4760 Clinical Packaging Operator

Summary:

• 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 systems.

Basic Expectations:

• Attending 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 manage production needs effectively and efficiently within the department.
• May act as a Super User/Subject Matter Expert in Labeling and Packaging related activities.

Job Responsibilities (include but not limited to the following):

• 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.
• Pick up and deliver samples as assigned.
• Perform visual and dimensional inspection of labeling and packaging components such as labels,
• inserts, 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.

Level Criteria:

• Candidate must be able to meet the N3 job leveling criteria description of knowledge and scope, complexity, decision making, supervision, interaction and experience required to meet the job expectations. 
• The following behaviors measure the progression of the job expectation.
• 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.
• May serve as a team leader.
• Work under limited supervision.
• General instruction or direction required on routine work.
• Detailed instructions are 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.

Work Environment/Physical Demands/Safety Considerations:

• The environment requires gowning, gloves, steel toe boots and safety glasses (as required).
• Ability to work in controlled environments, as required.
• Candidates must be flexible to work overtime and adjust their working schedule beyond the normal work week.
• Ability to perform computer work and RF equipment, as required.
• Standing and sitting is required for extended periods of time.
• Must be able to perform repetitive packaging work for extended periods of time.
• Must be able to perform visual label inspection for extended periods of time.
• Must be able to lift 40lbs, push/pull 75lbs of force.

Job Requirements and Attributes:

• Education and Experience: a minimum of High School and 5-6 years related Production experience and/or AA degree and 3 years Technical related experience.

Compensation Range: $25.00 to $31.00/hr

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