Job Description

Location: Health Science 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-hour shifts; days, nights, evenings, weekends; standby; on-call *must report to work within 30 minutes when on-call)
Salary LX-33 ($38.12 - $47.99 per hour)
Competition Number 2024000616
Posted Date 1 March 2024
Closing Date 8 March 2024

About Us
Newfoundland and Labrador Health Services (NL Health Services) brings together five former separate health entities - Eastern Health, Central Health, Western Health, Labrador-Grenfell Health, and the Newfoundland and Labrador Centre for Health Information. The creation of a provincial health authority was announced following recommendations from Health Accord NL.

NL Health Services is responsible for delivering health and community services to more than 528,000 people living in Newfoundland and Labrador and employs over 21,000 people. NLHealthServices.ca

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.
Current or eligible for registration with Regulatory Affairs Certificate (RAC) or Canadian Association of Professionals in Regulatory Affairs (CAPRA) is an asset.

*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.

If this is an internal posting only, only applicants of the Eastern Health NAPE LX Regional Bargaining Unit will be considered. If this is an internal and external posting, all applications will be accepted and preference will be given to those qualified candidates who are internal to the Eastern Health NAPE LX Regional Bargaining Unit.

Apply online at https://employment.easternhealth.ca

Upon successfully applying for a vacancy then you will receive a confirmation email. If you do not receive this email please contact Recruitment 777-7777 ext 5-2 immediately

To become a part of our team, please submit an up to date resume/cover letter or application form online, clearly demonstrating how you meet the required qualifications. Include your current mailing address, day-time contact number, e-mail address, competition and employee number if applicable.

Contact Information for Recruitment Related Inquiries:

Telephone: (709) 777-7777 (5-2) or 1-800-563-3693
Email: employment@easternhealth.ca. Applications/resumes are not accepted at this email address.

If you are no longer interested in the position, you can withdraw your application by emailing employment@easternhealth.ca as soon as possible.

NL Health Services is committed to inclusive and barrier-free recruitment, selection, and onboarding processes. We will be happy to work with applicants requesting support during the process. If you have any questions, feel free to contact our Recruitment Line at 777-7777 press 5 then press 2 (long distance 1-800-563-3693) outlining how we can help.

EXTERNAL APPLICANTS: We thank all applicants for their interest, however, only those selected for an interview will be contacted. The successful candidate will be required to provide a satisfactory Certificate of Conduct from the RCMP or local Police (Vulnerable Sector Check may be required), educational documents, registration/licensure if applicable and Social Insurance Number.

Eastern Health