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Company Overview

Our Commitment

We are committed to our relationships with our clients, candidates, and consultants, as well as to one another and our communities. We hope our dedication to these relationships shines through with the partnerships we nurture daily. To achieve success in all facets, we value trust, communication, customer service, and diversity.

We demonstrate our commitment to diversity by recruiting from all backgrounds, cultures, and ethnicities. We recognize the unique differences each employee brings to the company and we support environments that encourage diversity, believing that it adds value to the organization. This value is evident in every aspect of the organization: new ideas and perspectives, motivation, buy-in, retention, and new sources of talent. By valuing differences, we affirm our dedication to treating everyone with fairness and respect.

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Job Description

Job Purpose:  Perform technical and compliance reviews of Systems SOPs, site departmental SOPs, and to lead the Change Management, Deviation and CAPA management for the site. As a member of the Quality Assurance team, be co-responsible for the site and the department results. Ensure personal objectives are aligned with site goals and objectives.
PRINCIPLE JOB DUTIES:
• Provide technical problem solving and investigation support to Production and Technical Operations to assure compliance to cGMP’s.
• Provide the QA oversight necessary to ensure compliance with cGMP, applicable regulatory requirements, product specific procedures, and product specifications.
• Assure that documentation packages are complete and accurate.
• Assist and facilitate personnel activities such as development of batch records, SOP writing, product investigations with operations personnel to develop trend analysis and identify improvement opportunities.
• Determine if the level of detail contained in the procedure/investigation is adequate as per the needs of the business.
• Ensure quality by being the QA responsible for site support departments.  This includes assisting in all the Quality system activities (Deviations, CAPA, Change Controls, and Procedures Management), validation activites (QA oversight), QC activities, and Maintenance/Calibration activities (QA Oversight).
• Act as the site subject matter expert for all questions and issues related to Global and Local Change Management systems to include:
• Key contact regarding subjects for other sites and outside contacts; receive the information and distribute to appropriate members of the site.
• Become the site leader in the process – attend conferences, develop technical expertise, conduct onsite training, etc.
• Act as the site consultant for each area of technical expertise when issues arise.
• Assist with project definition during design of projects that involve area of expertise.
• Be site review participant for GSOP development in their area of expertise to provide key review output from Marietta to assure the site needs are being addressed and improve our standing with GQA.

Procedures/ Product Investigations/Change Controls
• Investigate, troubleshoot and provide input on product deviations to determine product disposition.
• Act as QA liaison in conjunction with QA Operations in completing product deviation documentation.
• Lead the Change Control forum for site start-up and on-going development.
• Develop and coordinate the global Change Management system, and ensure an efficient, robust process.
• Providing technical problem solving and investigation support to Production and Technical Operations to assure compliance to cGMPs.
• Maintain and follow-up with CAPA schedule and initiatives.
• Review and approve deviation investigations and CAPA reports.
• Develop, maintain, and report quality metrics for the site quality systems.
• Develop and maintain SOP’s for change control, deviation and CAPA management.
• Develop and implement training programs for site quality systems.
• Provide Quality input and direction to site Lead Investigators.
• Assist with Deviation Review Board meetings and discussions.
• Review and approve Technical Services Validation and Quality Control SOPs.
• Provide QA support for Technical Services Maintenance and Calibration, Automation, Validation, and QC.
• Participate in site Industrial Excellence initiatives.
• Support the preparation and site management of regulatory inspections.
• Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.  Adhere to all GSK Safety guidelines and procedures.
• Adhere to all GSK Quality Management System (QMS) policies and procedures as applicable for functional area.
• Work on any assignment as directed.• 



Job Requirements

• BA/BS degree required in a related technical field.  Degree in other discipline if sufficient technical depth has been achieved by professional experience.
• 3-5 years pharmaceutical experience in a Quality Organization.
• In-dept experience in quality systems, including validation, documentation, compliance in a high volume, rapid turnaround release office or compliance department.  Strong technical understanding of industry and science practicies related to the business.
• Fully versed in GMP’s, NIH Guidelines, FDA and other regulatory agency requirements for validation and operations, analytical and stability functions and compliance.
• Demonstrated ability to drive initiatives across multiple business units under tight deadlines.
• Excellent analytical skills and attention to detail.
• Strong communication and problem solving skills with a demonstrated ability to work well with and influence others without direct reporting relationships.
• Must have demonstrated self-direct work habits and strong communication skills.
• Sense of urgency, flexibility and accountability.
• Ability to communicate at all levels.
• Ability to work in a high complex matrix environment.
• Must be a committed team player prepared to work in and embrace a team based culture.
• Ability to follow written procedures and document results in a neat and precise manner.
• Intermediate computer skills required.
• Proven record of providing excellent internal and external customer service.
• Stay current on developments in the field and GSK-Bio Standards.
• Work within a Multi-skilled team.
• Maintain attention to detail, while completing multiple or repetitive tasks.
• Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
• Maintain a high level of integrity while balancing multiple priorities and responsibilities.

 

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