JOB SUMMARY:
Prollenium is a Canadian-based company focused exclusively on the research and manufacturing of medical devices. Our commitment to product development, innovative research and manufacturing means we will continue to revolutionize the medical aesthetics market while maintaining to be one of the leading manufacturers of HA fillers, worldwide. Prollenium provides competitive compensation, benefits and development opportunities.
The Quality Assurance Associate is responsible for preparing Quality Management System (QMS) documentation within the Quality Assurance Department at Prollenium Medical Technologies (PMT) Inc. The Quality Assurance Associate is trained and supervised the Quality Assurance Manager.
MAJOR RESPONSIBILITIES:
Audits / Inspections
- Provide prepared documentation in support of audits and inspections from regulatory agencies ie. Health Canada, US FDA, Brazilian, European, UK, Australia, Japan).
QMS Documentation
- Assist in requesting Quality Metrics from PMT Depts for discussion during Management Review.
- Support the validation program by issuing validation report numbers, change control forms and obsolescence of older versions within the QMS.
QMS Training
- Edit and save SOPs as needed.
- Assist in coordinating PMT’s company-wide training program.
Customer Complaints / Supplier Evaluation
- Accession new customer complaints, collect information, prepare reports, submit within required timeframes.
- Develop and maintain documentation to ensure compliance for critical and non-critical suppliers (certificates, contracts/agreements, supplier audits, and corrective actions).
Manufacturing Records / ERP Release
- Maintain retrievable records (paper and/or electronic) of lower level inventory items.
- Fill paperwork as per GMP requirements.
- Participate in releasing lower-level inventory items using PMT’s ERP system.
Facility Management / Joint Health & Safety
- Participate in statutorily required meetings related to company health and safety policies.
MINIMUM QUALIFICATIONS:
Technical Knowledge/Experience
- 1-3 or more years of work experience in a Quality Assurance function in an ISO 9001, 13485 or 17025 environments.
- University degree in the science (chemistry, biology, pharmacy or similar).
- Excellent written and oral communication skills.
Behavioural
- Demonstrated ability to apply the following behavioral competencies on the job:
- Problem Solving: Anticipating, analyzing, diagnosing and resolving problems
- Organization and Planning: Utilizing logical and systematic tools to meet objectives
- Written Communication: Writing clearly, succinctly and understandably
- Teamwork: Working effectively and productively with others
- Punctuality: Must be willing to arrive on time
- Flexibility: Agility in adapting to change
PREFERRED QUALIFICATIONS:
- Experience supporting regulatory agency audits in a QA environment
- SOP writing experience
WORKING CONDITIONS:
- Primary work location is Richmond Hill, with possibility of 1 day a week at Aurora facility
