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
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Perform all tasks safely and promptly report any safety concerns to area supervision.
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Successfully complete training requirements for executing production activities, including GMPs, safety protocols, policies, and procedures necessary for tasks within the functional area.
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Execute day-to-day production activities such as cylinder prep, bake-out, blow-down, filling, and packaging of finished drug products.
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Follow the daily operations schedule, communicating with Functional Leads and Quality Assurance about schedule changes that may impact production requirements and QA coverage.
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Manage process staging, segregation, documentation, and safety requirements.
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Execute the weekly schedule to meet production demands.
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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.
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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.
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Execute equipment cleaning and preventive maintenance procedures within the Manufacturing area.
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Retrieve SOPs and forms from the Master Control quality system.
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Assist throughout the production department as needed, ensuring proper housekeeping of all facilities according to established procedures.
Minimum Requirements
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High school diploma or equivalent
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Technical background in Chemistry or Compressed Gases
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Knowledge of CGMPs
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Strong leadership skills with a results-oriented approach as well as the ability to train, motivate, and otherwise develop resources.
Preferences:
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2 years’ experience working in a manufacturing environment.
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Process Technology (PTEC) degree
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Prior exposure within a manufacturing environment subject to FDA requirements.
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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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What We Do
At Mallinckrodt, we use strategic vision and employee-driven momentum to pursue a powerful mission: Listening for needs and delivering solutions.
As a leader in specialty pharmaceuticals, we develop, manufacture, market and distribute innovative treatments for underserved patient populations within neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes and gastrointestinal products. . Our expertise also extends into acute and critical care hospital products, as well as our broad portfolio of generic prescription medicines and active pharmaceutical ingredients.
Together, we’re helping shape the future of the specialty pharmaceuticals industry by leveraging the values our founders instilled over 155 years ago – quality, integrity and service.
To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Equal Opportunity Employer
Mallinckrodt Pharmaceuticals provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or genetics. In addition to federal law requirements, Mallinckrodt Pharmaceuticals complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
