Quality Control Specialist, Microbiology

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:
The QC Microbiology Specialist will support the QC Microbiology Department by maintaining compliance with Quality Systems (Change Controls, CAPAs and Deviations), and managing status updates to ensure team members, and internal customers have up to date information. The QC Microbiology Specialist will support the department with creating, implementing and closing Change Controls and CAPAs in a timely manner. This will also require understanding of QC Microbiology processes as SOP updates will be required to support implementation. The QC Microbiology Specialist will also support the department with logbook/data review, EM trending (and data entry) and creating of EM trend reports. Finally, the incumbent will support the QC Manager with creation of presentations (including retrieval of all supporting data) for the monthly Quality Council Meeting, and the Contamination Control Review Meeting. Accuracy, and timelines of execution and reviews are critical to the role.

MAJOR RESPONSIBILITIES:

- Assist with creating, implementation 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 Environmental Monitoring program and Utility Systems
- Support creation of presentations in support of monthly Quality Council and monthly Contamination Control Review Committee (CCRC)meeting
- Perform all other related duties as assigned

MINIMUM QUALIFICATIONS:

- Experience in a GxP position
- Knowledge of GMP and various regulatory guidelines such as Health Canada, FDA, CFR, EMEA etc. is an asset
- Intermediate to advanced competency with EXCEL and ability to learn new systems
- Detail focused and attentive to accuracy
- Adaptable and flexible in response to a dynamic operating environment

PREFERRED QUALIFICATIONS/EXPERIENCE:

- University Bachelor’s degree or College Diploma in Science with a major in Microbiology or Life Sciences
- Aseptic operations experience and understanding of aseptic operations controls
- Experience with Microbiology Laboratory testing
- Experience with Environmental Monitoring

ADDITIONAL REQUIREMENTS:

- Ability to read, understand, and execute instructions in accordance with SOPs, and other documentation

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

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._