Process Support Investigator

Werfen • Norcross, GA

5d

About The Position

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. We are seeking a Quality Engineer / Process Support Investigator to provide investigation assistance using statistical analysis to support rationale/justification for root cause or combination factors. This position is not eligible for sponsorship for work authorization. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.

Requirements

• Excellent communication skills, both oral and written, to interpret scientific and technical journals, financial reports and legal documents.
• Problem-solving and critical thinking skills to identify issues, draw valid conclusions and deal with several abstract or concrete variables.
• 4 years of pharmaceutical experience or biotech industry performing similar duties
• 2-4 years in (Good Manufacturing Practice) GMP environment
• Proficient use of Quality Management Systems such as Trackwise
• Proficient use of Excel and statistical software (Minitab, Jump, etc.)
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, permutations, frequency distribution, and analysis of variance

Nice To Haves

• Bachelor’s degree in Life Sciences, Chemistry or Chemical Engineering, preferred
• ASQ Certified Quality Engineer, Six Sigma Green Belt, preferred
• Strong Quality Investigation background with proven training, preferred

Responsibilities

• Performing complex multivariate analysis and creating complex graphs and charts within the manufacturing/healthcare industry.
• Support product and process evaluation activities associated with product complaints to ensure constant improvement in quality and operational practices.
• Creating objective, thorough documentation of investigation activities
• Ensuring that expectations in regard to investigations, corrections, CAPA's, and all corresponding documentation are continually met
• Providing technical input and assisting in gathering appropriate operations and other functional inputs on issues
• Evaluating deliverables for compliance, completeness, and clarity, and providing feedback/disposition as appropriate
• Communicating significant issues or developments identified during quality assurance activities and recommend improvements
• Providing and presenting technical information to the team members and management

Benefits

• Equal Opportunity employer
• committed to a diverse workplace
• If you have a disability and need an accommodation in relation to the online application process, please contact [email protected] for assistance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level