Compliance Specialist

• Lead event investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence,
• Lead CAPA investigations and at times manage the implementation of CAPA.
• Own manufacturing related change controls.
• Responsible for organizing data and preparing appropriate documentation, including presenting materials, for assigned projects.
• Recommending batch record and SOP improvements to reduce or eliminate GDP errors or correct root causes of deviations.
• Review production documentation and perform quality walk-throughs during manufacturing events
• Participate in continuous improvement teams such as 5s, Gemba and the Production Systems (GPS).
• Provide training and guidance to team members on compliance-related matters to promote a culture of compliance throughout the organization.
• Lead team meetings and facilitate multidepartment discussions.
• Stay current with biopharmaceutical industry best practices and technologies.
• Other duties as assigned

• Bachelor's degree or equivalent experience.
• 3+ years of related experience.
• Demonstrated knowledge of cGMP manufacturing with knowledge in manufacturing operations in downstream processing utilizing single use technology (SUT).
• Experienced with standard troubleshooting approaches (problem statement, root cause analysis, Ishikawa (fishbone diagram), 5 Whys).
• Good computer skills, knowledge of Microsoft office products - Word, Excel, Office.
• Collaborate with cross-functional teams to integrate compliance measures into various aspects within manufacturing operations.
• Ability to meet schedule is required; this position may infrequently include shift, weekend, or holiday work and overtime as dictated by a 365-day production schedule.
• Ability to work in a cleanroom environment and comply with hygiene standards and use of clean room gowning.
• This job is on-site M-F at Binney Street in Cambridge. There is limited ability to work from home.

• SME or experienced with some or all of the following process equipment; homogenizers, tangential flow filtration (TFF), ultrafiltration/diafiltration (UFDF), Single use technology (SUT), buffer preparation and filtration.
• Experience with regulatory agency interactions and inspection discussions preferred but not required.
• Excellent verbal/written communication skills.
• Facilitation and demonstration skills
• Attention to detail and the ability to work individually and within multi-disciplinary teams
• More advanced knowledge / proficiency with business software (i.e. Excel, Visio) and industry systems (LIMS, ERP, SAP)

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!