Werfen North America · 1 day ago
Technologist III, QC - San Diego
San Diego, CA
Full-time
Onsite
Mid Level
$29/hr - $34/hr
4+ years expWerfen North America is a family-owned, innovative company specializing in diagnostics in various healthcare areas. The QC Technologist III will execute bench test procedures, support investigations, and maintain compliance with quality standards in the QC laboratory.
Health CareManufacturing
Responsibilities
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
Qualification
Required
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
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
Preferred
Bachelor's degree in Science or equivalent experience preferred
Previous experience within a regulated medical device manufacturing or In-Vitro Diagnostic Device (IVDD) strongly preferred
Phlebotomy certification a plus
Proficiency with Large Enterprise Resources Planning (ERP) and Laboratory Information Management (LIMS) systems preferred
Company
Werfen North America
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
Founded in 1959Bedford, Massachusetts, USA
1001-5000 employees
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 StageLeadership Team
Giovanni Russi
Chief Operating Officer
Dominique J.
Human Resources Business Partner
Recent News
2025-07-19
2025-05-17
2025-04-04
Company data provided by crunchbase