Manufacturing Specialist - 1st Shift & 2nd Shifts

Job Title:
Manufacturing Specialist - 1st Shift & 2nd Shifts

Location: Fall River, MA

Job :

- 28476
Employment Type: Full-Time | 1st & 2nd Shifts (07:00-15:30 / 15:00-23:30)
Salary Range: $72,800 - $93,600
Work Authorization: U.S. Citizen or Green Card Holder

Position Overview:

We are seeking an experienced Manufacturing Specialist (MDI Operations) to support packaging and production activities at a leading pharmaceutical facility. The ideal candidate will possess strong knowledge of cGMP
, FDA regulations
, and hands-on experience in pharmaceutical packaging operations
, preferably in Metered Dose Inhalers (MDI).

Key Responsibilities:

• Coordinate and monitor daily packaging operations to meet production schedules.
• Ensure compliance with cGMP, FDA, and internal quality standards.
• Maintain accurate batch records, logs, and deviation documentation.
• Support investigation of non-conformances and CAPAs.
• Collaborate with Quality, Supply Chain, Engineering, and R&D teams to resolve operational issues.
• Create and manage SAP purchase requisitions for materials, equipment, and services.
• Analyze operational data to identify process improvements and reduce inefficiencies.
• Support audits and regulatory inspections; ensure compliance documentation readiness.
• Participate in safety programs and enforce PPE and cleanroom standards.

Required Qualifications:

• Education: Bachelor's degree in Pharmaceutical Sciences, Electrical, Mechanical, Production, or related field.
• Experience: 5-11 years in packaging, operations, or team management within Pharma, Nutraceuticals, or Medical Devices.
• Strong understanding of cGMP
  , FDA regulations
  , and pharmaceutical packaging processes
  .
• Proficiency in SAP
  , Microsoft Office Suite
  , and packaging data analysis tools.
• Excellent problem-solving, organizational, and communication skills.
• Ability to work independently and collaboratively in a regulated environment.

Preferred Qualifications:

• Experience in Metered Dose Inhaler (MDI) or inhalation product packaging.
• Familiarity with writing and revising cGMP records and SOPs
  .
• Experience in compliance and regulatory audits.

Physical Requirements:

• Stand or walk for extended periods.
• Lift up to 50 lbs when required.
• Use of PPE (respirator, goggles, gloves, etc.) required.
• Benefits:
• Competitive salary and annual bonus potential
• 401(k) with company match
• Health, dental, and vision insurance
• Health Savings & Flexible Spending Accounts (HSA/FSA)
• Paid Time Off (vacation, sick, holidays, parental leave)
• Short-term & long-term disability coverage
• Employee discounts and other perks

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