Lean Manufacturing Specialist jobs in New Brunswick, NJ

Description

Kashiv BioSciences is a fully integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline. We are looking for an experienced QMS Specialist to join our Piscataway, NJ Operations team.

Under the direction of Manufacturing Management, the Manufacturing QMS Specialist will be executing routine documentation work which includes 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).

Requirements

Essential Duties & 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 (shifts) during critical campaign.
• 10% wet lab work.
• Performs other functions as required or assigned.
• Complies with all company policies and standards.

Education and Experience:

• A Minimum BA or BS in Biological Sciences or related technical field is required.
• Minimum 5 years of experience in Biopharmaceuticals.
• Knowledge in USP and DSP process

Special Skills:

• Ability to work with other team members and independently - good interpersonal skills.
• Good communication skills: verbal and written, good computer and organization skills, detail oriented.
• Basic computer skills, including knowledge of Word, Excel, and spread sheet.
• Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
• Knowledgeable in cleaning verification/validation.