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Quality Assurance Specialist
2 months ago
Calea Ltd. is seeking a highly skilled Quality Assurance Specialist to support the compliance of our Compounding business unit to applicable corporate and regulatory requirements. The successful candidate will ensure the Quality Management Systems (QMS) is maintained and continuously improved to maximize performance, business efficiency, customer service requirements, and patient safety.
Key Responsibilities- Adhere to corporate, regulatory, and individual responsibilities supporting the Company's quality management programs, policies, procedures, work instructions, and relevant software.
- Ensure adherence to organizational and individual health and safety responsibilities in the workplace.
- Support the environmental monitoring, aseptic processing, quality non-conformances, CAR, training, calibration, preventative maintenance, documentation, validation, and change control programs.
- Conduct quality investigations, perform root cause analysis, and determine materials disposition actions.
- Ensure 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.
- Participate in product and material complaints investigations and resolutions.
- Create and implement Standard Operating Procedures (SOPs) and participate in personnel training.
- Participate in self-inspections; verification of aseptic processing, product storage, transportation, and distribution conditions to minimize quality risk.
- Assist in the preparation and review of Good Manufacturing Practice (GMP) documentation to ensure compliance.
- Maintain knowledge database of applicable Standards and Guidelines via electronic Document Management System (eDMS) or similar software.
- Assist in the development and implementation of plans, teams, and activities supervision to ensure goals are achieved within time frames, measure effectiveness of changes.
- Assist in data trending and analysis and in the maintenance, improvement, and communication of facility and quality Key Performance Indicators (KPIs). Maintain assigned KPI Database, and associated Records and Reports.
- Participate in continuous improvement initiatives and/or revisions of workflow to reduce errors. Participate in and facilitate process improvement meetings, making recommendations as applicable.
- Participate in special projects as requested by the Senior Manager Quality for needed improvements.
- Focus on the maintenance and improvement of Compounding's Quality Management Program with the goal of maximizing patient safety and customer satisfaction.
- 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 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, Risk Management, Root Cause Analysis, and continuous quality improvement. Knowledge of GMP/ISO, particularly as they relate to quality control/assurance.
- 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.
- ISO 9001 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 Ltd. is committed to ensuring we can provide critical and lifesaving medical products and services to vulnerable members of our communities. We are dedicated 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 Ltd. is dedicated to breaking down barriers to accessibility, preventing new barriers from arising, and meeting the accessibility requirements prescribed by the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation at any time, please contact us.
