QC Analyst

Atom Vie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer 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 Atom Vie today and help us achieve our vision: to transform lives by revolutionizing healthcare.

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 Atom Vie portfolio.

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

Location: Atom Vie Global Radiopharma Inc, Hamilton ON (Onsite)

• 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 Atom Vie 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 Atom Vie 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.

• 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.

• 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…