Qa Ra Compliance Specialist - 1802343

🌐 Job Title: QA/RA Compliance Specialist 🌐

📍 Location: St. Petersburg, FL, USA

📚 100% ONSITE WORK- DURATION

🤝 6 MONTHS EXTENSION POSSIBLE BUT NOT 100% - SHIFT - MON - FRI 8AM - 5PM OR 9AM - 6PM

III. Specific Activities and Responsibilities:

🔄 Coordinate, track, and trend Change Controls for the facility.
📝 Provide initial regulatory impact assessment on all change controls.
🤝 Liaise with customers to ensure satisfaction of their requirements.
📑 Preparation and submission of A/NDA submissions, drug master files, plant/site master files, licenses, permits, and registrations.
📂 Prepare and submit all federal, state, and local permits in a timely manner.
🌐 Interact with customers to gather information supporting registration activities.
📘 Assist in the preparation and approval of SOPs.
🧾 Assist in regulatory/health authority audits and collect requested information.
🤝 Collaborate with Subject Matter Experts, management, and supervisory personnel to resolve quality-related problems.
📋 Prepare APRs in accordance with site procedures and timelines.
📝 Prepare complaint investigation reports and work closely with others on site events.
📄 May author other types of quality system documents as directed.
🛠️ Other duties as required in support of Catalent Pharma Solutions high performance.

IV. Knowledge Requirements:

🎓 Bachelor’s Degree in Science or related field required.
🔍 Minimum of 3 years related experience in the pharmaceutical manufacturing industry.
🔄 Strong background working with Change Controls and management processes.
📈 Prior experience with investigation writing, including root cause analysis and report writing.
🏆 PathWise Certification preferred.
📚 Working knowledge of US application regulations, cGMPs, and FDA Guidance.
📆 Excellent organizational skills and extreme attention to detail.
🗣️ Excellent oral and written communication skills.
🚀 Motivated, self-starter, team player.
🌟 Reflect a strong quality work ethic.

Are you ready to make a commitment to daily onsite work in St. Petersburg, FL?

If you're ready to contribute to high-performance standards, drive compliance, and be part of a dynamic team, apply now! 🔍

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