Quality Control Analyst

AtomVie Global Radiopharma Inc.; Hamilton; On-site; CAD 54,000 - 66,000; Full time

Benefits offered by this job

Health & dental benefits

RRSP matching

Wellness programs

Job summary

AtomVie Global Radiopharma Inc. in Hamilton, Ontario, seeks a QC Analyst to perform quality control testing of finished drug products, raw materials and in-processing testing according to established STMs, with emphasis on analytical chemistry, biology, and microbiology.

The role supports GMP compliance and contributes to the security of product quality across the portfolio. Responsibilities include documenting data, generating certificates of analysis and test reports, calibrating equipment,

Qualifications

• 1–3 years of analytical chemistry experience including HPLC, GC, TLC.
• Experience with biological/microbial tests is a plus.
• Proficiency with Empower data processing software.

Responsibilities

• Perform quality control testing of finished drug products, raw materials and in-processing testing per STMs.
• Document analytical data and generate certificates of analysis and test reports.
• Maintain calibration/maintenance of lab equipment and manage inventory of reagents and materials.
• Coordinate testing with contract labs per USP/EP where applicable.
• Ensure compliance with GMP and Health and Safety policies.
• Assist in training colleagues and supporting regulatory documentation.

Skills

Test method following

Safety minded

Team collaboration

Education

College Diploma or B.Sc. in Chemistry/Biology related field

Tools

Empower (Waters HPLC)

Excel

Word

Job description

As a QC Analyst, you will be responsible for working in accordance with company policies and within GMPs while contributing your technical expertise to support current products and develop future drugs within the AtomVie portfolio.

This posting is for an existing vacancy to support the expansion of the company.

What You Will Do

• Perform quality control (release & retrospective) testing of finished drug products, raw materials and in-processing testing according to standard testing methods (STMs) which may either be compendial or developed/validated in-house; technique areas include analytical chemistry, biology and microbiology.
• Conduct all work in accordance with AtomVie Standard Operating Procedures (SOPs) and raise any deviations immediately to the attention of Lab Management and Quality Assurance. Report testing failure and non-conformances (both orally and in written), assist in conducting investigations and implement corrective actions with supervision.
• Proper documentation of analytical data and information.
• Write technical documents (e.g. generate Certificate of analysis, test reports, data summaries, etc.).
• Perform calibration/maintenance of fundamental lab equipment.
• Responsible for maintaining inventory of analytical reagents, critical material, reference standard and laboratory consumables.
• Responsible for maintenance of documentation to fulfill applicable regulatory requirements relating to nuclear safety (e.g. radioactive material transfer forms).
• Responsible for the housekeeping in accordance with AtomVie Standard Operating Procedures (SOPs).
• Coordinate quality control (release &retrospective) testing of drug substances with contract laboratories or contract research organizations according to standard testing procedures, USP or EP.
• Plan, implement, and successfully complete assigned tasks in a timely fashion ensuring consistent high quality.
• Liaises with higher level laboratory personnel to learn the use of all applicable physical & chemical testing equipment and to acquire a fundamental understanding of departmental and regulatory practices.
• Assist in training of other colleagues.
• Ensure compliance with Health and Safety for all policies, procedures and regulations applicable to their work.
• Adhere to Canadian Nuclear Safety Commission.
• Adhere to GMP regulations.
• Complete all other related duties assigned.

What You Bring to the Role

• Basic understanding and ability to follow test methods/SOPs/compendia and Certificates of Analysis.
• Ability to make routine decisions around simple task priorities but governed strictly in their work by SOPs. Typically seeks the input of higher-level team members in non-routine matters.
• Ability to work in a safe manner collaborating as a team member to achieve all outcomes.

Requirements

• College Diploma or B.Sc. in Chemistry, Biotechnology, or a related field.
• 1 to 3 years of related experience in analytical chemistry techniques such as HPLC, GC and TLC, microbiology tests such as Bacterial Endotoxins, and/or Biology tests such as IRF, ELISA and SDS-PAGE.
• Proficiency with equipment data processing software such as Empower (Waters HPLC).
• Proficiency with spreadsheets (e.g. Excel), word processing software (e.g. Word) and ability to write technical documents and reports.
• Good communication skills (in English) and ability to work both independently and cooperatively in a team environment.
• Experience in a pharmaceutical cGMP environment, experience in aseptic operations (use of a BSC - Biological Safety Cabinet) and working under Canadian Nuclear Safety Commission regulations are assets in this role.
• This position requires shift work and alternating weekends.
• Ability to lift and move heavy weights up to 23 kilograms is required.

Compensation:

Annual salary starts at $60,000. Compensation is based on relevant industry experience, academic credentials, and qualifications.

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

AtomVie does not use artificial intelligence or automated decision-making tools in any part of the recruitment, screening, or selection process.

We are 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.