Associate, QC Microbiology & Environmental Monitoring Sampling Technician (Night Shift)

Employer
Resilience
Location
Mississauga, ON
Posted
Jun 17, 2022
Ref
R-102450
Required Education
High School or equivalent
Position Type
Full time

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 main responsibility for this job is to perform monitoring of the manufacturing facility to provide assurance that all areas continue to operate under a state of control. This monitoring consists of non-viable particulate testing, viable air sampling, compressed air sampling, and viable surface sampling.

**This is a Night-Shift position (hours: 10:30pm - 7:00am; Sun-Thur/Tue-Sat - rotating schedule).

MAJOR RESPONSIBILITIES:

  • Employ good documentation practices when generating raw data, reports, SOPs and other documentation.

  • Perform routine sampling of all qualified areas to ensure that all sampling frequencies are met as per current procedures.

  • Log-in test samples for tracking purposes.

  • Follow established procedures for use of released media that has a valid expiry date.

  • Report to Supervisor/Manager any deviations from company procedures, or other discrepancies that may affect product quality or environmental monitoring results.

  • Perform environmental monitoring of new areas to support room performance qualification.

  • Perform spot checks of manufacturing personnel during filling operations to ensure strict adherence to aseptic technique/processing procedures.

  • Analyze, interpret and report data.

  • Assist in collecting data to prepare quarterly and annual Environmental Monitoring and Utility System trending reports.

  • Participate in environmental monitoring investigations with the Environmental Monitoring supervisor.

  • Review environmental data, initiate and complete investigations i.e. EMAR (EM Action Report), DR, etc., for any environmental results and or excursions and assist in identifying root causes and corrective actions for environmental monitoring excursions

  • Check and follow up with materials, inventory and equipment calibration/maintenance when required.

  • Attend validation media fill training sessions to prepare for protocol execution.

  • Maintain gown qualification status to perform environmental monitoring in clean room.

  • Provide gown demonstration training to new hires during initial gown qualification training.

  • Should be able to stand for 50% of the shift and lift equipment related to environmental monitoring.

  • Request equipment calibration/maintenance quote when required and send equipment for calibration/maintenance on time.

  • Participate in scheduled cleaning and other laboratory housekeeping duties.

  • Remain crossed trained on Microbiology test methods to act as a back up to Microbiologists for testing of raw material and product samples when required.

  • If required, perform daily water sampling of manufacturing plant that could involve heights over three (3) meters.

  • If required, perform monthly Compressed Air sampling of manufacturing plant

  • Report Health and Safety incidents, accidents or potential hazards

  • Performs all other job-related duties as assigned.

MINIMUM QUALIFICATIONS:

TECHNICAL KNOWLEDGE/EXPERIENCE:

  • Bachelor’s degree in Life Sciences or Microbiology college diploma/certification

  • Basic understanding of microbiology test methodologies

  • Basic understanding of Aseptic techniques.

  • Basic understanding of data analysis, statistics and report preparation with knowledge of MS Word and Excel

  • Must have the ability to work independently, multi-task, be self-motivated, highly organized and able to work in a fast-paced quality control environment.

PREFERRED QUALIFICATIONS/EXPERIENCE:

  • Knowledge and understanding of GMP, compendial test requirements, US and European Pharmacopeia is an asset.

  • Knowledge and understanding of aseptic processing including requirement of Annex 1.

ADDITIONAL REQUIREMENTS:

  • Pre-employment medical and medical re-examination; inclusive of eye examination and colour blindness test, performed every 2 years or as per RESILIENCE’s SOPs

  • This position requires vaccination for Hepatitis A and B

  • Job requires shift work, weekends and occasional extended shifts and possible short notice schedule shift changes

BEHAVIOURAL:

Demonstrated ability to apply the following behavioural competencies on the job:

Problem Solving: Anticipating, analyzing, diagnosing and resolving problems

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

Written Communication: Writing clearly, succinctly and understandably

Decision Making: Utilizing effective process to make decisions

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

Flexibility: Agility in adapting to change. Ability to work independently

Attention to Detail: Ensure work or reviews are correct and Right First Time.

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.

While we appreciate your interest in this opportunity, only qualified candidates will be contacted. Resilience Biotechnologies Inc. (RESILIENCE), will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to directly Resilience Biotechnologies Inc. (RESILIENCE), or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Resilience Biotechnologies Inc. (RESILIENCE), Human Resources team.

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