Production Operations Coordinator

2 weeks ago


Port Allen, Louisiana, United States Mallinckrodt Full time

Job Title: Operations Specialist

Job Overview:
The Operations Specialist plays a critical role in ensuring that production processes comply with industry regulations, standards, and internal policies.

Key Responsibilities:
1. Prioritize safety by promptly reporting any safety issues to supervisory personnel.
2. Complete all necessary training for production tasks, including Good Manufacturing Practices (GMPs) and safety protocols.
3. Carry out daily production tasks such as cylinder preparation, bake-out, blow-down, filling, and packaging of pharmaceutical products.
4. Adhere to the daily operations schedule, coordinating with Functional Leads and Quality Assurance to address any schedule adjustments that may affect production and quality oversight.
5. Manage the staging, segregation, documentation, and safety protocols associated with production processes.
6. Implement the weekly production schedule to fulfill operational demands.
7. Ensure compliance with Production Batch Records and Procedures, reviewing them regularly to maintain adherence to established guidelines and GMP standards.
8. Procure necessary components for manufacturing operations and conduct inventory assessments to avoid disruptions in the production schedule.
9. Maintain daily logbooks to ensure compliance with operational procedures.
10. Execute cleaning and preventive maintenance tasks for equipment within the manufacturing area.
11. Retrieve Standard Operating Procedures (SOPs) and related documentation from the Master Control quality system.
12. Provide assistance across the production department as needed, ensuring that all facilities are maintained according to established cleanliness standards.

Minimum Qualifications:
- High school diploma or equivalent.
- Technical background in Chemistry or Compressed Gases.
- Knowledge of CGMPs.
- Strong leadership capabilities with a focus on results, along with the ability to train and motivate team members.

Preferred Qualifications:
- Two years of experience in a manufacturing setting.
- Degree in Process Technology (PTEC).
- Previous experience in a manufacturing environment regulated by FDA standards.

Additional Skills:
- Familiarity with ERP systems such as SAP.

Reporting Structure:
Position is officially supervised by the Area Manufacturing Supervisor and informally managed by the Lead Operations Specialist within the designated functional area.

Work Environment:
The current work schedule consists of four 10-hour shifts per week, subject to change. Most work is conducted indoors, with occasional outdoor tasks required.



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