Quality Specialist (IV Sterile Compounding)

at  Calea Ltd

Under the direction of the Senior Manager Quality, the Quality Specialist supports the compliance of the Compounding business unit to applicable corporate and regulatory requirements. The role ensures the Quality Management Systems (QMS) is maintained and continuously improved to maximize performance, business efficiency, customer service requirements, and patient safety.

QUALIFICATIONS

• Diploma in Biological Technology with an emphasis on Industrial Microbiology or Aseptic Processing: i.e. Certification in industry-specific Post-secondary science- based education covering the major requirements of the pharmaceutical industry.
• 5+ years years quality and compliance experience in the pharmaceutical industry and in particular clean room environment preferred
• Experience with Sterile Compounding environments, Aseptic Technique, and Validation
• Extensive knowledge in Microsoft Office tools, SAP, Quality Management System (QMS) software such as TrackWise, electronic Document Management System (eDMS), etc.
• Working knowledge of Quality and Aseptic processing principles, NAPRA, USP<797>, Risk Management, Root Cause Analysis and continuous quality improvement Knowledge of GMP / ISO, particularly as they relate to quality control/assurance

SKILLS

• Excellent communication skills (written and verbal)
• Excellent customer service skills and the ability to collaborate with all levels both inside and outside the organization
• Microbiology background and aseptic processing experience
• Experience and/understanding with various QMS software
• ISO9001 Auditor Certification or Auditor training
• Strong computer skills in MS Office Excel database management/development
• Self-motivated and able to work with minimal supervision
• Strong attention to detail with the ability to multi-task and handle fluctuating workload
• Excellent organizational and problem-solving skills
• Proven ability to adhere to standards & procedures and maintain confidentiality
• Strong problem-solving skills
• Excellent continuous improvement skills
  Calea is responsible for ensuring we can provide critical and lifesaving medical products and services to vulnerable members of our communities. We are committed to fostering a caring culture, a safe environment, and a healthy workplace for all employees. Everyone must follow safe work practices and comply with our health and safety policies.
  The company is committed to meeting the accessibility needs of people with disabilities. Calea is dedicated to breaking down barriers to accessibility, preventing new barriers from arising and to meet the accessibility requirements prescribed by the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation at any time please contact us.

• Adherence to corporate, regulatory and individual responsibilities supporting the Company’s quality management programs, supporting policies, procedures, work instructions, and relevant software (eDMS)
• Adherence to organizational and individual health and safety responsibilities in the workplace
• Supports the environmental monitoring, aseptic processing, quality non-conformances, CAR, training, calibration, preventative maintenance, documentation, validation and change control programs
• Conducts quality investigations, performs root cause analysis, and determines materials disposition actions
• Ensures that Quality holds and non-conforming materials are identified, segregated, processed, handled, stored, and dispositioned in a manner consistent with company safety and quality policies and aligned with Quality disposition and regulatory requirements.
• Participates in product and material complaints investigations, and resolutions.
• Creates and implement SOPs and participates in personnel training.
• Participates in self-inspections; verification of aseptic processing, product storage, transportation, and distribution conditions to minimize quality risk.
• Assists in the preparation and review of GMP documentation (test results, log books, batch records, SOPs, validation records, inspection requests, etc.) to ensure compliance.
• Maintains knowledge database of applicable Standards and Guidelines (FK, Compounding / Compliance, Patient Safety, Risk Management, ISO) via eDMS or similar software.
• Assists in the development and implementation of plans, teams and activities supervision, to ensure goals are achieved within time frames, measure effectiveness of changes,
• Assists in data trending and analysis and in the maintenance, improvement and communication of facility and quality KPIs. Maintain assigned KPI Database, and associated Records and Reports.
• Participates in continuous improvement initiatives, and/or revisions of workflow in an effort to reduce errors. Participates in and facilitate process improvement meetings, making recommendations, as applicable.
• Participates in special projects as requested by the Senior Manager Quality, for needed improvements.
• Focuses on the maintenance and improvement of Compounding’s Quality Management Program with the goal of maximizing patient safety, and customer satisfaction.