Responsibilities:

• Coordinate the day-to-day Quality Assurance release activities associated with 3PL operations (i.e.. receipt inspection review and disposition) in accordance with the GMPs and all other contractual obligations.
• Coordinate with clients and/or foreign sites or other internal departments with product launch activities the compilation of complete GMP Quality documents to support the importation of client products. Provide Quality Assurance guidance and support to potential new clients or new products as assigned.
• Assist QA Management with the management of both the deviation program the change control program and CAPA program acting as a Team Lead when required. Provide input relating to the initiation investigation root cause analysis and the identification of corrective and preventive actions. The Senior QA Specialist will have the authority to review and approve change control documents and deviation reports if so designated by Senior QA Management.
• Assist QA Management in the preparation of routine key quality performance indicators (KPIs) to generate client specific report metrics acting as a Team Lead when required.
• Assist QA Management in the development/revision and implementation of QA policies and procedures acting as a Team Lead when required.
• Assist QA Management during the execution of Product Recalls including customer notification coordination of customer returns and maintaining documentation acting as a Team Lead when required.
• Develop effective relationships with Operations Team in order to ensure that the Milton Warehouse and Innomar DCs are maintained in a state of GMP compliance.
• Perform timely review and assessment of documents received from clients/foreign sites including but not limited to manufacturing and packaging records Certificates of Analysis Certificates of Manufacture and other product release documents.
• Perform quality and regulatory reviews and oversight on imported products as assigned making quality decisions and addressing or resolving problems based on analysis and consultation with clients.
• Participate and complete Internal Audits as part of the Internal Audit Program acting as Lead Auditor when required.
• Actively contribute to the development maintenance and improvement of the Innomar GMP Quality Systems. Act as Project Lead for Improvement Initiatives / Projects if assigned by QA Management.
• Support client regulatory corporate and internal audits as requested by Management.
• Provide support to the QPIC / RPIC (if requested) to help ensure the continued compliance of Innomars Milton Facility with Health Canada regulations on the control of Narcotics Controlled Substances Precursors and Cannabis products.
• Understand and apply company Confidentiality Privacy and Quality Agreements.
• May be required to travels up to 20% of the time.
• Other duties and tasks that may from time to time be assigned by QA Management.
• May be required to be on standby/ on call as part of this role.

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Education:

• Bachelor of Science degree in a pharmaceutical or healthcare related field (e.g. chemistry microbiology pharmacy and pharmacology).

Experience:

• Minimum of 2 years experience in Quality Assurance or Quality Compliance.
• Experience working in a GMP Operations/Warehouse environment is considered an asset.
• Regulatory Affairs or Quality Assurance Certification is considered an asset.
• Experience in supporting Regulatory or client audits is considered an asset.

Skills:

• Comprehensive knowledge of the Food and Drugs Act Health Canada GMP regulations and associated guidelines.
• Demonstrated ability to assess/manage risk in a quality operations environment.
• The ability to identify pragmatic solutions to compliance/operational problems and challenges.
• Demonstrated leadership organizational inter-personal and communication skills (verbal and written).
• Proven ability to organize individual workloads set priorities and multi-task in order to meet competing deadlines with the ability to remain flexible adaptable and responsive to changing business needs.
• Strong attention to detail proven data analysis skills and the ability to present these findings effectively.
• Ability to work both independently and in a team environment always promoting positive respectful and professional relationships.
• Strong proficiency in common office applications (e.g. MS Word Excel PowerPoint Outlook Adobe Acrobat etc.) and the ability to achieve rapid fluency in business related electronic applications / platforms (e.g. eQMS EMS WMS CRM etc.).

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 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.

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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 companys 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 . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Accessibility Policy

AmerisourceBergen is committed to fair and accessible employment requested AmerisourceBergen will accommodate people with disabilities during the recruitment assessment and hiring processes and during employment.

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