Manufacturing QMS Specialist

We are searching for a 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 associated forms / formats required for manufacturing process.
• Responsible for requesting / submitting all GMP documents to QA.
• Support manufacturing process during critical campaign.
• 10% wet lab work.
• Performs other functions as required or assigned.
• Complies with all company policies and standards.

Experience/Qualifications:

• A Minimum BA or BS in Biological Sciences or related technical field is required.
• At least 3 years of experience in Biopharmaceuticals.
• Knowledge in USP and DSP process
• Experience working with Biologics molecules
• Strong knowledge for QMS investigation skills, CAPA, Deviations, Change Control