Product Release Associate

Fresenius Kabi Canada; Toronto; Hybrid; CAD 65,000 - 85,000; Full time

Benefits offered by this job

Health benefits

RRSP match

Vacation accrual

Float days

EAP

Casual dress

Recognition program

Perkopolis/Goodlife

Job summary

Fresenius Kabi Canada is seeking a Full-time Product Release Associate to support drug and medical device releases in Canada. Hybrid role with on-site work three days per week.

Coordinate with warehouse, review batch records, and ensure Health Canada compliance. Requires a BSc in Chemistry or Microbiology, GMP/GLP knowledge, and TrackWise/SAP experience is a plus.

Qualifications

• Bachelor of Science in Chemistry and/or Microbiology required.
• Knowledge of GMP and GLP essential.
• Experience in healthcare/pharma or medical device industry preferred.
• Sterile injectables experience is an asset.

Responsibilities

• Release drugs and medical devices for the Canadian market.
• Coordinate with warehouse to finalize receiving and release requirements.
• Review batch documentation to ensure compliance with Health Canada guidelines.
• Review analytical/microbiological test results for confirmatory testing.
• Assess transport and storage conditions for compliance.

Skills

Communication

Customer service

Microsoft 365

Attention to detail

Organization

Confidentiality

Results oriented

Education

Bachelor of Science (Chemistry/Microbiology)

Tools

TrackWise

SAP

Job description

Build your Future with Fresenius Kabi Can ada

We are Committed to Life

Share with friends or Subscribe!

As a part of Fresenius Kabi Canada, you can enjoy an exciting career, a company culture based on a clear purpose and principles, and the knowledge that your work makes a real difference.

We value integrity, encourage collaboration, celebrate passion, reward creativity, and demand excellence, because our customers deserve nothing less and our customers are at the heart of every one of our goals.

As a global healthcare company, Fresenius Kabi is Committed to Life. The company's products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 41,000 employees and presence in over 100 countries, Fresenius Kabi's expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.

WHAT WE OFFER!

At Fresenius Kabi Canada we foster a collaborative environment where employees are encouraged to share ideas and contribute to meaningful work. We offer unique learning opportunities to grow and build your career. In addition, we value each and every contributor and offer various benefits and rewards (as applicable) including:

• Company paid health and dental benefits that start on your first day of employment
• Company matched RRSP program
• Generous vacation plan with one extra day accrual for each year of service
• Paid float days and paid sick days
• Employee assistance program
• Casual office dress code
• Employee recognition program
• Perkopolis & Goodlife Discounts
• Professional growth and development opportunities

We are currently seeking a Full-time PRODUCT RELEASE ASSOCIATE to join our team!

Hybrid role, on-site requirement 3 days/week

The pay range for this role is: $65,000.00 - $85,000.00.

Placement within the range will be determined based on relevant skills, experience, qualifications, and internal equity. The final offer will reflect the successful candidate's background and demonstrated capabilities.

This position is an existing vacancy within the organization.

MAIN RESPONSIBILITIES

• Coordinate with warehouse to ensure all receiving and release requirements are complete.
• Reviews drug batch documentation including executed batch records to ensure the product is manufactured in compliance with Health Canada guidelines.
• Reviews documentation associated with medical device releases for compliance.
• Assessments transportation and storage conditions for compliance to GUI-0069 and issues deviations if non-conformances are found.
• Reviews analytical and microbiological test results for confirmatory testing.
• Release drugs and medical devices for the Canadian market.

QUALIFICATIONS

• Minimum Bachelor of Science degree in Chemistry and/or Microbiology, or a related field.
• Knowledge of GMP and GLP along with testing technology in chemistry and microbiology required.
• Prior experience in the healthcare or pharmaceutical and/or medical device industry is preferred.
• Experience with sterile injectables is an asset.
• Working experience with TrackWise and SAP is considered an asset.

SKILLS

• Excellent communication skills (written and verbal).
• Excellent customer service skills and the ability to collaborate with all levels both inside and outside the organization.
• Strong computer skills Microsoft 365®. Experience in word processing and spreadsheets required.
• Self-motivated and able to work with minimal supervision.
• Strong attention to detail with the ability to multi-task and handle fluctuating workloads.
• Excellent organizational and problem-solving skills.
• Proven ability to adhere to standards and procedures and maintain confidentiality.
• Result oriented and ability to prioritize efficient

MORE ABOUT US!

As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.

In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients' nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. The company's I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.

Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience, expertise, innovation, and dedication - making a difference in the lives of almost 450 million patients annually.

Inclusion and Equal Opportunity Employment

At Fresenius Kabi Canada, we embrace diversity and inclusion for innovation and growth. We are committed to building inclusive teams and an equitable workplace for our employees to bring their true selves to work. We are taking actions to tackle issues of inequity and systemic bias to support our diverse talent, clients and communities. We are an equal opportunity employer.

In accordance with the Accessibility for Ontarians with Disabilities Act, 2005 and the Ontario Human Rights Code, we are committed to providing accommodations and will work with candidates to meet their needs and provide an accessible candidate experience. If you are a person with a disability and require assistance during the application process, please let us know ([e-mail] ). We welcome members of all backgrounds, experiences and perspectives to apply.

Artificial Intelligence (AI) Use in Recruitment:
Fresenius Kabi uses AI-supported tools to help compare applicant résumés with job requirements and identify potential matches. These tools do not make hiring decisions. All candidate reviews, selections, and decisions are made by our recruitment team.