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Senior Quality Assurance Associate -
PetIQUnited Statesfull_timeVerifiedPosted 3 Aug 2023
About the role
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 seeking a QA Associate or Senior QA Associate to join our team in Omaha, NE. A Senior QA Associate 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 Effectiveness Checks) 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 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). The Primary Role· Support the manufacturing of pet health and wellness products· Focus will be on the Investigations, Root Cause Analysis, Risk/Impact Assessments in support of Deviations, CAPAs, Complaints and Change Controls· Provide guidance to external departments and facilitate impact/risk assessments and gap-analyses.· Direct and oversee the Deviation process, ensuring timeliness to support on-time batch release while ensuring product quality.· Direct and oversee the Corrective and Preventive Action (CAPA) process, ensuring timeliness while clearly identifying root causes, establishing actions to prevent recurrence, and verifying effectiveness of actions taken.· Support the complaint process, ensuring timeliness while identifying root causes, assessing impact and risk, and recommending actions to prevent recurrence.· Assist with quality metrics analysis and reporting to site Quality Management as needed In addition to the primary role as stated above, a Quality System Associate may also hold responsibilities in the following areas, as assigned:· Writing, reviewing and/or approving documents including, but not limited to, change controls, procedures, work instructions, protocols and reports.· Support supplier approval / qualification· Support internal audit scheduleSupport site audits / inspections
PetIQ is committed to creating a diverse environm
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 seeking a QA Associate or Senior QA Associate to join our team in Omaha, NE. A Senior QA Associate 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 Effectiveness Checks) 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 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). The Primary Role· Support the manufacturing of pet health and wellness products· Focus will be on the Investigations, Root Cause Analysis, Risk/Impact Assessments in support of Deviations, CAPAs, Complaints and Change Controls· Provide guidance to external departments and facilitate impact/risk assessments and gap-analyses.· Direct and oversee the Deviation process, ensuring timeliness to support on-time batch release while ensuring product quality.· Direct and oversee the Corrective and Preventive Action (CAPA) process, ensuring timeliness while clearly identifying root causes, establishing actions to prevent recurrence, and verifying effectiveness of actions taken.· Support the complaint process, ensuring timeliness while identifying root causes, assessing impact and risk, and recommending actions to prevent recurrence.· Assist with quality metrics analysis and reporting to site Quality Management as needed In addition to the primary role as stated above, a Quality System Associate may also hold responsibilities in the following areas, as assigned:· Writing, reviewing and/or approving documents including, but not limited to, change controls, procedures, work instructions, protocols and reports.· Support supplier approval / qualification· Support internal audit scheduleSupport site audits / inspections
Minimum Qualitifications
- 5+ years’ experience in Quality role (with associate’s degree)
- 3+ years’ experience in Quality role (with bachelor’s degree)
- 1-year GMP (or other regulated industry) experience, 21 CFR Part 210 & 211 experience a plus
- Excellent oral and written communication skills
- Self-motivated and action-oriented with ability to work independently to problem solve and work cross functionally across departments
- Must be able to read and understand English-written job instructions and safety requirements
Preferred Qualifications
- 5+ years working in a quality role within a GMP production environment (pharmaceutical, medical device, food, etc.)
- 3+ years working within a QMS
Education Requirement
- Associate’s degree – required
- Bachelor’s degree in science-related discipline – preferred
- HS Diploma - Consideration can be given to a non-degree candidate who meets all other qualifications
Physical Requirements
- Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
- Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards.
- Must be able to lift and carry up to 50 lbs.
PetIQ is committed to creating a diverse environm
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