Quality Operations Specialist

This role is in support of Cencora's third party logistics service in the US operating through our ICS business

The Quality Operations Specialist serves as a critical quality partner within production operations, ensuring that warehouse, packaging and manufacturing activities are executed in full compliance with cGMP, SOPs, and internal quality standards. This role provides real-time quality oversight on the warehouse/production floor, reviews and audits batch documentation, executes in-process and final quality checks, and supports root cause analysis of quality events. The Quality Operations Specialist plays a hands-on role in maintaining product integrity through timely issue escalation, data-driven problem solving, and cross-functional collaboration.

• Provide day-to-day quality assurance support for warehouse, production and packaging lines to ensure adherence to cGMP and quality standards.
• Perform process audits throughout the warehouse production process.
• Conduct in-process quality checks, such as line clearance verifications, component inspection, and packaging integrity evaluations.
• Investigate non-conformances and author Planned Deviations; actively lead root cause analysis and recommend corrective/preventive actions.
• Collaborate cross-functionally with Compliance, Warehouse, Inventory, Operations, and Documentation teams to ensure operation continuity.
• Identify and resolve system discrepancies for non-controlled product and packaging components.
• Create, revise, and maintain SOPs, Work Instructions, and Quality documentation as assigned.
• Serve as a QA representative on the site Internal Audit Team and contribute to continuous improvement initiatives.
• Ensure compliance with all safety policies and quality procedures; maintain a strong cGMP presence on the floor.
• Participate in all required technical and compliance training.
• Perform other duties as assigned.
• Maintain all equipment calibrations per cGMP compliance
• Monitor environmental systems within the facility investigating issues in a timely manner
• Prepare required Monthly Quality Reports

Education:

• High school diploma or GED required.
• Associate's or Bachelor's degree in Life Sciences, Chemistry, Engineering, or related field preferred but not required.

Experience:

• Minimum 5 years of experience in a pharmaceutical or regulated manufacturing environment, preferably within QA or production support.
• Strong working knowledge of cGMP regulations, quality systems/eQMS, and batch documentation.
• Understanding of 21, 29, 40, & 49 Code of Federal Regulations
• Experience with ISO 9001:2015 Standards
• Experience in packaging line support, in-process testing, and batch record review required.
• Prior use of ERP systems, quality databases, and Microsoft Office Suite required.
• Experience in deviation writing, CAPA support, and serialization is highly desirable.

Skills & Abilities:

• Exceptional attention to detail with a strong focus on documentation accuracy and process compliance.
• Ability to identify quality issues in real time and escalate appropriately.
• Sound judgment and ability to work independently in a fast-paced warehouse/production environment.
• Strong organizational and time management skills.
• Effective verbal and written communication skills across all levels of the organization.
• Must be physically capable of standing for extended periods and lifting up to 50 lbs. with assistance.
• Comfortable working in a warehouse/production setting with variable noise levels and climate conditions.

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

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