Compliance Specialist - Pharma Mfg.

Company: The Accuro Group
Location: Cambridge
Posted on: February 2, 2025

Job Description:

Business Title: 105384 - Compliance Specialist

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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)

Keywords: The Accuro Group, Newton , Compliance Specialist - Pharma Mfg., Other , Cambridge, Massachusetts