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.
Job Description
Title: Packaging Operator
Duration: 12 months
Location: Groton, CT
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.
Additional Information
All your information will be kept confidential according to EEO guidelines.