Position Summary

The Manufacturing Specialist is a staff member who performs the duties of an assigned job and is also responsible for transmitting work assignments to others in a department; giving them guidance, direction and instruction in work procedures; checking work operations or set-ups and troubleshooting. This person will be required to use their knowledge and experience and be able to communicate effectively.

Responsibilities

• Under minimal supervision, performs component preparation, bulk compounding, filling, vialing, labeling, assembly, and packaging activities for the Manufacturing department, in compliance with current Good Manufacturing Practices (cGMP’s) and according to approved Standard Operating Procedures
• Perform daily checks of departmental activities to ensure all work is compliant with company procedures and current Good Manufacturing Practices (cGMP’s).
• Excellent communication skills enabling them to work with staff members, other departmental staff members and heads and management in a dynamic environment, while maintaining a professional attitude.
• Maintains all departmental equipment in good working order by implementing and performing maintenance utilizing Standard Operating Procedures and Work Instructions.
• Manage department’s daily scheduling to ensure completions of tasks.
• Contributes positive ideas for the improvement of product, processes and procedures
• Perform at a high level of proficiency on all or most departmental functions.
• Identify and properly resolve process problems as they occur. Refer difficult situations to supervision.
• Perform additional activities, under proper direction, when assigned.
• Responsible for alerting management or maintenance personnel of potential or impending equipment repairs/failures in order to avoid critical downtime.
• Ensures all documentation is complete and accurate.
• Completes all job assignments in a timely manner.
• May assist in updating, maintaining and creating new department procedures, work instructions and device history records.
• Performs other duties assigned by the supervisor that are directly related to support of the business operations
• Share knowledge and instruct on techniques whenever appropriate.
• Be alert to priorities and consult regularly with supervisor to establish priorities.
• Monitor quality and quantity of work and observe work habits.
• Recognize individual progress.
• Be fair and consistent with all staff members.

Required Skills

• Bachelors degree in a biological or equivalent field
• 3+ years experience
• Ability to execute all job duties and responsibilities
• Ability to accomplish tasks with a minimum of supervision
• Functional understanding of cGMP principles and practices
• Strong track record of consistent performance
• Ability to read, comprehend and follow SOP and Work Instructions
• Ability to communicate effectively