Specialist, Deviations

3 weeks 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:

The Deviation Specialist will play an important role in the department by writing deviations, participating in Out of Specification analysis investigation, closing batch documentation prior to release, and communicating with internal stakeholders/SME and clients. In addition, the Specialist will act as a point of contact between the manufacturing group, QA/client QA, and regulatory agencies.

MAJOR RESPONSIBILITIES:

• Authors deviations, Investigations, Environmental Monitoring Excursion, and CAPA for Manufacturing (USP/DSP/Fill/Finish Buffer and PST) including but not limited to investigation handling, leading corrective and preventive actions (CAPA) and tracking batch release items to meet company targets.

• Participates and applies Root Cause Analysis (RCA) tools and ensures CAPAs are implemented to eliminate deviation reoccurrence

• Works closely with department manager and QA to support batch release activities while ensuring investigations comply with quality system requirements.

• Actively participates in regulatory, client, and internal audits by compiling and providing information to department manager.

• Ensures Deviations are closed within assigned timelines to meet client demand and company targets. • Participates in data gathering and analysis for Monthly and Quarterly quality matrix as well ad departmental KPI.

• Ensure adherence to GDP, GMP, and safe practices at clinical and commercial scales.

• Implement process improvement-related changes.

• Ensure corrective and preventative actions that have been implemented are effective via Effectiveness Checks (EC)

• Provide support in ensuring batch readiness action items are completed before batch start

• Performs all other job-related duties as assigned

This is a fixed-term contract position for the next 18- months

MINIMUM QUALIFICATIONS:

• Demonstrate ability to review manufacturing, engineering, and quality documentation

• Strong working knowledge GMP requirements.

• Experience in top-tier biopharmaceutical environment

• Knowledge of regulatory agencies HC, FDA and others

PREFERRED QUALIFICATIONS:

• Diploma with 3+ years of industrial experience in pharmaceutical practices or a B.Sc.

• Demonstrate ability to perform RCA investigations and lead CAPA initiatives.

BEHAVIOURAL:

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

Teamwork: Working effectively and productively with others Independence: Ability to work with minimal supervision

Flexibility : Agility in adapting to change Written Communication: Writing clearly, succinctly and in a manner understood by the target audience.

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

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

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

Diligence: Attention to detail.

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 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 $24.00 - $33.00 per hour. 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.

  • Specialist, Deviations

    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...

  • Specialist, Deviations

    3 weeks 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...

  • Quality Systems Specialist, Quality Assurance

    6 months ago

    Mississauga, Canada Church & Dwight Full time

    A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take...

  • Deviation Expert

    2 weeks ago

    Mississauga, Ontario, Canada Resilience Full time

    Company OverviewAt Resilience, we're revolutionizing the biomanufacturing industry with our cutting-edge technology and sustainable approach. Our team is passionate about creating a better future for medicine, and we're looking for talented individuals to join us on this journey.

  • Quality Control Specialist, Microbiology

    6 months ago

    Mississauga, 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...

  • Pharmaceutical Investigator and Quality Assurance Specialist

    1 week ago

    Mississauga, Ontario, Canada SGS Full time

    The SGS team is seeking a highly skilled Pharmaceutical Investigator and Quality Assurance Specialist to join our dynamic organization. As a key member of our quality assurance team, you will be responsible for leading investigations into out-of-specification (OOS) test results and deviations from established procedures. Your primary goal will be to identify...

  • Quality Assurance Specialist Lead/Senior Consultant

    1 month ago

    Mississauga, Canada Q&C Full time

    The Quality Assurance Specialist - Pharmaceutical role is a "Lead or Senior Consultant" position at Q&C. This pharmaceutical consultant role focuses on applying your GMP knowledge and experience to various projects, such that the client is confident in the approach and timing of execution of the project. Our consultants work independently within a team...

  • Reliability Engineering Specialist

    3 weeks ago

    Mississauga, Ontario, Canada Thermo Fisher Scientific Full time

    About the RoleWe are seeking a highly skilled Reliability Engineering Specialist to join our team at Thermo Fisher Scientific. This is a full-time position that offers a competitive salary and benefits package.Job DescriptionThe main focus of this position is to provide support for the Engineering department, with a primary emphasis on developing and...

  • Quality Assurance Specialist

    6 months ago

    Mississauga, Canada Kuehne+Nagel Full time

    Would you like to launch your career with one of the most successful logistics organizations worldwide? Here at Kuehne+Nagel, our Mississauga, ON site is looking for a new Quality Assurance Specialist to join our Contract Logistics team. ** Your Role **:As the Quality Assurance Specialist, you will assume responsibility for the ongoing support and...

  • Quality Specialist

    6 months ago

    Mississauga, Canada BAXTER Full time

    **This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Manufacturing Quality Control Specialist

    4 weeks ago

    Mississauga, Ontario, Canada JASP Manufacturing Full time

    Job Description:JASP Manufacturing is seeking a skilled Manufacturing Quality Control Specialist to join our team.Key Responsibilities:Measure and lay out work pieces in preparation for assembly using precise measuring instruments.Read and interpret engineering drawings, blueprints, charts and tables to ensure accurate production.Set up and adjust production...

  • Pharmacovigilance Quality Assurance Specialist

    6 months ago

    Mississauga, Canada MCKESSON Full time

    McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a...

  • Logistics & Transportation (Sales) Specialist

    3 months ago

    Mississauga, Canada Armstrong Moving Full time

    Armstrong Warehousing is an integrated logistics solution for all your storage, handling, and transportation and distribution needs. Due to continued growth, we seek **Logistics & Transportation (Sales) Specialist** to join our Armstrong Warehousing team from our Mississauga, ON office. **What we Offer**: - Competitive wages and group benefits plan,...

  • Pharma Supply Chain Specialist for Global Excellence

    3 weeks ago

    Mississauga, Ontario, Canada F. Hoffmann-La Roche Gruppe Full time

    We are seeking a highly skilled Pharma Supply Chain Specialist to join our team at F. Hoffmann-La Roche Gruppe. This role offers an exciting opportunity to work in a dynamic environment where you will be responsible for ensuring smooth, compliant, and timely execution of clinical and commercial order transactions for complex Cell and Gene Therapies...

  • Quality Assurance Specialist-associate

    7 months ago

    Mississauga, Canada Q&C Full time

    In this broad-based role, you will support the projects assigned to you, meeting the client's needs. The role specifically prioritizes, plans, organizes and executes projects related to quality and compliance of health products to ensure smooth implementations. The role may involve coordinating/working with client personnel to meet project goals. Reporting...

  • Pharmaceutical Quality Compliance Specialist

    2 weeks ago

    Mississauga, Ontario, Canada Q&C Full time

    Company Overview:Q&C is a leading consulting firm specializing in quality and compliance services for the pharmaceutical industry.We offer a unique opportunity to work with experienced professionals who share your passion for delivering exceptional results.Salary:$120,000 - $150,000 per year, depending on experience.Job Description:This role involves...

  • Patient Safety Compliance Specialist

    1 week ago

    Mississauga, Ontario, Canada TipTopJob - CA - Jobboard Full time

    Job Type: PermanentMain Industry: Healthcare and PharmaceuticalEstimated Salary: $60,000 - $80,000 per annumWe are seeking a dedicated Patient Safety Compliance Specialist to support local and global pharmacovigilance processes.Key Responsibilities:Safety Reporting: Receive and document domestic safety information, triage and prioritize incoming cases...

  • QA Specialist

    2 months ago

    Mississauga, Canada Temp Aid Full time

    Assist in the development of a quality management system (QMS) that meets all regulatory (e.g., Health Canada and U.S. FDA) requirements. - To maintain QMS documents and records in a centralized system. - To handle on-site documents electronically, archiving, and records retention as per the company’s record retention period requirements. - Review/verify...

  • Sea Logistics Operational Care Specialist

    3 months ago

    Mississauga, Canada Kuehne+Nagel Full time

    Would you like to launch your career with one of the most successful logistics organizations worldwide? Here at Kuehne+Nagel, our Mississauga site is looking for a new Sea Logistics Operational Care Specialist to join our Sea Logistic team. ** Your Role**: As our Sea Logistics Operational Care Specialist, you are responsible to manage all day-to-day...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Mississauga, Ontario, Canada Resilience Full time

    We're Resilience, a cutting-edge biomanufacturing company revolutionizing the way medicine is made. Join our team and contribute to a sustainable future.Salary Range: $90,000 - $131,250 per yearAbout the Role:The Senior Quality Assurance Specialist will champion sterility assurance principles at our site, leading microbial control efforts in aseptic...