Quality Assurance Associate - GMP
Quality AssuranceFull TimePembroke, ON
GlassHouse Botanics Inc, a licensed Cannabis producer, is looking to hire a Quality Assurance Associate - GMP
Job Type: Full-time
Reporting to the Quality Manager, the main task of the Quality Assurance Associate - GMP is to support all departments to ensure compliance with the requirements of European Good Manufacturing Practices (EU-GMP) as defined by the European Medicines Agency.
Duties Include but are not limited to:
- Assist the Quality Assurance Person (QAP) in ensuring GPP and EU GMP compliance throughout the facility.
- Assist in the development and implementation of GPPs and EU GMP standards.
- Assist all functional departments in establishing systems to eliminate regulatory gaps.
- Support coordination of new hires and conducting training on GPPs, GMP and health and safety protocols as required.
- Help develop, implement, and maintain the Risk Management System for compliance with EU GMP.
- Support the QAP with communication, education, and on-going training to ensure quality requirements of all departments are met.
- Develop and implement validation protocols.
- Qualification of equipment.
- Assist with audits and inspections’ preparation, management, and reporting.
- Record verification, collection, organization, and data entry of data/information.
- Participate in the creation, review, and maintenance of SOPs, Plans and GMP documentation.
- Assessments and investigation of deviations and customer complaints.
- Work cross functionally with various departments to execute on business Key Performance Indicators (KPIs).
- Manage and maintain relevant records and data through a QMS.
- Participate in the initiation and writing of change controls to controlled documents as needed to ensure defined quality objectives are met.
- Support with post-harvest process deviation management.
- Read, understand, and follow safe work procedures.
- Conduct risk assessments.
- Other duties as assigned.
The ideal candidate will have:
- Exceptional attention to detail.
- Ability to work independently.
- Proven ability to manage cross functional relationships.
- Self-motivated and resourceful.
- Knowledge of GPP/GACP would be considered an asset.
- Knowledge and previous experience with QMS in the food industry or pharmaceutical.
- Willingness to learn new techniques and follow direction.
- Ability to thrive in a fast-paced work environment.
- Ability to adapt to change.
- Exceptional communication and writing skills and ability to deal with all types of personalities.
- Self-starter, critical thinker and team oriented.
- High work ethic standards are a must.
Education & experience: – a combination of education and experience will be considered.
- A combination of bachelor’s degree in science related field and/or technical Diploma from an accredited post-secondary institution.
- 3 or more years of experience working with and/or having implemented a QMS.
- Practical experience in EU GMP implementation and certification process for cannabis and/or similar product (e.g., herbs) is an asset.
- Knowledge of Eudralex Volume 4.
Plants like heat and humidity. To be successful in this position you need to be comfortable working in an enclosed environment with high heat and humidity, wear protective clothing, hair covering and other Personal Protective Equipment. Exposure to some hazardous chemicals in a controlled environment.
Conditions of Employment:
All applicants being considered for employment will be required to pass a criminal background check prior to hire. Initial screening (Medical examination) of staff may be required. Annual medical examination may be required annually thereafter.
Note: The statements above are intended to describe the general nature of the work being performed by people assigned to the job. They are not an exhaustive list of responsibilities, duties and skills required of personnel in the job.
The position requires relocation to Whitewater Region, ON (Pembroke area and vicinity).