Specialist 1st shift

Description

Purpose

The objective of this position is to become the technical authority for the manufacturing and packaging operations required to produce pharmaceutical products in a timely manner that is compliant with cGMP, OSHA, and other regulatory requirements.

The Production Specialist will be the subject matter expert (SME) and principal trainer for both cold manufacturing and kit packaging operations.

Such operations include, but are not limited to, operation of automated manufacturing equipment with good aseptic technique, operation of labeling equipment, and review of paper-based production records and forms in accordance with GDP.

As the SME, the Process specialist will oversee troubleshooting and training for the aforementioned operations including planning, execution, and documentation where required.

Key Responsibilities / Essential Functions

Upholds, fosters, and demonstrates the Lantheus core values : Let people be their best; Respect one another and act as one;

Learn, adapt and win; Know someone's health is in our hands; Own the solution and make it happen

• Acts as a technical authority for the department. Utilizes own technical knowledge and / or coordinates resources to resolve manufacturing process problems.
• Participate in production activities.
• Leverages own experience and team resources to make decisions concerning complex issues in conjunction with management.
• Meets all requirements for operator level activities within Definity and Kit Packaging operations including operations set up, operation, and troubleshooting of equipment.
• Responsible for developing and achieving training plans for all 1st shift production operators and ensuring team compliance with the training requirements in conjunction with the Manufacturing Lead / Supervisor.

Accountable to verify knowledge transfer and competency on training materials.

• Works to resolve any process issues that result in a deviation or Quality Investigation Report. Initiates corrective actions and processes improvements that result in measurable metrics to be shared with leadership teams.
• Facilitates clear, concise communication between team members. Presents information to management. Reads and writes technical materials.

Reviews and / or approves the work of other team members, such as deviations reports, incident investigations and Quality incident investigations.

• Author and edit SOP's incorporating all applicable cGMP elements.
• Understands the end-use implications of product properties, labeling and packaging. Drives continuous improvement initiatives.
• Under general direction, supports Quality Systems department in completion and accuracy of any of the following : quality documentation, review for accuracy of product and or process testing, review and release of materials and corresponding documents to drive first pass quality initiatives.
• Demonstrates knowledge of inventory system(s). Applies analytical computer tools and operational knowledge to troubleshoot non-standard production processes.

Understands and communicates the business implications of ERP metrics to the team. Troubleshoots non-routine problems with ERP.

Is considered a resource in inventory management issues and transactions.

• Utilizes knowledge and experience to implement improvements in manufacturing processes that show measurable benefit and provide metrics to management.
• Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment.

Reports and takes initiative to correct safety & environment.

Leads by example by being safe, punctual, respectful, communicative, responsible and quality focused.

Basic Qualifications

• Bachelor's degree in a science related field and 3-5 years of experience in a pharmaceutical / biotech manufacturing environment
• Associate degree in a science related field with 5-7 years of experience in a pharmaceutical / biotech manufacturing or quality environment.
• A combination of education, training and experience may also be considered.
• Working in a clean-room environment and previous experience with cGMP's is a plus.

Other Requirements

• Knowledge of company product portfolio and manufacturing processes
• Exhibits a desire to learn and cross-train within the organization.
• Ability to work in accordance with cGMP guidelines.
• Practical working knowledge of computer systems and platforms
• In-depth knowledge of manufacturing equipment and new technologies
• Hands-on experience with manufacturing processes, including troubleshooting, scale-up, and optimization efforts.
• Ability to effectively train others through the qualified On-the-job training process is required.
• In the case of supervisory absence, the incumbent will function as a backup.
• May include working holidays, weekends, and mandatory overtime, as needed.

Last updated : 2024-02-25