Clinical Packaging Operator Technician

Bristol Myers Squibb•New Brunswick, NJ

11d•$41 - $41•Onsite

About The Position

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. Require interface with computer-based documents and instructions such as but not limited to SAP. As required, handling of potent compounds which 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 required. It is essential that incumbents be involved in stooping, lifting, 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.

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.

Responsibilities

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.
Inspect 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.
Assist in the (re)qualification and (re)validation of processing equipment.
As necessary, cleans and wipes ceilings, floors and walls in the prescribed manner.
Perform 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 in 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.

Benefits

Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.

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