Pharmaceutical Compliance & Packaging Specialist

Pharmaceutical Compliance & Packaging Specialist

Location: Fall River, Massachusetts, USA (Onsite)

Employment Type: Full-time

Experience

Required:

5–11 years (Packaging / Manufacturing Operations)

Shift: 1st Shift: 7:00 AM – 3:30 PM or 2nd Shift: 3:00 PM – 11:30 PM (may vary)

Salary Range: USD 72,000 – 93,000 annually

The Manufacturing Specialist supports daily pharmaceutical packaging operations to ensure production targets are met in compliance with cGMP, FDA, and internal quality standards. This role focuses on coordinating resources, monitoring packaging performance, supporting investigations, improving efficiency, and working cross-functionally to maintain safe and compliant operations.

• Support daily packaging activities to meet production schedules
• Monitor packaging operations for cGMP and regulatory compliance
• Identify inefficiencies and resolve routine issues; expand complex matters as needed
• Ensure accurate completion of batch records, logs, and documentation
• Track production schedules and minimize delays
• Support deviation investigations, non-conformances, and CAPA activities
• Collaborate with Quality Assurance to ensure SOP compliance
• Coordinate materials, equipment, and workforce to optimize resources
• Identify and support process improvement initiatives
• Assist with the implementation of new packaging technologies and automation
• Work cross-functionally with Manufacturing, Quality, Supply Chain, Engineering, Project Management, and R&D
• Support training on standard operating procedures
• Monitor and analyze operational metrics
• Support productivity improvement initiatives through data review
• Coordinate with suppliers and vendors for timely and compliant delivery
• Create and manage purchase requisitions in SAP
• Maintain clear communication with internal and external stakeholders
• Follow company procedures and current good manufacturing practices
• Participate in safety programs and maintain a clean work environment
• Perform additional duties as assigned

• Bachelor’s degree in Pharmaceutical Sciences, Engineering, or a related field

• 5–11 years of experience in pharmaceutical packaging or manufacturing operations
• Experience with MDI (Metered Dose Inhaler) packaging is preferred

• Knowledge of cGMP, FDA regulations, and packaging processes
• Experience with SAP and production data tools
• Ability to manage and maintain GMP documentation and SOPs
• Familiarity with quality systems and regulatory requirements
• Ability to support regulatory inspections
• Strong problem-solving and attention to detail
• Ability to work in a regulated, fast-paced environment
• Strong verbal and written communication skills
• Proficiency in Microsoft Office
• Ability to work independently and in cross-functional teams

• Ability to stand or walk for extended periods
• Frequent use of hands and arms for reaching, handling, and operating equipment
• Ability to lift up to 50 lbs when required
• Mandatory use of Personal Protective Equipment (PPE)

• Competitive salary
• 401(k) savings plan with company match
• Medical, dental, and vision insurance
• Health Savings Account (HSA) and Flexible Spending Account (FSA)
• Paid Time Off (Vacation / Sick / Flex Time)
• Paid holidays
• Short-term and long-term disability
• Parental leave
• Employee discounts and additional company benefits