Quality Assurance Specialist

3 weeks ago

Charlottetown, Canada Next Level Group Full time

Position Description:

Responsible for the implementation and maintenance of site core quality systems (Change Control, Global Quality Standards, Deviation, investigations, etc.) to ensure the quality and compliance of biologics is compliant with GMP standards and guidelines set forth by regulatory agencies.

Functions, Duties, Tasks:

  • Responsible to work within and enforce the established quality systems based on company Global Quality Standards and GMP guidelines such as change control, deviation, root cause investigation and CAPAs, etc.

  • Participate in and/or lead cross functional teams (when required) for implementation and maintenance of systems or aiding in the resolution of issues.

  • Organize and lead training for implementation of new systems or processes.

  • Management (tracking and trending) of systems to ensure timely closure and follow up where actions are required.

  • Collate and prepare the required information to support the Quality Leadership Team meetings.

  • Providing guidance and working closely with manufacturing personnel.

  • Review and approval of quality documents such as SOPs, forms, protocols, etc.

  • Writing/revision of standard operating procedures and forms when applicable.

  • Conducting training sessions when required.

  • Participating in the self-inspection program.

  • Development of Quality Agreements.

  • Review and approval of batch documentation (where applicable) for material used for further manufacture.

  • Other duties as required.

Minimum Qualification (education, experience and/or training, required certifications):

  • Minimum of a Bachelor’s degree or equivalent with emphasis in Microbiology.

  • Training in QA, cGMP, or an equivalent quality system.

  • At least 5 years in Quality Assurance and or cGMP facility operation experience

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