Eurofins Lancaster Laboratories Quality Auditor I, II or III in Lee's Summit, Missouri
Viracor Eurofins is dedicated to being the leading specialty diagnostics laboratory partner in immunology, infectious disease, and allergy testing. We offer a range of unique clinical laboratory and biopharmaceutical services and provide exceptional test turnaround times. More than 4,000 healthcare providers, commercial laboratories, and biopharmaceutical companies rely on us for our unique and convenient services.
Viracor Eurofins is searching for aQuality Auditor* I, II or III* in Lee’s Summit, MO.
This is a Full Time position. Schedule is Monday – Friday, 8:00AM – 5:00PM, with overtime as needed. Candidates currently living within a commutable distance of Lee’s Summit, Missouri are encouraged to apply.
_Basic Function and Scope of Responsibility: _
Quality Auditors provide an independent verification of quality for Viracor Eurofins that is focused on maintaining confidence that the Company’s quality requirements will be fulfilled. Compliance with applicable regulation, guidance and standards is assessed through auditing, reporting, performing and evaluating trend analyses, and reviews of validation, procedures, policies, deviations, laboratory errors or occurrences, out-of-specification results, corrective and preventative actions and associated documentation.
Essential Job Duties:
Level I – Minimum
- Support, maintain and continually improve Viracor Eurofins’ Quality System
- Perform periodic audits and inspections of Quality System activities 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
- Prepare reports of audit and inspection observations
- Discuss audit and inspection findings with management staff to develop appropriate corrective and preventive actions where appropriate
- Assist senior QA Specialists and Quality Auditors with internal independent audits of the Quality System for compliance assessment
- Assist with external audits performed by regulatory/inspection agencies or surveys and clients such as pharmaceutical companies or referral laboratories
- Assist with external supplier and vendor audits
- Assist RA/QA Management with the compilation of audit findings for management purposes
- Support platforms and tools utilized for the performance of Quality System activities such as the Document Control System, Deviation & CAPA system, certification/accreditation database, and those required for regulatory contacts or other purposes
- Maintain familiarity with laboratory operating and quality assurance/quality control procedures to effectively perform laboratory quality assurance functions
- Maintain current and accurate records of all relevant communications, audits, corrective action plans, and effectiveness monitoring
- Represent department and the organization favorably and in accordance with established Company standards and associate attributes at all times
- Other duties as assigned by management
Level II – Fully meets the responsibilities of Level I plus the following:
- Perform regulatory and scientific review of validation SOPs, protocols, plans, reports and documentation for compliance to Quality System and regulatory requirements; understand and demonstrate proficiency with quality monitoring activities such as quality indicators and quality reporting
- Advise and assist management staff on Quality System development and review
- Ensure policies and procedures are monitored and updated to include regulatory change
- Typically operates as lead auditor for both internal and external audits
- Understand and apply appropriate sampling methods based upon the particular audit requirements
- May participate in investigation activities of quality events
- Evaluate root cause analysis assessments to ensure that they accurately identify root case so that elimination or correction of the problem will prevent recurrence; ensure that root cause investigations are thorough and well-documented
- Use and interpret quality tools, e.g., pareto charts, cause and effect diagrams, flowcharts and process mapping, checklists, check sheets, histograms, when appropriate
- Provide scientific review of BioPharma results as required by client contract.
- Maintain archive of Quality System records as needed
- Provides consultation and direction to ensure programs are implemented at the highest standard
Level III – Fully meets the responsibilities of Level II plus the following:
- Identify, analyze, and develop improvements in productivity, quality, and client relationships
- Formulate Quality System initiatives by evaluating the effectiveness of the quality system in meeting its stated goals and objectives
- Evaluate the effectiveness of corrective actions taken to prevent recurrence of deviations, errors or occurrences, out-of-specification results
- Participate in assay design review activities to ensure that assays are designed and developed in accordance with regulation, guidance and standards resulting in assays that are clinically robust, accurate, safe and effective
- Mentor and direct the activities of less-experienced Quality Auditors and QA Specialists
- Provide continuous mentoring and coaching to peers
Essential Knowledge, Skills and Abilities:
Level I – Minimum
- BS in a laboratory science or equivalent experience in a regulated laboratory (CLIA and/or GxP)
- Must be familiar with the Clinical Laboratory Improvement Amendments (CLIA 42 CFR Part 493) and/or Current Good Laboratory Practices (21 CFR Part 58). Preferable to be also familiar with Quality Systems Regulation (QSR 21 CFR Part 820), Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs (21 CFR 210), Current Good Manufacturing Practice for Finished Pharmaceuticals (21 CFR 211).
- Ability to follow instructions and pre-established guidelines to perform the functions of the job
- Ability to perform audits
- Ability to conduct oneself with Diplomacy and tact
- Ability to handle multiple tasks assignments in a timely manner
- Ability to coordinate activities with other departments
- Excellent documentation skills
- 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
- 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:
- 5+ years of progressively increasing experience and judgment to plan and accomplish goals
- Superior oral and written communication skills
- Relies on limited experience and judgment to plan and accomplish goals
- Ability to apply some creativity and latitude to position
- May mentor and coach others
Level III – Fully meets the qualifications of Level II plus the following:
- May require an advanced degree and 10 years direct experience in a regulated laboratory (CLIA and/or GxP)
- Must be current with revised or new regulation and guidance applicable to Company
- 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
- Flexibility to adapt to changing task assignments and ability to handle multiple complex 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
- 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 stand for extended periods of time as necessary in the laboratory (4 or more hours)
- Ability to lift and move items weighing up to 15 pounds
- 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. Work environment may consist of exposure to infectious disease, bio hazardous and hazardous materials, and regulated medical waste.
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.
To learn more about Viracor Eurofins, please visit the following websiteshttp://www.viracor-eurofins.com andwww.eurofinsus.com.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
Organization: Eurofins Viracor, Inc.
Location: MO, Lee's Summit
Job Code: 14231