Associate – 3rd Party Quality Operations

• Administer customer complaints within the applicable quality systems
• Assist with review of batch records, investigations, specifications, complaint reports, and other GMP documentation received from third-party manufacturers
• Maintain supplier and contract manufacturer quality documentation files
• Coordinate documentation requests with third-party manufacturers and internal stakeholders
• Maintain accurate records in accordance with company procedures and regulatory requirements
• Support continuous improvement initiatives and quality system compliance activities
• Perform other duties as assigned.

• Bachelor's degree in a scientific discipline preferred
• Associate degree may be considered in combination with relevant industry experience
• Experience in pharmaceutical, biotechnology, medical device, or other regulated industry preferred
• Experience with GMP documentation, quality systems, and regulatory requirements is preferred
• Strong organizational, communication, and technical document review skills
• Strong attention to detail and organizational skills
• Effective written and verbal communication skills
• Ability to review technical documentation with training and guidance
• Familiarity with cGMP regulations and quality systems preferred
• Proficiency with Microsoft Office applications
• Ability to manage multiple priorities and meet deadlines
• Ability to work independently while appropriately escalating issues
• Experience with electronic quality management systems such as Veeva preferred
• Working knowledge of quality system processes including complaints, deviations, investigations, and document management preferred
• Ability to interpret and apply company procedures, quality standards, and regulatory requirements
• Strong problem-solving and critical-thinking skills with the ability to identify and communicate potential compliance risks
• Demonstrated ability to collaborate effectively with internal stakeholders and external business partners
• Ability to learn and apply technical concepts related to pharmaceutical manufacturing, product quality, and regulatory compliance
• Strong customer-service mindset with the ability to maintain professional relationships with third-party manufacturers and suppliers
• Demonstrated commitment to quality, accuracy, and continuous improvement.

Demonstrates expertise in GMP Documentation, Quality Systems, and Regulatory Requirements, with a strong focus on maintaining compliance and supporting continuous improvement initiatives. Proficient in managing technical documentation and collaborating with internal and external stakeholders to ensure product quality and adherence to industry standards.

• GMP Documentation
• Quality Systems
• Regulatory Requirements
• Electronic Quality Management Systems
• Technical Document Review

• GMP Documentation
• Quality Systems
• Regulatory Requirements
• Technical Document Review
• Quality System Processes
• Problem-Solving
• Critical Thinking
• Pharmaceutical Manufacturing
• Continuous Improvement
• Attention to Detail

• Organizational Skills
• Effective Communication
• Customer-Service Mindset
• Collaboration
• Ability to Manage Multiple Priorities

• Pharmaceutical
• Biotechnology
• Medical Device
• Regulated Industry
• CGMP Regulations

• Microsoft Office
• Electronic Quality Management Systems
• Veeva