Packaging Operator

We are reputed staffing agency, founded in 1999, Mindlance is a certified diversity business (MBE) and has been ranked one of the fastest growing U.S staffing firms by SIA for eight consecutive years. 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.