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Antech Diagnostics Quality Assurance Auditor in Morrisville, North Carolina

We understand that the world we want tomorrow starts with how we do business today, and that’s why we’re inspired to make A Better World for Pets. Antech is comprised of a diverse team of individuals who are committed to each other’s growth and development. Our culture is centered on our guiding philosophy, The Five Principles: Quality, Responsibility, Mutuality, Efficiency and Freedom. Today Antech is driving the future of pet health as part of Mars Science & Diagnostics, a family-owned company focused on veterinary care.

Current Associates will need to apply through the internal career site. Please log into Workday and click on Menu or View All Apps, select the Jobs Hub app, then click the magnifying glass to Browse Jobs.

Pay rate: $57,400-71,700 annually

PURPOSE OF JOB:

The Quality Assurance Auditor, as a member of the quality assurance team, is responsible for ensuring compliance with current GLP standards and applicable global regulatory requirements for testing performed in the high-volume Antech GLP Laboratory.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

To perform this job successfully, an individual must be able to satisfactorily perform each essential function. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Maintain knowledge of requirements for GLP compliance with FDA, EPA, OECD, Japanese Ministry of Health and other governmental regulations.

  • Audit GLP studies for GLP compliance in timely manner.

  • Issue QA Statements, GLP Statements and Method Reports

  • Review and provide comment on study documentation as needed, such as protocols, client site-audit responses, CAPAs, Training Materials and SOPs.

  • Assist in hosting regulatory inspections and client visits by acting as scribe and providing documents as needed.

  • Review required SOP revisions to direct the conduct of audit or auditor functions.

  • Conduct external audits of vendors.

  • Conduct critical phase and in-process audits.

  • Audit assay qualification reports, validation plans and reports, etc.

  • Support management as a team member for process improvement.

  • Conduct training for any persons involved in GLP assays.

  • Write required SOPs to direct the conduct of audit or auditor functions.

  • Maintain a copy of the Master Schedule of studies being conducted at Antech Diagnostics.

  • Maintain GLP training files on Antech personnel.

  • Other duties as assigned by management to maintain GLP compliance and operation of the GLP laboratory at Antech Diagnostics.

  • Performs other duties as assigned

  • We share a collaborative obligation to ensure that we conduct ourselves in the utmost ethical manner and that we hold each other accountable to the values and standards of the organization. Every associate has the responsibility to ask questions, seek guidance, and report concerns and/or violations of company policy or ethical standards. Antech Diagnostics has several processes in place to communicate with leadership and expects that associates will have a commitment to integrity and uncompromising values.

EDUCATION/EXPERIENCE:

  • BA/BS in life science or other applicable field

  • Minimum of 2 years of GLP Lab experience

  • RQAP-GLP Certification preferred

REQUIRED SKILLS AND ABILITIES:

  • Working knowledge and understanding of current Good Lab Practices in diagnostic lab industry

  • Technical and people skills

  • Flexible, Innovative, Team player, Committed, Should be a self-starter and Result-oriented

  • Broad Thinking

  • Personal Computer literate

  • Analytical skills pertaining to scientific and laboratory activities

  • Good verbal and written communication skills

  • Know how to accurately record and evaluate data using statistics software

  • Problem solving abilities

  • The ability to follow and enforce SOP’s

  • The ability to communicate information and ideas is speaking so others will understand

  • The ability to work with and through others to achieve success

PHYSICAL DEMANDS:

  • Capable of standing continuously for up to 2 hours

  • Extend and reach with hands and arms and use hands and fingers

  • Occasionally required to bend, kneel, stoop, or crouch

  • May be required to lift, move, and carry up to 20 lb.

  • Specific vision abilities required include close vision, color vision, depth perception, and the ability to adjust focus

  • Hearing ability to effectively communicate via the telephone and in person

  • Ability to communicate verbally on the phone and in person

  • Fluency in the English language

  • Extended hours may be needed

WORK ENVIRONMENT:

  • Laboratory environment with potential biohazards present

  • Use of potentially hazardous chemicals as defined by the National Hazard Communication Standards

  • A complete list of such chemicals is available from department supervision

We are a rapidly growing, stable company with excellent advancement opportunity. We offer a great benefits package and associate pet health benefits too! If you are passionate about animal healthcare, are motivated by making a difference we want to hear from you!

We are proud to be an Equal Opportunity Employer - Veterans / Disabled. For a complete EEO statement please see our career page at Antech Careers (https://www.antechdiagnostics.com/about/careers/)

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