Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

How will you make an impact?

Management of Narcotic and Controlled Drugs activity within the site in order to comply with the Office Of Controlled Substances (OCS) regulations and Company Standard Operating Procedures (SOP's) (QPIC).
Management of Class A precursor activity within the site in order to comply with the Precursor control regulations and Patheon SOP's (RPIC).

What will you do?

Essential Functions:

• Issue and return Narcotic & Controlled Drug Substances and Class "A" Precursor materials from their secure zones (approved licenced storage locations) to facilitate the timely execution of processing, packaging and shipping activity.
• Secure Narcotics & Controlled Drug Substances rejects and Class "A" Precursor rejects and maintain monthly inventory.
• Manage and witness Narcotic & Controlled Drug Substances destruction.
• Manage the Class "A" Precursor destruction process.
• Complete log entries as per procedural requirements and maintain records to facilitate monthly and annual reports.
• Process Narcotics & Controlled Drug Substances and Class "A" Precursor samples
• Maintains excise records for alcohol usage and prepares monthly returns.
• Maintains Narcotic data-base & reconciles it with log sheets in all 5 locations of Narcotics and controlled substances.
• Co-ordinates with OCS, RCA & Health Canada on all outstanding observations to remain in compliance.
• Performs Annual Inventory of Class "A" Precursors by physical count and submits report to Health Canada
• Completes report tracker on monthly basis to make sure that all reports required to be sent to RCA, HC, OCS, etc. are prepared and delivered on time
• Facilitates in import / export permits for Narcotics & Controlled Drug Substances and Class "A" Precursors.
• Maintains Narcotics & Controlled Drug Substances locations within illicit value limits assigned by Health Canada.
• Completes a comprehensive screening (per applicable regulations) to ensure no prior history of relevant criminal offences related to Controlled Substance Policy (CSPPs), denial for application for registration to handle CSPP, or revocation or surrender-for-cause of registration to handle CSPPs.
• Completes annual criminal background check as part of QARA-P0007, Narcotics Policy and POL-000105180 - PSG Controlled Substance Policy
• Participates in random employee searches as part of Anti-Theft/Employee Assigned Company Property Inspection Policy (Mississauga and Whitby, PSG) CAN-HR-Policy-370
• Participates in random drug testing as part of QARA-P0007, Narcotics Policy and POL-000105180 - PSG Controlled Substance Policy - not applicable to Canadian employees.
• Maintain Narcotics & Controlled Substances and Class A Precursor procedures to ensure alignment to corporate policies and regulations
• Manage Narcotics & Controlled Substances and Class A Precursor Regulatory, Corporate, and Internal Audits
• Collaborates with auditors and represent the site as required during inspections to ensure information is provided in a timely, accurate and complete manner.
• Maintain awareness of regulatory intelligence in support of gap identification and mitigation to ensure compliance.
• Provide ongoing coaching and mentoring to site A/QPICs and A/RPICs to ensure compliance to requirements across the site.
• Responsible to ensure the designated A/QPIC is trained to assume QPIC responsibilities for Narcotics & Controlled Drug Substances when the QPIC is absent or unavailable.
• Responsible to ensure the designated A/RPIC is trained to assume RPIC responsibilities for Class "A" Precursors when the RPIC is absent or unavailable.

How will you get here?

Education:

Bachelor's of Science degree in Chemistry, Chemical Engineering or related science.

Experience:

Minimum 5 years of previous related experience in the pharmaceutical industry.

Prior QPIC/ AQPIC experience would be an asset.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities:

Familiarity with the provisions of the Act and the regulations under it that apply to the license of the site where working. Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Effective written, interpersonal, and presentation skills. Ability to work on multiple projects simultaneously. Previous exposure to Pharmaceutical processing / packaging at Supervisory level; SOPs / WIs and Good Manufacturing Practice (GMP) environment. Ability to interact with different departments to get leverage & deliver results in timely fashion. Proficiency with the English Language.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Job Category

Quality

Thermo Fisher Scientific

is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.