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Quality Compliance Associate

7 months ago

Richmond Hill, Canada Prollenium Medical Technologies Inc. Full time

Prollenium is one of Canada’s fastest growing manufacturers and distributors of premium hyaluronic acid derma fillers and related 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 hyaluronic acid fillers, worldwide.

Prollenium is currently looking for a **Quality Compliance Associate **to join our team. You will be working at our Richmond Hill facility located at 29 East Wilmot Street, Richmond Hill, Ontario, L4B 1A3.

This is a permanent, full-time position, based on 40 hours per week. Further information respecting the position can be found below.

**Position**

As a Quality Compliance Associate, you will provide technical support to various projects related to chemical and biopharmaceutical research and analysis, and environmental management. You will also act as a liaison between Prollenium’s Quality Control/Manufacturing departments, and other departments including Quality Assurance and Regulatory Affairs.

Duties will include the following:

- Conducting chemical experiments, tests, and analyses on hyaluronic acid dermal filler products using appropriate techniques, including high-performance liquid chromatography (HPLC).
- Conducting trending and data analysis associated with ATP-based swab testing and investigational action limits.
- Leading the research, testing and analysis of the impact of long-term storage on drug products.
- Overseeing testing associated with safety and release of drug and cosmetic products.
- Compiling batch production records from medical devices/drugs, and interpreting the relevant experimental and analytical results.
- Assisting with air and water quality testing, recording results, and acting as a liaison to the Manufacturing department for continuous environmental monitoring, and development/compliance assessment to ISO 14001.
- Participating in the validation and maintenance of extrusion force instruments for combination products.
- Supporting the development and implementation of compliance programs, policies, reporting, and practices according to ISO 9001, ISO 13485, ISO 17025, ISO 45001, ISO 14001, GMP, GLP, and other standards as required.
- Participating in regulatory activities, inspections and audits associated with Prollenium’s Drug Products, Medical Devices, and Cosmetic Products, to ensure compliance with the regulatory requirements of Canada, US FDA, Europe, Brazil, and Australia.

**Qualifications**
- Successful completion of a university degree, or 3-year college diploma in Chemistry, Biology, Pharmacy, or a related science.
- 1 to 2 years of experience in chemical and biopharmaceutical research and analysis, working in an ISO 9001, ISO 13485 or ISO 17025 environment.
- 1 to 2 years of experience in environmental management, working to ISO 14001 standards.
- Prior experience using HPLC techniques.
- Preference given to applicants with prior experience (min. 6 months) working with hyaluronic acid dermal fillers.
- Preference given to applicants who have successfully completed certified training in ISO 9001, ISO 13485, ISO 17025 or ISO 14001.
- Proven success writing Standard Operating Procedures.
- Prior experience supporting regulatory agency audits in a QA/QC environment.
- Fluent in English.
- Excellent written and oral communication skills.
- Great problem solver, with an ability to anticipate, analyze, diagnose and resolve problems.
- Superior organization and planning skills, and an ability to use logical and systematic tools to meet objectives.
- Flexible and able to adapt to change.
- A team player who is able to work effectively and productively with others.

**Compensation**

We offer a generous compensation package, which includes:

- Salary: $56,200 per annum based on 40 hours of work per week
- Vacation: 10 paid days per year
- Benefits: extended medical, dental, disability and life insurance, RRSP contributions, and eligible for participation in our corporate pension plan
- Other: eligible for discretionary bonuses and incremental salary increases in accordance with standard company policies

**Apply**

**Company**

Prollenium Medical Technologies Inc.

29 East Wilmot Street

Richmond Hill, Ontario

L4B 1A3

**Salary**: $56,200.00 per year

**Benefits**:

- Dental care
- Extended health care
- Paid time off
- Vision care

Schedule:

- Monday to Friday

Application question(s):

- Do you have experience working with hyaluronic acid dermal fillers?

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- chemical and biopharmaceutical research and analysis: 1 year (preferred)
- ISO Environment: 1 year (preferred)
- HPLC: 1 year (preferred)

Work Location: In person