Eurofins USA Clinical Diagnostics Hiring For Quality Assurance Specialist at Lenexa, KS, United States , United States Full Time

Job Description

Company Description
Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory 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 diagnostic testing in Europe and the USA.
Group’s key figures are approx. 5.4 billion Euros turnover, over 900 laboratories across 50 countries and about 55,000 staff.

Basic Function and Scope of Responsibility:
The position is primarily responsible for Quality Management System (QMS) activities and compliance with applicable regulatory requirements by ensuring the effectiveness of the QMS in meeting its stated goals and objectives. This position is also responsible for the management and maintenance of the electronic document management system, including training staff on document control processes and procedures. This position is also responsible for managing both paper and electronic records to ensure that controlled records are created, identified, changed, reviewed, retained, stored, and maintained in a manner that meets requirements.
Essential Job Duties:
Level I – Minimum

• Support, maintain and continually improve the QMS
• Assist team members with and/or perform internal audits and inspections of the QMS for compliance assessment which may include but is not limited to clinical study work and records, study reports, laboratory method SOPs, product batch records, and other quality records, processes, and activities
• Assist with external audits or surveys performed by regulatory/inspection agencies and clients such as pharmaceutical companies or referral laboratories
• Maintain overall document control structure within an electronic document management system
• Define and maintain user roles and permissions in electronic document management system
• Store, arrange, index and classify controlled records while maintaining on-site access-controlled document storage room and facilitating storage and retrieval of materials with the off-site storage facility
• Devise and ensure the implementation of retention and disposal schedules, including maintaining records in such a way so as to meet requirements and the laboratory’s own policies and procedures
• Assist management with the compilation of audit findings for management purposes
• Resolve electronic document management system problems and issues in collaboration with users, system vendors and IT
• Administer regulatory notebook and binder documentation system, assigning and numbering notebooks and binders, tracking and archiving; order and control access to adequate stock of custom notebooks and regulated binders
• Maintain regulatory licensure and accreditation documentation; develop and maintain a spreadsheet of licensure and accreditation effective/expiration dates with renewal requirements
• Complete and submit regulatory licensure and accreditation filings in collaboration with Regulatory management
• Maintain familiarity with laboratory operating and quality assurance/quality control procedures to effectively perform laboratory quality assurance functions
• Support development of system and process improvements that would enhance compliance to documentation/training requirements
• Represent department and the organization favorably and in accordance with established company standards and associate attributes at all times
• Participate in developing department goals, objectives, and systems
• Assist with other administrative duties as assigned/required

Level II – Fully meets the responsibilities of Level I plus the following:

• Discuss audit and inspection findings with management to develop appropriate corrective and preventive actions where appropriate
• Understand and demonstrate proficiency with quality monitoring activities such as quality indicators and quality reporting
• Advise and assist management on QMS development and review
• Ensure policies and procedures are monitored and updated to include regulatory change
• Assist in facilitating the Corrective Action Management processes, including evaluating root cause analysis assessments to ensure they accurately identify root case so that elimination or correction of the problem will prevent recurrence
• Provide consultation and direction to ensure programs are implemented at the highest standard

Level III – Fully meets the responsibilities of Level II plus the following:

• Assist in facilitating the supplier management activities, including the facilitation of qualifications, evaluations and the supplier database
• Assist in the planning and preparation of the Master Audit Schedule
• Identify, analyze, and develop improvements in productivity, quality, and client relationships
• Understand and apply appropriate sampling methods based upon the particular audit requirements
• Use and interpret quality tools when appropriate (e.g., pareto charts, cause and effect diagrams, flowcharts and process mapping, checklists, check sheets, histograms)
• Mentor and direct the activities of less-experienced QA Scientists and Specialists.
• Provide continuous mentoring and coaching to peers

Qualifications
Essential Knowledge, Skills and Abilities:
Level I – Minimum

• High school diploma/GED required, with undergraduate degree (AA/BA/BS) preferred
• 1 to 2 years of experience in a regulated environment, with experience in regulated laboratory preferred
• Understanding of applicable compliance requirements
• Goal oriented, with excellent time management and organizational skills
• Excellent interpersonal skills, with ability to interact effectively and work efficiently with people at all levels in an organization
• Ability to handle multiple task assignments in a timely manner
• Excellent verbal & written communication skills
• Keenly attentive to detail.
• Ability to keep sensitive information confidential.
• High level of proficiency with PC based software programs.

Level II – Fully meets the qualifications of Level I plus the following:

• Undergraduate degree (AA/BA/BS) or 5 years equivalent experience in a regulated laboratory (CLIA and/or GLP)
• 5+ years of progressively increasing experience and judgment to plan and accomplish goals
• Ability to apply some creativity and latitude to position
• Superior oral and written communication skills

Level III – Fully meets the qualifications of Level II plus the following:

• Undergraduate degree (AA/BA/BS) or 10 years equivalent experience in a regulated laboratory (CLIA and/or GLP)
• Relies on 10+ years of progressively increasing experience and judgment to plan and accomplish goals
• Ability to apply a wide degree of creativity and latitude to position
• Ability to mentor and coach others
• Flexibility to adapt to changing task assignments and ability to handle multiple task assignments
• Demonstrated ability to effectively accomplish goals and complete projects in a collaborative setting
• Proven ability to work effectively with others and as a team member
• Demonstrated interpersonal and negotiation skills

Additional Information
What Happens Next

Our people are the backbone of what we do, so it’s incredibly important we find the right individuals to join us. As a potential new recruit you’ll be invited to meet the team in the form of an assessment centre or a staged interview process dependent on the role and it’s requirements, this will give you the opportunity to see what working for Eurofins is really like and enable us to get you know your key skills and strengths.

Your data

As part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.

Closing Date

We reserve the right to close or extend this position depending on application numbers. Therefore we would urge candidates to submit an application as early as possible.

Due to the high volume of applications we receive please be aware that if you do not receive a response within 4 weeks of the vacancy expiry date unfortunately, on this occasion your application has been unsuccessful.
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.