Manufacturing QMS Specialist

About the Role

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company with robust infrastructure and highly skilled teams providing global R&D, clinical, manufacturing, regulatory, and IP capabilities. We are dedicated to advancing patient care and access to important medicines through our people, partners, and shared purpose.

Under the direction of Manufacturing Management, the Manufacturing QMS Specialist will execute routine documentation work, including writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, and CAPA. This role requires technical expertise in upstream and downstream processes of biologics (cytokines, monoclonal antibodies manufacturing).

Responsibilities

• Support the manufacturing team with a wide variety of documentation, including reviewing executed batch records, logbooks, and other associated documents for both Upstream and Downstream departments.
• File change controls, deviations, and CAPAs for the manufacturing department.
• Use investigation tools like 5-Why or 6M method for critical/major investigations.
• Attend daily meetings with upstream and downstream processes to gather documentation requirements.
• Meet weekly with QA to avoid delays in QMS closure.
• Author batch records, SOPs, and associated forms/formats required for the manufacturing process.
• Request and submit all GMP documents to QA.
• Support the manufacturing process (shifts) during critical campaigns.
• Perform wet lab work (not exceeding 10% of time).
• Perform other functions as required or assigned.
• Comply with all company policies and standards.

Requirements

Minimum Qualifications:

• BA or BS in Biological Sciences or a related technical field.
• Minimum of 5 years of experience in Biopharmaceuticals.
• Knowledge of USP and DSP processes.

Preferred Qualifications:

• Previous investigation training.
• Ability to work collaboratively and independently with strong interpersonal skills.
• Good verbal and written communication skills, detail-oriented, and strong organizational abilities.
• Basic computer skills, including proficiency in Word, Excel, and spreadsheets.
• Knowledgeable in GMP batch manufacturing, packaging documentation, audit, and review.
• Knowledgeable in cleaning verification/validation.

Benefits

• Medical Insurance (Aetna)
• Prescription Drug Coverage (Converge | Rx)
• Virtual Visits (Aetna/Teladoc)
• Health Savings Accounts (HSA)
• Flexible Spending Accounts (FSA)
• Dental Insurance (Aetna)
• Vision Insurance (VSP)
• Life and AD&D Insurance
• Disability Benefits
• Supplemental Benefits
• Legal Services
• ID Theft Protection
• Travel Assistance
• Health Advocate
• Life Assistance Program (LAP)
• Student Loan Assistance Program
• 401K
• Monthly Cell Phone Allowance

Pay

Base Salary Range: $70,000–$100,000 with up to an 8% yearly cash bonus.

Work Environment & Physical Demands

• Wear appropriate PPE to work in cleanrooms and/or laboratories that are adequately lit, ventilated, and temperature-controlled.
• Desk/computer work (reading, editing, writing documents) required.
• Potential exposure to chemical odors and dust.
• Ability to move around the facility to reach various equipment.
• Physical lifting and shifting required for pushing and pulling pre-made buffer containers.
• Must be able to lift at least 25 lbs. for daily scale verification.
• Must be able to stand for long periods of time.
• Occasional bending, squatting, kneeling, stooping, pushing, pulling, reaching, and walking.
• Ability to work flexible hours as needed and under pressure to meet deadlines.