Careers

Position Summary:

The Pre-Production Lead is responsible for label design, printing and secondary packaging design activities across three (3) global facilities – Canada, Ireland, USA. This is a key role that requires the candidate to have proven clinical trial secondary packaging design experience and the ability to fulfill RxSource’s vision, mission and values.

Responsibilities:

Strategy

• Design and print clinical trial labels using specialized software.
• Ensure label compliance with global regulatory standards i.e., Annex XIII and clinical trial specific requirements.
• Design labels and cartons to meet the requirements for the clinical trial i.e., booklet labels.
• Collaborate with the purchasing team to manage label vendors ensuring KPIs/metrics are met.
• Manage the performance and maintenance of the label printers
• Coordinate printing and packaging activities with the Production Leads in Canada and Ireland.
• Create dummy kits for client approval, demonstrating the packaging design for products associated with the clinical trial.
• Collaborate with the Project Management team to ensure client timelines are met for label design.
• Coordinate labeling activities for multiple concurrent projects.
• Assist with secondary packaging where required.
• Further develop procedures around label design, label printing, dummy kit design and other associated pre-production activities.

Collaboration and Reporting

• Communicate frequently with all the departments to ensure information flows seamlessly (QA, Project Management, Account Management, Procurement, Business Development etc.).

General

• Travel when required.
• Other responsibilities as required for the successful fulfillment of this role.

Qualifications:

• Diploma or degree from an accredited University or College in Business Management or related field
• 2+ years of experience in a label design and printing role
• Experience designing labels and secondary packaging for clinical trials.
• Experience with regulatory compliance in both EU, Canada and USA
• Experience using Prisym 360 would be an advantage
• Computer literacy, proficient in MS Office suites and CRM systems
• Excellent communication and presentation skills
• Willingness to work within different Global time zones

Position Summary

We currently have an opening for a Senior QA Specialist at our New Jersey facility. If you are a personable and proactive Quality professional with experience in clinical trial packaging and quality assurance, we would like to hear from you.

What you will do

• Proactively identifies and implements best-in-class quality assurance practices
• Provides quality assurance support for process improvement initiatives
• Acts as an effective leader or team member in making quality decisions
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues
• Review and release clinical trial packaging batch records
• Investigate quality-related incidents and ensure appropriate documentation and resolution
• Review and approve Quality Management System reports (i.e. Deviation, CAPA, Change Control, etc.) 
• Serve as the on-site Quality point of contact and provide day-to-day support to operational teams
• Qualify GMP Equipment, Facilities and computerized systems
• Plan and conduct training on GMP, SOPs, etc.
• Provide support for customer audits and regulatory inspections
• Qualify suppliers and customers 
• Act as the QA point of contact for facility alarms, including temperature excursions or alerts
• Perform quality inspections as needed 

Your qualifications, skills and experience include:

• 5 or more years in a QA role supporting clinical trial packaging
  Batch Record review and release
• Approval of Quality Management System documentation (Deviation, CAPA, Change Control, etc.)
• Internal and/or external quality audits
• A degree or diploma from a recognized college or university
• In depth knowledge of Good Manufacturing Practices
• Strong written and verbal communication skills
• Ability to prioritize
• Team player who works well with others
• A commitment to providing excellent internal and external customer service
• Experience with facility/equipment qualification and/or computerised system validation is highly preferred