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.
This program deepens our knowledge of the human body, introduces us to the biological processes that govern human life, and plunges us into the heart of current biomedical research.
The Natural Sciences program makes it possible to discover the world through science and to learn more about natural phenomena and scientific innovations.
Perform microbial swabbing of equipment and room surfaces for environmental monitoring of clean rooms.
Perform bioburden on raw materials, solutions, in process and finished products.
Perform conductivity measurements on the different point of use of the water system, solutions, rinse water of equipment cleaning (CIP)
Review SOPs and forms of the department
Participate in the identification and resolution of technical problems associated with the analyzes performed
Identify out-of-specification results (OOS) and non-conformities and complete documents related to the quality system, such as laboratory investigation reports (LIR), non-compliance reports as well as alerts and actions
Write the reports inherent to the analyzes carried out as well as the documents related to the quality system
Apply good manufacturing practices (GMP) and good documentary practices
Ensure that all product manufacturing operations and analyzes are performed in accordance with applicable licenses, regulations and customer expectations
Revise all GMP (Good Manufacturing Practices) documentation attesting that products have been manufactured and that production, laboratory and analytical equipment have been validated in accordance with established standards while respecting release schedules
Verify and approve all production records and associated documentation from issue to release
Propose and authorize the release or rejection of products by preparing relevant documentation. Identify, in the production area, the status of the products. Process the returns of the products in the ERP system (e.g.: MSSS, GSK)
Participate in audits and response to observations
Act as a resource person and provide coaching support to other departments on the operation of the various GMP systems included in the annual quality review (e.g., deviations, RPC)
Write, verify and send official documentation to government authorities and other GSK sites according to specific requests from different markets. Review regulatory submissions and provide information as required
Execute the site KPIs and the quarterly review of deviations
Review the documentation related to the quality review by obtaining information from the various departments (e.g.: production files, quality systems, process validation), compile data and carry out trend monitoring
Coordinate and modify spec sheets. Conduct product inventory
Participate, revise, or complete the writing of various GMP documents
Support the maintenance of Quality Systems policies and procedures
Assist with oversight of the deviation/CAPA programs
Review and approve deviations and CAPAs
Conduct timely Quality review of associated data, including data utilized to support lot release, to meet business and operations requirements, and to ensure data meets the industry requirements for data integrity
Perform GMP internal audits and monitor compliance
Ensure that procedures are being followed as outlined under FDA and the Quality System requirements
Represent department in cross-functional teams, projects and GXP-related problem resolution
Review and approval of change controls
Provide on the floor QA oversight and support to ensure compliance of GMP activities throughout the site
Elevate to supervisor when non-conformances are identified as outlined per applicable procedures. Serve as a resource for compliance and corrections
Ensure documentation is recorded in accordance with ALCOA principles
Perform AQL particle inspection of in-process product vials prior to packaging
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.
Dr. Steve Lacroix's laboratory: he runs a laboratory specialized in neuroimmunology and regenerative medicine at Centre de recherche du CHU de Québec – Université Laval (CRCHUQc-UL). Research conducted in his lab focuses on spinal cord injury, peripheral nerve injury and multiple sclerosis.
Purpose of the internship: To develop an in vivo method of overexpression of the human α-synuclein gene in neurons of dorsal root ganglia in mice.
Writing of a 30-page scientific report
Poster presentation of the results obtained during the internship
Research the scientific literature to answer the following question: Could alpha synuclein play a role in the survival of the neuron in a context of neurodegenerative disease or axotomy?
Do lab experiments to check if αSyn is overexpressed in neurons of the mutant Wallerian mouse degeneration slow (Wlds)?
Writing of two scientific reports of twenty pages each
Knowledge of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP)
Knowledge of 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), management of OOS, OOT and OOE, change controls, etc.
Knowledge of aseptic manufacturing processes
Knowledge of equipment, facility, and utility IQ/OQ/PQ
Working under a laminar air flow hood with proper aseptic techniques