Directs and schedules daily group activities in the Kit Packaging group. Serves as a technical resource and is knowledgeable in all areas of the Kit Packaging operations including visual inspection, labeling, and secondary packaging. Plans and assigns activities for self and other team members in order to maintain daily, weekly and off-hours operations and to meet specific manufacturing objectives.
Acts as a technical resource on the team. Utilizes own technical knowledge and/or coordinates resources to resolve manufacturing process problems.
Leverages own experience and team resources to make decisions concerning complex issues.
Meets all requirements for operator level activities within Kit Packaging including operations set up, troubleshooting of headspace analyzer equipment, and label print operations.
Works with supervision 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. Drives team involvement on committees. 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.
Takes the active role in setting team objectives. Recognizes the value of engaging in constructive conflict. Values and seeks out diverse opinions and ideas. Facilitates the resolution of destructive conflict within the team. Willingly transfers own knowledge to other team members. Works with Kit Packaging team members to develop their levels of competency.
Author and edit SOP???s incorporating all applicable cGMP elements. Works with supervision to ensure that all training records are complete. Trains team members for future development opportunities.
Working hours: 7:00 AM - 3:30 PM
Minimum three years' experience in a pharmaceutical or other highly regulated manufacturing environment working in a team environment while performing visual inspection, labeling, kitting or operating automated processing equipment
Knowledge of cGMP requirements strongly preferred
Previous experience/familiarity using inventory management systems
Demonstrated leadership abilities and strong communications skills, both written and oral, with ability to communicate effectively to a variety of individuals in a manner that promotes productive relationships.
Bachelors of Science degree in science, business, or equivalent experience.
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