Job Description

Job Title: Manufacturing Specialist – 1st & 2nd Shift

Location: Fall River, Massachusetts, USA

Employment Type: Full-Time

About the Role

We are seeking an experienced Manufacturing Specialist to support Metered Dose Inhaler (MDI) production operations at our Fall River, MA facility. This role involves overseeing packaging processes, ensuring compliance with cGMP and FDA standards, and supporting continuous improvement initiatives within a fast-paced, regulated manufacturing environment.

The Manufacturing Specialist will coordinate daily production activities, monitor efficiency and quality, and collaborate with cross-functional teams to maintain operational excellence.

Key Responsibilities

• Coordinate and oversee daily production and packaging activities to meet schedules.
• Ensure compliance with cGMP , FDA regulations , and internal quality standards.
• Maintain and review documentation, including batch records, logs, and deviation reports.
• Assist in investigations related to deviations, non-conformances, and CAPAs .
• Collaborate with QA, Engineering, Supply Chain, and R&D teams to troubleshoot issues.
• Support the implementation of process improvements and new technologies.
• Track operational metrics and performance data to identify efficiency opportunities.
• Create and manage purchase requisitions (PRs) in SAP for equipment, consumables, and services.
• Maintain strong communication with internal teams and external suppliers/vendors.
• Promote and enforce safety protocols and Good Packaging Practices (GPPs) .

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Mechanical, Electrical, or Production Engineering (or related field).
• 5–11 years of experience in manufacturing, packaging, or operations (pharmaceutical preferred).
• Experience in pharmaceutical MDI packaging is a plus.
• Strong knowledge of cGMP and FDA regulations .
• Experience with SAP and data analysis tools.
• Excellent communication , problem-solving , and teamwork skills.
• Strong attention to detail and ability to thrive in a high-volume, regulated environment.

Work Hours / Shifts

• 1st Shift: 07:00 AM – 03:30 PM
• 2nd Shift: 03:00 PM – 11:30 PM
• (Shift assignment will depend on business needs and candidate preference.)

Salary & Benefits

Pay Range: (based on experience and shift)

Comprehensive Benefits Package Includes:

• 401(k) with company match
• Health, dental, and vision insurance
• Health Savings Account (HSA) & Flexible Spending Account (FSA)
• Paid Time Off (vacation, sick, flex days, and holidays)
• Short-term and long-term disability coverage
• Parental leave and employee discounts

Physical Requirements

• Ability to stand or walk for long periods.
• Must be able to lift up to 50 lbs as needed.
• PPE use and adherence to safety protocols required.

Job Tags

Similar Jobs