• The Laboratory Quality Contractor, GMP Quality Assurance, reporting to the Manager, GMP Quality Assurance, or designee, will be responsible for assisting in the management of Client's Quality Management System (QMS) and will strongly support Client'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 15% of the time) expected.

• Manage assigned day-to-day QA responsibilities in support of Quality Control and Analytical Development department activities.
• Collaborate successfully with the Analytical Development and the Quality Control departments to ensure that direct and supportive tasks are completed within project timelines. Providing deliverables and resolving issues; perform quality unit review and approval of documentation including raw data, test methods, protocols and executed method qualification/ transfer/verification/validation reports and stability protocols in compliance with internal and regulatory requirements.
• Partner with Analytical Development and Quality Control department personnel to ensure successful internal and external transfer of analytical methods in support of GMP manufacturing campaigns.
• 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 Analytical Method Development in an R&D and GLP/GMP setting.
• Support the department Change Control, Document Management, and Deviation Management Systems, and liaison with applicable department investigation writers to ensure their complete and timely resolution.
• Review and Approve said document types as assigned.
• Continually evaluate systems and procedures for improvement for efficiency and compliance to applicable regulatory requirements and standards.
• 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.
• Other duties as assigned by area management.

• Bachelor's degree in a scientific field.
• 5+ years of experience in pharmaceutical, biotech, or biologics GMP regulated manufacturing environment with 3+ years in Quality and/or Manufacturing.
• Experience in compliance requirements related to method development and validation of the following method types: Nucleic acid analytical methods (DNA/RNA extraction, qPCR, ddPCT, RT-PCR, etc), Cell Based Assays, ELISA, Microbial testing assays (Mycoplasma and Sterility), H/UPLC, and Capillary Electrophoresis.
• 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 fast-paced, highly interactive environment.
• Excellent verbal and written communication skills, and the ability to effectively collaborate with peers including scientific/technical colleagues.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

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.