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Senior Quality Assurance Specialist

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Mississauga, Ontario, Canada Resilience Full time

Job Summary:

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Resilience. As a key member of our quality control team, you will be responsible for ensuring the highest standards of quality in our biomanufacturing processes.

Key Responsibilities:

  • Perform sample analysis using advanced bioanalytical techniques, including HPLC, UPLC, PCR, and ELISA, to ensure compliance with regulatory guidelines.
  • Develop and execute quality control studies, and write detailed reports to document results.
  • Lead and execute instrument qualification work, and participate in method transfer and qualification activities.
  • Collaborate with cross-functional teams to resolve quality-related issues and implement corrective actions.
  • Develop and maintain SOPs, protocols, and other documentation to ensure compliance with regulatory requirements.
  • Provide training and guidance to junior team members on quality control procedures and best practices.
  • Stay up-to-date with industry developments and regulatory changes, and implement new procedures and protocols as needed.

Requirements:

  • Advanced degree in Biochemistry, Biotechnology, or a related field, with a minimum of 7 years of experience in a quality control environment.
  • Strong knowledge of GMP, GLP, 21 CFR, ICH, and other regulatory guidelines.
  • Advanced bioanalytical instruments, including HPLC, UPLC, and spectrophotometers.
  • Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
  • Strong problem-solving and analytical skills, with the ability to interpret complex data and make informed decisions.

Preferred Qualifications:

  • Master's degree in Biochemistry, Biotechnology, or a related field, with a minimum of 5 years of experience in a quality control environment.
  • Advanced knowledge of HPLC, UPLC, and other bioanalytical instruments.
  • Experience with method transfer and qualification activities.

Additional Requirements:

  • Pre-employment medical examination, including eye examination and color blindness test.
  • Vaccination for Hepatitis A and B.
  • Ability to work in a fast-paced environment, with flexibility to adapt to changing priorities and deadlines.