Compliance Specialist - Pharma Mfg.

Business Title: 105384 | Compliance Specialist
Location: Cambridge, MA 02142
Job Type: Contract (12 M+)
Note: Nearby garage parking is available for roughly $420/month. Parking will NOT be reimbursed by the client.

Job Responsibilities:

• 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 company 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

 
Skills & Experience Required:

• Bachelor's degree or equivalent experience
• • Bachelor's degree highly preferred
• 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
• 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
• SME or experienced with some or all 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 desired
• More advanced knowledge / proficiency with business software (i.e. Excel, Visio) and industry systems (LIMS, ERP, SAP)