Job Description

At RxSource, our passion drives us to be the bridge between pharma and patient. With offices in Canada, USA and Ireland we provide bespoke global clinical trial supply management services to pharma, biotech and CROs. Whether it’s employing demand-led packaging, a local sourcing model or another flexible option, we guarantee on-time delivery without compromising quality. Our clients are our partners; success for them = success for us.

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 computerized system validation is highly preferred

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