Quality Improvement Specialist

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?

Diteba currently has an opening for the following role.

The Opportunity:

The role of Quality Improvement Specialist is to support and enforce quality systems to ensure compliance with cGMP, GLP, ISO and other applicable regulations and industry standards within Diteba. This position also involves reviewing technical documents, raw data and writing protocols and reports.

Key Responsibilities & Tasks

• To enforce quality system and encourage continuous improvement at Diteba to ensure 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.
• Provide 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 on 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 records.
• Support instrument qualification review.
• Support review of raw data generated by lab operations, analytical reports and CofA’s.
• Perform assigned technical review tasks of QIR/OOS/UR/CAPA/Deviation investigations with accuracy and in accordance with SOPs.
• 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.
• Good understanding of common analytical technologies (e.g. HPLC, GC, UV spectroscopy, titration) and basic understanding of cGMP, ICH and FDA requirements.

Skills/Competencies

• Ability to meet deadlines and prioritize. Good interpersonal and oral communication skills are required.

Effort

Mental Effort

• Deadline pressure.
• Providing results within specified time frame.
• Demonstrated effectiveness in good time management skills as work will be assigned between control and assurance tasks based on workload and business priorities.

Physical Effort

• Walking, standing up to 50% of day.
• Computer work for more than 50% of the day.
• Fine motor skills.

Working Conditions

• Office environment requiring the ability to operate standard office equipment and perform work in a sedentary position.
• Laboratory environment requiring the ability to walk short distances and alternate between standing and sitting while performing lab-specific tasks.
• Laboratory environment requiring the use of personal protective equipment as individuals will be working with hazardous materials.
• Some work may require moving and lifting items up to 50 lbs.

Job Type: Regular, Full-Time

Annual/Hourly Salary Range: Starting at $56,000

Where: 1680 Tech Avenue, Unit 1, Mississauga, ON, Canada

Hours of Work: Monday – Friday, 8 hours per day with potential for evening work and overtime as required.

In Person