-organized internal training course which is taken by all new staff to enable them to quickly gain thorough knowledge of the company.
In addition to a salary package with pension, we offer flex time, a bonus system, health insurance, as well as free use of the company’s own gym.
For further information about the position, please contact Susan Agerholm Ballegaard, Manager, Quality Assurance, phone: +45 56 86 86 86/e-mail: email@example.com.
Deadline for applications is October, 7 2019.