Validations Contractor GMP Quality Assurance

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

For further inquiries about this opportunity please contact our Talent Specialist Sri Balan at

Title: Validations Contractor - GMP Quality Assurance
Duration: 10 Months
Location: Research Triangle Park NC

This position will be based at our headquarters facility in RTP NC with domestic travel (less than 15% of the time) expected.

Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.

Description:

The Validations Contractor GMP Quality Assurance reporting to the Director GMP Quality Assurance 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.

Job Responsibilities

Work alongside department customers on development implementation and integration of Equipment and Computer Systems Validation plans for site wide equipment onboarding.

Provide timely quality support and thorough reviews and approvals of various records including but not limited to Change Controls; SOPs; analytical method equipment and computer system qualification and validation plans protocols and summary reports; batch records; QC data; non-conformities and Corrective Action/Preventive Action (CAPAs).

Ensure QA related activities are performed within the associated project timeline. Effectively escalate concerns to area and project management.

Report on applicable key metrics to drive continuous improvement in compliance.

Participate in project meetings as a quality lead and support colleagues by acting as a technical resource for quality and compliance related issues. Effectively collaborate in team environment(s) to ensure timely resolution of compliance and process concerns associated with equipment/computer systems validation activities.

Maintain Quality Systems in support of clients QMS and GMPs including:

o Review and approve SOP drafts and revisions.

o Process change controls.

o Support equipment and computer system qualification and validation activities and vendor management program.

Communicate project status to stakeholders and escalate issues in a timely manner.

About you

Bachelors 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.

Solid 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.

Ability to manage workload effectively in order to meet project timelines.

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).

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.

For further inquiries about this opportunity please contact our Talent Specialist Sri Balan at Title: Validations Contractor - GMP Quality Assurance Duration: 10 Months Location: Research Triangle Park NC This position will be based at our headquarters facility in RTP NC with domestic travel (...