Head of quality control and Safety

2 days ago

Winnipeg MB, Winnipeg Census Division, MB; Manitoba, Canada Prollenium Medical Technologies Inc. Full-time
Prollenium Medical Technologies Inc. is a fast-growing Canadian developer, manufacturer, and international distributor of premium hyaluronic acid (HA) dermal fillers and cosmetic products. We are proud to address all of our client's needs through streamlined innovation. Prollenium is able to ensure a continual flow of creation, unique ideas, and a steady pipeline of new and exciting products that provide safe and effective results. With regulatory approvals from the US FDA and Health Canada, Prollenium has sold over 5 million syringes from its Revanesse® product line across more than 80+ countries worldwide. Join our dedication to innovation. The QC Supervisor is the point person for all staff in the QC laboratory on items related to testing. This position reports to the QC Manager.
The QC Supervisor is the point person for all staff in the QC laboratory on items related to testing. This position reports to the Director of Quality.
Responsibilities include QC laboratory operations at both locations of Prollenium Medical Technologies (Aurora and Richmond Hill) including raw materials testing and retain programs, in-process and finished product release testing, stability programs and equipment calibration and validation programs.
The QC Supervisor will be expected to participate in regulatory audits and represent the QC Department when auditors / inspectors raise questions about departmental activities.
Management Reviews: The QC Supervisor will participate in scheduled management reviews and present the relevant trending, successes, obstacles faced over the relevant period time covered by the management review activities.
Staffing, Resources and Training: The QC Supervisor role will include periodic meetings with the Director of Quality Assurance to relay requests related to staffing, resources and training (internal or external) which will in turn be brought to the attention of upper management (ie Director of Human Resources, Logistics Supervisor, Director of Business Operations or President and CEO) on a case by case basis.
Coaching and Mentoring: The QC Supervisor role will include the responsibility of interacting with the QC chemists and encouraging individual interests as they relate to learning new QC tests or addressing correcting human error in the performance of a test. This role will also (ie Director of Human Resources, Logistics Supervisor, Director of Business Operations or President and CEO) on a case by case basis.
Staff Performance: The QC Supervisor role will involve input related to QC staff performance reviews which will be discussed with the Director of Quality Assurance and brought to the attention of upper management (ie Director of HR, President and CEO) on a case by case basis.
QC Testing and Record Keeping: The QC Supervisor role will be expected to participate in routine QC testing activities when other duties are not being conducted. The priority is to find a balance in the fulfilment of the requirements of the ISO13485 quality system and the need to efficiently supervise the QC laboratory.
Technical Knowledge/ExperienceM.
University Degree in a Scientific Discipline (Chemistry, Biology, or related).
Knowledge of Chemistry and Chemical test methods.
Inventory management systems, set-up and management.3-5 years supervisory experience in a QC function in a GMP/GLP or ISO compliant environment.
BehaviouralDemonstrated ability to apply the following behavioral competencies on the job:Leadership: Effectively manage, coach and mentor QC AssociatesTeamwork: Working effectively and productively with others. Willing to assist in laboratory testing.
Writing clearly, succinctly and understandablyProblem Solving: Anticipating, analyzing, diagnosing and resolving problemsOrganization and Planning: Utilizing logical, systematic and orderly procedures to meet objectivesFlexibility: Agility in adapting to changePREFERRED

QUALIFICATIONS:
Experience in Microbiological TestingExperienced in Validation Protocol Development and Report WritingExperience in Stability Protocol Development and Report WritingSOP writing experienceTraining experienceThe position is based in We use AI-enabled tools to support certain aspects of our recruitment process. #