Packaging Coordinator

Packaging Coordinator

Employee Responsibilities:

• Interfacing globally with Supply Chain Leads (SCL), and all other groups within or outside the supply chain required to bring a job to completion within Clinical Supply Packaging (CSP) 
• Acting as a Project Manager to ensure that these activities are performed within agreed to timelines and that the final packaged output meets initial request parameters
• Work with the SCL to review and interpret the clinical protocol to develop practical and efficient packaging designs for Clinical Supplies.  Partner with the SCL to generate and approve the Clinical Packaging Request
• Partner with the SCL and other work-streams to generate and approve the Clinical Label Request
• Work with the SCL to ensure the Packaging Diagram contains sufficient detail regarding the packaging to be completed
• 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, etc, and assemble into patient/treatment packs, while maintaining the blind of the study
• Accurately complete packaging documentation and internal paperwork to support packaging operations
• Effectively manage multiple projects and interact with various groups to ensure operational timelines are achieved
• Assess packaging requirements and procure specific materials to meet study needs.
• Using modules within the Current Approved Inventory Management system to generate packaging requests to enable the fulfillment of packaging operations, such that packaged materials can be shipped or transferred for distribution to clinical sites or depot holding areas
• Facilitate the use of Clinical Supply Distribution System for importing packaged inventory for distribution purposes
• Fully utilize scheduling tools to proactively identify job assignments; work with the SCL to determine submission of the Clinical Request
• Update scheduling tools with the progress of work and immediately raise issues with the SCL and local schedulers that may result in failure to meet timelines. Work with Internal Operations Global Lead, local scheduler and enabling work-streams to remediate/prioritize
• Work with Inventory Management and Quality Assurance to co-ordinate and drive the progress of the packaging operation to ensure timelines are met
• Manage multiple projects working with colleague Packaging Coordinators and local planner to resolve packaging operation schedule conflicts and issues
• Utilize Project Management skills to plan, schedule and assess risks to complete the job
• Prepare packaging batch record documentation and generate internal study paper work to support internal packaging operations
• Review internal packaging and labeling documents making recommendations where appropriate to ensure compliance with Clinical Supply Packaging procedures, study requirements and Good Manufacturing Practice
• 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, etc and assemble into patient / treatment packs, whilst maintaining the blind of the study
• Accurately complete packaging documentation and internal paper work to support packaging operations
• Generate final release documentation and where appropriate carry out a final review of packaging documentation before submission to Quality Assurance
• Support internal GMP audits/self-inspections
• Work with EHS on safety related issues and support safety inspections, and work with Global Operations and Inventory Management to address any facility issues
• Keep current with all Good Manufacturing Practice training

The Ideal Candidate would possess:

• Relevant industry experience:  working to Good Manufacturing Practice (GMP) standards and compliance with Standard Operating Procedures (SOP)
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivated, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Minimum Qualifications:

• Bachelor’s degree in chemistry or other science related degree concentration, or equivalent directly-related experience
• Authorization to work in the United States indefinitely without restriction or sponsorship

What we offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed.  Candidates currently living within a commutable distance of Groton, Connecticut are encouraged to apply.

Eurofins Lancaster Laboratories Professional Scientific Services^® (PSS) is a global, award-winning insourcing solution that places our people at our clients’ site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.EurofinsUS.com.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.