The Quality Control Lead’s main role is to oversee the external laboratory quality control testing of incoming, in-process, stability, and final drug products, as well as the environmental monitoring program of the facility. The QC Lead leads QC personnel in their day-to-day responsibilities and manages the turnaround of incoming raw materials, and finished goods in a timely manner. The QC Lead ensures that QC personnel are properly trained and qualified to perform their job functions and that they understand and comply with current company, departmental and regulatory requirements.
- Strong knowledge of the pharmaceutical GMP regulations and their appropriate application in a Quality Control Laboratory.
- Experience working in a pharma GMP QC Lab
- Ability to drive results in a fast-paced environment
- Knowledge of analytical method validations in accordance with USP/ICH/FDA/EU regulations
- Good Understanding of Cannabis Regulations, Controlled Drugs and Substances Act, Pest Control Products Act, Fertilizer act, Guidelines for residual solvents ICH Topic Q3C (R5).
Duties and Responsibilities
- Provides oversight and manages the interface of any contracted laboratories and ensures that these are working to company standards.
- Manages the stability program, prepares protocols and reports, ensures timely testing and result approval/rejection.
- Manages the environmental monitoring program of the facility ensuring appropriate sample collection and testing.
- Approve specifications, sampling instructions, test methods and any other Quality Control procedures
- Support of cGMP operations, including technical review of change control documentation and reports, OOS and other manufacturing and laboratory investigations
- Supervises and schedules day-to-day activities of QC personnel.
- Ensures timely inspection, testing, and disposition of QC samples; including raw materials, packaging components, finished products, and R&D materials.
- Provides QC leadership in resolving technical problems, investigations and corrective actions.
- Ensures that the required initial and continuing training of the QC department is performed.
- Works closely with other departments to understand production priorities and adjust lab priorities as needed.
- Ongoing assessment of current lab operations with an eye towards continuous improvement.
- Assists in data collection and analysis of QC metrics.
- Generates or revises controlled documents such as SOPs and data forms
- Requires a Bachelor’s degree in a Scientific/Technical field
- 5+ years’ experience in the Pharmaceutical, Healthcare or related industry with 2 years supervisory experience in a QC laboratory
- Requires extreme adeptness in attention to detail/follow up
- Practical knowledge of at least one ERP application an asset
- Experience in developing and delivering training
- Problem-solving and decision-making skills;
- Computer proficiency including LIMS and MS Office
- Excellent communication and organizational skills
- Excellent interpersonal skills (dynamic, strong relationship builder, negotiator and influencer)
- Bilingual Mandatory – English & French (only for the Atholville site)
Salary: Commensurate with experience and qualifications
Security Clearance: Security Clearance may be required for this position.
Working Hours: Full-Time
Physical Requirements: None
Job Type: Full-time
Zenabis is quickly becoming a key player in the rapidly growing Canadian cannabis industry. As a publicly traded company (TSX: ZENA) with over 30 years of experience in commercial agriculture, we have the potential to become one of the largest licensed producers of medical and adult-use cannabis in the world. We are a diverse and passionate team of doctors, scientists, cultivators, educators, and advocates with the same goal: to increase access to high quality cannabis products.
While headquartered in downtown Vancouver, Zenabis’ facilities are located coast to coast across Canada. As the reach of our products continues to expand nationwide and internationally, we are looking for exceptional talent to propel our company to the next level. Join us as we help build this budding industry! For more information, please visit: https://www.zenabis.com.
Job Type: Full-time
- Quality Control: 5 years (Required)