STEMCELL Technologies Hiring for Senior Quality Control Analyst, Microbiology at Vancouver, BC Full Time

Do you have a microbiology background and Quality Control experience in a GMP environment? This may be the opportunity for you! We are currently looking for a Senior Quality Control Analyst to join our dynamic Quality Control Microbiology team. In this role you will be responsible for performing environmental monitoring of our cleanrooms and microbiological analysis of materials from every step of the manufacturing process. The incumbent Senior Quality Control Analyst will also provide support for non-conformances, investigations and continuous improvement projects.

STEMCELL employees share a passion for making a difference in the world. We thrive along like-minded, driven, interesting individuals, each of whom brings unique expertise and experiences to the table. You’ll work with a supportive team and collaborate with many other Quality Control teams, as well as other departments including Quality Assurance and Manufacturing. If you are looking for a stable career with Canada’s largest biotechnology company, combined with opportunities for growth in a fast paced environment, this is the role for you!

Job Description

Duties and Responsibilities

Perform Environmental Monitoring (EM) of controlled cleanrooms and laboratory areas, including data analysis and generating/reviewing documentation.

Perform routine sampling and testing of purified water system for bioburden and endotoxin including data analysis and generating/reviewing documentation.

Perform QC tests for regulated and non-regulated products according to approved procedures, including data analysis and report preparation. (Sterility, Endotoxin, Bioburden, Mycoplasma)

Assist in the investigation and documentation of out-of-specification (OOS) results and non-conformances (and related CAPAs) to support and maintain Quality Systems requirements.

Support development of QC testing procedures, including writing/updating SOPs and other documents (protocols etc).

Perform daily activities to support the routine operation of the Microbiology laboratory and EM of the cleanroom areas.

Operation of specialized lab equipment as required (BACT system, MCS reader, etc.)

Collaborate with individuals from other departments to resolve problems.

Participate in technology transfer activities, method validations, metrics and other compliance activities as required.

Participation in and compliance to QMS.

Work with QC Manager to support process improvement projects within QC and across departments for regulated and non-regulated products.

Liaise with external parties such as contract laboratories and vendors, as instructed

General laboratory and equipment maintenance and monitoring.

Purchasing and inventory management of laboratory supplies.

Communicate with managers and coworkers to achieve departmental objectives and promote a safe and cooperative working environment .

Occasional weeknight or weekend work may be required.

Other duties as required including, but not limited to, Aseptic Process Simulation (APS) activities.

Qualifications

BSc or technical degree with 2-4 years related laboratory experience; or MSc with 1-2 years post graduate related laboratory experience.

Working knowledge and technical skills relating to sterility, endotoxin and bioburden testing (USP, EP).

Excellent aseptic technique.

Demonstrate initiative and critical thinking skills

Knowledge of cleanroom environments/environmental monitoring an asset

Knowledge of FDA, GMP (21 CFR part 820), ISO9001, ISO13485 regulatory guidelines an asset .

Effective communication skills and demonstrated problem-solving abilities.

Knowledge of mycoplasma testing requirements an asset.

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STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. Scientists performing stem cell, immunology, cancer, regenerative medicine and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as “Scientists Helping Scientists” – standing by our customers to provide outstanding products, technical support and training. We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. STEMCELL is proud to be the largest Biotechnology employer in Canada.

This is an opportunity to work with highly motivated colleagues in a science-oriented, creative and dynamic environment. We offer a competitive salary, excellent benefits and significant career development opportunities.

To apply please select the apply button. You will then be directed to a login screen asking you to set up an account. You must set up an account in order to apply.

Create an account by selecting the create account button. You will then be asked for your email and to create a password. Your Password must be eight characters long, contain at least one special character, one capital letter, and a number.Once you have created your password you will be asked to upload your resume. Uploading your resume will provide the ability to auto-populate your application with information from your resume. If you prefer to manually complete all of the fields in the application you can do this by clicking next. You can upload your cover letter as an attachment in the attachments screen. Thank you for your interest in STEMCELL!