Manufacturing QMS Specialist

Kashiv BioSciences, LLC•Chicago, IL

9d•Onsite

About The Position

The Manufacturing QMS Specialist is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC, located in Chicago, IL. Under the direction of Manufacturing Management, this role involves executing routine documentation work, including writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, and CAPAs. The position requires technical expertise in the upstream and downstream processes of biologics manufacturing (Cytokines, monoclonal antibodies).

Requirements

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.
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 spreadsheet.
Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
Knowledgeable in cleaning verification/validation.

Nice To Haves

Ability to work flexible hours as needed.
Ability to work under pressure and meet deadlines.
Some travel may be involved.

Responsibilities

Supporting the manufacturing team with all kinds of documentation.
Reviewing executed batch records (both Upstream and Downstream).
Filing change controls, Deviations, and CAPAs for the manufacturing department.
Using investigation tools like 5Why or 6M method for critical/major investigations.
Attending daily meetings with upstream and downstream process teams to gather documentation requirements.
Meeting weekly with QA to ensure timely QMS closure.
Authoring batch records, SOPs, and associated forms/formats for the manufacturing process.
Requesting/submitting all GMP documents to QA.
Supporting the manufacturing process during critical campaigns (rotating shifts).
Performing wet lab work, not exceeding 10% of time.
Performing other functions as required or assigned.
Complying with all company policies and standards.