QA Systems Specialist
- York, PA
Site Name: USA - Pennsylvania - Marietta
Posted Date: Aug 3 2020
The QA Systems Specialist is responsible for the oversight, monitoring, and reporting function to support quality systems that are used at Marietta facility to support production of vaccines. The Quality systems under the scope of this role include deviation system, change management system, CAPA system, customer complaints, Product Quality review, & GSK Quality Management system. The QA Systems Specialist is responsible to ensure compliance with GSK internal procedures, policies, standards, FDA regulations.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Responsible for quality system process expertise and daily oversight activities for cGMP quality systems.
- Responsible for ensuring the Quality Systems LSOP/processes are robust and compliant with Regulatory and global requirements.
- Responsible for reporting and monitoring on cGMP quality systems, site KPIs, and other miscellaneous quality unit systems.
- Responsible for execution of training activities on cGMP quality Systems (Qualified Trainer)
- Responsible for acting as QA liaison with QA operations and site personal to resolve technical problems or provide quality system expertise to help provide solutions while still assuring compliance to cGMP.
- Responsible for acting as QA liaison with global support functions to resolve technical problems or provide quality system expertise to help provide solutions while still assuring compliance to cGMP
- Responsible for backup roles for Quality Systems Manager when applicable.
- Responsible for backup roles for documentation systems responsibilities within the quality systems disciplines (includes; procedures management, documentation control, archival & logbooks).
- Lead quality systems improvement/simplification projects and site initiatives as applicable.
- Complete all work with highest regard to quality and safety by ensuring compliance with GMPs, applicable EHS regulations, standard operating procedures, and industry practices
Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- BA/BS degree in sciences or business ( Biology, Microbiology, Chemistry, Biochemistry, Business, Statistics). Degree in other discipline if sufficient technical depth has been achieved by professional experience
- A science or business discipline is required to comprehend the technical aspects of the manufacturing processes.
- 3-5 years pharmaceutical experience in a Quality Organization.
- Strong communication and problem solving skills with a demonstrated ability to work well with and influence others without direct reporting relationships
- Experience in managing process changes and relationship building
- Strong technical understanding of industry and science practices related to the business
- Experience in continuous improvement initiatives
- Relevant experience in industry and with hands-on experience working through situations and processes is necessary to apply and manage quality system activities
- SAP Experience
- Experience in startup facility
- Experience with operational excellence concepts
- Experience in process design
- Master's degree in science or business discipline or an additional BS such as Quality Assurance, Regulatory, Business, or relevant technical discipline.
- Provides a higher level understanding of the business and industry related issues.
- Versed in GMP's, NIH Guidelines, FDA and other regulatory agency requirements for validation and operations, analytical and stability functions and compliance.
- Experience with implementation in deviation management, CAPA, or change control, and versed in reporting and KPI functions
- A wide scope of industry experience allows for a more holistic view of potential impact areas and problem resolution.
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
*This is a job description to aide in the job posting, but does not include all job evaluation details.
"US work authorization is required for this role. Sponsorship is not available for this position"
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