Quality Assurance

Req ID #: 227734

Den Bosch, Noord Brabant, NL

Al meer dan 75 jaar werken de medewerkers van Charles River samen om te helpen bij het ontdekken, ontwikkelen en veilig maken van nieuwe geneesmiddelen. Wanneer u bij onze familie komt, heeft u een belangrijke impact op de gezondheid en het welzijn van mensen over de hele wereld. Of uw achtergrond in levenswetenschappen, financiën, IT, verkoop of een ander gebied is, uw vaardigheden spelen een belangrijke rol in het werk dat we uitvoeren. In ruil hiervoor helpen wij u een carrière op te bouwen waar u over gepassioneerd kunt voelen.

**Job Summary**

Are you an experienced QA auditor and seeking a challenge elsewhere? Or are you currently working as a laboratory technician or e.g. study director in GLP/GxP laboratory setting and do you want to pursue a different career path?Is adherence to rules and protocols important to you and do you have a keen eye for quality?In a quality driven and written standards environment, we look for a communicative, solution-oriented and analytical person who enjoys working together with the different operational departments to maintain the high quality of our work.At Charles River Laboratories we are currently hiring a:
**Quality Assurance Auditor 1**

**Department**:Our Quality Assurance team consists of 20 staff members. Besides having quality of data as top priority all our auditors have a scientific background in the various disciplines ranging from chemistry and toxicology (e.g. environmental/genetic) to in vitro and in vivo metabolism.With the team we safeguard the adherence to GLP compliance of study data by, among other things, conducting process
- and facility inspections, and audits on critical in-life study phases its data and reporting. The versatility of our work further includes providing up-to-date GLP training at the operational level, being available for GLP questions, and participating in customer audits and regulatory agency visits.

**About your role**:As one of the Quality Assurance auditors, you will conduct audits on challenging multi-phase non-clinical studies in an OECD GLP lab environment. Your daily responsibilities are diverse and range from auditing protocols, study data and associated reports to executing process and facility audits to ensure regulatory compliance. In your role as an auditor, you will be liaising with laboratory personnel during on-site study audits and take on an advisory role with respect to the latest requirements of OECD GLP principles and adherence to Charles River’s Standard Operating Procedures.

**Primary responsibilities**:

- Perform audits of protocols, in-life critical phases; raw data and final reports to assure compliance with GLP and SOP;
- Identify, document, and report deviations from regulations, protocol, SOPs, and specifications;
- Deliver advise to Charles River staff (including management and study directors) on issues relating to GLP compliance;
- Perform or lead process and facility audits and reviews corresponding regulatory documentation to ensure compliance;
- Participate in inspections and audits of subcontractors and vendors;
- Assist in providing basic regulatory training;
- Harmonize and improve quality processes;
- Participate in regulatory compliance projects.

**What is required**:

- Bachelor’s degree in life science and/or experience with GLP or a comparable quality system;
- Preferably high affinity with in vivo and in vitro toxicology;
- Understanding of relevant quality systems; in this role you need to be very precise and quality focused;
- An excellent proficiency of the Dutch and English language;
- Good advising and communication skills;
- Residential in the Netherlands;
- Good communications and advisory skills;
- Work as a team member;
- Accurate and quality minded;
- Critical but positive;
- Quickly in learning software programs.

**Job Qualifications**

**Our offer**:Working at our organization means working in a dynamic international organization with a modern laboratory and a wide variety of equipment and techniques at your disposal. In addition, we offer excellent primary and secondary working conditions including:

- 27.5 holidays and 2 collective days per year;
- Possibility to purchase 10 additional holidays per year;
- Annual one-off 8% holiday pay of your gross annual salary;
- Annual one-off payment based on company results;
- Company fitness membership;
- Travel allowance at €0.23 cents per kilometer with a maximum of €250 net per month or an NS Business Card;
- Bicycle (lease) plan;
- Collective pension with a small own contribution of 2.9%;
- The opportunity to play sports with colleagues on our own sports field;
- The possibility of a consultation with our in-house ergonomist;
- Free fresh fruit every day.- (Opens in a new tab)

**Over Safety Assessment**Charles River helpt zijn partners bij het versneld uitvoeren van preklinische geneesmiddelontwikkeling dankzij uitstekende programma’s voor veiligheidsbeoordeling, de allern