Specialist, Inspection

2 weeks ago

Mississauga, Ontario, Canada Resilience Full time

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:


Under the guidance of a Supervisor, the Specialist, Inspection & Packaging is responsible for set-up, operation and sanitation of inspection/packaging/capping equipment and productions areas.

This position will follow GMPs/cGMPs, SOPs and all company policies/regulations.

MAJOR RESPONSIBILITIES:

  • Set up and operation of equipment including capper and blister sealer
  • Visual Inspection of filled vials and syringes
  • Prepare / sterilize components and manufacturing equipment using autoclave, vial washer and Depyrogenation oven
  • Documents and record all necessary information/data as per SOPs and cGMPs.
  • Performs all duties according to the SOPs and cGMPs, and all other established Health & Safety standards.
  • Cleaning of aseptic manufacturing areas / suites as per established procedure
  • Notifies supervisor in the event of a manufacturing issue or any deviation from manufacturing and quality standards
  • Performs all other jobrelated duties as assigned
  • MINIMUM QUALIFICATIONS:
  • TECHNICAL KNOWLEDGE / EXPERIENCE:
  • Science Degree or Technical Diploma with relevant experience
  • PREFERRED QUALIFICATIONS / EXPERIENCE:


Experience in GMP environment
  • Minimum 2 years experience in GMP environment
  • ADDITIONAL REQUIREMENTS:
  • Preemployment medical and medical reexamination; including eye exam and colour blindness test, performed every 2 years or as per RESILIENCE's SOPs. Included as part of the medical is a respirator fit test (half mask and full mask), and pulmonary function test
  • Occasional use of a half face, and fullface respirator
  • This position requires vaccination for Hepatitis A and B
  • Gown qualified for sterile operations in Class A/B clean rooms
  • Job requires shift work including weekends, occasional extended shifts, and possible short notice schedule shifts
  • Lifting/pushing/pulling up to 25kg, and direct contact with alcohol/chlorine based disinfectant agents
  • BEHAVIOURAL:
  • Teamwork: Working effectively and productively with others
  • Flexibility: Agility in adapting to change
  • Interpersonal Skills: Effectively communicating, building rapport and relating well to all personality types
  • Organization and Planning: Detail oriented, punctual, sense of urgency and accountability
  • Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective
  • This job profile provides an overview of the minimum requirements of the job and does not include all of 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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