Packaging Operator II

Position Title: Packaging Operator II

Work Location: South San Francisco, CA, 94080

Assignment Duration: 6 months

Work Arrangement: Onsite

Position 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 system.

Key Responsibilities:

* 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.

Qualification & Experience:

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.

Work Environment/Physical Demands/Safety Considerations:

* 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 working schedule beyond 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.