Quality Assurance Auditor - Qpcr

Our Labcorp site in Greenfield, IN, is currently recruiting for a Quality Auditor to support our Molecular Bioanalysis team. We are looking for someone with at least 3 years in a regulatory environment and/or Molecular Bio A. Do you have QPCR experience and love supporting quality?

Within the CMC business unit, the Molecular department is dedicated to the development, validation and execution of molecular techniques, such as QPCR, RTqPCR and Digital PCR to support Cell Therapies, Gene Therapies and Vaccines. We structure ourselves to deliver scientific expertise to our clients; collaborating closely with them to support the development of medicinal products through the drug development process and onto market.

This role supports the Molecular department as a Quality Auditor. You will perform quality audit reviews in the molecular biology for clinical and pre-clinical studies.

This position is at the Greenfield, IN. facility (This position is not remote).

Job Duties:

• Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution

• Report on relevant quality metrics (for multiple topics/departments) and highlight trends.

• Provide consultation to the operational team (e.g. as they revise/write controlled documents)

• Delivery of training in performance of audits (basic, intermediate audit activities)

• Work with operational management to support Quality topics and/or working on projects with

• Contribute to local Quality initiatives and process improvement initiatives aimed at improving compliance and/or efficiency of the local QA organization.

• Create and/or re-write QA SOPs based on findings from local quality initiatives.

• Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities.

Experience: Minimum Required:

• 3 years in regulatory environment

• Knowledge of industry quality systems/standards and able to apply (applicable) regulations to monitor compliance.

• Experienced in process improvement and able to influence process improvement initiatives / offer solutions.

• Clear communication skills, including ability to provide clear feedback.

• Able to clearly articulate processes to provide training.

Education/Qualifications/Certifications and Licenses Recommended:

• A minimum of a Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience)

• Experience may be substituted for education.

Why People choose to work at Labcorp?

At Labcorp, it's our people that make us great - it's what our clients, our partners and, most importantly, what our employees say. Here, you'll have the opportunity to work with extraordinary people with diverse viewpoints. You'll discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond. We help our clients develop medicines that improve health and improve lives of their family and friends.

Pay Range: $60,000-85,000/year.

Work Schedule: 8am-5pm

Work Location: 671 S Meridian Rd, Greenfield, IN 46140

Benefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Commissions, and Company bonus where applicable. For more detailed information, please click here.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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