QC Technican with Elisa experience

Werkgever CheckMark Labrecruitment
Plaats regio Groningen
Provincie Groningen
Dienstverband Voltijd (> 36 uur)
Contract Tijdelijk
Plaatsingsdatum woensdag 9 mei 2018
Sluitingsdatum woensdag 6 juni 2018

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Functieomschrijving

Are you a technician with Elisa experience (MLO/HLO) and do you want to act as owner and/or subject matter expert for assigned equipment and assays and related procedures? And do you want to work for a (bio)pharmaceutical company in the Groningen area? QC GMP experience is preferred but not required. Read this vacancy and apply!


As QC technician with Elisa experience you should be practically and theoretically good in the field of expertise (Analytical methods). Knowledge of analytical methods and processes according to cGMP and EH&S guidelines and quality systems is achieved by keeping training status up to date and increasing own knowledge related to own activities. You will support investigations related to OOS results and deviations and other Quality system related activities and act as owner and/or subject matter expert for assigned equipment and assays and related procedures;

Tasks:

- Execute routine testing activities(cGMP projects, development, validation or stability programs) and testing activities for customer projects, in the Quality Control department according to procedures and work plans, local EH&S and quality guidelines;
- Execution of generic tests for monitoring activities, raw material testing, GMP- and PD projects in the (bio)chemical laboratory and the microbiological laboratory and execution of general QC activities, if assigned;
- Organization of own operational routine testing and independent execution of project related experiments according to approved procedures, work plans, local EH&S and quality requirements;
- Interpret and report the results of the work carried out in report format (if requested) and timely (verbal) updates Labhead QC and Quality Control Scientist. Related documentation has to be of good quality;
- Timely determines needs for raw materials for project activities and orders in consultation with Quality Control Scientist;
- Contributes to implementation and understanding new process techniques based on client requirements or internal technology;
- Write documentation for the work carried out for: generic analysis (analytical methods and equipment manuals), data logging (analytical protocols and logbooks) raw material testing (specification sheets) validation studies (E.g. PQ’s), development studies (work plan and summary reports);
- Review, data interpretation of the work carried out in written form: analytical protocols, analytical methods, validation studies (e.g. PQ’s), development studies (work plan and summary reports), spread sheets, forms (test application report form), deviation report, out of specification, and logbooks;
- Able to support investigations related to OOS results and deviations, and able to write Change requests;
- Delegated responsibilities of Labhead QC, if assigned;
- Responsible as subject matter expert of assigned assays, and assures correct execution of testing according to procedures;
- Responsible for the proper functioning of specific equipment, as equipment owner expert user and/or trouble shooter, as agreed upon with the line manager;
- Supports in the maintenance and continuous improvement of the procedures, techniques and equipment as used in the Quality Control department;
- Actively pursue potential improvements of the Quality Control quality system and revise Quality Control documentation in consultation with other document owners, users and Labhead QC;
- Executes general QC-activities like clerical- and administrative tasks;
- Participates in audits as a subject matter expert on tasks/assays assigned;
- Responsible for being fully trained in specific assays / work plan, before execution of the assay/ work plan;
- Contributes to the training of (new) colleagues in the Quality Control department.

Profiel

Opleiding HBO
Ervaring Starter (0 - 3 jaar)
As QC technician with Elisa experience you have a MLO or HLO degree in (micor)biology or (bio)chemistry.





Further requirements:

- Experience in analytical techniques in the bio(pharmaceutical) fields.

- Specific knowledge of biopharmaceutical analytical fields like biochemical, microbiological and physical/chemical methods and applications.
- Excellent knowledge and working in cGMP environment is desired.
- Relevant work experience with Elisa.
- Fluent in Dutch;  verbal and written English at HBO level is required;

Aanvullende informatie

- a temporary employment contract with the intention to extend and convert into a permanent contract
- a fulltime position

Contact

Neem voor meer informatie contact op met Barbara Razenberg: 020 820 44 30 // 06 54 96 30 07
Vacaturenummer: 5803

Bedrijfsprofiel

This site is a multi-product and multi-client biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for clinical trials (phase 1, 2 and 3) and commercial production.

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