Compliance Specialist - Alpha Numeric
Cambridge, MA 02142
About the Job
Alphanumeric is hiring a COMPLIANCE SPECIALIST - Level 3 to join our team in Cambridge, MA, supporting our client of 20 years-a global leader committed to improving lives through medical and pharmaceutical advancements.
This is an onsite contract position with an hourly range of $40 - 43. Key Responsibilities*Demonstrate excellent verbal and written communication skills, with strong attention to detail.
*Collaborate as a team player in a cross-functional environment.
*Adhere to clean room hygiene standards and gowning requirements to ensure compliance in a clean room environment.
*Lead event investigations to identify root causes and implement corrective and preventative actions (CAPAs) to prevent reoccurrence.
*Manage and implement CAPAs, ensuring timely completion and effectiveness.
*Own and oversee manufacturing-related change controls to ensure compliance with standards.
*Organize data, prepare documentation, and present materials for assigned projects.
*Recommend and implement batch record and SOP improvements to reduce or eliminate GDP errors and address root causes of deviations.
*Review production documentation and conduct quality walk-throughs during manufacturing events.
*Participate in continuous improvement initiatives such as 5S, Gemba, and the GSK Production System (GPS).
*Provide training and guidance to promote a culture of compliance throughout the organization.
*Facilitate and lead team meetings and cross-departmental discussions.
*Stay current with biopharmaceutical industry best practices and technologies to enhance operational compliance.
*Other duties as assigned.
Knowledge, Skills, and Abilities*Demonstrated knowledge of cGMP manufacturing and downstream processing using single-use technology (SUT).
*Proficient with troubleshooting approaches, including root cause analysis, 5 Whys, and Ishikawa diagrams (fishbone analysis).
*Subject Matter Expertise (SME) or experience with process equipment, such as:*Homogenizers
*Tangential Flow Filtration (TFF)
*Ultrafiltration/Diafiltration (UFDF)
*Buffer preparation and filtration
*Familiarity with regulatory agency interactions and inspection discussions is preferred but not required.
*Strong computer skills, including proficiency in Microsoft Office (Word, Excel, Visio) and industry systems such as LIMS, ERP, and SAP.
*Advanced knowledge of data analysis and reporting tools to support compliance efforts.
*Ability to work both independently and collaboratively in multi-disciplinary teams.
*Exceptional facilitation and demonstration skills to lead discussions and promote best practices.
Education and Experience Requirements*Bachelor's degree or equivalent experience required.
*Minimum of 3+ years of related experience in the biotech or pharmaceutical industry.
*Strong background in compliance, manufacturing operations, and quality systems.
This position offers an exciting opportunity to integrate compliance expertise within a cutting-edge biopharmaceutical environment. Join a team that values innovation, collaboration, and excellence in ensuring product quality and safety.
Must be able to work W2
This is an onsite contract position with an hourly range of $40 - 43. Key Responsibilities*Demonstrate excellent verbal and written communication skills, with strong attention to detail.
*Collaborate as a team player in a cross-functional environment.
*Adhere to clean room hygiene standards and gowning requirements to ensure compliance in a clean room environment.
*Lead event investigations to identify root causes and implement corrective and preventative actions (CAPAs) to prevent reoccurrence.
*Manage and implement CAPAs, ensuring timely completion and effectiveness.
*Own and oversee manufacturing-related change controls to ensure compliance with standards.
*Organize data, prepare documentation, and present materials for assigned projects.
*Recommend and implement batch record and SOP improvements to reduce or eliminate GDP errors and address root causes of deviations.
*Review production documentation and conduct quality walk-throughs during manufacturing events.
*Participate in continuous improvement initiatives such as 5S, Gemba, and the GSK Production System (GPS).
*Provide training and guidance to promote a culture of compliance throughout the organization.
*Facilitate and lead team meetings and cross-departmental discussions.
*Stay current with biopharmaceutical industry best practices and technologies to enhance operational compliance.
*Other duties as assigned.
Knowledge, Skills, and Abilities*Demonstrated knowledge of cGMP manufacturing and downstream processing using single-use technology (SUT).
*Proficient with troubleshooting approaches, including root cause analysis, 5 Whys, and Ishikawa diagrams (fishbone analysis).
*Subject Matter Expertise (SME) or experience with process equipment, such as:*Homogenizers
*Tangential Flow Filtration (TFF)
*Ultrafiltration/Diafiltration (UFDF)
*Buffer preparation and filtration
*Familiarity with regulatory agency interactions and inspection discussions is preferred but not required.
*Strong computer skills, including proficiency in Microsoft Office (Word, Excel, Visio) and industry systems such as LIMS, ERP, and SAP.
*Advanced knowledge of data analysis and reporting tools to support compliance efforts.
*Ability to work both independently and collaboratively in multi-disciplinary teams.
*Exceptional facilitation and demonstration skills to lead discussions and promote best practices.
Education and Experience Requirements*Bachelor's degree or equivalent experience required.
*Minimum of 3+ years of related experience in the biotech or pharmaceutical industry.
*Strong background in compliance, manufacturing operations, and quality systems.
This position offers an exciting opportunity to integrate compliance expertise within a cutting-edge biopharmaceutical environment. Join a team that values innovation, collaboration, and excellence in ensuring product quality and safety.
Must be able to work W2
Source : Alpha Numeric