Pharmaceutical Packaging Specialist
1 day ago
Job Title: Packaging Specialist
Location: Fall River, MA
Shift: 1st Shift (07:00 – 15:30) – may vary based on business needs
About the Role:
We are seeking an experienced MDI Operations Specialist to support daily pharmaceutical packaging operations. This role involves coordinating production activities, ensuring compliance with cGMP and FDA regulations, and contributing to process improvements in a fast-paced, regulated environment.
Key Responsibilities:
- Coordinate daily packaging activities to meet production schedules.
- Monitor adherence to cGMP, FDA, and internal quality standards.
- Document batch records, logs, deviations, and CAPAs accurately.
- Assist in investigating deviations and implementing corrective actions.
- Collaborate with Quality, Supply Chain, Engineering, R&D, and Project teams to resolve operational issues.
- Support training and clear communication of SOPs.
- Maintain operational metrics and identify opportunities for efficiency improvements.
- Manage SAP purchase requisitions for materials, equipment, and services.
- Participate in safety programs and enforce compliance with safety protocols.
- Support audits and regulatory inspections at local and federal levels.
Qualifications:
- Bachelor's degree in Pharmaceutical Sciences, Electrical, Mechanical, Production, or related fields.
- 5–11 years of experience in pharmaceutical packaging, operations, or team management. Experience with MDI packaging is a plus.
- Knowledge of cGMP, FDA regulations, and pharmaceutical packaging processes.
- Experience with SAP and packaging data analysis tools.
- Strong problem-solving skills, attention to detail, and ability to work in a fast-paced environment.
- Excellent communication skills and ability to work independently and in a team.
- Experience creating/revising SOPs and quality records.
- Comfortable handling compliance and regulatory audits.
Physical Demands:
- Stand or walk for extended periods.
- Lift up to 50 lbs when required.
- Use hands and arms for handling materials.
- PPE required for safety compliance.
Job Type: Full-time
Pay: $72, $93,000.00 per year
Work Location: On the road
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