Manufacturing QMS Specialist

Kashiv BioSciences, LLC•Piscataway, NJ

4h•$70,000 - $100,000•Onsite

About The Position

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSciences Private Limited in India (together “Kashiv BioSciences”), operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines. 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 processes of biologics (Cytokines, monoclonal antibodies manufacturing).

Requirements

A Minimum BA or BS in Biological Sciences or related technical field is required.
Minimum 5 years of experience in Biopharmaceuticals.
Knowledge of USP and DSP processes.
Previous investigation training.
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 spreadsheets.
Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
Knowledgeable in cleaning verification/validation.

Responsibilities

Supporting the manufacturing team with a wide variety of documentation.
Reviewing executed batch records, logbooks, and other associated documents, both Upstream department and Downstream batch records.
Filing change controls, deviations, and CAPAs for the manufacturing department.
Using investigation tools like 5why or 6M method for all critical/major investigations.
Attending daily meetings with both upstream and downstream processes to get all the documentation requirements for the day.
Meeting weekly with QA to avoid any delay in the QMS closure.
Authoring batch records, SOPs, and associated forms/formats required for the manufacturing process.
Requesting/submitting all GMP documents to QA.
Supporting the manufacturing process (shifts) during critical campaigns.
Performing other functions as required or assigned.
Complying with all company policies and standards.