Jr. Quality Assurance Associate

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 push the boundaries of problem-solving while providing the highest standard of testing across the Pharmaceutical, Cannabis, Nutraceutical, and Food and Agriculture industries. We’re on a mission to advance science-based innovation with a commitment to truth and transparency. 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 Jr. Quality Assurance Associate is responsible for assisting in the continuous improvement to assure quality and compliance through the execution and monitoring of Diteba’s Quality System.

KEY RESPONSIBILITIES & TASKS

• Organizes, coordinates and evaluates the operation of the Quality Assurance Department
• Implements quality systems and encourage continuous improvement at Diteba to ensure compliance with GMP, GLP, ISO 17025 and other applicable regulations as well as industry standards within the organization
• Anticipates and identifies emerging issues, trends and problems affecting Diteba’s quality systems, counsel and recommendations concerning compliance with all legislation and standards impacting the organization.
• Executes the concept and implementation of quality by design and risk-based approach throughout the organization, including all processes/procedures
• Establishes tracking and measurement to increase quality based on established quality metric
• Champions quality investigations and work collaboratively with cross functional departments, suppliers and customers on quality investigations to determine root cause, evaluate impact and identify applicable CAPAs to improve quality and ensure compliance with GMPs and SOPs
• Organizes self-inspection and third party independent annual inspection program.
• Maintains reporting for the status of investigations, CAPA, change control records along with quality trends
• Identifies and generates training and education program needs with all departments
• Manages the audit, review and approval process for vendor qualification prior to service
• Manages Quality Assurance Agreement
• Maintains Quality Manual
• Performs review, approval and release of reports including but not limited to deviation and complaint investigations CAPA’s and change control records

JOB REQUIREMENTS

Education & Experience

• Minimum of a degree in Chemistry, Biochemistry, Pharmaceutical Science or other related science from a recognized Canadian institution or accredited as equivalent
• Minimum 1+ years of experience in laboratory operation or quality control in the pharmaceutical
• Minimum 1+ years of experience in quality assurance experience

Knowledge

• Thorough understanding of continuous improvement concepts and methodologies as well as risk-assessment tools
• Thorough understanding of pharmaceutical manufacturing processes and concepts, analytical methodology, instrumentation qualification and pharmacopeias (USP, BP, EP, JP) as they pertain to analytical and bioanalytical
• Fully immersed expertise in the standards of GMP/cGMP, GLP, GPP, ISO, FDA Guidance (including CFR 21 Part 11) and Data Integrity principles as well as relevant compliance legislation, including FDA guidelines as well as Health Canada Cannabis regulation .

Instrumentation

• Good knowledge in laboratory instrumentation and software applications such as NuGenesis, Empower, ChemStation
• Fluent in Microsoft Office applications

SKILLS

• Interpersonal skills: Educates internal and external customers on facts by considering differences in the level of understanding, needs, and expectations.
• Advanced communication and technical writing skills: Ability to clearly and logically explain ideas in a concise and organized manner with the use of proper grammar
• Presentation & training/facilitation skills
• Intense attention to detail in order to read, understand and interpret laws, regulations and standards
• Strategic thinking
• Leadership

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.