Quality Specialist

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

This role is in support of Cencora's veterinary and livestock production solutions marketed through our MWI Animal Health business. MWI Animal Health is a leading brand of Cencora, offering animal health services globally.

Location : Remote, USA with travel required to facilities based in Idaho.

The Quality Specialist will report to the Senior Manager of Quality and Regulatory and will be responsible for quality systems and quality assurance activities for MWI compliance within addition support release of finished product and investigations of product related issues.

Duties and Responsibilities :

• Oversee the management, organization, maintenance and record retention of all controlled documents within the company's quality management system (QMS)
• Ensure compliance with regulatory requirements, company policies, and industry standards, supporting the efficient operation of the development processes for MWI's private brands
• Identify and implement process improvements to enhance the efficiency and effectiveness of the document control system
• Develop and maintain document control procedures, work instructions, and training materials
• Approve and execute all regulatory updates to product labelling to ensure timely & compliant launch of finished products
• Create and maintain National Drug Codes (NDC) & Universal Product Codes (UPC)
• Provide oversight of the deviation and CAPA programs, including tracking, trending, and periodic reporting of quality and adverse events
• Validate all packaging information, label artwork & print proof to ensure its compliance with applicable regulation and standards
• Participate in the development of Product Quality Assurance strategy to support company brands as well as contract manufacturing and supplier facilities
• Participate in new product teams to bring products through the design control process to deliver on-time product launches
• Provide support for quality audits, initial site approvals and due diligence activities
• Participate and lead product quality investigations to identify root cause and implement corrective actions
• Coordinate activities to support follow-up on complaint trend investigations for non-medical and medical (adverse events)
• Support the business quality risk management program through evolving current process, annual and interim review scheduling, ensuring escalation of any quality / critical control point failures and promoting completion of quality impact assessments as required to maintain business regulatory compliance.
• Develop the business validation program. Engage with key stakeholders regularly, review and sign off validation reports, engage with relevant departments to ensure that recommendations are closed out and actions documented.
• Support the business in change management through evolving current process, being actively involved in change impact assessment and promoting risk elimination / minimization as standard.
• Measure key performance indicators (KPIs) to monitor areas of responsibility and identify areas for improvement
• Drive functional data-driven activity through regular data review meetings to continuously improve service quality and regulatory compliance.
• Review quality trend data, propose and execute quality improvement projects utilizing lean and six sigma principles and promote throughout day-to-day activities within departmental teams.
• Support all quality engagement programs and have an active role in quality education & training initiatives.
• Perform related duties as assigned

Education :

Experience :

Skills and Abilities :

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https : / / www.virtualfairhub.com / cencora

Full time

Salary Range

$74,000 - 105,820

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Affiliated Companies :

Affiliated Companies : Centaur Services