Compliance Specialist Cambridge, MA Posted: 1/22/2025
Job Description
Job ID#:
8129
Alphanumeric is hiring a COMPLIANCE SPECIALIST - Level 3 to join our team in Cambridge, MA, supporting our client of 20 years-a global leader committed to improving lives through medical and pharmaceutical advancements.
This is an onsite contract position with an hourly range of $40 - 43.
Key Responsibilities
Demonstrate excellent verbal and written communication skills, with strong attention to detail.
Collaborate as a team player in a cross-functional environment.
Adhere to clean room hygiene standards and gowning requirements to ensure compliance in a clean room environment.
Lead event investigations to identify root causes and implement corrective and preventative actions (CAPAs) to prevent reoccurrence.
Manage and implement CAPAs, ensuring timely completion and effectiveness.
Own and oversee manufacturing-related change controls to ensure compliance with standards.
Organize data, prepare documentation, and present materials for assigned projects.
Recommend and implement batch record and SOP improvements to reduce or eliminate GDP errors and address root causes of deviations.
Review production documentation and conduct quality walk-throughs during manufacturing events.
Participate in continuous improvement initiatives such as 5S, Gemba, and the GSK Production System (GPS).
Provide training and guidance to promote a culture of compliance throughout the organization.
Facilitate and lead team meetings and cross-departmental discussions.
Stay current with biopharmaceutical industry best practices and technologies to enhance operational compliance.
Other duties as assigned.
Job Requirements
Knowledge, Skills, and Abilities
Demonstrated knowledge of cGMP manufacturing and downstream processing using single-use technology (SUT).
Proficient with troubleshooting approaches, including root cause analysis, 5 Whys, and Ishikawa diagrams (fishbone analysis).
Subject Matter Expertise (SME) or experience with process equipment, such as:
Homogenizers
Tangential Flow Filtration (TFF)
Ultrafiltration/Diafiltration (UFDF)
Buffer preparation and filtration
Familiarity with regulatory agency interactions and inspection discussions is preferred but not required.
Strong computer skills, including proficiency in Microsoft Office (Word, Excel, Visio) and industry systems such as LIMS, ERP, and SAP.
Advanced knowledge of data analysis and reporting tools to support compliance efforts.
Ability to work both independently and collaboratively in multi-disciplinary teams.
Exceptional facilitation and demonstration skills to lead discussions and promote best practices.
Education and Experience Requirements
Bachelor's degree or equivalent experience required.
Minimum of 3+ years of related experience in the biotech or pharmaceutical industry.
Strong background in compliance, manufacturing operations, and quality systems.
This position offers an exciting opportunity to integrate compliance expertise within a cutting-edge biopharmaceutical environment. Join a team that values innovation, collaboration, and excellence in ensuring product quality and safety.