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Quality Assurance Senior Associate
Job Description
Our client is seeking a highly motivated and detail-oriented Quality Assurance Senior Associate to join the manufacturing team. This role offers a unique opportunity to collaborate closely with production and quality teams, ensuring compliance with cGMP standards and maintaining product quality throughout the manufacturing process. The ideal candidate will be instrumental in driving quality improvements, supporting audits, and fostering a culture of continuous compliance and excellence within a dynamic production environment. development.
Key Responsibilities:
- Provide ongoing quality oversight to ensure all products are manufactured, tested, stored, and distributed in accordance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and other regulatory requirements.
- Maintain compliance of facilities, equipment, materials, processes, and documentation with all applicable regulations, safety standards, and quality systems.
- Facilitate the review and approval of cGMP documentation, including deviations, investigations, and CAPAs, ensuring timely closure and accuracy.
- Oversee analytical testing performed on the manufacturing floor, providing guidance to ensure data integrity and compliance.
- Assess and document changes that could impact product quality, ensuring proper evaluation and approval processes are followed.
- Investigate deviations from established procedures, ensuring thorough documentation and appropriate resolution.
- Alert senior management to potential quality, compliance, safety, or supply risks to support proactive mitigation.
- Lead project management efforts to achieve timely completion of tasks, supporting system improvements and process enhancements.
- Identify opportunities for continuous improvement within quality and manufacturing systems, implementing enhancements to optimize compliance and efficiency.
- Support and represent the Quality Assurance team during internal and external audits, including direct interactions with regulatory agencies during inspections.
Qualifications:
- High School diploma or equivalent plus 4 years of related work experience; Associate's degree plus 2 years of experience; Bachelor's degree plus 6 months of experience; or Master’s degree in a relevant field.
- Strong background in manufacturing and quality assurance within a GMP-regulated environment.
- Demonstrated ability to learn quickly, adapt to changing priorities, and contribute effectively to team initiatives.
- Excellent communication, problem-solving, and project management skills.
- Experience with quality systems, investigations, audits, and regulatory compliance.
Work Location:
Onsite - Holly Springs, North Carolina
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Ready to take the next step in your career? Explore job opportunities in the bustling area around Holly Springs, North Carolina, where growth awaits at every corner. Nestled in the heart of the Tar Heel State, Holly Springs offers a perfect blend of small-town charm and big-city amenities. From its vibrant arts scene at the Holly Springs Cultural Center to the mouthwatering Southern cuisine found at local favorites like the Mason Jar Tavern, this region has something for everyone. Boasting proximity to Raleigh, Durham, and Chapel Hill, as well as being a stone's throw away from attractions like the NC Museum of Art and PNC Arena, Holly Springs provides a unique and attractive environment for professionals looking to thrive. Dive into our job listings today and discover the endless opportunities this lively area has in store for you!