QC Analyst II at Werfen GmbH

Orangeburg, New York, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Apr, 26

Salary

29.0

Posted On

16 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Control, Clinical Chemistry, Coagulation, Microbiology, GMP Requirements, Assay Interpretation, Documentation, Product Stability Testing, Preventive Maintenance, Troubleshooting, Calibration, Microbial Testing, Laboratory Supplies Management, Statistical Process Control, Hazardous Material Disposal, SOP Updates

Industry

Medical Equipment Manufacturing

Description

Introduction 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. Overview Position Summary: Performs analyses of Clinical Chemistry, Co-Oximeter, Coagulation and/or Microbiology controls and reagents using various automated and manual techniques in accordance with established Quality and GMP requirements. Responsibilities Key Accountabilities Essential Functions: Performs automated and manual assays as detailed in departmental/plant SOPs and QC Monographs including raw material, in-process and finished product. Interprets test results against specifications and decides if assays pass or fail. Maintains documentation of all work performed in accordance with GMP requirements. Evaluates product complaints upon Team Leader or Team Champion's request. Performs product stability, proficiency, environmental testing and water system testing. Responsible for routine preventive maintenance, general trouble shooting, general cleanliness and calibration of Lab equipment. Updates departmental SOP's and QC Monographs as directed by Team Leader or Senior QC Analyst. Performs microbial testing per SOP's and QC Monographs. Orders required laboratory supplies, reagents and other consumables. Monitors proper storage conditions and expiration dates. Disposes hazardous and biohazardous materials. Other duties as directed by Team Leader or Sr. QC Analyst. Maintains samples in accordance with established procedures. Maintains statistical process control charts and other tracking reports Budget Managed (if applicable): N/A Internal Networking/Key Relationships: To be determined based on department needs Skills & Capabilities: Functional/technical skills Qualifications Min Knowledge & Experience Required for the Position: B.S./B.A. Degree in Science or Medical Technology or equivalent required, plus 2 years clinical laboratory experience with a basic knowledge of quality control principles. Physical Requirements: This position requires the ability to lift and move materials per current OSHA standards. International Mobility: Required: No Travel requirements: No The hourly wage range Werfen reasonably expects to pay for the position is $24 to $29. Compensation is reasonably based upon multiple factors including education, relevant experience, skillset, knowledge, and specific needs of the business. 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

Responsibilities

The QC Analyst II performs analyses of various controls and reagents, interpreting test results and maintaining documentation in compliance with GMP requirements. They are also responsible for routine maintenance of lab equipment and evaluating product complaints.