About the Role
Performs method validation and biostudy analysis tasks to generate analytical test results in compliance with Standard Operating Procedures.
Responsibilities
- Performs method validation and biostudy analysis tasks in accordance with SOPs.
- Utilizes common analytical laboratory equipment including sample preparation equipment, general laboratory equipment, and LC-MS/MS.
- Conducts all work in a team environment, focusing on meeting project timelines.
- Assists in planning and coordinating projects, accommodating frequently changing priorities.
- Generates analytical test results in compliance with applicable Standard Operating Procedures.
- Generates method procedures, results, validation, re-validation, and analytical reports for regulatory submission.
- Coordinates projects and work activities with Laboratory Management to meet objectives.
- Demonstrates innovation in solving bioanalytical and laboratory process problems.
- Provides assistance in troubleshooting and maintenance of laboratory equipment.
- Assists in reviewing Standard Operating Procedures.
- Demonstrates excellent written and verbal communication skills.
- Performs job duties in a cost-effective manner.
- Compiles and archives study/validation data.
- Performs job duties according to approved Protocols and applicable GLP (OECD), EMA, ICH, FDA, and TPD requirements.
- Works in a safe manner, complying with all relevant safety procedures and requirements.
- Exhibits good interpersonal skills, a professional attitude, and motivation for high-quality work.
- Performs other related duties assigned by management.
- Generates analytical test results in compliance with SOPs, protocols, study plans, and applicable GLP (OECD), EMA, ICH, FDA, and TPD requirements.
- Documents and communicates deviations to the Principal Investigator (GLP) or Study Director (Non-GLP).
- Records raw data promptly and accurately in compliance with OECD Principles of Good Laboratory Practice.
- Exercises health precautions to ensure personal safety and study integrity.
- Communicates relevant health or medical conditions to Laboratory Management.
Requirements
- B.Sc. or College Diploma in Analytical chemistry or related subject
- Minimum of 1-3 years of related experience
Skills
- Method validation
- Biostudy analysis
- Analytical laboratory equipment
- Sample preparation
- LC-MS/MS
- Project coordination
- Problem-solving
- Equipment troubleshooting
- Equipment maintenance
- SOP review
- Written communication
- Verbal communication
- Cost-effective performance
- Data compilation
- Data archiving
- GLP (OECD)
- EMA
- ICH
- FDA
- TPD
- Safety procedures
- Interpersonal skills
- Professional attitude
- High-quality work
- Good Laboratory Practice
Location
- North York
Work Type
- Full Time
- Onsite
Experience Level
- 1-3 years
Education Level
- B.Sc.
- College Diploma
Salary/Compensations
- $40,000
About the Company
- BioPharma Services Inc.
