- Perform chemical and biochemical analyses using approved methods
- Conduct testing to support manufacturing operations and validation activities
- Analyze samples of raw materials, plasma-derived products, and services/utilities
- Maintain the calibration, verification, and qualification of laboratory equipment
- Maintain instrument usage and calibration records
- Manage inventory and order, store, and receive laboratory supplies
- Perform activities in accordance with GMP/cGMP requirements
- Draft and revise standard operating procedures (SOPs)
- Perform testing in accordance with USP, EP, and BP pharmacopoeias
- Prepare reagents, clean equipment, and perform routine equipment maintenance
- Identify and report OOS, OOT, or atypical results and participate in laboratory investigations
- Complete GMP documentation and ensure data integrity and traceability
- Support method transfers and analytical method validation studies
- Participate in complex projects and develop expertise in analytical techniques

Requirements

- Minimum of a bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline
- Experience in a biotechnology or pharmaceutical quality control laboratory is strongly preferred
- GMP experience is required
- Minimum of three (3) years of experience working in a GMP laboratory role
- Working knowledge of cGMPs, the QC laboratory environment, and equipment used for biopharmaceutical product testing
- Knowledge of GMP requirements and the USP, BP, and EP pharmacopoeias




- Knowledge of valuable documentation practices and data integrity requirements
- Excellent computer skills, including Microsoft Office (Word and Excel)
- Experience with LIMS is preferred
- Bilingual in French and English
- Ability to work independently and as part of a team
- Ability to manage multiple tasks simultaneously and meet strict deadlines
- Excellent oral and written communication skills
- Ability to carefully follow written procedures with strong attention to detail

Core Competencies

Demonstrates expertise in chemical and biochemical analyses, adhering to GMP/cGMP requirements, and maintaining data integrity in laboratory settings. Proficient in drafting SOPs and conducting testing in compliance with USP, EP, and BP pharmacopoeias.

Highest-signal resume keywords

- GMP Experience
- Biotechnology Quality Control
- Analytical Method Validation
- LIMS Proficiency
- Bilingual in French and English

Hard Skills

- Chemical Analysis
- Biochemical Analysis
- Laboratory Equipment Calibration
- Standard Operating Procedures (SOPs)
- Good Documentation Practices
- Data Integrity
- Analytical Techniques
- Reagent Preparation
- Testing Compliance
- Inventory Management

Soft Skills

- Attention to Detail
- Oral Communication
- Written Communication
- Team Collaboration
- Task Management

Industry Keywords

- GMP
- CGMP
- USP
- EP
- BP
- Quality Control Laboratory
- Pharmaceutical Testing
- Biopharmaceuticals
- Laboratory Investigations
- Pharmacopoeias

Tools & Technologies

- Microsoft Office
- LIMS

📌 Quality Control Analyst II - Chemistry, Evenings (Montreal)
🏢 Jobtailor
📍 Montreal