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- Groton, Connecticut
- Job Type
- 30 Jul 2022
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Job Title: Packaging Operator
Shift: Other (08:00 AM - 05:00 PM)
Desired Start Date: 7/26/2022
Duration: 12 Months
Location: Groton, CT
Rate Card Category 2: Level III (5-7 years) 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
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.
Working to timelines
Customer focussed work experience
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. Skills: Name Required Experience Attention to Detail Yes Excellent interpersonal and communication skills Yes Punctual and diligent Yes Strong IT skills and competent in the use of email and MS Office Applications Yes Industry experience working to GMP standards and compliance with SOPs No Supply chain experience No Will overtime be needed?: No If Yes, how many hours of overtime (on average) per week?: What is the minimum education experience required?: High School Diplom
Work Environment: Onsite
- Job Reference: 671930199-2
- Date Posted: 30 July 2022
- Recruiter: Integrated Resources, Inc
- Location: Groton, Connecticut
- Salary: On Application
- Sector: Healthcare & Medical
- Job Type: Permanent