Job Description
The Company:
Founded in 2004, Diteba was born out of a passion for uncovering and understanding complex scientific problems. Since our inception, we’ve helped hundreds of companies with testing and in navigating the U.S. Food and Drug Administration (FDA) approval process. Our reputation is built not just on great analytical and bioanalytical testing, but on an unwavering commitment to helping our clients achieve their goals.
We’re on a mission to advance science-based innovation with an unwavering commitment to truth and transparency and a promise to provide best in class analysis through a science first approach. We’re looking for incredible people, fueled by passion and curiosity, to be a part of our journey of growth –will you join us?
The Opportunity:
The role of Quality Assurance Associate is to support and enforce quality system to ensure the compliance with cGMP, GLP, ISO and other applicable regulations and industry standards within Diteba. This position involves decision making and team coordinating tasks.
Key Responsibilities and Tasks:
- To enforce quality system and encourage continuous improvement at Diteba to ensure the compliance with GMP, GLP, ISO 17025 and other applicable regulations and industry standards within the organization.
- Conduct self-inspection within Diteba; identify quality deficiencies and advise on procedures, processes, and compliance issues. Follow up on remaining quality and regulatory issues to ensure CAPA completion.
- Provides support during regulatory inspections and client audits. Follow up according to audit report to ensure CAPA are completed in a timely manner.
- Prepare protocols, reports, SOPs, change controls; review OOS/UR/OOT investigations and deviation investigation reports with supervision. Consult regarding changes to existing production processes and the impact to product quality and stability.
- Review raw data, analytical reports and CofAs generated by laboratory operations. Ensure SOPs, test methods, protocols and applicable SOPs have been followed during the testing. Verify the integrity and traceability of all data generated and reported.
- Notify direct manager regarding omissions, incomplete testing results or other irregularities.
- Conduct quality deviations investigations related to QA department.
- Documentation control, archiving activities and department administration coordination.
- Manage training curriculum, coordinate training and maintain training record.
- Other tasks as assigned.
Job Requirements:
Education/Certifications/Experience
- Minimum B.Sc. degree in Chemistry, Biochemistry and other relevant life science fields.
- Minimum 3 years of experience, preferably one year in pharmaceutical industry, with good understanding of laboratory operations and relevant QA functions.
Knowledge
- Fully comprehend Standard Operating Procedures (SOP) and current Good Manufacturing Practices (GMP/cGMP) and Good Laboratory Practices (GLP).
- Understand pharmaceutical manufacturing processes and concepts, analytical methodology, instrumentation
Skills/Competencies
- Ability to meet deadlines and prioritize.
- Good interpersonal and oral communication skills are required.
- Ability to provide results within a specified time frame
Working Conditions:
- Walking, standing up to 50% of day
- Computer work for more than 50% of the day
- Fine motor skills
- Morning and afternoon shift requirements
- Potential for some weekend work and overtime
Job Type: Contract, 12 months
Address: 1680 Tech Avenue, Unit 1, Mississauga, ON, Canada
In Person 5 days a week