Packaging Operator

Title: Packaging Operator
Duration: 12 months
Location: Groton, CT
Job Description:
To package clinical trial supplies, utilizing packaging batch records and diagrams to primary pack solid dosage forms, and label them, prior to assembly into patient/treatment packs.
Set-up and operate packaging equipment to bottle-fill supplies and work to current Good Manufacturing Practice (cGMP) guidelines.
Technical responsibilities – Packaging Processes:
• Set up and operate equipment to bottle-fill or hand-fill solid dosage forms into primary containers.
• Label finished dosage forms, e.g. pre-packs, vials, devices, etc and assemble into patient / treatment packs, whilst maintaining the blind of the study.
• Engage with the PC to develop practical and efficient packaging designs of Clinical Supplies to support studies.
• Engage with PC to ensure the Packaging Diagram contains sufficient detail regarding the packaging to be completed.
• Using modules within the currently approved inventory system, fulfil Packaging Requests following the completion of primary and/or secondary packaging operations.
• Accurately complete packaging documentation and associated forms to support packaging operations.
• Update the local planning schedule with the progress of work and immediately raise issues with the PC / Team lead that may result in failure to meet timelines.
• Work with Inventory Management and Quality Assurance to co-ordinate and drive the progress of the packaging operation to ensure timelines are met.
• Carry out a completion review of packaging documentation before submission to a PC.
• Support the packaging of stability packaging requests.
• Inspect printed labels that have been produced in the CAIS

Other attributes
• Deliver excellent customer service and consistently strive to meet commitments to customers and optimize operational effectiveness.
• Demonstrate a ‘patient focused’ and ‘quality culture’ approach to packaging and labelling operations.
• Keep current with all Good Manufacturing Practice training.
Experience (required)
• Working to timelines
• Customer focussed work experience
Experience (preferred)
• 3-5 years of experience
• Relevant industry experience: working to Good Manufacturing Practice (GMP) standards and compliance with Standard Operating Procedures (SOP).
• Experience of primary and secondary packaging in a GMP environment.
• Experience using Inventory based software.
• Experience working in a supply chain.
• Work placement which has incorporated handling/ dispensing dosage forms, e.g., retail or hospital pharmacy. Will consider hospitality/retail industry background.
Technical Ability (required)
• Strong IT skills and competent in the use of email and MS Office applications.
• Attention to detail; ability to work with accuracy and demonstrate ‘Right First Time’ documentation completion.
• Able to work with autonomy and self-organization.
The right candidate is/will:
• Self-motivated to complete work on schedule with 100% ‘Right First Time’ accuracy;
• Deliver quality under challenging timelines.
• Keen and willing to learn new skills and share knowledge with others.
• Ability to take ownership of various tasks and work autonomously.
• Excellent interpersonal and communication skills.
• Enthusiastic, approachable, energetic and effective in a team environment.
• Willing to learn from others and share knowledge.
• Adheres to high standards, and consistently focuses on customers and quality.
• Adaptable to changing priorities.
• Punctual and diligent.

All your information will be kept confidential according to EEO guidelines.