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Compliance Specialist

Compliance Specialist

Alphanumeric Systems Inc.Cambridge, Massachusetts, United States
25 days ago
Salary
$40.00–$43.00 hourly
Job type
  • Quick Apply
Job description

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 a 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.

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.

    Must be able to work W2

    About Alphanumeric Systems Inc. :

    Alphanumeric is a dynamic company born of a diverse mindset and held to a distinctly high standard. You may know us as a tech and communications firm established in 1979, but we also lead life science and healthcare organizations toward a more efficient future across the globe, bringing patients and providers together to build personalized relationships that fit their needs.But at our core, we are a family with a shared and passionate dedication to our customers. We treat our candidates as amazing (because they are!)Apply today to join our family and Make Your Mark!