Job Overview
This role will have knowledge of the function of a Quality Management System in a manufacturing environment. Will support management and tracking of quality records (i.e. Deviations, Corrective and Preventive Actions, Impact Assessments, Complaints, Change Controls, and Documentation) for adherence to organizational expectations and regulatory requirements. Will oversee open quality records, collaborating with internal customers to ensure compliance and timeliness, providing support and guidance as needed. Will support management review process through generation of quality system metrics and trending, escalating issues as required. Will participate in and support Inspection Readiness activities including participation in regulatory inspections as needed. Will actively participate and provide guidance in additional quality topics as needed including risk management, self-inspection, training and quality culture excellence. Will collaborate with a broad range of internal customers (Manufacturing, Supply Chain, Quality Assurance, Regulatory Affairs, VTS).
Essential Job Functions And Duties
• Understanding of Quality systems and procedures, as they relate to the manufacture and release of raw materials, intermediates and final products
• Assists in writing and reporting of investigations, deviations, CAPAs, procedures, change controls, and complaints, as assigned
• Support batch record review
• Support internal and external audits and inspections
• QA data generation, review, control and retention
• Performs other support functions as assigned
• Able to perform job duties with close direction of senior Quality personnel
Minimal Qualifications
• Associate’s degree in scientific discipline or equivalent work experience in a scientific or pharmaceutical field; Bachelor’s degree preferred
• Experience with cGMP and Quality Management Systems (QMS) in a regulated manufacturing environment
• Basic knowledge in computer system compliance
• Strong attention to detail and documentation practices
• Ability to read and follow written procedures
• Strong analytical skills and ability to think critically, identify risks, identify root causes and corrections for issues and gaps
• Strong communication skills, oral and written
• Ability to work independently against multiple deadlines
• Must be proficient in Microsoft Outlook (or similar) and comfortable working in Microsoft Word and Microsoft Excel.
• Previous Quality experience in a regulated environment preferred.
• Computer skills in the use of inventory systems and databases.
Education Requirements
• Associate’s degree – required
• Bachelor’s degree in science-related discipline – preferred
• Consideration can be given to a non-degree candidate who meets all other qualifications.
Company Overview
PetIQ provides convenient and affordable pet health and wellness products and veterinary services to pets and their families through retail and ecommerce channels across the country.
We are advocates for pet parents, because we believe that all pet parents should be able to provide necessary care that enhances the lives of their pets.
Why join the PetIQ Team?
• Great company culture
• Company is in growth mode, come be a part of our exciting growth
Full Time Employee Benefits Include
• Medical, Dental, Vision
• Flex Spending Account
• Company Paid Life Insurance
• 401(k) with Company Match
• Employee Assistance Program (EAP)
• 8 Paid Holidays, 2 Personal Days and PTO
• Short and Long Term Disability Insurance
PetIQ is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race (including traits historically associated with race, including hair texture and protective hairstyles, such as afros, braids, locks, and twists), creed, caste, color, religion, sex (including pregnancy, childbirth, and related medical conditions), gender identity or expression, sexual orientation, national origin (including ancestry), genetics, physical or mental disability (including obesity, HIV, or hepatitis C status), age, marital status, or honorably discharged veteran or military status, or any other applicable characteristics protected by applicable federal, state, or local law.
By submitting this application, I certify that my answers are true and complete to the best of my knowledge. If this application leads to employment, I understand that false or misleading information in my application or interview may result in my release.
Tagged as: Assurance associate