Job Description

Are you looking to make a difference in a patient\xe2\x80\x99s life? At AmerisourceBergen, you will find an innovative and collaborative culture that is patient focused and dedicated to making a difference. As an organization, we are united in our responsibility to create healthier futures. Join us and Apply today!

What you will be doing

PRIMARY DUTIES AND RESPONSIBILITIES:

• Maintenance of importer Drug Establishment Licenses (DELs) and the approval process for a large number of foreign sites for multiple clients.
• Coordinate with clients and / or foreign sites for the receipt, review and updates to master documents to ensure compliance to GMPs and in relation to product release activities.
• Release of commercial drug product and / or clinical trial supply to the Canadian market for Innomar or customers as required.
• 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.
• Assist Management in the preparation of routine key quality performance indicators (KPIs) to generate client specific report metrics, acting as a Team Lead when required.
• Maintain and review in-house and client-based quality documents, e.g. SOPs, APQR, stability reports, qualification / validation protocols and reports, artwork, temperature studies etc.
• Process Deviation investigations, including report generation and any associated trend analysis.
• Process Product Quality Complaints (PQCs), including report generation and any associated trend analysis.
• Process Change Control Requests (CCRs), including report generation and any associated trend analysis.
• Assist QA Management in the development / revision and implementation of QA policies and procedures, acting as a Team Lead when required.
• Sustain an effective system for maintaining copies of documents received from clients / foreign sites as well as those submitted to Health Canada, allowing ease of location and retrieval of records.
• Provide support during audits / inspections (i.e. internal, client, third party or regulatory agencies) as required.
• Provide support during recall / mock recall events (client and internal) as required, acting as a Team Lead when required.
• Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with potential clients.
• Participate in and support project teams and advise other departments on Quality Assurance issues and strategies, when required.
• Travel up to 20% may be required.
• Other duties, as assigned.

What your background should look like

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

• Bachelor\xe2\x80\x99s degree in a pharmaceutical or healthcare related field (e.g. chemistry, biology, microbiology, pharmacy, and pharmacology).
• Minimum of 5 years\xe2\x80\x99 experience in Quality Assurance.
• Regulatory Affairs or Quality Assurance Certification is considered an asset.
• Experience in conducting vendor audits is considered an asset.
• Experience in hosting/co-hosting client audits is considered an asset.
• Experience working in an Operations environment is considered an asset.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

• Comprehensive knowledge of the Food and Drugs Act, Health Canada GMP regulations and associated guidelines.
• Demonstrated ability to effectively prioritize, coordinate and complete multiple projects within established timeframes.
• Demonstrated ability in the effective management of deviations, root cause analysis, and CAPA implementation.
• The ability to identify pragmatic solutions to compliance / operational problems and challenges.
• 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.).
• Excellent written and verbal communication skills.

What AmerisourceBergen offers

We offer a competitive total rewards package which includes benefits and compensation. Our commitment to our eligible population of team members includes benefit programs that are comprehensive, affordable, diverse, and designed to meet the needs of our team members\xe2\x80\x99 and their families. Some of these programs include paid time off including paid parental leave, access to retirement savings vehicles, medical, dental, vision, and life insurance options, an employee stock purchase program, and other financial, health, and well-being focused benefits.

Because we take a balanced, global approach to our benefits, benefit offerings may vary by location, position, and/or business unit. Some benefits are company-paid, while others are available through team member contributions. For details visit .

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Schedule

Full time

Affiliated Companies: Affiliated Companies: Innomar Strategies

Equal Employment Opportunity

AmerisourceBergen 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.

COVID-19 Vaccine Policy

As of October 18, 2021, AmerisourceBergen requires all Canadian team members to be fully vaccinated and show proof of completed vaccine status at time of hire. If you cannot receive the COVID-19 vaccine due to a qualifying medical condition or sincerely held religious belief you will be required to follow AmerisourceBergen\xe2\x80\x99s policy and process to apply for an exemption/accommodation.

Accessibility Policy

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

AmerisourceBergen