Zone: Eastern Urban Zone
Location: Health Sciences Centre

Radiopharmacy Laboratory and Quality Specialist
(Laboratory Technologist IIF)
Subject to Classification Review
Medical Imaging

Radiopharmaceutical Sciences Section (Nuclear and Molecular Imaging)
Permanent Full-time
27336POS

Hours 70 bi-weekly (8 hours; Days, Evenings, Nights, Weekends)
Salary LX-33 ($38.88 - $48.95 per hour)
Competition Number VAC0006283
Posted Date 2025-01-16
Closing Date 2025-01-23
Demands, duties, qualifications
Job Summary
NL Health Services are seeking a Laboratory and Quality Specialist, reporting to the Manager of Radiopharmaceutical Sciences and Cyclotron Operations, the Laboratory and Quality Specialist will work in a multidisciplinary team to assist in the routine production and setup of processes for the implementation of new radiopharmaceuticals.
The Laboratory and Quality Specialist will have a hybrid role supporting the Quality Assurance program in conducting periodic reviews of paper and computer-based systems, conducting audits and inspections, and the certification of production records. The Laboratory and Quality Specialist will also support the Radiopharmaceutical production program by conducting on demand experiments under the supervision of the subject matter experts (SME), perform non-routine analysis of samples, and assist in troubleshooting and repairing equipment in accordance with the facility preventive maintenance schedule.

The Laboratory and Quality Specialist will also support routine equipment calibrations, equipment and software qualification and repairs on various analytical equipment including but not limited to HPLC, GC, radio-TLC, Timers, pH-meters, Rotovap, Balances, Automated Synthesis Units (ASUs), Hotcells, and cyclotrons.
Under the guidance of the Radiopharmaceutical Sciences subject matter experts, the Laboratory and Quality Specialist will be required to participate in the development and maintenance of standard operating procedures and technical documents in accordance with Radiopharmaceutical Sciences quality assurance program. The Laboratory and Quality Specialist must ensure that all activities are carried out by following established Quality Assurance and Quality Control procedures in a GMP environment, applicable environmental and safety regulations, and other requirements applicable to the production of clinical radiopharmaceuticals.

Job Demands
By applying for this job, you acknowledge an understanding that regular requirements and demands of this job include (but are not limited to):
Regularly moves or lifts objects between 10-50+ lbs. such as shielded radioactive sources and lead bricks and analytical equipment.
Very often sits to perform paper/computer work and operation of remote equipment; regularly walks or stands to perform radiopharmaceutical production, cyclotron and equipment maintenance.
Regularly performs fine finger/precision equipment repair work and computer work; handling of open source radioactivity and radioactive equipment/components requiring steadiness and accurate movement/control.
Regularly works in confined/awkward spaces where reaching, bending, and crouching are required to complete maintenance work.
Personal Protective Equipment (PPE) are a regular requirement, including gloves and gowns.

Job Qualifications
A Bachelor of Science degree in engineering, chemistry, physics, laboratory technology, microbiology or a science related field is required.
Master level degree is an asset.
Current or eligible for registration with Regulatory Affairs Certificate (RAC) or Canadian Association of Professionals in Regulatory Affairs (CAPRA) is an asset.
A minimum of three years of experience within the last five years working in a laboratory or clinically regulated environment by Health Canada, CNSC, or equivalent is required.
Direct experience performing formal audits of an established process and creating audit reports is required.
Direct experience in the lifecycle and creation of policies and procedures is required.
Experience developing and maintaining documentation within a quality assurance program is an asset.
Experience working with analytical equipment such as HPLC, GC, radio-TLC, and Automated Chemistry Modules is an asset.
Experience involved in the maintenance and repair of analytical equipment such as HPLC, GC, TLC, and Automated Chemistry modules is an asset.
Experience working in a Health Canada GMP, CNSC Class-II facility is an asset.
Demonstrated evidence of data analysis and laboratory report preparation.
Demonstrated evidence of regulatory and compliance process and procedures.
Demonstrated computer skills.
Demonstrated strong teamwork skills.
Demonstrated strong leadership skills.
Demonstrated strong writing and communication skills.
Proven analytical, critical thinking, problem solving, decision-making and organizational skills.
A satisfactory record of attendance and work performance and attendance is required.

*This position may require extensive, additional on-the-job training. The successful applicant must be willing to complete any education/training that is required by the department.

**The successful applicant must be eligible for Nuclear Energy Worker (NEW) status.

*** If there are no applicants who possess the required bachelor degree, applicants who have successfully completed an approved regulatory affairs program may be considered following an assessment of their experience and other qualifications.

Employees, to review your attendance record please refer to your employee portal on the Intranet for details. The attendance record is only available to employees who are currently in positions that accumulate sick time.