What are the responsibilities and job description for the Data Coordinator position at Aphena Pharma Solutions-tennessee Llc?
Join the Aphena Pharma Phamily!
Aphena Pharma Solutions is seeking a Data Coordinator to join our team in Tennessee. This role is vital to supporting the Quality groups mission by managing data-related activities and ensuring regulatory compliance. If you're a data-driven individual who enjoys organizing and reporting data, this is the perfect opportunity to contribute to our mission and drive improvements across our processes.
Job Summary: As a Data Coordinator, you will manage all data-related activities according to standard operating procedures. Your focus will be on analyzing and reporting data to improve processes, identify trends, and support regulatory compliance. You will work closely with our manufacturing and Quality teams, ensuring all data meets the highest standards.
Key Responsibilities:
- Ensure compliance with cGMP standards, especially 21 CFR 210 & 211.
- Gather, organize, and report data related to Quality and Operations.
- Handle reporting for regulatory agencies (FDA CDER, DEA, CFSAN, etc.).
- Manage data preparation and action items for Quality Management Review and Data Analysis meetings.
- Perform DEA ARCOS and YERS reporting activities, focusing on process efficiencies.
- Assist in the Biennial Inventory verification process, ensuring data accuracy.
- Support the Training Department with data management and presentation.
- Collaborate to improve routine spreadsheet and data activities across departments.
Qualifications:
- Minimum high school diploma and a four-year degree (or equivalent experience).
- Extensive knowledge of data management and statistical analysis.
- Proficiency in Microsoft Office and other relevant software tools.
- Strong written and oral communication skills.
- Detail-oriented with a passion for process improvement and efficiency.
Why Aphena Pharma Solutions?
- Competitive salary and benefits package.
- Opportunity for professional growth and development.
- Be part of a team that values quality, safety, and continuous improvement.
If you're ready to make an impact and take your career to the next level with a dynamic team, apply today!
Aphena Pharma Solutions is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
