Hplc Analyst- Qc Lab

Perform quality control release testing of finished drug products raw material, in process according to standard testing methods including analytical chemistry method and other tests according to the USP, EP.
- Coordinate quality control (release &retrospective) testing of drug substances with contract laboratories or contract research organizations according standard testing procedures, USP or EP.
- Support analytical method development, transfer, and validation activities: Draft routine validation protocols.Perform routine validation activities independently and more complex validations with guidance, as per approved protocols. Draft validation reports according to regulatory guidelines (ICH, USP, etc.)
- Conduct all work in accordance with (SOPs)and raise any deviations immediately to the attention of Lab Management and Quality Assurance.
- Conduct peer review of laboratory records; create the release certificate of analysis.
- Write technical documents (e.g. author/create specifications, test reports, data summaries, investigations, CAPAs); prepare CAPA implementation plans and participate in closing laboratory investigations.
- Write (author) SOPs controlled forms, data entry templates, etc., provide peer review and provide input for co-workers. Initiate change controls (prepare change control proposal) and revise/improve existing methods.
- Responsible for training other colleagues, colleagues from other departments, and new staff.
- Perform routine quality operations including calibration/maintenance of equipment and inventory/material management of incoming raw materials/container closures and analytical reagents, when required.
- Responsible for the housekeeping of the facility including the disposal of hazardous waste (chemical and radioactive) through the appropriate waste-streams. Monitor effectiveness of the housekeeping and waste procedures and propose improvements to management.
- Responsible for maintenance of documentation to fulfill applicable regulatory requirements
- Work as a member of a team to achieve all outcomes; ensure that daily work activities are aligned with a production and stability plan/calendar.
- Plan, implement, and successfully complete assigned tasks in a timely fashion ensuring consistent high quality.
- Conduct investigations for testing failure and non-conformances and implement corrective actions.
- Adhere to GMP regulations by maintaining complete records pertaining to all aspects of training, analytical testing, routine operations, and equipment maintenance.
- Understand and work under the Health Canada and FDA GMP requirements
- Ensure compliance with Health and Safety for all policies, procedures and regulations applicable to their work.

**Job Types**: Full-time, Permanent

**Benefits**:

- On-site parking
- Paid time off

Flexible Language Requirement:

- French not required

Schedule:

- Monday to Friday
- Weekend availability

Supplemental pay types:

- Overtime pay

Work Location: In person