Manufacturing Quality Specialist

Manufacturing QMS Specialist who will be responsible for writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, CAPA etc. This position requires technical expertise in upstream and downstream process of biologics (Cytokines, monoclonal antibodies manufacturing).

Responsibilities:

• Responsible to support manufacturing team with all kinds of documentation.
• Documentation includes reviewing executed batch records (both Upstream department and Downstream batch record).
• Responsible for filing change controls, deviation, CAPA for manufacturing department.
• For all critical / major investigation, will have to use investigation tools like 5why or 6M method.
• Attend daily meetings with both upstream and downstream process to get all the documentation requirement for the day.
• Meet weekly with QA to avoid any delay in the QMS closure.
• Author batch records, SOPs and...

About us

TydenBrooks brings our customers over 150 years of experience in the manufacturing of security seals and solutions. We maintain market leadership through innovation, research, quality, design and customer service globally. We are committed to producing competitively priced, quality high-security seals, tamper-evident plastic security seals, security tapes, labels and other security products such as our security bags and name tags. We also offer our new state-of-the-art GPS, BLE, and RFID security seals and solutions. We are always focused on customer service and peace of mind solutions. We are continually “Leading the Way, Securing the World.”

POSITION SUMMARY:

The Product Quality Specialist is responsible for the thorough testing and inspection of TydenBrooks’ manufactured and purchased products and raw materials to ensure they meet quality and safety standards. This role focuses on developing...