Quality Specialist
EurofinsAbout the role
Company Description
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. The Group also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.
Job Description
Essential Duties and Responsibilities:
* Understand and follow Quality System documents relevant to responsibilities, e.g., Quality Manual, SOPs, and Methods.
* Acts as a resource for laboratory personnel for correct application and interpretation of internal quality documents relevant to their assigned tasks.
* Responsible for assisting in annual 17025 Self-audit as well as method audits and generating non-conformances as a result of audit.
* Responsible for ensuring non-conformances and complaints are documented via the electronic tracking system and that timeliness requirements are met. Monitor non-conformances, root cause analysis, and complaint resolutions for trends.
* Responsible for ensuring equipment calibration schedules are maintained.
* Responsible for ensuring training documentation is completed in a timely manner and maintained.
* Responsible for testing sample traceability and documenting the results of sample trace back exercises.
* Responsible for corporate quality projects as assigned.
* Identify process difficulties and report these together with proposed solutions to supervisor.
* Maintain a perpetual state of readiness and willingness to respond to the queries and needs of clients, staff, and co-workers.
* Maintain a cooperative working relationship with lab operations to ensure daily, weekly, monthly quality tasks are completed and reviewed in a timely manner.
* Maintain cooperative working relationships with all company employees. Communicate orally and in writing to co-workers. This includes “intra” and “inter” departmental employees.
* Promote the company image through the exercising of sound and ethical business practices as related to the public and our customers.
* Other duties as assigned.
Qualifications
Basic Minimum Qualifications (BMQ): To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required:
* demonstrable attention to detail
* knowledge of GxP preferred
* knowledge of microbiology techniques an advantage
* understanding of basic statistics
* intermediate to expert MS Office suite skills
* high integrity, excellent communication, conflict resolution
* English language skills Education/Experience (BMQ): BS Degree plus 1+ years’ laboratory experience
Additional preferences: Previous experience in a production style laboratory preferred. Prior experience working with a variety of regulatory guidelines (ISO 17025) and QC/QA programs an advantage.
Other Factors: * Excellent interpersonal and communication skills.
* Excellent organizational skills with excellent attention to detail.
* Self-motivated and driven critical thinker able to work in high pace and rapidly changing environment.
* Responsive problem solver and action oriented.
Additional Information
Position is full-time varied shifts/hours , weekend and overtime hours as needed. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply.
As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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