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Senior Quality Control Scientist

3 months ago


Toronto, Ontario, Canada PE Global (UK) Full time

Position Overview:

PE Global is seeking a Senior Quality Control Scientist to join a prominent biotechnology organization. This role is pivotal in ensuring the integrity and quality of products through rigorous quality control processes.

Key Responsibilities:

  • Operate with minimal oversight in various quality control functions, including sample and data management, as well as equipment upkeep.
  • Enhance team performance by maintaining high standards in the quality of work delivered.
  • Assist in achieving project milestones and objectives within the team framework.
  • Support quality control and production activities, which may require flexibility in working hours, including weekends.

Specific Duties:

  • Manage sample activities across the facility, including distribution, logging in LIMS, and receiving shipments.
  • Conduct activities related to the Stability Program, such as retrieving stability samples and initiating studies.
  • Develop, own, and approve protocols, sample plans, standard operating procedures (SOPs), and training documentation.
  • Perform transactions in SAP, LIMS, and CIMS relevant to sample management.
  • Act as an out-of-hours contact for sample management equipment including fridges, freezers, and incubators.
  • Ensure personal training and compliance with safety regulations.
  • Oversee sample shipments and monitor temperature conditions.
  • Coordinate LIMS data for commercial and import batches.
  • Manage and maintain the Site Inventory of Reference Standards, Assay Controls, and Training Samples.
  • Serve as the QC representative for New Product Introduction (NPI) activities and routine product meetings.
  • Collaborate with site planning, manufacturing, and inspection teams regarding the manufacturing schedule and necessary QC testing.
  • Engage with Stability Product Representatives and Product Quality Leads as needed.
  • Execute routine sample management tasks according to established procedures.
  • Participate in audits, initiatives, and projects that may impact departmental or organizational objectives.
  • Continuously assess sample management practices for compliance and operational excellence.
  • Coordinate LIMS data for commercial and import testing lots as applicable.

Qualifications:

  • A Bachelor's degree in a scientific discipline.
  • A minimum of 3 years of experience in the pharmaceutical or biotechnology sector.
  • Strong written and verbal communication skills.
  • Proven ability to work effectively within dynamic cross-functional teams and make informed decisions.

Application Process:

Interested candidates are encouraged to submit their updated CV for consideration.