Manufacturing QMS Specialist

Amneal India • Piscataway, NJ

6d • $65,000 - $80,000

About The Position

The Manufacturing QMS (Quality Management System) Specialist supports the manufacturing team by executing routine documentation work, including writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, and CAPAs. The role requires technical expertise in upstream and downstream biologics processes, including cytokine and monoclonal antibody manufacturing.

The specialist reviews executed batch records, logbooks, and related upstream and downstream documents; files change controls, deviations, and CAPAs; and uses investigation tools such as 5 Why or the 6M method for critical or major investigations. The role involves attending daily upstream and downstream meetings to identify documentation needs, meeting weekly with QA to support timely QMS closure, authoring batch records, SOPs, and related forms, and requesting or submitting GMP documents to QA. During critical campaigns, the specialist may support manufacturing shifts. Wet lab work is expected to comprise no more than 10% of the role. Other functions may be assigned, and the employee must comply with company policies and standards.

The work environment includes cleanrooms and/or laboratories, where appropriate PPE is required. The work areas are adequately lit, ventilated, and temperature controlled; chemical odors and dust may be present. Desk and computer work involving reading, editing, and writing documents is required. The role also involves moving around the facility, pushing and pulling pre-made buffer containers, lifting at least 25 pounds, and standing for extended periods, with occasional bending, squatting, kneeling, stooping, reaching, and walking. Flexible hours may be needed, and the position requires working under pressure and meeting deadlines.

Requirements

• Bachelor of Arts or Bachelor of Science in Biological Sciences or a related technical field.
• At least 5 years of experience in biopharmaceuticals.
• Knowledge of upstream and downstream processes (USP and DSP).
• Previous investigation training.
• Ability to work both independently and with other team members; good interpersonal skills.
• Good verbal and written communication, computer, and organizational skills; attention to detail.
• Basic computer skills, including Word, Excel, and spreadsheets.
• Knowledge of GMP batch manufacturing and packaging documentation, including audit and review.
• Knowledge of cleaning verification and validation.
• Ability to work flexible hours as needed, under pressure, and to deadlines.
• Ability to move around the facility, push and pull pre-made buffer containers, lift at least 25 pounds, and stand for long periods; occasional bending, squatting, kneeling, stooping, reaching, and walking.
• Ability to wear appropriate PPE in cleanrooms and/or laboratories.

Responsibilities

• Support the manufacturing team with a wide variety of documentation.
• Review executed batch records, logbooks, and associated documents for both upstream and downstream departments.
• File change controls, deviations, and CAPAs for the manufacturing department.
• Use investigation tools such as 5 Why or the 6M method for critical or major investigations.
• Attend daily meetings with upstream and downstream teams to identify documentation requirements.
• Meet weekly with QA to avoid delays in QMS closure.
• Author batch records, SOPs, and forms or formats required for manufacturing processes.
• Request and submit GMP documents to QA.
• Support manufacturing shifts during critical campaigns.
• Perform other functions as required or assigned.
• Comply with company policies and standards.

Benefits

• Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
• Comprehensive, flexible benefits program for eligible positions, including health and insurance benefits.
• 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior