Operations Specialist
Talascend is currently seeking an Operations Specialist for a contract opportunity with our client in Port Allen, Louisiana.
Overview
The Operations Specialist position is responsible for performing production activities in compliance with applicable government regulations and guidelines as well as with company policies and procedures.
Responsibilities
- Complete training requirements related to the execution of activities within the production function, including GMPs, safety, policies, and procedures.
- Execute day-to-day activities such as cylinder prep, bake-out, blow-down, filling, and packaging of finished drug products.
- Perform daily operations as scheduled; communicate with functional leads and quality assurance regarding schedule changes that may impact production requirements and QA coverage.
- Process staging requirements, segregation, documentation, and safety requirements; execute the weekly schedule to meet production demands.
- Ensure compliance with production batch records and procedures; review batch records for adherence to policies, procedures, and GMP requirements.
- Procure components to support manufacturing operations.
- Conduct inventory reviews of components and parts to prevent production interruptions.
- Review logbooks daily to ensure compliance and completion according to procedure.
- Execute equipment cleaning and preventive maintenance procedures within the manufacturing area.
- Assist in various tasks throughout the production department and maintain proper housekeeping of all facilities.
Qualifications
- High school diploma required; PTEC degree preferred.
- Technical background in chemistry or compressed gases with 2 years of manufacturing experience preferred.
- Prior exposure to FDA-regulated manufacturing environments preferred.
- Knowledge of CGMPs.
- Computer literacy in Excel and Word required.
- Good written and oral communication skills.
- Strong leadership skills with a results-oriented approach, including the ability to train, motivate, and develop resources.
- Experience using ERP systems, such as SAP, preferred.
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We thank all applicants for their interest. However, only those qualified individuals who closely meet the qualifications of the position will be contacted. The details of the position are only a summary, other duties may be assigned as necessary.
Background Check and Drug Screen may be required.
Talascend is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.