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Production-QC Associate - Belgium
Posted on : 30 April 2017
General Job Description
- The Production-QC Associate is a hands-on person and is responsible for the performance of lab activities in the production of mRNA based products in an aseptic clean room environment and QC lab, in due time, according to cGMP requirements, to current procedures, to batch records and to supervisor’s instructions.
- The Production-QC Associate is a member of the mRNA production team.
- This position reports into the Production Lead and the QA/QC Lead.
Responsibilities and Duties
The Production-QC Associate duties shall include, but not be limited to:
- Primary responsibilities will be to perform, under general supervision, a variety of routine and specialized laboratory operations in the production and quality control of mRNA based pharmaceutical products (API and vaccines) according to cGMP requirements, to current procedures and to batch records;
- Inventory management and ordering of laboratory materials;
- Document and report data and results in accordance with the current procedures and GMP requirements;
- Check the “conform” status of the equipment and material before use;
- Clean the production area according to the procedures and instructions,
- Perform routinely check of the installations and premises;
- Follow training in adequacy with the function;
- Perform on regular intervals routine maintenance, calibration, qualification activities;
- Warn the supervisor in case of problems, analyze the data, help in trouble-shooting and propose technical solutions;
- Assist in the development and implementation of new techniques;
- Assist in the technology transfer from third parties (customers and/or development partners);
- Draft production and QC instructions, forms and protocols.
Professional BS in Laboratory Techniques or BS/MS in biology, (bio)medicine or life sciences or related field or equivalent relevant laboratory experience.
- Minimum of two years of relevant laboratory experience (can be both academic or industrial) in the field of immunology and cell biology;
- Broad technical expertise and mastering of several laboratory techniques;
- Working knowledge of good manufacturing practices (GMP) and/or lab quality assurance practices is a plus.
Other Qualifications, Skills and Abilities:
- Detail-oriented and accurate in following instructions, record keeping and completion of reports;
- Affinity with GMP guidelines and working in a quality-oriented environment;
- Able to perform experimental trouble-shooting and propose technical solutions;
- Good organizational capacities and detailed documentation practices;
- Good knowledge of English;
- Good communication skills;
- Well organized, well-structured, hands-on, result focused;
- Able to work under stringent time lines;
- Ability to foster teamwork and a collaborative atmosphere;
- Enthusiastic, flexible and able to multitask;
- Understanding of MS Office (Excel, Word, PowerPoint, Outlook).
- An exciting job in a dynamic and entrepreneurial environment with room for personal development;
- Employment contract of unlimited duration with a competitive salary package.