Job Details

Inspection/Packaging Operator II
South San Francisco, CA
06 Months

Summary

In this unique position, you will be responsible for leading the in-house printing and final labeling and 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 III role will be expected to work with management to establish priorities and timelines and exercise independent judgment, seeking guidance from leadership, as needed, when determining the course of action.

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.
• Lead efforts to quality, safety and efficiency improvements.
• Act as Subject Matter Expert in Packaging related activities.

Job Responsibilities (include but not limited to the following)

• Perform packaging, labeling, inspection, online/offline tasks, and other responsibilities, when necessary.
• Complete appropriate process related documentation (including but not limited to the following: FNs, batch records, room/equipment use logs, etc) per cGMP.
• Act as a single point of contact on shop floor for Packaging and In House Labeling issue communication and provide resolution on complex issues.
• Ensure batch records, forms and applicable documents are reviewed in a timely manner.
• Manage all process related issues with applicable groups and initiate discrepancy, when necessary.
• Effectively communicate with peers, management and Quality to ensure that all process related issues are properly resolved.
• Support training initiatives for the department. Work closely with PTD Training.
• Lead/Support department related projects that may include investigating, analyzing, formulating possible solutions, documenting processes and communicating results.
• Lead/Support Change Management activities, as appropriate.
• Prepare and submit departmental metrics to leadership, as appropriate.
• Attend scheduling meetings and provide input with safety, quality mindset.
• Coordinate and schedule staff meetings, when appropriate.

Job Requirements and Attributes

Education and Experience: a minimum of High School and years related production experience and/or Bachelor's degree technical related experience.

• Have extensive knowledge in the job and a solid knowledge in related functions.
• Uses ability as a technical/functional expert to contribute in development of concepts and techniques and to complete complex assignments in creative and effective ways.
• May serve as a team leader.
• Work under general supervision.
• Require minimal instruction or direction on routine work.
• Detailed instruction is given on new lines of work or special assignments.
• Works on complex assignments and solve problems within situations ordinarily encountered with occasional, limited deviation from standard work.
• Typically makes decisions within established policies and procedures.
• Makes recommendations to management on operating policies and procedures.
• Frequent contacts with peer positions across the organization.
• Interactions at the Supervisor and Management levels on matters pertaining to immediate area of work.
• Interactions require tact and effective communication skills as they often involve complex and sensitive information.

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.

Onsite position
Interview: 1. phone 2. in-person

#TB_OTH
#ZRHC