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Clinical Packaging Technician
3 months ago
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
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The following positions will require the employees to work with chemical, radiological, or biological agents that may be hazardous to health if mishandled (including Agents which may potentially affect reproduction or the fetus). Employees will be required to follow all safety procedures and use personal protective clothing/Equipment where specified. Inquires for further information should be directed to the hiring manager.
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Permanent Position - Clinical Packaging Technician - 25 - Clinical Supply Operations
Shift: 7 AM - 3:30 PM EST
Site: New Brunswick, NJ
Bldg #107 (excluded)
Rate: $38.47/hour
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
JOB FUNCTION: 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 Parenterai 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 requalification 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. 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. 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.
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If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
