Quality Associate

Oshawa, ON, Canada

Full Time

Entry Level

#LI-DNI

JOB DESCRIPTION

POSITION                                           Quality Associate
COMPANY AND LOCATION             Aved, Head Office
EMPLOYMENT TYPE                                Full-Time, Permanent
HOURS WORKED                                      37.5 hours/week, Monday to Friday

DEPARTMENT Quality
REPORTING TO Quality Manager

POSITION SUMMARY:
The Quality Associate plays a crucial role in maintaining Aved’s commitment to quality and compliance. The Quality Associate will assist with daily quality operations, ensuring regulatory standards are met across all areas of pharmaceutical compounding. This role will involve executing quality checks, maintaining records, supporting compliance activities, and working closely with cross-functional teams.
GENERAL RESPONSIBILITIES & ESSENTIAL FUNCTIONS:

Quality Oversight Support:

Ensure all quality activities adhere to regulatory and company standards.
Support the Quality Department Manager in maintaining accurate and up-to-date documentation for both quality control and quality assurance processes.
Conduct the organization of paper-based and electronic records, ensuring they are easily retrievable and compliant.
Participate in the ongoing maintenance and improvement of the electronic Quality Management System (eQMS).

Quality Control (QC) Tasks:

Monitor environmental conditions, record environmental monitoring data, and address any deviations identified.
Coordinate the submission of samples to third-party analytical laboratories for testing.
Review laboratory reports and certificates of analysis for compliance with specifications.
Support stability studies via trending results and preparing reports.
Participate in the final product release process, ensuring that all required documentation and quality checks are completed before approval.

Quality Assurance (QA) Tasks:

Support the investigation of deviations, incidents, and complaints by assisting in gathering data and preparing investigation reports.
Participate in root cause analysis and the implementation of Corrective and Preventive Actions (CAPAs) for identified quality issues.
Maintain and review defect logs, tracking any non-conformances.
Communicate with suppliers for documentation requirements to ensure product quality and compliance with standards.
Ensure all quality assurance documentation is complete and complies with relevant guidelines and regulations.

QUALIFICATIONS

Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Microbiology, or a related field
Minimum of 1-2 years of experience in a regulated pharmaceutical or compounding environment
Familiarity with NAPRA standards, USP, ISMP, ISO, and other relevant regulatory guidelines
Experience in cGMP, sterile compounding, or aseptic processing is an asset
Strong attention to detail and organizational skills
Excellent communication skills and the ability to work effectively in a team environment
Experience with electronic Quality Management Systems (eQMS) is a plus

WORKING CONDITIONS

Prolonged periods of sitting and computer-based work
Required to wear appropriate Personal Protective Equipment (PPE) as per established company procedures
May involve exposure to controlled environments, including non-hazardous and hazardous compounding areas, with occasional handling of hazardous preparation

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Do you have a Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Microbiology, or a related field?*

Do you have 1-2 years of experience in a regulated pharmaceutical or compounding environment?*

Are you familiar with NAPRA, USP, ISMP, ISO, or other regulatory guidelines?*

Have you worked in a cGMP, sterile compounding, or aseptic processing environment?*

Are you comfortable working with electronic Quality Management Systems (eQMS) and maintaining quality documentation?*

Are you legally able to work in Canada?*

Are you able to work full-time onsite, here in our office in Oshawa, Ontario?*

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Quality Associate

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