Quality CAPA and Investigation Supervisor

About the job

Job Details

Sign- On Bonus:
2,000

Position hours :
First shift, Monday through Friday, with start time flexibility.

Location:
This position is located onsite at our facility in New Hyde Park, NY. There is no option for remote or hybrid work.

This role is in support of Cencora's global logistics and storage services marketed through our World Courier business.

The Quality CAPA and Investigation Supervisor plays a crucial role in ensuring compliance with World Courier policies and procedures at the local level.

• Key Areas of Responsibility:
• Responsible for overseeing quality-related activities within the Transport divisions of the organization.

• Provides guidance to office and divisional associates on matters of quality and compliance.

• Responsible for ensuring compliance with local regulatory requirements related to operations and may have regulatory responsibilities in front of local authorities.

• Incident Management
• Review and manage the documentation on incidents.

• Actively participating in investigations on non-conformities or deviations from established quality standards.

• Provide quality input for investigations, root cause analysis and CAPA and support corrective and preventive action initiatives to address root causes. Assisting in the creation of comprehensive reports, and diligently monitoring deviations and subsequent actions as outlined in the specific internal guidelines.

• Report any deviations or potential problems to global QA and local leadership

• Ensure that relevant customer complaints are dealt with effectively.

• QMS Management
• Develop and maintain a robust QMS that defines the organization's quality objectives, policies, procedures, and performance metrics.

• Organize and support management review meetings in accordance to applicable SOP.

• Supplier Qualification Management
• Oversee the Suppliers Evaluation Program in accordance with internal guidelines, including local suppliers approval / rejection.

• Ensure suppliers meet quality expectations through supplier audits, performance monitoring, and corrective actions when necessary.

• Inspections and certification Audits
• To be the main auditor contact and to communicate with relevant parties within the organization.

• Respond promptly to auditor inquiries by providing accurate information, supporting documentation, or clarification as needed.

• Work with management teams to develop and follow up action plans for addressing any identified non-compliance issues and provide audit responses in due time.

• Risk Management and Change Control
• Assist in setting up and participating in Risk Management and Change Control processes.

• Ensure that clients are contacted whenever required in order to communicate changes such as but not limited to expansions, depot moving process, regulatory updates clarifications, etc.

• Pest Control and Facility Cleaning
• Ensures that pest control and cleaning programs are properly implemented and documented following applicable SOPs.

• Technical Quality Support
• Review and verify technical change controls, calibration, maintenance and qualification / validation program according to internal guidelines, supporting the local facility representative and QA manager technical compliance.

• Support the review of temperature graphs as defined in applicable SOP.

• Documentation Management
• Ensure accurate documentation of all quality-related activities such as SOPs, work instructions, test records, audit reports, etc.

• Quality Data Management
• Execute all tasks using dedicated software tools such as Master Control and SharePoint (or other applicable software tools).

• Quality Checks and Control
• Implement processes to monitor product or service quality throughout the entire lifecycle from design to delivery.

• Responsible for quality related activities related to the Self-Inspection Report as well as quality checks as defined in standard procedure.

• Compliance Assurance
• Ensure compliance with industry standards, customer requirements, and internal policies.

• Stay up-to-date with changes in regulations and implementing necessary QMS changes.

• Ensure all employees are compliant with Company Policies and Procedures as applicable.

• Quality Training and Education
• Develop training programs to educate employees on quality standards, quality processes, and quality techniques.

• Ensure that initial and continuous training programs are implemented and maintained related to Good Documentation, Good Manufacturing, Good Distribution and Good Clinical Practices (when applicable).

• Monitor training compliance and escalate non-compliance as needed.

• Process Improvement
• Identify opportunities for process improvements through data analysis and continuous evaluation of existing workflows. This may include implementing Lean Six Sigma methodologies or other improvement frameworks in collaboration with the Continuous Improvement department.

• Participate in client meetings, monitoring client feedback and satisfaction levels to identify areas for improvement in services.

Perform other duties and responsibilities as assigned.

#LI-MP1

• Experience and Education:
• High School Diploma/GED required; BS in Science, Quality Management, Engineering, or related field is desired.

• Minimum 2-5 years of experience in Quality, Operations, or related field in the healthcare industry.

• Minimum of 2 years of coordination/supervisory experience in Quality, Operations, or related field in the healthcare industry.

• Skills and Abilities:
• Basic PC skills, including MS Word, Excel, and PowerPoint.

• Demonstrated understanding of quality assurance in a regulated environment.

• Effective problem solving.

• Strong communication (written and verbal).

• Strong organizational skills.

• Ability to develop and maintain good relationships with associates at all levels within the company and with external parties (e.g. clients, vendors etc.).

• Able to work independently and with a team when required.

Schedule

Full time

Salary Range*

$62,400 - 97,900

*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/Massacusetts/Illinois State-specific locations may be up to 10% lower than the minimum salary range, and 12% higher than the maximum salary range.

Affiliated Companies
Affiliated Companies: World Courier Inc
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