Careers

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

Strategy and Management

• Focusing on developing new clients and sales opportunities globally.
• Identify and follow up on new sales opportunities, utilizing existing network of contacts, referrals from inside sales and cold call introductions.
• Stay up-to-date and knowledgeable to comply with all of RxSource’s service offerings and competitive Industry environment.
• Drive business for RxSource’s core service offerings – sourcing, packaging & labelling and depot services.
• Responsible for the growth of gross profit through a healthy pipeline of opportunities.
• Manage and oversee client relationships, ensuring accuracy, profitability and customer satisfaction.
• Work closely with other Business Development team members to identify opportunities for global projects.
• Present detailed proposals to the client, either individually or with the support from operations colleagues.
• Review contracts and collaborate with the internal Legal, Compliance, and Finance team to ensure formal review, approval and signing of contracts.
• Ensure client projects are valuable to the RxSource business (negotiation of pricing, terms and conditions etc.)
• Identify areas of new ideas/opportunities, process improvement and implementing processes
• Other responsibilities as assigned for the successful fulfillment of this role

Collaboration and Reporting

• Collaborate with Head of Business Development, Project Management, QA, Procurement and Logistics teams when establishing new client accounts.
• Communicate frequently with all the departments to ensure information flows seamlessly (QA, Logistics, Customer Service, Purchasing, Operations, HR and Regional Teams etc.).
• Provide regular reports as required on progress, opportunities, financials, etc. to head office.

Experience and Education Requirements:

• Bachelor’s degree
• 5+ years of Business Development or Account Management experience within the Pharmaceutical industry
• Experience presenting clinical trial supply service offerings

Why Join RxSource:

• Be part of a purpose-driven company that puts patients and people at the heart of everything.
• Lead a mission-critical function during an exciting period of global growth and transformation.
• Join a collaborative, entrepreneurial culture where your ideas and leadership will shape the future.