Compliance Specialist - Alphanumeric Systems, Inc.

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.

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.

• 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.