Packaging Operator II

Role: Packaging Operator II
Location: 1 DNA Way, South San Francisco, CA 94080
Contract Duration: 6 Months (Potential for Extension or Full-Time Conversion)
Pay Rate: $22.00-$28.22/hour + Benefits
Benefits: Weekly Pay, Medical, Dental, and Vision Insurance


Shift & Attendance Flexibility

• Current schedule is a 10-hour shift, 6:00 AM-4:30 PM .
• Schedule is generally Monday-Thursday or Tuesday-Friday .
• Candidates need to be comfortable with the early start and maintaining reliable attendance.

Position Summary
We are seeking a Packaging Operator II to support the final packaging of clinical pharmaceutical products in compliance with cGMP, PQS, quality, and safety standards . The successful candidate will work collaboratively with cross-functional teams to meet production schedules while maintaining high standards of quality, efficiency, and documentation.
The Clinical Packaging Operator is expected to have strong knowledge of packaging operations, a general understanding of related functions, and technical expertise in one or more GMP systems.


Key Responsibilities

• Perform final packaging, labeling, and printing activities for clinical pharmaceutical products according to approved procedures.
• Complete process-related documentation, including batch records, forms, equipment/room use logs, and other GMP documentation.
• Operate, set up, and troubleshoot packaging equipment and applicable GMP systems.
• Perform receiving, handling, and delivery of products and materials using established procedures and automated systems.
• Review batch records, forms, and other applicable documentation in a timely and accurate manner.
• Identify and resolve process-related issues in collaboration with appropriate departments and initiate discrepancies when required.
• Perform visual and dimensional inspections of packaging and labeling components, including:
  • Labels
  • Inserts
  • Folding cartons
  • Container closure components
• Perform documentation reviews for COA-released components.
• Pick up and deliver samples as assigned.
• Support department training initiatives and work closely with the PTD Training team.
• May serve as a Super User or Subject Matter Expert (SME) for labeling and packaging-related activities.
• Support quality, safety, efficiency, and continuous improvement initiatives.
• Participate in Change Management activities as appropriate.
• Support department projects, including investigation, analysis, process documentation, solution development, and communication of results.
• Complete assigned project work and other duties as required.

Basic Qualifications

• High School Diploma/GED with 3-6 years of relevant production experience , or
• Bachelor's degree with at least 1 year of technical experience .
• Experience working in a GMP/cGMP-regulated manufacturing or pharmaceutical environment is highly preferred.
• Strong understanding of packaging and production processes.
• Ability to work independently within established procedures and guidelines.
• Ability to troubleshoot and resolve moderately complex operational issues.
• Strong attention to detail, particularly when reviewing labels, packaging components, and GMP documentation.
• Ability to work effectively as part of a team and communicate with cross-functional groups.
• Ability to learn and maintain required training and qualifications.

Work Environment & Physical Requirements

• Work in controlled environments requiring appropriate gowning and PPE, including gloves, steel-toe boots, and safety glasses as required.
• Ability to work in controlled/GMP environments.
• Flexibility to work overtime and adjust schedules based on production requirements.
• Ability to perform computer-based work and operate RF equipment as required.
• Ability to stand and/or sit for extended periods.
• Ability to perform repetitive packaging and visual inspection activities for extended periods.
• Ability to lift up to 40 lbs.
• Ability to push/pull loads requiring more than 75 lbs. of force .
• Must maintain a strong commitment to workplace safety, product quality, and GMP compliance.

Ideal Candidate
The ideal candidate will have hands-on experience in pharmaceutical, biotech, clinical packaging, manufacturing, labeling, or other GMP-regulated production environments . Strong attention to detail, documentation accuracy, equipment operation, and the ability to work effectively in a fast-paced production environment are essential.

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