Quality Specialist

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:

• Bachelor's degree, preferably in healthcare or science discipline, is required.
• Certified Regulatory Compliance Manager (CRCM) preferred.

Experience:

• Three (3) or more years of professional experience in a healthcare setting, pharmaceutical company, or supporting clinical trials required.
• Experience with complex regulatory filing(s) and post-approval regulatory activities.
• Experience in auditing, risk management, and/or quality management.

Skills and Abilities:

• Excellent oral and written communication skills.
• Ability to effectively manage and participate in cross-functional problem-solving teams.
• Excellent teamwork and people skills.
• Ability to handle a variety of tasks simultaneously.
• Excellent critical thinking skills to evaluate quality problems and apply knowledge to identify appropriate solutions.
• Working knowledge of FDA guidelines for post-marketing drug and medical device safety surveillance.
• Knowledge of QMS software preferred.

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

*This Salary Range reflects a National Average for this job. The actual range may vary based on your locale. Ranges in Colorado/California/Washington/New York/Hawaii/Vermont/Minnesota/Massachusetts/Illinois State-specific locations may be up to 10% lower than the minimum salary range, and 12% higher than the maximum salary range.

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

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