Quality Assurance position

Quality Assurance position

A full time, permanent position as a Quality Assurance manager is available at Ocean TuniCell, located in Bergen, Norway.

The QA is responsible for ensuring that the entire process meets standards of GMP quality and rigorous documentation that are compliant with laws and regulations. Other responsibilities include assistance during audits and inspections. The QA will be part of the management team, reporting directly to the CEO.

Work tasks/responsibilities
  • Build a QMS, including non-conformance/deviations, change control, customer complaints, risk management, and document controls of procedures
  • Design, implement and evaluate quality assurance standards and procedures
  • Write, review and process Standard Operating Procedures and quality policies
  • Perform quality assurance for equipment and products maintaining compliance with Good Manufacturing Practice
  • Perform inspection and measurement of in-process and finished products
  • Review batch records to ensure the appropriate procedures and processes have been used during production
  • Release finished products to customers
  • Document audits, prepare reports with data to assess quality, document customer complaints and non-conformance issues to identify areas for improvement
  • Review and approval of shipping documentation for commercial products
  • Conduct GMP training of staff to meet quality standards
  • Assure compliance with quality and regulatory requirements
  • Responsible for cleanroom activities such as monitoring, assessing room logs, equipment calibration and ensuring staff compliance with cleanroom protocols
  • Present updates at meetings as requested and be responsible for internal and external quality audits
  • Attend off-campus training if required
  • Respond to emergency calls
Qualifications
Required skills/education:
  • Bachelor's degree. Preferred area of study in biochemical and/or biomedical sciences
  • At least 3 years of QA experience, preferably within the biotech/biopharma industry
  • Proficient in database management
  • Quality inspection, auditing and testing experience
  • Experience in data and statistical analysis
  • Knowledge of relevant European and international ISO (including ISO9001:2015) and GMP regulatory requirements
Preferred skills/education:
  • Experience with GMP facility and cleanroom operations
  • Certifications from recognized institutions related to quality
  • Experience with aseptic techniques
Key competencies
  • Attention to detail and ability to interpret data
  • Excellent problem-solving skills
  • Strong analytical capacity
  • Excellent communication in both verbal and written format
  • Strong organizational and documentation skills
  • Ability to complete assignments on-time and accurately
  • Strong sense of responsibility and ability to take initiatives
  • High level of awareness for the identification, and resolution, of events impacting the Quality of products and processes.
Languages
  • Verbal and written proficiency in English is required. Preference given to those also proficient in Norwegian.
What we offer
Ocean TuniCell offers an inclusive, dynamic and challenging workplace with a competitive salary and benefits package. Employees are encouraged to update their skills and develop their career through training opportunities. Ocean TuniCell is an innovative, sustainable, biotechnology company that promotes diversity and equal opportunity in the workplace.

General information
Application must include:
  • Letter clearly outlining motivation for the position
  • CV
  • 3 references
Contact information: Christofer Troedsson, (+47) 41215576, christofer.troedsson@oceantunicell.com

Application deadline: January 28th 2020
Mer info
Område Hordaland
Yrkesroll Industri & Anläggning, Quality Assurance
Typ av anställning Heltid, Tillsvidareanställd
Sista ansökningsdag 28 jan 2020 (3 dagar kvar)

Om arbetsgivaren

Ocean TuniCell is an innovative biotechnology company that produces nanocellulose for research and biomedical applications with an international network of partners.

The nanocellulose is produced from a sustainable marine source harvested on the west coast of Norway. We are dedicated to high quality production in our new state-of-the-art facilities in Bergen.