Packaging Operator

In this unique position, you will be responsible for the final packaging of clinical pharmaceutical products following cGMP, PQS and Safety standards while maintaining a teamwork attitude to effectively manage production needs and meet the production schedule. The Clinical Packaging Operator role will be expected to bring full knowledge of the job, a general knowledge of related functions and bring technical expertise in one or more GMP system.

Basic Expectations:
Attend cGMP s, safety and on-the-job-training, as required. Maintain required training and qualifications. Maintain a safe and clean work environment. Support quality, safety and efficiency improvements. Adopt and maintain a teamwork attitude to effectively and efficiently manage production needs within the department. May act as a Super User/Subject Matter Expert in Labeling and Packaging related activities.

• Complete appropriate process related documentation (including but not limited to the following: FNs, batch records, room/equipment use logs, etc) per cGMP.
• Perform printing, labeling and final packaging execution activities as assigned per appropriate procedures using appropriate automated systems in place with a focus on quality and efficiency.
• Perform receiving and delivery of products and materials as assigned per appropriate procedures using appropriate automated systems in place with a focus on quality and efficiency.
• Ensure batch records, forms and applicable documents are reviewed in a timely manner.
• Safely setup, operate, troubleshoot equipment and GMP systems, as appropriate.
• Effectively manage all process related issues with applicable groups and initiate discrepancy, when necessary.
• Perform routine and semi-routine assignments that are complex, e.G.:
  Pick up and deliver samples as assigned.
• Perform visual and dimensional inspection of labeling and packaging components such as labels, inserts, and folding cartons, and container closure.
• Perform documentation review of COA released only components.
• Support training initiatives for the department.
• Work closely with PTD Training.
• Support department related projects that may include investigating, analyzing, formulating possible solutions, documenting processes and communicating results.
• Support Change Management activities, as appropriate.
• Complete assigned department project work.
• Other duties may be assigned.

Education and Experience:

a minimum of High School and 3-6 years related Production experience and/or BS/BA degree and 1 years Technical related experience. Have full knowledge of the job and a general knowledge of related functions. Uses ability as a skilled specialist in accordance with company policies and procedures to complete complex assignments within defined parameters. Work independently within defined parameters General instruction or direction required on routine work.

Detailed instruction is given on new lines of work or special assignments. Works on assignments that are moderately difficult, requiring resolution of issues within defined parameters and occasional, limited deviation from standard practices. Makes decisions within established policies and procedures. May make recommendations to management on operating policies and procedures. Contacts are typically with peer positions in other or areas of the organization.

Contacts involve obtaining or providing information or data on matters of moderate importance to the function of the department or which may be sensitive nature.

Environment requires gowning, gloves, steel toe boots and safety glasses (as required). Ability to work in controlled…