Laboratory Technician I – Quality Control

Introduction

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

Job Summary

The Laboratory Technician I in Quality Control is responsibe to perform tasks and functions associated with receiving inspection/testing, in-process or final inspection and testing of manufactured products and maintenance of product retention simples. This includes performing tasks and functions associated with the Microbiology Department on a rotation basis or as required.

Responsibilities

Key Accountabilities

• Performs required microbiological procedures (including sampling, colony counts, control prepration, identification, culture maintenance, etc.) in accordance with departmental procedures

• Performs routine aspects of tasks including the required recording of test results and interpretations (pass or fail status), according to department procedures, process control, SOPs, and/or work instructions

• Performs sterile culturing (bulk, pre-vialing and post-vialing) according to Quality Control procedures

• Performs validation activities, as required; Performs inspection, documentation, verification and acceptance tests on incoming materials, chemicals and test kits

• Maintains appropriate inventory of required department materials

• Operates, cleans and maintains department equipment - including computers, printers, incubators, pH meters, analytical balances, etc.

• Ensures environmental, personnel or product sampling and testing is completed according to documented procedures and within defined time frames

• Performs administrative aspects of tasks including recording of required results and interpretations (pass or fail status)

• Performs inspections of labeling and packaging operations and labeled and packaged product for conformance to specifications

• Performs inventory control tasks as reference materials or retention of final products

• Performs receiving inspections on chemicals, labeling, packaging, vials and droppers used in the manufacture of product and verifies compliance to company specifications

• Documents, quarantines, isolates and/or destroys unevaluated or nonconforming materials or products

• Prepares chemical solutions, reagents, reference materials according to laboratory procedures (including liquid and dry measurements, labeling, testing)

• Performs periodic calibration verification or recalibration of department equipment according to department procedures (including documentation, identification and troubleshooting of unacceptable performance)

• Operates, cleans, and maintains department equipment including computers, printers, incubators, centrifuges, mechanical shakers, pH meters, analytical balances or floor scales, spectrophotometer, etc

• Assists in product complaint investigations and responds to customer technical inquiries

• Creates and maintains legible written records according to procedure- or department-defined time frames

• Maintains a thorough understanding of all required safety standards/regulations and biohazardous disposal procedures in accordance with WHMIS and Ministry of the Environment regulations

• Understands cGMP and Health Canada requirements for manufacture of in vitro diagnostic devices

• Understands source, composition and characteristics of raw materials, final products and associated chemical and biosafety hazards

• Maintains inventory and assists in ensuring raw materials, components and supplies (THIO, TSB, analytical filters, etc.) are available to meet company and departmental protocol requirements and assist in the verification (growth promotion, etc.) that they meet minimum requirements;

• Understands manufacturing processes and equipment including repairs, cleaning and operational procedures necessary to maintain cGMP compliance;

• Performs other duties and responsibilities as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

Works closely with all manufacturing departments, quality compliance, customer service, and shipping.

Qualifications

Minimum Knowledge & Experience required for the position:

• Bachelor’s degree in Biological Sciences (BS/BSc) or related field

• Minimum six months of related quality control experience

• Demonstrated exerpeince with mathmatical concepts such as probability and statistical interference and fundamentals of plane and solid geometry and trigonometry and apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

• Strong proficiency with Microsoft Office applications and electronic document management systems and databases.

• Must be available to work both weekend and holiday shifts on a rotation basis. Must be available to work irregular hours and overtime as necessary to meet company requirements.

• Strong ability to speak, read, and write in English fluently.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Ability to read, analyze, and interpret publications, reports, technicial procedures, instructions in multiple formats, and government regulations.

• Effective communication to include business correspondence, report writing, and effectively present information and respond to questions from various employee and other stakeholders.

• Proactive problem-solving

• Stategic thinking

• Organizational skills and time management

• Coaching skills for improvement and problem solving

• Continous learning and development mindset

• Foster a positive and inclusive work environment

Travel requirements:

Travel is not required for this position.

Closing

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com