Clinical Packaging Operator Technician

HOURLY UNION POSITION — This position is represented by the United Steelworkers (USW) Local #4-438

Permanent Position – Clinical Packaging Technician – 25

Shift: 7:00 am - 3:30 pm

Site: New Brunswick         

Bldg: 107

Rate: $42.04

Non-Excluded

Classification Description

The goal of Product Development within Global Product Supply (GPS) is to develop new drug candidates and the processes to manufacture them into commercial realities. This is achieved by designing and conducting a variety of experimental studies using the latest scientific methods and state of the art equipment and instrumentation. The development process is very dynamic, with performance in both laboratory and process scale-up facilities. Scientific rigor, timeliness, and compliance with all GMP and federal/state/local regulations are a necessity.

In order for the development process to be successful, there must be excellent collaboration between the professional and union staffs. Often, the professional staff will need to take a hands-on approach during the course of an experiment as necessary, based on sound scientific judgment. Involvement of the union staff in the various experimental studies and other processes is determined by the professional staff on a case-by-case basis, because of the non-routine, dynamic nature of the development process.

Daily assignments will be based on demonstrated technical competence of the individual operator and the demands of the process. Priorities will be set based on the needs of the business. Both written procedures and verbal instructions by a supervisor will be executed with strict attention to safety and quality. Accurate and timely execution and documentation of activities and results are a requirement. Strict adherence to GMP, federal, state, and local regulations is required. Collaborative work with other employees is a necessity to achieve departmental and company goals.

Education Requirements

• Two year Associates degree or equivalent. In lieu of a two-year degree, a minimum four years applicable experience within a CGMP regulated industry will meet requirements.
• Proficiency in the use of computer programs/systems is essential. Technicians must maintain their skills and knowledge current with the advances in the field of Pharmaceutical Development. Incumbents may attend internal or external training courses as approved by management.
• Training will be implemented to ensure operators receive relevant training to facilitate the performance of their job responsibilities. Assessment after training specific to a task will be an ongoing requirement. Interactive training modules may be used for training on specific competencies. If testing is not passed, the interactive learning and testing will be repeated.

Working Conditions

• Works under direction of supervision and follows established practices in performing all duties. Makes a decision when general instructions, established methods, or clearly defined precedents indicate action to be taken, but refers unusual problems to supervisors. Department requires zero error rate and employs multiple redundant checks to achieve this objective. Undetected errors may have serious implications and may result in costly withdrawals or the termination of a clinical study.
• Work is routine and repetitive, requiring application of judgement within limitations established by CGMP regulations, defined SOP's, and processing instructions. Required to document operations in exacting fashion without error. Requires interface with computer-based documents and instructions such as but not limited to SAP.
• As required, handling of potent compounds requires annual gown/respirator training and medical respirator clearance.
• Work environment may be subject to odors and fumes, dust, powders, oil, grease, and noise. Significant physical effort is required. It is essential that incumbents be involved in stooping, lifting, and bending, sometimes in awkward positions.
• Employees must have annual eye exams and be able to qualify as required to perform Visual Inspection of Parenteral Products (i.e., liquid filled and lyophilized vials and syringes). This requires individuals to pass biennial re-qualification.

Job Function — Clinical Supply Operations Packaging and Labeling

In accordance with specific instructions, performs a variety of functions involved in the preparation of packaged clinical supplies, including:

• Filling, labeling, capping, and sealing a variety of vials, bottles, unit dose blister cards, pouches, or other containers prepared for use in clinical studies, clinical stability, or product registration use
• Using equipment, assembles combination products/devices to be used in clinical studies
• Performs in-process sampling during operations and records data obtained
• Weighs and/or hand counts dosage forms and records data obtained within the appropriate documents
• Inspects labels (manually and with use of electromechanical equipment) against label proofs and other supporting documentation for confirmation of, but not limited to, the following characteristics: count, variable text, character verification, and cosmetic defects. Label inspection must be accurate with no room for deviations
• Completes all documentation supporting the preparation of clinical supplies and label inspection through interface with software-based processing instructions and data collection systems, and use of equipment PLC's
• Performs product inspection of supplies using SAP interface or other electromechanical equipment for verifying contents
• Through interface with SAP, performs calculations of label and product accountabilities
• Alerts supervision of any irregularities in procedures or equipment operations
• Makes up carriers and shippers and prepares finished supplies for shipment
• Assists in the (re)qualification and (re)validation of processing equipment
• As necessary, cleans and wipes ceilings, floors, and walls in the prescribed manner
• Performs, as required, Visual Inspection of Parenteral Products (i.e., liquid filled and lyophilized vials and syringes). This requires the operation of the semi-automated vial inspection machine or the use of manual inspection booths. Individuals must pass inspection qualification and biennial re-qualification, including annual eye exams
• Completes all documentation supporting the inspection of parenteral supplies through interface with software-based processing instructions
• Performs other duties of equal or lesser nature as required, such as but not limited to: movement of material between work locations, organizing CSO warehouse, and general housekeeping
• Follows Current Good Manufacturing Practices, departmental SOP's, good housekeeping principles, and all safety rules
• Interfaces with computer-based applications for self-paced online training of both company and departmental policies and procedures
• Follows Current Good Manufacturing Practices, all safety rules and good housekeeping principles.