Quality Control Analyst I

AtomVie Global Radiopharma Inc.; Hamilton; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company in Hamilton is seeking a QC Analyst I to ensure the quality control of radiopharmaceuticals. This role focuses on testing materials using advanced analytical techniques like HPLC and GC, with responsibilities including equipment maintenance and compliance with GMP regulations. The ideal candidate has a B.Sc. in Chemistry or Biotechnology and experience in a GMP environment. AtomVie offers competitive benefits from day one, including health and dental coverage and an RRSP matching program.

Benefits

Group Health & Dental Benefits (from day 1)

RRSP Matching Program

Perkopolis

Employee Assistance and Wellness Programs

Parking Allowance

Qualifications

• Experience executing chemistry techniques like HPLC, GC, and TLC.
• Good math skills are critical.
• Experience with sterile products is an asset.

Responsibilities

• Quality control testing of materials and finished drug products.
• Perform routine calibration and maintenance of equipment.
• Conduct investigations for testing failures and non-conformances.

Skills

HPLC

GC

TLC

Mathematics

Education

B. Sc. in Chemistry, Biotechnology or a related field

Tools

ICP

Gamma Spectroscopy

Liquid Scintillation Counter

Job description

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributor of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.

We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.

Overview

About the Role

The QC Analyst I will be responsible for working in accordance with company policies and within GMPs while contributing technical expertise to support current products and develop future drugs within the AtomVie portfolio. They will also be responsible for quality control testing of materials and finished drug products, specifically radiopharmaceuticals. The ideal candidate will be proficient in executing chemical tests using advanced analytical techniques, including HPLC, GC, TLC, bacterial endotoxin testing, and pH measurements, while adhering to standard operating procedures (SOPs) and Good Manufacturing Practices (GMP).

This position involves set evening, night, or early morning shifts, with weekend availability required (e.g., Thursday to Monday).

Responsibilities

• Quality control testing of materials and finished drug products (radiopharmaceuticals) including chemical tests using various analytical techniques such as HPLC, GC, TLC, bacterial endotoxin testing, pH, etc. according to standard operating procedures.
• Perform routine calibration/maintenance of equipment.
• Responsible for the facility maintenance and housekeeping, maintain inventory of reagents and supplies, waste disposal, etc.
• Peer review of laboratory records
• Conducting investigations for testing failure and non-conformances
• Author, revise, and review technical documents, including SOPs, validation documents, standard test methods according to good documentation practices and reports.
• Support analytical method transfer and validation activities as required.
• Adhere to Canadian Nuclear Safety Commission and GMP regulations.

Qualifications

• Experience routinely executing chemistry techniques such as HPLC, GC and TLC is preferred for this role.
• Good math skills are critical in this role.
• Experience with other lab equipment such as ICP, Gamma Spectroscopy, or Liquid Scintillation Counter is an asset.
• Experience working with sterile products is considered an asset

Requirements

• B. Sc. in Chemistry, Biotechnology or a related field
• 1-3 years of relevant experience working in a GMP or ISO environment is required
• Ability to lift 23 kilograms required
• Shift flexibility to support 24-hour/7-day manufacturing schedule

AtomVie Offers

• Group Health & Dental Benefits (from day 1)
• RRSP Matching Program
• Perkopolis
• Employee Assistance and Wellness Programs
• Parking Allowance

AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.