Quality Technician

To assure the quality of manufactured products through documents review and control, investigation, reconciliation, master batch production record review, product audits and inspection.
- Conducting regular internal audit per yearly audit schedule
- Perform batch record reviews, investigation, and audits
- Conduct line inspection and approve line standard
- Handling issues and non-conformances such as preparing NCR and CAPA Report
- Perform line clearance check and ensure compliance with SOPs
- Assessment of drug product and cosmetic quality and conformance to specifications by reviewing batch production and testing / inspection records; reviews and evaluate quality-related data from inspection activities and reports these data using statistical techniques
- Review batch production records and other QA documentation and report any deviations to Quality Assurance Manager and affected departments.
- Clarify information and address deviations.
- Reviews reconciliation calculations for drug items as part of batch production record review prior to release of finished goods.
- May assist production in doing the calculations, Completes product inspection reports, release products after review of documents and related test parameters.
- Gathers all batch production documents and keeps as batch production packet; does overall review and completion.
- Responsible for FG product releases and ensures that batch production records are complete, accurate and in compliance; Releases products for shipment according to specifications and keeps tracks of drug products produced.
- Provides information on latest standards, specifications, procedures and requirements related to existing and new products.
- Provides necessary specification documents and inspection forms to Production before filling and packing of drug products, issues & reviews batch cards for drug products and cosmetics.
- Prepare Micro samples to be sent to the micro testing lab.
- Conduct incoming inspection on cosmetic components and labels following sampling plan.
- Collect bulk samples, perform bulk testing, and prepare certificate of analysis.
- Assist in conducting root cause analysis for internal quality issues. Recommends corrective and preventive measures and maintain records. Ensure root cause/preventive measures are identified and corrective actions are taken.
- Assists in writing, and reviewing SOPs according to GMP requirements.
- Assists in conducting regular internal Quality/GMP audits according to self-improvement program (SIP) and according to GMP requirements. Prepares audit reports and action plans.
- Assist in monitoring the calibration program of the site by maintaining calibration log and certificates
- May assist in any QA/QC activities as required.
- Follow safety rules and regulations at all times.
- Qualifications and Skills: Education and Training
- Bachelor/Diploma in Chemistry, Chemical Engineering, Chemical Technician, or any related science field.
- 2 years experience as quality technician/Quality Inspector
- Self-motivated, highly organized and good documentation skills.
- Process oriented person with GMP awareness, Strong interpersonal and communication skills to handle production questions and concerns and to initiate necessary actions.
- Collect bulk samples, perform bulk testing, and prepare certificate of analysis.
- Assist in conducting root cause analysis for internal quality issues. Recommends corrective and preventive measures and maintain records. Ensure root cause/preventive measures are identified and corrective actions are taken.
- Assists in writing, and reviewing SOPs according to GMP requirements.
- Assists in conducting regular internal Quality/GMP audits according to self-improvement program (SIP) and according to GMP requirements. Prepares audit reports and action plans.
- Assist in monitoring the calibration program of the site by maintaining calibration log and certificates
- May assist in any QA/QC activities as required.
- Follow safety rules and regulations at all times

**Salary**: From $18.00 per hour

Additional pay:

- Bonus pay

Schedule:

- 8 hour shift

Ability to commute/relocate:

- Scarborough, ON: reliably commute or plan to relocate before starting work (required)