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Quality Improvement Specialist

4 weeks ago

Mississauga, Canada Diteba Inc. Full time

Diteba has a current 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 wring protocol and reports.

**KEY RESPONSIBILITIES & 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.
- 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.
- Instrumentation_
- N/A
- 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

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

Pay: From $56,000.00 per year

Additional pay:

- Bonus pay

**Benefits**:

- Casual dress
- Company events
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Flexible schedule
- Life insurance
- Paid time off
- Tuition reimbursement
- Vision care

Flexible language requirement:

- French not required

Schedule:

- 8 hour shift
- Day shift
- Monday to Friday

Application question(s):

- Are you legally eligible to work in Canada?
- Do you have experience working in a laboratory?
- Do you hold at least a bachelor’s degree within the life sciences field of study?

Work Location: In person