Technologist III, QC - San Diego

Werfen

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.

Position Summary:

The QC Technologist III is responsible for the execution of a broad range of bench test procedures used in raw material qualification, the testing of finished goods prior to release, the investigations of product performance, and for conducting routine validation studies, as well as assisting with routine maintenance of the Quality Control (QC) laboratory. The QC Technologist III works with cross-functional teams to resolve product performance issues and maintenance of QC Standard Operating Procedures (SOP) in compliance with applicable regulations and ISO standards. Additionally, QC Technologist III supports investigations and assists in trending and statistically analyzing finish product testing data.

Key Accountabilities

Essential Functions:

• Perform and organize testing of biological raw materials and finished goods per relevant SOP with minimal supervision; subject matter expertise in at least one product line.
• Assist with planning of method, product and process validations on existing products; perform and organize testing as needed.
• Perform testing and prepare reports as required for environmental monitoring or investigation of out-of-specification results, as required.
• Perform testing and assist with preparation of reports for various special projects as deemed necessary by technical review team.
• Responsible for tracking relevant trends.
• Maintain proper laboratory housekeeping and supply levels in the QC laboratory, including submission of purchase requisitions and inventory adjustments.
• Document all test results and maintain product release records (including electronic records).
• Document existing product/process validation test results (including electronic records).
• Maintain product testing database and perform relevant statistical analyses associated with product specifications as specified in laboratory SOPs.
• As required, coordinate and assist with investigation and resolution of complaints, non-conforming material and product performance issues.
• Submit complex change orders to update procedures as required.
• As required, work cross-functionally to investigate and resolve issues deriving from finish product testing.
• Ensure and maintain compliance with the Company's quality system requirements through training and adherence to policies, procedures and processes.
• Other duties as assigned.

Minimum Knowledge & Experience Required for the Position:

• High school diploma required; Bachelor's degree in Science or equivalent experience preferred.
• A minimum of four (4) years previous Quality Control lab (QC) and/or Quality Assurance (QA) experience required; previous experience within a regulated medical device manufacturing or In-Vitro Diagnostic Device (IVDD) strongly preferred.
• Thorough understanding of Good Laboratory Practices (GLP) required.
• Practical experience with laboratory controls, internal audits, and lab training/maintenance.
• Phlebotomy certification a plus.
• Knowledge of FDA-GMP/QSR and ISO standards for quality.
• Excellent written and verbal communication skills.
• Ability to work independently and as part of a team.
• Proficiency with common laboratory techniques, such as pipetting and use of balances.
• Proficiency with Microsoft Office suite.
• Proficiency with Large Enterprise Resources Planning (ERP) and Laboratory Information Management (LIMS) systems preferred.

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