Manufacturing QMS Specialist

Amneal

5d

About The Position

The Manufacturing QMS Specialist executes routine quality-system documentation and supports manufacturing teams working with upstream and downstream biologics processes, including cytokine and monoclonal antibody manufacturing. The role reviews and authors GMP documents, helps manage QMS records through closure, and provides documentation support during critical campaigns. Wet-lab work is expected to account for no more than 10% of the position’s time.

The work environment includes cleanrooms and/or laboratories, with appropriate PPE, and desk/computer work involving reading, editing, and writing documents. The position may involve chemical odors and dust, movement around the facility, lifting and shifting materials, prolonged standing, and occasional bending, squatting, kneeling, stooping, pushing, pulling, reaching, and walking. Flexible hours may be needed, and the role requires working under pressure and meeting deadlines.

The stated salary range is $65,000–$80,000 per year. The company also offers a short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months. Eligible positions include a flexible benefits program with health and insurance benefits and a 401(k) matching contribution.

Requirements

• Minimum BA or BS in Biological Sciences or a related technical field.
• Minimum 5 years of experience in biopharmaceuticals.
• Knowledge of upstream and downstream processes.
• Previous investigation training.
• Ability to work with others and independently; good interpersonal skills.
• Good verbal and written communication skills.
• Good computer and organizational skills; detail-oriented.
• 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 lift at least 25 lbs., stand for long periods, and perform the stated physical activities.

Responsibilities

• Support manufacturing teams with documentation, including reviewing executed batch records, logbooks, and associated upstream and downstream documents.
• File manufacturing department change controls, deviations, and CAPAs.
• Use investigation tools such as 5 Why or the 6M method for critical or major investigations.
• Attend daily upstream and downstream meetings to identify documentation needs.
• Meet weekly with QA to help prevent 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 processes during shifts for 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.
• Flexible benefits program for eligible positions.
• Health and insurance benefits.
• 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

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