Technologist II, QC Lab

Country

United States

Shift

1st

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 II 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 II assists with resolving product performance issues and maintains the documentation files of approved QC Standard Operating Procedures (SOP) in compliance with applicable regulations and ISO Standards.

Key Accountabilities

Essential Functions:

• 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.

Internal Networking/Key Relationships:

• Quality Release, Research and Development, Quality Engineering, and Manufacturing Persononel

Minimum Knowledge & Experience Required for the Position:

• High school diploma required;
  Bachelor’s degree in Science or equivalent experience preferred.
• Thorough understanding of Good Laboratory Practices (GLP) required.
• Work Experince:
  • 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
  • Experience with in a regulated medical device manufacturing or In-Vitro Diagnostic Device ( IVDD) strongly preferred.

Skills & Capabilities

Required Skills
:

• 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.
• Proficiency with Large Enterprise Resources Planning (ERP) preferred.
• Must occasionally lift up to 25 lbs.
• Attention to Detail: Ability to pay close attention to detail is required
• Accuracy: Work is accurate…