Manufacturing Compliance Specialist at The Accuro Group

Business Title: 102839 | Manufacturing Compliance Specialist
Location: Cambridge, MA 02142
Job Type: Contract (12 Months)
Note: Parking will not be reimbursed by the CLIENT. Parking is roughly $420/mo.
Important: MFG background is mandatory.

Job Description:

• THE CLIENT is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
• THE CLIENT has an exciting new opportunity for an experienced Compliance Specialist who will work closely within the Manufacturing Compliance group to achieve department goals. The Compliance Specialist is also responsible for owning and driving manufacturing compliance improvement through deviation resolution, applied root cause analysis and the application of CAPA to elevate safety, quality, cost, on-time delivery, and right first-time performance. The Compliance Specialist supports by working cross-functionally with internal support departments to drive improvements to completion.

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 CLIENT 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.

 
Skills & Experience Required:

• Bachelor's degree in relevant field
• 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

 Preferences:

• 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.
• More advanced knowledge / proficiency with business software (i.e., Excel, Visio) and industry systems (LIMS, ERP, SAP).