Manufacturing QMS Specialist

About the role

The Manufacturing QMS Specialist is a full-time exempt position at Kashiv BioSciences, LLC. Located in Chicago, IL.

Responsibilities

• Supporting the manufacturing team with all kinds of documentation, including reviewing executed batch records and filing change controls, deviations, and CAPAs.
• Using investigation tools like 5Why or 6M method for critical/investigation purposes.
• Attending daily meetings with both upstream and downstream processes to gather documentation requirements.
• Meting weekly with QA to ensure timely QMS closure.
• Authoring batch records, SOPs, and other manufacturing-related forms.
• Submitting all GMP documents to QA.
• Supporting manufacturing processes during critical campaigns (rotating shifts).
• Performing wet lab work, but not more than 10% of the time.

Requirements

• A minimum BA or BS in Biological Sciences or a related technical field.
• Minimum 5 years of experience in Biopharmaceuticals.
• Knowledge in USP and DSP processes.
• Ability to work with others and independently, strong interpersonal and communication skills.
• Good computer skills, including knowledge of Word, Excel, and spreadsheet software.
• Experience with GMP batch manufacturing and packaging documentation, audits, and reviews.
• Understanding of cleaning verification/validation.

Special Skills

• Excellent communication skills (verbal and written).
• Detail-oriented.
• Basic computer skills.
• Ability to work under pressure and meet deadlines.

Benefits/Perks

• Medical
• Dental
• Vision
• 401K
• FSA HSA
• Convenient parking
• Monthly cell phone allowance
• Free parking (company-paid)
• Close to Chicago White Sox Stadium
• Conveniently located near Metra, Green, and Red Line
• Flexible work schedule