QC Analyst II at Werfen GmbH

Orangeburg, New York, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Jan, 26

Salary

29.0

Posted On

15 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

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

Industry

Medical Equipment Manufacturing

Description

Overview Position Summary: Performs analyses of Clinical Chemistry, Critical Care, Coagulation and/or Microbiology controls and reagents using various automated and manual techniques in accordance with established Quality standards 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.

Responsibilities

The QC Analyst II performs analyses of various controls and reagents using automated and manual techniques while adhering to quality standards and GMP requirements. They are responsible for interpreting test results, maintaining documentation, and conducting various testing procedures.