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QA Associate - Wholesale Release in Milton at Innomar Strategies

Date Posted: 9/22/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Milton
  • Job Type:
  • Experience:
    3 to 5 years
  • Date Posted:
    9/22/2018

Job Description

Under the direction of the Senior Manager, the QA Associate Wholesale Release, ensure that Innomar Strategies Inc. operates and is in compliance with GMP requirements as set out by Health Canada regulations.
 
This position is categorized as compliance critical and, as such, requires and is assigned specific responsibility for ensuring continual and proper compliance with all regulatory, corporate and division requirements.
 
It is the associate’s responsibility to observe and obey all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately.
 
PRIMARY DUTIES AND RESPONSIBILITIES:
  • Wholesale Release Management: Responsible for receipt, inspection and release of client specific wholesale product to market. Perform timely review and assessment of documents received operations, including but not limited to, receiving documents and data from temperature monitors. Perform QC Inspection and product release of Innomar Strategies Inc. wholesale products.
  • Inspections: Provide support during audits/inspections by internal, client, third party or regulatory bodies.
  • Support Quality Organization: Provide assistance to the QA Senior Manager Quality Assurance as required. Performs other projects as assigned
  • Facility Temperature Management: Maintain daily, weekly and/or monthly logs of temperature for all GMP warehouses. Ensure calibration of temperature monitors are completed in a timely manner and rotated for all GMP facilities. Ensure monitoring maps are updated as required and maintained.
  • Facility Maintenance Management: Maintain daily, weekly and/or monthly logs of pest control activities, equipment/programs and/or facilities maintenance. Ensure all maintenance activities are completed in a timely manner and trend reports are completed to monitor the facility systems. Ensure monitoring maps are updated as required and maintained
  • Management and control of changes: supports the initiation of change requests for equipment and systems; monitors follow-up with parties involved; ensures that deliverables are compliant pursuant to the change; closes changes upon implementation. Management of trend reporting for changes.
  • Returns Management: receipt and review and documentation of product returns in conjunction with the client procedures and current GMPs
  • Deviation/Non- Conformance Investigations: Investigate and document any discrepancies recorded during Facility management activities and ensure facility/product disposition decisions are made in conjunction with client and current GMPs regulations..
  • Recall Management: provide support to the Senior Manager, QA for Product Recalls, including customer notification, coordination of customer returns and maintaining documentation
  • AQPIC Activities: Assist the QPIC in the maintenance of standard operating procedures (SOPs) in compliance with Health Canada regulations. Assist the QPIC in ensuring that Innomar Strategies Inc. operates and is in compliance with the Narcotic Control Regulations as set out by Health Canada. Assist the QPIC to ensure that all transactions occurring at the respective distribution centre are in compliance with Innomar SOP’s relevant to the Narcotic, Precursor, and GMPs, including but not limited to Shipping, Receiving, Returns, Pick & Pack, Inventory Control, Credits, Security/Maintenance, Government Reporting, Record Maintenance, Destruction and Government reporting. Assist the QPIC in providing the Senior Manager, QA with any reporting to Government, regarding narcotic discrepancies and other required reports. Act as the back up to the QPIC.
  • Involved in activities geared towards process and or document improvements: Support the QA department in ensuring Innomar GMP facilities operate and are in compliance with Good Manufacturing Practices and applicable Health Canada regulations at all times which may include review and approval of quality failures and non-compliance investigations; perform follow-up on corrective and preventive actions pursuant to an incidents; assist with process optimization; review of standard operating procedures; assist with internal and external audits.
  • Support Quality Organization: Provide assistance to the QA Senior Manager Quality Assurance as required. Performs other projects as assigned

Job Requirements

  • Requires broad training in relevant scientific fields such as pharmacology, biology, chemistry, biochemistry or similar vocations generally obtained through completion of a bachelor’s degree program recognized by a Canadian educational institution.
  • 3-5 years previous experience in the industry
  • Official documentation of a clear police record for previous 10 years
  • Knowledge of the Narcotic and Precursor Control Regulations, as well as the Controlled Drugs and Substances Act as it applied to Narcotics and Precursors
  • Full and complete knowledge of the Good Manufacturing Practices as they relate to wholesalers, distributors and importers
 MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
  • Working knowledge of Good Manufacturing Practices (GMP), Health Canada regulations and guidelines, including Narcotics and Precursors.
  • High level of organization and attention to detail, with the ability to manage a number of projects with tight timelines and minimal supervision.
  • Team player who respects all functional levels internally and externally.
  • Motivated and self-starter demonstrating a solution-oriented working style
  • Effective interpersonal, written and verbal communication skills
  • Knowledge of computers to operate effectively with Outlook, PowerPoint, Word and Excel.
  • Limited travel may be required.