Skip to main content

This job has expired

You will need to login before you can apply for a job.

Analyst II, Quality Control

Employer
Resilience
Location
Mississauga, ON
Start date
Jun 14, 2024

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

Job Details

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 www.resilience.com

Position Summary:

The Analyst II, Quality Control will be responsible for testing In-process materials, validation, stability, and final products for bio-chemical and chemical assessment according to cGMP and company specifications. Responsibilities also include bio-analytical and analytical instrument qualification reviewing, training troubleshooting, instrument maintenance, high-quality technical writing, leading and authoring Laboratory investigations, writing protocols/reports as well as cross-training of QC Technologists.

Position Responsibilities:

  • Perform sample testing using analytical and bioanalytical test methods.
  • Assist Lab management in internal, client and regulatory audits
  • Once qualified as a trainer, perform cross training of other personnel
  • Report to supervisor any deviations from company procedures, or other discrepancies that may affect product quality or cGMP status according to established procedures
  • Participate in lab investigations and deviations by following sound scientific rationale
  • Perform routine maintenance on laboratory instruments
  • Follow established procedures for reference STDs receipt, inventory, use and discard
  • Author procedural changes using the change control program in Quality Management System.
  • Review raw data and audit trails
  • Participate in scheduled cleaning and other laboratory housekeeping duties
  • Employ good documentation practices when generating raw data, reports, SOPs, and other documentation
  • Perform other routine testing after training to support analytical testing requirements in the lab
  • Ensure documentation and training 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
  • Able to apply understanding of regulatory guidelines and experience to documents and reports
  • Performs all other related duties as assigned
  • Able to work flexible shifts and weekends as required
  • Understanding of data integrity concepts and relevance to good documentation practices
  • This is a fixed term contract position until 12/31/2024

Minimum Qualifications:

  • Experience with MS Word, Excel and Outlook
  • Strong attention to detail, self-motivated, highly organized, and able to work in a fast-paced laboratory environment
  • Ability to multi-task and be flexible based on the job priorities
  • Understand the theory of new bioanalytical and analytical techniques
  • Strong verbal and written communication skills
  • Strong presentation skills

Preferred Qualifications:

  • Bachelor’s degree (Biochemistry/ Biotechnology/ Chemistry) with a minimum of 2 years related experience within a quality lab environment (biologics preferred)
  • Knowledge in HPLC/UPLC/Plate readers/spectrophotometers
  • Experience with advanced Bioanalytical instruments /HPLC/GC/Imager/IEF
  • Strong understanding of GMP, GLP, 21 CFR, ICH, Pharmacopeial and Regulatory guidelines
  • Knowledge and practical experience in protein analysis such as BCA, Western blot, SDS-PAGE, ELISA, concentration analysis using UV-Vis
  • Strong instrument troubleshooting skills
  • High-quality technical writing


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.

Behavioral:

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

Teamwork: Working effectively and productively with others

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

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

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

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


The items described here are representative of those that must be met successfully to perform the essential functions of this job.

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.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package, fertility healthcare and family-forming benefits, flexible time off, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program. Our target base pay hiring range for this position is $60,000.00 - $78,750.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

Company

Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development. For more information, visit www.Resilience.com and follow us on Twitter @IncResilience 

Company info
Website
Location
9310 Athena Circles
La Jolla
CA
92037
United States

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert