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Team Member 2 - 2nd Shift - Billerica Massachusetts
Company: Lantheus
Location: Billerica, Massachusetts
Posted On: 04/17/2024
DescriptionPurpose
Responsible for the labeling and packaging of pharmaceuticals for worldwide distribution. This packaging operation is a largely a manual operation, with some labeling operations which are performed with automated labeling machines. Kit Packaging operations personnel also perform the visual inspection of filled vials. Must follow departmental SOP's and the ability to follow manufacturing batch records. Understands and complies with GMP work environment standards and support a strong safety culture. Ability to work in a fast-paced work environment while maintaining attention to detail. Ability to work in a team-oriented work environment. Willing to work overtime when required.
Essential Functions
- Effectively organizes resources and self manages to execute plans and schedules. Interacts with team members to coordinate functions and maximize efficiency. Pursues multiple tasks simultaneously.
- Responsible for meeting daily production objectives, for prompt response to challenges impacting goal achievement and for reporting end-of-shift status to management daily.
- Resolves non-routine manufacturing problems independently or by utilizing the appropriate technical team.
- Utilizes knowledge, experience and team resources to make decisions regarding non-routine issues. Trains team members to be independently capable of one, or more, operation within the department.
- Trains team members in procedures and reports on various topics. Reads operation manuals and writes SOP's. Prepares deviation reports, incident investigations and aberrant cycle reports. Communicates effectively in situations involving pressure. Represents the team on various committees.
- Initiates discussions by actively soliciting input and feedback from others on issues that affect the efficient operations of the team. Influences other team members to make decisions which support mutual objectives. Requests feedback from other members on own performance. Demonstrates ability to assume a leadership role when appropriate.
- Demonstrates the ability to apply knowledge of cGMP Regulations (parts 210 and 211) to routine and non-routine situations.
- Uses process control and validation knowledge in job practices. Understands and applies statistical process control. Participates in process validation and re-validation efforts and understands the relationship of validation of final product quality.
- Demonstrates ability to derive expressions and procedures from basic math and science concepts and apply them using documented and approved methods. Makes practical use of SPC to analyze process parameters and recommends process change improvements. Performs operations using written procedures such as control limits, standard deviations and process means. Demonstrates ability to analyze processes using basic principles of mathematics.
- Demonstrates knowledge and fundamental understanding of operating and troubleshooting computer-controlled production equipment. Performs numerous tasks ranging from routine to complex non-routine functions. Demonstrates thorough knowledge of applicable software. Trouble shots standard computer related problems.
- Performs ERP transactions and troubleshoots inventory discrepancies. Trains operators on initial ERP access modules.
Essential Functions
- Recommends process/quality improvements. Collaborates with team members to identify more cost effective, efficient and high-quality processes. Offers innovative solutions to manufacturing problems. Takes an active role in implementing approved changes. Has awareness of budgetary constraints and performance.
- Recognizes and suggests personal objectives which complement and support team and organizational goals. Influences others in meeting their team objectives through support and cooperation.
- 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 & environmental hazards.
- Actively demonstrates the Lantheus values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
Typical Minimum Skills and Experience and Education
- Associates Degree with 1 - 3 years experience in manufacturing operations (Pharmaceutical environment preferred). Possess a working knowledge of ERP software application systems (Pharmaceutical preferred).
- A combination of education, training and experience may be considered in lieu of above stated requirements.
Other Requirements
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