LanceSoft
GMP Quality Assurance
LanceSoft, Durham, North Carolina, United States, 27703
The QA Contractor, GMP Quality Assurance, reporting to the Manager, GMP Quality Assurance, or designee, will be responsible for assisting in the management of company's Quality Management System (QMS) and will strongly support company's Culture of Quality. This role will assure corporate compliance with applicable GMP national, international, and state regulations. This position will be based at our headquarters facility in RTP, NC with domestic travel (less than 10% of the time) expected.
Job Responsibilities:Manage assigned day-to-day QA responsibilities in support of the company's Quality Management Systems (QMS).Provide timely support of Learning Management System, Change Control, Deviation Management Systems, or other QMS based customer requests. Liaison with applicable department record owners to ensure their complete and timely resolution. Review and Approve said record types as assigned.Provide accurate and timely weekly and quarterly QMS metric and Key Performance Indicator updates to QA and CMC senior management.Collaborate successfully with the other departments to ensure that direct and supportive tasks are completed within project timelines. Providing deliverables and resolving issues; Draft SOPs/controlled documents as well as perform quality unit review and approval of Quality Management Systems requests/ records related to Learning Management, Non-Conformance Management, CAPA management, and metric/KPI reporting.Continually evaluate systems and procedures for improvement for efficiency and compliance to applicable regulatory requirements and standards.Participate in project meetings as a Quality Unit representative and support colleagues by acting as a technical resource for quality and compliance related issues.Perform daily customer-facing activities, as assigned by area management. Maintain health of customer-facing activities such as document archival activities and notebook/logbook assignment and management.Identify and collaborate with colleagues to implement continuous improvement initiatives; provide Quality Unit oversight of QMS based activities.Assist in the qualification and oversight of vendors, contract manufacturers, contract laboratories, and service providers.Support regulatory (FDA, EMA) and internal audits/inspections per company procedures and applicable regulatory requirements.Communicate project status to stakeholders and escalate issues in a timely manner.Perform and support other duties as assigned by area management.About you:
Bachelor's degree in a scientific field and 4+ years of experience in GMP based Quality Assurance, particularly in support/oversight of a company QMS, or 10+ years of GMP based Quality Assurance experience using a company QMS.3+ experience working within a pharmaceutical/biotech Quality Management system, such as Trackwise, ZenQMS, Veeva, is a requirementStrong understanding of GMP guidelines and Quality Systems with the ability to apply GMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.Ability to author, review, and interpret Standard Operating Procedures (SOPs).Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.Strong service-oriented mindset with excellent verbal and written communication skills, and the ability to effectively collaborate with peers including scientific/technical colleagues.Experience in analytical method validation and QC testing, especially in the fields of mammalian cell culture and Gene Therapy/Biologics based potency testing, is preferred.Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Job Responsibilities:Manage assigned day-to-day QA responsibilities in support of the company's Quality Management Systems (QMS).Provide timely support of Learning Management System, Change Control, Deviation Management Systems, or other QMS based customer requests. Liaison with applicable department record owners to ensure their complete and timely resolution. Review and Approve said record types as assigned.Provide accurate and timely weekly and quarterly QMS metric and Key Performance Indicator updates to QA and CMC senior management.Collaborate successfully with the other departments to ensure that direct and supportive tasks are completed within project timelines. Providing deliverables and resolving issues; Draft SOPs/controlled documents as well as perform quality unit review and approval of Quality Management Systems requests/ records related to Learning Management, Non-Conformance Management, CAPA management, and metric/KPI reporting.Continually evaluate systems and procedures for improvement for efficiency and compliance to applicable regulatory requirements and standards.Participate in project meetings as a Quality Unit representative and support colleagues by acting as a technical resource for quality and compliance related issues.Perform daily customer-facing activities, as assigned by area management. Maintain health of customer-facing activities such as document archival activities and notebook/logbook assignment and management.Identify and collaborate with colleagues to implement continuous improvement initiatives; provide Quality Unit oversight of QMS based activities.Assist in the qualification and oversight of vendors, contract manufacturers, contract laboratories, and service providers.Support regulatory (FDA, EMA) and internal audits/inspections per company procedures and applicable regulatory requirements.Communicate project status to stakeholders and escalate issues in a timely manner.Perform and support other duties as assigned by area management.About you:
Bachelor's degree in a scientific field and 4+ years of experience in GMP based Quality Assurance, particularly in support/oversight of a company QMS, or 10+ years of GMP based Quality Assurance experience using a company QMS.3+ experience working within a pharmaceutical/biotech Quality Management system, such as Trackwise, ZenQMS, Veeva, is a requirementStrong understanding of GMP guidelines and Quality Systems with the ability to apply GMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.Ability to author, review, and interpret Standard Operating Procedures (SOPs).Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.Strong service-oriented mindset with excellent verbal and written communication skills, and the ability to effectively collaborate with peers including scientific/technical colleagues.Experience in analytical method validation and QC testing, especially in the fields of mammalian cell culture and Gene Therapy/Biologics based potency testing, is preferred.Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).