Laboratory Quality Coordinator

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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For further inquiries regarding the following opportunity, please contact one of our Talent Specialists:
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Title: Laboratory Quality Coordinator
Location: Research Triangle Park, NC
Duration: 12 Months (with Possible extension)

100% on site - Work hours are flexible, but must work the core business hours from 9am to 3pm. Can start as early at 7:30am if they wish.

Job Description :

• 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.
• Involved in analytics, and process development in the quality control lab.

Job Responsibilities:

• 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 RandD 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.
• They must be able to work with customers (internal customers and internal stakeholders).
• Understanding of equipment associated with the quality lab, analytical equipment, the process involved docs review, review of summary reports.
• There will be a lot of desk work review and approval of reports and docs, meeting a timeline, appropriate escalations, cross-collaborations, and work in a team environment.
• Work order systems are used by Client for tracking activities, so individuals will work in that system.

About you:

• 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).
• Validation activity, review of SOPS, method validations, therapeutic methods, PCR, ELISA, HPLC.
• Early phase clinical activity, life cycle activity, method qualification and validation review reports, preview and approval of protocol and reports, review of sops, working side by side in the QC lab.
• Methods- PCR, ELISA, (all of them are not mandatory atleast 1 or 2 should be there).
• They must know ICH guidelines and validation methods.
• In the analytical side, understanding of qPCR.

Education:

• For Quality- BS in science, anything Higher is also fine.
• For validation BS in engineering or life sciences.
• Bachelor's degree in a scientific field.

Experience required:

• Experience in any area in pharma, GMP Lab, GLP experience, not in research development, QA, equipment qualification, or computer system validation, change control exp.
• Very strong Lab exp is overqualified.
• LIMS exp, documents management system.
• 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.

About us:

DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West 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.