Analyst Ii, Quality Control Raw Materials

6 months ago

Mississauga, Canada Resilience Full time

A career at Resilience is more than just a job - it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit

JOB SUMMARY:
This job is responsible to a wide range of activities in helping/assisting the Supervisor/Manager in performing the day-to-day activities of the department, ensuring all work is completed accurately within specified time frames, always following the GMP. At the direction of the Supervisor/Manager, communicates and coordinates with warehouse and production departments for the release of materials in a timely manner.

Responsible for releasing and sampling, inspecting raw materials, components, containers and closures, packaging, and printed materials, according to cGMP and company specifications with little supervision required.

Note: Performance of testing or any other activities may also be required to meet department and business needs.

MAJOR RESPONSIBILITIES:

- Ensure that assigned tasks are carried out on schedule and are performed according to the company policies, established procedures and cGMP regulations.
- Perform incoming material sampling, testing (as required), completion of documentation and labelling, to release/reject materials for use by Production.
- Assist/help the Supervisor/Manager for release of received raw materials/components/container-closure/packaging/printed material intended for use in Production for manufacture of clinical or commercial product.
- Assist/help in the completion of documents, SOP writing, document review, help/participate to investigate OOS results.
- Maintain records and Quality control database.
- Participate in scheduled cleaning and other raw material sampling areas housekeeping duties. Ensure the weekly housekeeping and EMs are followed up and completed in a timely manner.
- Assist/help in Out-of-Specification Result investigations with Supervisor/Manager.
- Report to Supervisor/Manager any deviations from company procedures, or other discrepancies that may affect product quality or cGMP status according to established procedures.
- Maintain Raw Materials areas and instrumentation and facility.
- Ensure documentation systems are accurate and up to date.
- Assist in implementation of corrective action plans, participate in identifying root causes and communicate with other departments regarding pending issues.
- After hours shift coverage / weekends, and overtime may be required to meet business needs.
- Perform all other job-related duties as assigned

MINIMUM QUALIFICATIONS:

- Experience in cGMP environment with compendial test requirements, US, JP, and Europe Pharmacopeia
- Understanding and knowledge of SDS (safety data sheets)
- Basic understanding of data analysis, statistics, and report preparation with knowledge of MS Word, Excel, and Outlook
- Must be able to multi-task
- Ability to learn new analytical techniques quickly, when required

PREFERRED QUALIFICATIONS:

- Bachelor’s degree with a minimum of 2-3 years of related work experience
- College diploma in a scientific discipline with a minimum of 4-5 years experience
- Good working knowledge of cGMP
- Strong technical writing, and computer skills
- Good interpersonal, and communication skills

ADDITIONAL REQUIREMENTS:

- Pre-employment medical and medical re-examination performed every 2 years or as per RESILIENCE’s SOPs. Included as part of the medical is a respirator fit test (half mask), and pulmonary function test
- This position requires vaccination for Hepatitis A and B
- Due to the nature of the position, lifting of heavy materials may be required

BEHAVIOURAL:
Problem Solving: Anticipating, analyzing, diagnosing, and resolving problems

Decision Making: Utilizing effective process to make decisions

Leadership: Achieving extraordinary business results through people

Interpersonal Skills: Effectively communicating, building rapport, and relating well to all personality types

Teamwork: Working effectively and productively with others.

Goal Orientation: Energetically focusing efforts on meeting a goal, mission, or objective

Organization and Planning: Utilizing logical, systematic, and orderly procedures to meet objectives

Ability to work independently, when needed.
- 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._

Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities

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