Company Description
Eurofins Scientific is an international life sciences company which provides aunique range of analytical testing services to clients across multipleindustries. The Group believes it is the world leader in food, environmentand pharmaceutical products testing and in agroscience CRO services. It isalso one of the global independent market leaders in certain testing andlaboratory services for genomics, discovery pharmacology, forensics,advanced material sciences and for supporting clinical studies. In addition,Eurofins is one of the key emerging players in specialty clinical diagnostictesting in Europe and the USA.
Group's key figures are approx. 6.7 billion Euros turnover, over 900laboratories across 61countries and about 61,000 staff.
Job Description
To supervise the activities of quality staff responsible for developing andimplementing quality programs in accordance with applicable requirements,Standard Operating Procedures (SOPs), Good Laboratory Practices(GLPs, current Good Manufacturing Practices (cGMPs) and in complianceof ISO 17025 to ensure integrity and consistency of quality systems andtrainin
Full responsibility for supervising assigned quality staff. This includeshiring, coaching, scheduling/delegating work, conducting performancereviews and determining pay/ promotions.
Essential Duties and Responsibilities:
Applies ISO17025/cGMP/GLP in all areas of responsibility, as appropriateMay be required to assume responsibilities of Quality Director in the absenceof the Quality Director.Coordinates with multiple locations and Business UnitsDevelops appropriate training plans and ensures staff are trainedAssists with performance evaluations, staffing decisions and othersupervisory activities for the assigned functional groupTrains and mentors staff, sharing expertise in quality complianceSchedules staff and assigns resourcesCompiles and communicates corporate quality metricsConducts internal audits, both Technical and QMSGenerates management review reports and facilitates management review meetingsDevelops and implements SOPsDetermines SOP applicability, peer reviews SOPs and other controlled documentsIdentifies process improvement opportunities, recommends solutions, andimplements action plans to improve qualityManages proficiency testing (PT) schemes, scheduling, reportingresults, updating PT database and communicating results to operationsParticipates in external audits and evaluates responses to audit reportsManages customer feedback/ complaintsManages non-conformity documentation, creating, completing, reviewingand approving where applicableEnsures complaint and non-conformity documentation remains under controlthrough periodic communicating of status/metrics to operations.Manages vendor/ subcontractor qualificationsGenerates other quality metrics as required (e.g. change control / controlchart / OOS / standard/reagents etc.)Performs monthly review of USP updates (USP-NF & Standards) andcommunicates to operationsPerforms other duties as assigned
Qualifications
Basic Minimum Qualifications (BMQ):
To perform this job successfully, the individual must be able to performeach essential duty satisfactorily. The requirements below are representativeof the knowledge, skill or ability required.
Minimum of 3 years in a supervisory roleKnowledge of appropriate regulatory agency guidelines.At least 5 yearsin laboratory operations and/or laboratory qualitycontrol/ assurance.Successful development and completion of self-directed projects.
Education/Experience (BMQ):
BS/ BA degree in Science, or equivalent degree plus 5-6 years relatedexperience. Experience may be substituted for education.Excellent written and verbal communication skills.Strong aptitude and proficiency in spreadsheets and word processing software.Knowledge of applicable regulations and requirements.
ther Factors:
Work may require use of PPE (personal protective equipment)Overtime and weekend work as required.Expected to understand the process for handling hazardous wastes and receiveon-the-job training for handling specific waste types in their job areaWill be exposed to potential food allergens
Additional Information
Candidates within theLafayette, CO area are encouraged to apply
Position isFull-time,with a flexible schedule changing as needed in the lab
Shift: 1st shift 9:00am-5:30pm
Work Schedule (Hours and Days) Mon-Fri Times may change during training as