Quality Specialist II (Recombinant Proteins)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

LOCATION: This is a fully onsite position based at our Cranbury, NJ site. Unfortunately, relocation assistance is NOT provided.  Priority will be given to LOCAL candidates currently residing in Cranbury area.

• Must be legally authorized to work in the United States without sponsorship now or in the future. 
• Must be able to pass a comprehensive background check, which includes a drug screen.

Our Recombinant Proteins (REP) Business Unit in Cranbury, NJ is part of our Biosciences Division. REP unites deep scientific expertise with a collaborative culture to build a product portfolio that includes cytokines, growth factors, antibodies and ELISA kits used to support the research of our academic, government, biotech, and pharmaceutical customers.

DESCRIPTION

We are seeking a highly motivated and meticulous Quality Systems Specialist to join our team. The Quality Systems Specialist will play a meaningful role in the implementation, maintenance and improvement of the company's quality assurance program, the Quality Management System (QMS) and ensuring that other departments operate in accordance with the highest quality standards and adhere to all applicable requirements. This position functions under the supervision of the Quality Manager.

What will you do:

• Maintain the company's QMS based on ISO 9001:2015 standard
• Conduct and assist with internal and external audits, including Quality Management System audits
• Facilitate the identification, investigation and effective closure of deviations, non-conformances, corrective and preventive actions (CAPAs), etc.
• Lead and manage root-cause investigations and facilitate problem-solving initiatives to implement effective corrective actions and drive process performance improvement (GMP OOSs, NCRs, DRs, CAPAs, and Change Controls)
• Coordinate in-house and external QC testing activities including sample submissions, results analysis, and reporting for WIP and finished goods. Tests include Biological Assays, HPLC, SDS-PAGE gels, Endotoxin, ELISA, Protein Concentration by UV Spectroscopy, Mass Spectrometry, Western Blot, Mycoplasma, Sterility, and Residual E.coli DNA testing
• Manage GMP finished product lot release and material disposition (Quarantine, Hold, Release, Rework, Scrap)
• Coordinate and implement GMP media fill challenges
• Review quality-related documentation such as manufacturing batch records, worksheets, and training forms for legibility, accuracy and completeness
• Ensure the accuracy, accessibility and version control of key company documents, including SOPs, work instructions, test methods and checklists
• Perform daily tasks critical to seamless operation, including material and product quarantine and release, batch record and label issuance
• Manage product complaints and investigations, and authorize replacements, credits and refunds stemming from technical investigations
• Analyze quality data such as environmental monitoring and complaints to identify quality issues and recommend corrective and preventive actions for continuous improvement
• Establish and manage systems for collection and analysis of statistical data, monitor and predict trends that may affect product quality
• Oversee site cleanroom integrity, contamination control, and state of control
• Complete and review quality questionnaires and desk audits
• Manage customer CDAs/NDAs
• Support maintenance of the Supplier Management Program
• Generate and disseminate change notifications, customer notifications, and product documentation (Certificates of Analysis, Certificates of Origin, Safety Data Sheets, customer letters)
• Manage equipment maintenance programs with Facilities and maintain Quality Assurance-owned equipment
• Monitor and report on site quality metrics
• Collaborate with other departments to develop and maintain a robust QMS
• Follow all ISO 9001 and GMP guidelines
• Demonstrate and drive the Thermo Fisher values – Integrity, Intensity, Involvement, and Innovation (The F