Incoming Material Senior (QA) Specialist - Alphanumeric Systems, Inc.
Cambridge, MA
About the Job
Alphanumeric is hiring an INCOMING MATERIAL SENIOR (QA) SPECIALIST to work in Cambridge, MA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.
As an Incoming Material Senior QA Specialist, you will play a critical role in ensuring the quality and compliance of materials procured by our organization. Your primary responsibility will be to evaluate incoming materials to ensure they meet the required standards and specifications. You will collaborate closely with procurement, manufacturing, quality control, and quality assurance teams to maintain high standards of quality throughout the supply chain process.
Responsibilities:
* Material Inspection: Conduct thorough review of documentation of incoming materials to ensure they meet quality standards and specifications. Release materials in SAP and provide final quality decision.
* Documentation and Record-keeping: Maintain accurate records. Ensure all documentation meets ALCOA principle, is organized, and accessible for reference and auditing purposes.
* Supplier Communication: Communicate effectively with QA suppliers' team regarding quality issues, non-conformances, and corrective actions related to incoming materials. Collaborate with
procurement and QA suppliers' team to address any quality concerns and ensure timely resolution.
* Root Cause Analysis (RCA): participate on RCA, investigate root causes of quality issues or non-conforming materials, and implement corrective and preventive actions to prevent recurrence.
Compliance Authority for deviations, CAPA and change controls.
* Quality Assurance Support: Provide support to the quality assurance team in developing and implementing quality assurance procedures, protocols, and standards for incoming materials.
* Continuous Improvement: Identify opportunities for process improvement and efficiency enhancements in the incoming material lifecycle. Propose and implement solutions to optimize quality assurance procedures.
* Compliance: Ensure compliance with relevant regulations, standards, and industry best practices pertaining to incoming material quality assurance.
* Oversight of the incoming material process and warehouse activities
* Create, revise and approved standard operating procedures in accordance with guidelines
* Support incoming material qualification for phase III requirements including material specifications and release requirements
* Additional responsibilities as needed by site priorities and Quality, Business or Safety requirement
Responsibilities:
* Material Inspection: Conduct thorough review of documentation of incoming materials to ensure they meet quality standards and specifications. Release materials in SAP and provide final quality decision.
* Documentation and Record-keeping: Maintain accurate records. Ensure all documentation meets ALCOA principle, is organized, and accessible for reference and auditing purposes.
* Supplier Communication: Communicate effectively with QA suppliers' team regarding quality issues, non-conformances, and corrective actions related to incoming materials. Collaborate with
procurement and QA suppliers' team to address any quality concerns and ensure timely resolution.
* Root Cause Analysis (RCA): participate on RCA, investigate root causes of quality issues or non-conforming materials, and implement corrective and preventive actions to prevent recurrence.
Compliance Authority for deviations, CAPA and change controls.
* Quality Assurance Support: Provide support to the quality assurance team in developing and implementing quality assurance procedures, protocols, and standards for incoming materials.
* Continuous Improvement: Identify opportunities for process improvement and efficiency enhancements in the incoming material lifecycle. Propose and implement solutions to optimize quality assurance procedures.
* Compliance: Ensure compliance with relevant regulations, standards, and industry best practices pertaining to incoming material quality assurance.
* Oversight of the incoming material process and warehouse activities
* Create, revise and approved standard operating procedures in accordance with guidelines
* Support incoming material qualification for phase III requirements including material specifications and release requirements
* Additional responsibilities as needed by site priorities and Quality, Business or Safety requirement
Qualifications:
* 8+ years of industry experience (6+ years of QA experience) for a biopharma company
* Excellent attention to detail and accuracy in data collection and analysis.
* Effective communication skills, both verbal and written, with the ability to interact confidently with internal stakeholders.
* Analytical mindset with the ability to problem-solve and perform root cause analysis.
* Bachelor's degree in a relevant field such as Quality Assurance, Chemistry, Biology, Engineering, or related discipline.
* Proven experience in quality assurance or quality control, preferably in a manufacturing or production environment.
* Strong knowledge of quality assurance principles, practices, and methodologies.
* SAP Experience: Proficiency in using SAP or similar enterprise resource planning (ERP) systems to review material-related documentation, track inventory, and facilitate communication with internal stakeholders. Experience in generating reports, conducting transactions, and navigating within SAP modules related to materials management, CAPA, Unplanned Events and Change Control is highly desirable.
Preferred Qualifications:
* Knowledge of Good Manufacturing Practices (GMP) and regulatory requirements in pharmaceutical industry.
* Experience working with SAP's Quality Management (QM) modules or similar quality management software within an ERP system.
* Familiarity with SAP's Materials Management for procurement and inventory management.
Work Environment:
* The Incoming Material QA Senior Specialist will work onsite. Collaboration with cross-functional teams, including procurement, manufacturing, quality assurance, and logistics, is common in this role.
* Strong interpersonal skills are essential for effective communication and collaboration with internal and external stakeholders.
* The work environment may also involve occasional tight deadlines and pressure situations, especially during periods of increased production or urgent quality issues. The Incoming Material QA Specialist must demonstrate resilience, adaptability, and the ability to prioritize tasks to meet business objectives while maintaining high-quality standards.
* 8+ years of industry experience (6+ years of QA experience) for a biopharma company
* Excellent attention to detail and accuracy in data collection and analysis.
* Effective communication skills, both verbal and written, with the ability to interact confidently with internal stakeholders.
* Analytical mindset with the ability to problem-solve and perform root cause analysis.
* Bachelor's degree in a relevant field such as Quality Assurance, Chemistry, Biology, Engineering, or related discipline.
* Proven experience in quality assurance or quality control, preferably in a manufacturing or production environment.
* Strong knowledge of quality assurance principles, practices, and methodologies.
* SAP Experience: Proficiency in using SAP or similar enterprise resource planning (ERP) systems to review material-related documentation, track inventory, and facilitate communication with internal stakeholders. Experience in generating reports, conducting transactions, and navigating within SAP modules related to materials management, CAPA, Unplanned Events and Change Control is highly desirable.
Preferred Qualifications:
* Knowledge of Good Manufacturing Practices (GMP) and regulatory requirements in pharmaceutical industry.
* Experience working with SAP's Quality Management (QM) modules or similar quality management software within an ERP system.
* Familiarity with SAP's Materials Management for procurement and inventory management.
Work Environment:
* The Incoming Material QA Senior Specialist will work onsite. Collaboration with cross-functional teams, including procurement, manufacturing, quality assurance, and logistics, is common in this role.
* Strong interpersonal skills are essential for effective communication and collaboration with internal and external stakeholders.
* The work environment may also involve occasional tight deadlines and pressure situations, especially during periods of increased production or urgent quality issues. The Incoming Material QA Specialist must demonstrate resilience, adaptability, and the ability to prioritize tasks to meet business objectives while maintaining high-quality standards.
Source : Alphanumeric Systems, Inc.