Werfen North America · 16 hours ago
Technologist II, QC Lab
Werfen North America is a family-owned, innovative company specializing in diagnostics. The QC Technologist II is responsible for executing a range of bench test procedures, maintaining compliance with quality standards, and assisting with product performance investigations.
Health CareManufacturing
Responsibilities
Perform testing of biological raw materials and finished goods per relevant SOP
Perform testing for product validation and process validation on existing products
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, assist with investigation and resolution of complaints, non-conforming material and product performance issues
Submit basic change orders to update procedures as required
Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures and processes
Other duties as assigned
Qualification
Required
High school diploma required
Thorough understanding of Good Laboratory Practices (GLP) required
Without Related degree: A minimum of two (2) years previous Quality Control lab (QC) and/or Quality Assurance (QA) experience required
With related degree, a minimum of one (1) years previous Quality Control lab (QC) and/or Quality Assurance (QA) experience required
Strong 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
Must occasionally lift up to 25 lbs
Attention to Detail: Ability to pay close attention to detail is required
Accuracy: Work is accurate and completeness of records
Outstanding Performance Standards: Demonstrated ability to meet department goals
Communication: Good written and verbal communication skills
Discretion: Acts Honest, Loyal, trustworthy
Multi-Tasking: Intermediate ability to Juggle Priorities, and support changing business needs
Collaboration: Ability to actively develop a network to bring best solutions to the team or customer
Independence: self-motivated-works under minimal supervision
Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties
Takes Initiative: Serves as a role model for 'Quality First' by continuously improving on what matters most to customers
Problem Solving: Promptly and effectively handles intermediate issues and problems
Preferred
Bachelor's degree in Science or equivalent experience
Experience within a regulated medical device manufacturing or In-Vitro Diagnostic Device (IVDD)
Phlebotomy certification
Proficiency with Large Enterprise Resources Planning (ERP)
Company
Werfen North America
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
H1B Sponsorship
Werfen North America has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageRecent News
2025-07-19
2025-05-17
2025-04-04
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