Job Title

Operations Specialist

Requisition

JR000014370 Operations Specialist (Open)

Location

Port Allen, LA

Additional Locations

Baton Rouge, LA

Job Description Summary

Job Description

The Operations Specialist ensures production activities adhere to government regulations, guidelines, and company policies and procedures.

Essential Functions

Perform all tasks safely and promptly report any safety concerns to area supervision.

Successfully complete training requirements for executing production activities, including GMPs, safety protocols, policies, and procedures necessary for tasks within the functional area.

Execute day-to-day production activities such as cylinder prep, bake-out, blow-down, filling, and packaging of finished drug products.

Follow the daily operations schedule, communicating with Functional Leads and Quality Assurance about schedule changes that may impact production requirements and QA coverage.

Manage process staging, segregation, documentation, and safety requirements.

Execute the weekly schedule to meet production demands.

Comply with applicable Production Batch Records and Procedures. Review Batch Records and Procedures to ensure adherence to policies, procedures, and GMP requirements. Procure components needed for manufacturing operations.

Conduct inventory checks of components and parts in your area of responsibility to prevent production schedule interruptions. Review logbooks daily to ensure compliance and completion as per procedures.

Execute equipment cleaning and preventive maintenance procedures within the Manufacturing area.

Retrieve SOPs and forms from the Master Control quality system.

Assist throughout the production department as needed, ensuring proper housekeeping of all facilities according to established procedures.

Minimum Requirements

High school diploma or equivalent

Technical background in Chemistry or Compressed Gases

Knowledge of CGMPs

Strong leadership skills with a results-oriented approach as well as the ability to train, motivate, and otherwise develop resources. 

Preferences:

2 years’ experience working in a manufacturing environment. 

Process Technology (PTEC) degree

Prior exposure within a manufacturing environment subject to FDA requirements.

Experience using ERP system such as SAP

Organizational Relationship/Scope:

Officially supervised by the Area Manufacturing Supervisor and informally managed by the Lead Operations Specialist within the designated functional area.

Working Conditions:

The current work schedule is four 10-hour days per week, but subject to change.  Work is mostly performed indoors.  Occasional periods of work outdoors required.

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