Quality Assurance Specialist I or II

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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It 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 Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

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, training and competency, and other systems and processes including training staff on document control processes and procedures. This position will manage 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. This position will support the laboratory with maintaining CLIA and other state permit accreditation, where applicable.

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 BioPharma and Clinical study work and records, study reports, laboratory method SOPs, and other quality records, processes, and activities ensuring Good Documentation Practices (GDP) is being adhered to
• Assist with external audits or quality surveys performed by regulatory/inspection agencies and clients such as pharmaceutical companies or Clinical Research Organizations (CROs)
• Assist with maintenance of overall document control structure within an electronic document management system
• Assist with defining and maintaining user roles and permissions in electronic document management system
• Assist with storage, indexing, and classifying controlled records
• Assist management with the compilation of audit findings for both internal and external audits
• Administer regulatory binder documentation system, assigning and numbering binders, tracking, and archiving; order and control access to adequate stock of regulated binders
• Maintain familiarity with laboratory operating and quality assurance/quality control procedures to effectively perform laboratory quality assurance functions
• Support new hire orientation
• 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
• Oversee Document Management activities that include training manuals for associates, generating the training past due reports, training reports for external requests, assignments of new documents to correct manuals, ensuring the manual structure is directly and accurately developed and maintained, and assist with document formatting
• Perform and/or assist with the proficiency testing program ensuring the paperwork and communications are handled appropriately
• Manage the training, competency, and continuing education activities ensuring documentation of events and participants are assigned in cooperation with management and the laboratory director
• Quality review and approve use of critical material per internal critical material release process
• Facilitate the Corrective Action / Preventative Action management (CAPA) program for the BioPharma Services department, including evaluating root cause analysis assessments to ensure they accurately identify root case so that elimination or correction of the problem will prevent recurrence
• Participate in data reporting of company KPIs and providing discussion at quality meetings
• Provide consultation and direction to ensure programs are implemented to the appropriate regulatory standards
• Provide feedback to operations to help drive continuous improvement through the routine analysis of the CAPA program

Essential Knowledge, Skills and Abilities:

Level I - Minimum

• High school diploma/GED or equivalent required, with undergraduate degree (AA/BA/BS) preferred in biological, physical, chemical, or clinical laboratory science preferred
• 1 to 2 years of experience in a regulated environment, with experience in regulated laboratory preferred
• Ability to initiate tasks and work efficiently with minimal supervision
• Ability to work both independently and as part of an integrated quality team
• 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 GCP/GLP)
• 5 years of progressively increasing experience and judgment to plan and accomplish goals
• Working knowledge of good laboratory practices and laboratory test methodologies.
• Superior oral and written communication skills.
• Ability to identify aberrant data and potential quality/compliance concerns escalating to management.
• Ability to apply some creativity and latitude to position
• Superior oral and written communication skills

• 
  Physical Requirements:

• Physical dexterity sufficient to use hands, arms, and shoulders repetitively to operate a keyboard and other office equipment, use a telephone, access file cabinets and other items stored at various levels, including overhead.
• Ability to speak and hear well enough to communicate clearly and understandably with sufficient volume to ensure an accurate exchange of information in normal conversational distance, over the telephone, and in a group setting.
• Ability to continuously operate a personal computer for extended periods of time (4 or more hours).
• Mental acuity sufficient to collect and interpret data, evaluate, reason, define problems, establish facts, draw valid conclusions, make valid judgments and decisions.
• The essential physical and mental requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Applicants must be authorized to work for ANY US employer. We are unable to sponsor or take over sponsorship of an employment Visa at this time

Eurofins Viracor BioPharma Services are committed to promoting an equal employment opportunity workplace environment and is an equal opportunity employer. It is the policy of the Company that all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, citizenship, pregnancy, genetic information (GINA), disability, military and/or veteran status, and/or any other status protected by applicable Federal, state, or local law. The Company’s policy is to recruit, hire, train, promote and administer all employment-related matters on the basis of an individual's qualifications, abilities and efforts without regard to protected status.

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Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.