Associate, Quality Control

We are currently looking for a driven and motivated team-player to join our QC Materials team in Hillerød. You will be part of a smaller team of 12 people who is responsible for sampling and testing raw materials and packaging materials.

Job Description

The team is a combination of five people primarily supporting the Assembly, Label and Pack functions and reporting to the Manager, QC Materials, and five people primarily supporting the Raw Materials function and reporting to the Sr. Supervisor, QC Raw Materials.

You will be responsible for contributing to key functional, tactical, strategic and operational aspects of the Quality Control Raw Materials group in Hillerød. This includes performing material disposition (LSM and AL&P), shipment of samples to internal and external laboratories, sample planning etc.
Your main responsibilities will be;

  • Performs material disposition (LSM and AL&P).
  • Author investigational protocols, investigational reports, change  control requests, validation/qualification protocols and reports
  • Participate and support the execution of method transfer and/or method qualification, laboratory improvement projects, and troubleshooting of analytical methods in collaboration with teams as appropriate
  • Provides technical input for decisions related to complex problem solving while helping to manage non-complex problems routinely
  • Provides knowledge as needed to aide in the development of peers
  • Participate effectively in a membership role for site cross-functional teams as a representative of the QC Materials laboratory related to laboratory improvements and projects

Additional responsibilities include ensuring adherence to all GMP requirements, interfacing with Quality and manufacturing customers, personal development and supporting investigations impacting the QC Materials department.
If needed, you will also support the Supervisor/Manager for activities related to training of employees, compliance with GMP, and identifying and implementing corrective actions on the floor.

Qualifications

We are looking for a team-player who has the ability to work effectively and has experience working in a cross-functional role, furthermore you should be able to work independently and within a team. You should also have;

  • Solid written and verbal communication skills in both Danish and English
  • Experience using various IT systems
  • The ideal candidate has a minimum of 3 years GMP experience preferably in the raw material area.

Education

  • Educational background as Laboratory Technician, Pharmaconomist, BSc or equivalent


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