Quality Control Reviewer

Our Ideal Candidate: Candidates who hold a degree in CHEMISTRY, with some regulatory affairs/quality control education or training. Experience from an analytical chemistry lab is ideal. We welcome new graduates from Bachelor's/Master's Chemistry programs.

The Opportunity:

The role of the QC Reviewer is to ensure that all documentation related to the successful release of laboratory work is complete and conforms to all Diteba Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs). The QC Reviewer is responsible for reviewing raw data and various technical reports with minimum supervision.

KEY RESPONSIBILITIES & TASKS

· Review raw data generated by laboratory operations, analytical reports and CofAs with minimum supervision.

· Ensure test methods, protocols and applicable SOPs have been followed during the testing and follow up to ensure that all necessary corrections are executed in accordance with cGMP standard.

· Review instrument qualification data package.

· When required, review protocols, reports, and change controls.

· Verify the integrity and traceability of all data generated and reported. Notify direct manager regarding omissions, incomplete testing results or other irregularities.

· Perform technical review of QIR/OOS/UR/CAPA/Deviation investigations, ensuring through facilitation that the writing, review andapproval of investigation documentation are accurate, complete and performed according to internal SOP.

· Identify errors and discrepancy in methods, SOPs and other technical documents.

· Other tasks as assigned.

JOB REQUIREMENTS

Education/Certifications/Experience

· Minimum B.Sc. in Chemistry, Biology, Life Sciences or other related field and/or equivalent experience.

· 2+ years of pharmaceutical industry experience, preferably in an analytical laboratory.

Knowledge

· Good understanding of common analytical technologies (e.g. HPLC, GC, UV spectroscopy, titration)

· Basic understanding of cGMP, ICH and FDA requirements.

Instrumentation

· Not Applicable

Skills/Competencies

· Good interpersonal and oral communication skills are required.

· Comfortable working cross-functionally with lab Chemists, QA teams, Project Coordinators and Clients

EFFORT

Mental Effort

· Ability to meet deadlines and deal with conflicting priorities and work demands, as well as to identify, analyze and solve problems independently

· Providing results within specified time frame

· Excellent attention to detail

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

· Will require flexibility in working hours should instances arise needing attention outside of core hours

· Some work may require moving and lifting items up to 50 lbs

Diteba is committed to providing accessible employment practices that follow the Accessibility for Ontarians with Disabilities Act (AODA). Upon request, we will, in consultation with the applicant, determine the nature of any accommodation that may be required during the hiring process.

Job Type: Temporary, Contract

Number of Vacancies: 1

Reason for Vacancy: Temporary, Fixed-Term Contract, 6 month Backfill

Annual/Hourly Salary Range: Starting at $50,924

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

Hours of Work: Monday – Friday, 8 hours per day

Work Location: In Person / Onsite Work Schedule

Company DescriptionFounded 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?Company DescriptionFounded 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?