The Analytical Validation Specialist IV will lead the validation activities, focusing on analytical equipment, software updates, new system introductions, and decommissioning. This role will collaborate with cross-functional teams to ensure compliance with GMP and quality standards. The Specialist will manage the validation process, equipment specifications, and risk assessments to maintain a compliant and efficient operational environment.

The Equipment Validation Specialist IV plays a crucial role in ensuring that all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters, and global regulatory guidelines. This position provides scientifically sound documented evidence to Operations, Quality Assurance, and regulatory bodies that systems and processes will perform as required, supporting a quality, compliant manufacturing environment.

The Equipment Validation Specialist is responsible for ensuring that all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters, and global regulatory guidelines. This role provides scientifically sound, documented evidence to Operations, Quality Assurance, and regulatory bodies, supporting a quality, compliant manufacturing environment.

The Analytical Validation Specialist III role focuses on supporting validation activities for analytical systems, such as software updates, new system introductions, and system decommissioning. This individual collaborates closely with senior specialists and other teams to ensure high-quality performance and compliance with industry standards. The role involves troubleshooting, executing qualifications, and supporting system changes while ensuring data integrity and quality systems adherence.

The QC Analyst II will support the Quality Control, Microbiology Safety Team by performing bioburden, microbial enumeration, endotoxin, sterility testing, and other microbiological assays. The role will assist with OOS investigations, maintaining laboratory equipment, and ensuring compliance with cGMP regulations. The ideal candidate will have experience with USP testing methods and a background in microbiology.

You’ll be responsible to coordinate and drive the successful completion of CMX projects including creative ad feedback and approvals, campaign launches and other key deliverables. Account Managers need to excel in problem-solving and project management and should be well-organized, detail-oriented and flexible. The Account Management team works cross-functionally with CMX Sales, Audience & Analytics, Creative and Media teams which require strong communication skills and the ability to follow through on projects while maintaining accountability, all critical elements of this role. Location: Chicago IL or Boston MA or Woonsocket RI or Wesley MA Hours: Mon-Fri 9-5 (40 hours a week)