I want to be part of a company that has a real impact on people's lives. I love health sciences especially biomedical research as well as pharmaceutical and biotechnology fields. Quality assurance and quality control are facets of the industry that fascinate me. I am honest, hard-working, punctual, versatile and able to work in a team. I am bilingual for French and English and have a basic knowledge of Spanish. In addition to having great ambitions, I am always looking to do quality work and exceed expectations.
Quality Control Microbiology Laboratory Technician at the Influenza Vaccine Manufacturing Plant (GSK Ste-Foy site)
Work performed in a highly regulated environment (site audited by Health Canada and the FDA)
Implementation of Good Manufacturing Practices (GMP) and Good Documentation Practices (BPD)
Perform LAL (Endotoxin) testing using Kinetic Turbidimetric.
Perform Bioburden testing of in-process samples, raw materials, equipment rinses, WFI and bulk drug substance using membrane filtration method and spread plate method.
Mirage, weight and age of eggs: age determination of embryos and egg weight using an analytical balance and evaluation of egg mortality rate
Streaking and freezing of various microbial strains. Perform microbial identification on Environmental Monitoring samples, in-process testing samples, and for other groups. Perform growth promotion testing of microbiological media.
Environmental monitoring: Incubation, transfer and reading of agar plates from the environmental monitoring program
Perform performance checks and calibration of different laboratory equipment
Qualify and release reagents for use in subsequent analyzes
Introduction to the different components of a quality management system that ensures the integrity and improvement of the system: deviations, Corrective and Preventive Action (CAPA), RCA (Root Cause Analysis), FMEA (Failure Mode And Effects Analysis), KPI (Key Performance Indicator), change control program, management of OOS, OOT and OOE, etc.
Assist in revising Standard Operating Procedures, as needed. Perform document reviews as required. Ensure sampling, testing and release timelines are met. Follow well-defined and established procedures and best practices.
Participation in the revision and verification of documentation concerning the results of analyzes (documentation of material and equipment, transcription of raw data, verification of the conformity of the results obtained according to established criterias, encoding of results in SAP, verification of data integrity)
Assist in the preparation of periodic trend reports and analysis of microbiological data.
Assist in laboratory investigations of microbiology excursions.
Enter data in QC SAP in a timely manner
Experience with GMP and GDP
Excellent pipetting skills
Excellent interpersonal and communication skills (both written and oral).
Ability to work under minimal direction and as part of a team.
Strong attention to detail
Good facilitation, organizational and problem solving skills.