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The Quality Assurance (QA) Operations department is responsible for quality oversight of operations at *** Framingham Biologics facilities. QA’s main responsibility is to ensure adherence to CGMPs during manufacturing operations through partnership with the site and direct engagement with daily operations activities. Quality Assurance Operations is responsible for providing support and guidance to the *** Operations function in order to protect the safety, quality and efficacy of ***’s products, thereby ensuring the availability of compliant and safe products for our patients and assuring the security of the company’s business and global markets.
Position Overview with Key Responsibilities:
The Senior Compliance Specialist is responsible for providing quality support and direction to Manufacturing, Quality Control, and support functions to ensure continued compliance to CGMPs as well as being responsible for providing technical support serving as a Subject Matter Expert (SME) to the QA team.
• Actively supports the QA Operations team by providing technical support
• Completes Phenix/Trackwise Laboratory Investigations/Deviations/CAPA/Change Controls
• Ensure all safety requirements are being met
• Performs batch record and logbook review
• Performs review of column packing and qualification records
• Review and approve CRs related to EBRs
• Function as SME on challenges related to production requiring quality input
• Provide on the floor (OTF) support to the operations department, including OTF support for critical operations steps
• Issue action notices and conduct affiliated provisional release
• Conduct log book audits against compliance requirements
• Review CV related documentation against specification
• Perform media / buffer and intermediate release
• Perform release of Cell Banks for forward processing (as applicable)
• Support cross-functional internal audit activities and conduct walkthrough inspections
• Execute containment activities
• Provide expertise during procedure/SOP revision process and function as DCR approver for department related SOPs and PRs
• Maintain a high level of personal compliance to the required standards
• Partner with manufacturing and support operations to ensure a culture of continuous compliance
• Master's Degree & 2 years of experience or Bachelor’s Degree and 4 years of experience in a Quality and /or other cGMP related field.
• Knowledge in external agency regulations (FDA, EMA, etc.)
• Strong computer, verbal and written communication skills.
• Experience in quality systems.
• Experience with Trackwise or equivalent system.
• Proficient in Microsoft Office
• Operations experience in one of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation.
• Experience with *** Manufacturing System (SMS) or comparable continuous improvement systems.
• Experience with root cause analysis tools.
• Demonstrated experience with change control, CAPA and deviation quality systems.
• Experience in a Quality Assurance role.
• Strong technical writing skills.
• Effective time management, attention to detail, organizational skills, teamwork and collaboration.
• Significant capability in problem solving methodology.
• Experience training and technically developing employees.
• Experience participating in external agency inspections.
• Knowledge of regulatory enforcement trends.
• Ability to work independently
Special Working Conditions:
• Ability to gown and gain entry to manufacturing and Quality Control areas.
• Ability to work a 12-hour rotating shift and every other weekend, including holidays.
• Ability to lift 10 lbs.
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