QA Contractor GMP Quality Assurance
QA Contractor GMP Quality Assurance
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Job Description
Hema at
Title: QA Contractor GMP Quality Assurance
Location: Research Triangle Park NC
Duration: 9 Months
Job Description :
- The QA Contractor GMP Quality Assurance reporting to the Manager GMP Quality Assurance or designee will be responsible for assisting in the management of Clients Quality Management System (QMS) and will strongly support Clients 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.
- Manage assigned daytoday QA responsibilities in support of the companys 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 NonConformance 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 customerfacing activities as assigned by area management. Maintain health of customerfacing 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 Client 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.
- Bachelors 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 requirement
- Strong 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 fastpaced highly interactive environment.
- Strong serviceoriented 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).
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the MidWest and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.
Employment Type
Full Time
