Packaging Operator IIWe 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, 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
in Change Management activities as
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, orBachelor'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
to work effectively as part of a team and communicate with cross-functional groups.
Ability to learn and maintain required training and
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.
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.
