Manufacturing QMS Specialist at Kashiv Biosciences LLC – Piscataway, New Jersey

RequirementsEssential 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 (night shifts, weekends, holidays) during critical campaign.
• 10% wet lab work.
• Performs other functions as required or assigned.
• Complies with all company policies and standards.

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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.