This position will be working with the QA manager and Edmonton Radiopharmaceutical Center (ERC) leadership with the primary responsibility of following Health Canada Good Manufacturing Practice (GMP) regulations. Key responsibilities include: writing, reviewing and approving protocols, procedures and master batch records for the products used in the manufacturing of radiopharmaceuticals, and active radiopharmaceutical ingredients (API), reviewing and approving installation qualification (IQ) and operation qualification (OQ) for new equipment and building systems (HVAC, BAS, pressure, temperature, etc.), participating in the performance qualification (PQ) and validation of equipment (new and current) used in ERC (SPECT, FDG, and API), reviewing analytical, manufacturing and/or packaging documentation, analyzing historical data to detect or establish trends and confirm effectiveness of preventative actions and preparing for the physical move of ERC to a different facility. This position operates in a multidisciplinary environment and therefore applicant must have the ability to cooperate and work effectively independently within the prescribed guidelines while promoting good teamwork.
As a Radiopharmacy Specialist II, you will prepare and dispense radiopharmaceuticals from both commercial kits and raw materials. You will assist in the use and maintenance of scientific equipment and instrumentation, radiation and workplace health and safety procedures, develop and write Standard Operating Procedures, check supply inventory, prepare and dispense radiopharmaceutical kit production and assist in the packaging and transportation of radiopharmaceuticals.
Classification: Radiopharmacy Specialist II
Union: HSAA Facility PROF/TECH
Department: ACB EDM CROSS Mrktd SrvAncOpr
Primary Location: Cross Cancer Institute
Multi-Site: Not Applicable
Posting End Date: 23-AUG-2019
Employee Class: Regular Full Time
Date Available: 16-SEP-2019
Hours per Shift: 7.75
Length of Shift in weeks: 2
Shifts per cycle: 10
Shift Pattern: Days
Days Off: Saturday/Sunday
Minimum Salary: $35.81
Maximum Salary: $47.67
Vehicle Requirement: N/A
Completion of an accredited program in Nuclear Medicine Technology or Chemical technology. Active or eligible for registration with the Canadian Association of Medical Radiation Technologists (CAMRT). Minimum two to five years' experience in handling radioactivity, in radiopharmacy or related field.
Additional Required Qualifications:
Knowledge of Good Manufacturing Practice (GMP) regulations and good documentation practices Quality Management system training or experience. Familiarity with Microsoft office applications. Technical understanding of regulatory and quality system elements for parenteral drug product manufacturing facility. Good communication skills to cooperate and work effectively in a multidisciplinary environment including customers, staff and external agencies.
BSc Degree with a specialization in microbiology/chemistry preferred. Five years of relevant experience in quality assurance work preferred. Computer skills and organizational skills considered a strong asset.