Qc Microbiology Specialist, Compliance
4 weeks ago
COMPANY SUMMARY:
- RESILIENCE is creating the first sustainable ecosystem for advanced biopharmaceutical manufacturing. We’re building a robust, dynamic, and diverse network of manufacturing capability and talent - investing in innovation every step of the way.- We provide high-tech, end-to-end manufacturing and development solutions to ensure the medicines of today and tomorrow are accessible to all in need. This includes complex medicines, such as cell and gene therapies, viral vectors, and vaccines; as well as proteins and the next generation of medicines.- RESILIENCE believes in access to quality and innovation for all. Our adaptive facilities serve partners big and small. We continuously invest in R&D for next-generation manufacturing and development, freeing our partners to focus on the discoveries that impact lives.- We offer customized and scalable processes, the highest quality and regulatory capabilities, and world-class facilities. Through manufacturing that’s faster, more flexible, and less risky, we safeguard the quality of critical medicines and protect the resilience of a vital supply chain.- JOB SUMMARY:
Major Responsibilities:
- Assist with creating, implementing, and closure of CAPAs in a timely manner
- Assist with creating, implementation and closure of Change Controls in a timely manner
- Attend meetings to provide status updates on CAPAs, Change Controls and Deviations on behalf of QC Microbiology
- Update procedures in support of Deviation, Change Control and CAPA closure
- Assist with logbook/data review
- Assist with trending of Environmental Monitoring data
- Support writing of trend reports for the Environmental Monitoring program and Utility Systems
- Support the creation of presentations in support of monthly Contamination Control Review Committee meeting
- Perform all other related duties as assigned
- Fixed term contract role with an end date of 12/31/2023
Minimum Qualifications:
- Bachelor's degree or Microbiology College diploma/certification
- 1-2 years of experience within a Quality/Compliance function
- Knowledge of GMP
Preferred Qualifications:
- Knowledge of various regulatory guidelines such as Health Canada, FDA, CFR, EMEA, etc.
BEHAVIOURAL:
Teamwork: Working effectively and productively with others
Interpersonal Skills: Effectively communicating, building rapport and relating well to all personality types
Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective
Organization and Planning: Utilizing logical, systematic and orderly procedures to meet objectives
Leadership: Achieving extraordinary operational results through inspiring, encouraging and developing people
Problem Solving: Anticipating, analysing, diagnosing and resolving problems
Decision Making: Utilizing effective processes to make timely decisions
Written Communication: Writing clearly, succinctly and in a manner understood by the target audience.
Flexibility: Agility in adapting to change. Ability to work independently
Conflict resolution - Effectively broker solutions to resolve conflicts between individuals and groups.
- This job profile provides an overview of the minimum requirements of the job and does not include all the duties inherent, included or associated with the job or with the performance of the job. The Company reserves the right to make changes to the job profile as it sees fit to meet the needs of the organization._
NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references, and criminal records checks (for which a pardon has not been granted).
Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.
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