Quality Assurance Release Specialist

AmerisourceBergen

Posted 13 days ago

Full Time

Milton, Ontario

In Person

Smart Summary

Responsibilities

The Quality Assurance Release Specialist monitors adherence to QMS requirements and maintains controlled documents and quality records. They also track deviations, complaints, and CAPAs while preparing audit materials and generating quality metrics.

Qualifications

You have a Bachelor's degree in life sciences, business administration, supply chain, or a related field, or equivalent experience. You possess less than 2 years of experience in quality assurance/quality management within a regulated environment, with knowledge of QMS concepts, GxP/GDP principles, and CAPA fundamentals.

Must Have Skills for ATS

QMS

GxP

GDP

CAPA

ISO 9001

Lean Six Sigma

ISTQB

data integrity

good documentation practices

Job Description

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 patient and provider support and pharma commercialization services in Canada marketed through our Innomar Strategies business.


This job profile description is a standardized, non-contractual reference description and global reference tool provided for organizational consistency and talent architecture purposes across Cencora. It does not alter actual job duties, responsibilities, reporting lines, working conditions, grading, compensation, or other essential terms and conditions of employment.

Actual duties and responsibilities may vary based on business needs, local requirements, and operational practices. Where a team member's role is governed by an employment agreement, local terms and conditions, prior job description or collective bargaining agreement, those documents shall prevail in case of any inconsistency. Mandatory local laws shall also prevail.


  • Monitors adherence to QMS requirements and applicable good practices across assigned operational activities and programs.
  • Maintains controlled documents and quality records, including SOPs, work instructions, forms, templates, and retention logs.
  • Tracks deviations, complaints, and CAPAs through closure, including documented investigations, corrective actions, and effectiveness checks.
  • Prepares audit and inspection materials, compiles objective evidence, and tracks response actions to completion.
  • Generates routine quality metrics and prepares quality reports that identify trends, recurring issues, and improvement opportunities.
  • Delivers assigned quality training and maintains training matrices and compliance reporting for assigned populations.
  • Assists with supplier and subcontractor qualification activities and maintains documentation for ongoing supplier quality oversight.

Education:


  • Bachelor's degree in life sciences, business administration, supply chain, or a related field, or equivalent experience required.

Work Experience:


  • Less than 2 years of experience in quality assurance/quality management within a regulated and/or operational services environment (e.g., GxP/GDP, logistics/distribution, shared services, customer contact centers, or technology delivery), or a related field required.

Certifications:


  • Certified ASQ Certified Quality Auditor (CQA), Certified Professional in Healthcare Quality (CPHQ), ISO 9001 Lead Auditor (QMS), or equivalent preferred. Certified Lean Six Sigma Green Belt or Black Belt preferred. Certified ISTQB Certified Tester – Foundation Level (CTFL) or equivalent preferred.

Skills & Knowledge:


  • Knowledge in quality management system (QMS) concepts and documentation control.
  • Knowledge in applicable good practices and regulated-quality principles (e.g., GxP/GVP/GDP) and audit expectations.
  • Knowledge in CAPA fundamentals, including deviation/complaint handling, root cause methods, and effectiveness checks.
  • Knowledge in internal and external audit/inspection readiness practices and evidence requirements.
  • Knowledge in risk management and change control principles within a quality environment.
  • Knowledge in supplier/subcontractor quality oversight concepts and qualification documentation.
  • Knowledge in quality metrics and trend analysis concepts for continuous improvement.
  • Knowledge in data integrity and good documentation practices.
  • Ability to interpret and apply procedures, work instructions, and quality standards to operational scenarios.
  • Ability to document quality events and investigations with clear, complete, and traceable records.
  • Ability to organize and maintain training matrices, training records, and compliance reporting.
  • Ability to analyze quality data, identify trends, and communicate findings through standard reports.
  • Ability to prepare audit documentation packages and track actions to closure.
  • Ability to use common business applications and quality platforms (e.g., eQMS, document management systems) to manage records and workflows.

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.

Full time

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

Accessibility Policy

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

This posting is intended to fill an existing vacancy for our Quality Assurance Release Specialist role.

Affiliated Companies:

Affiliated Companies: Innomar Strategies

AmerisourceBergen

On August 30, 2023, AmerisourceBergen became Cencora. Cencora is a leading global pharmaceutical solutions organization centered on improving the lives of people and animals around the world. We partner with pharmaceutical innovators across the value chain to facilitate and optimize market access to therapies. Care providers depend on us for the secure, reliable delivery of pharmaceuticals, healthcare products, and solutions. Previously known as AmerisourceBergen, our new name, Cencora, unites our 46,000+ team members under one identity in pursuit of a shared purpose: We are united in our responsibility to create healthier futures. : We are united in our responsibility to create healthier futures. AmerisourceBergen is ranked #11 on the Fortune 500 and #24 on the Global Fortune 500 with more than $200 billion in annual revenue.
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