Operational Quality Specialist - 3rd Shift

GSK is currently looking for an Operational Quality Specialist to join our team in Rockville, MD. In this role, you'll provide Quality Oversight for the GMP production areas including Upstream and Downstream Bulk Drug Substance Manufacturing, Warehouse, Laboratories, and Facilities to ensure site compliance to support product release

KEY RESPONSIBILITIES:

• Provide Quality Oversight for the production areas including Upstream and Downstream Bulk Drug Substance Manufacturing, Warehouse, Laboratories, and Facilities
• Perform rapid response, area walk throughs, and process assessments
• Perform batch record reviews of executed solution batch records and executed Bulk Drug Substance process batch records
• Review GMP related documentation such as SOPs, Glass Wash and Autoclave records, cleaning logs, and equipment logbooks
• Review EM and water data for facility and bulk processing
• Support deviation, CAPA, and change control records under the supervision of QA Management
• Support audits and Inspection Readiness efforts including making sure that area documentation is accurate and reviewed in a timely manner
• Work across multiple value streams to drive continuous improvement and promote quality culture
• Utilize and continuously improve the GPS standards (i.e., 5s, standard work, problem solving, Gemba, process confirmations, and performance management) towards the goal of Zero Accidents, Zero Defects, and Zero Waste
• Work closely with cross site teams to drive performance of product disposition
• Represent QA on product/project teams and in work group meetings
• Perform other functions as necessary or as assigned

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• HS Diploma and 6+ years GMP Experience Associate degree in Technical/Scientific discipline OR 3+ years GMP Experience Bachelor's / Master's Degree and 1+ years of GMP Experience
• Must be able to work 3rd shift hours which are 8pm - 7am, (Sun-Wed Or Wed-Sat)

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• BS/MS in Microbiology or Biology is preferred
• 1 to 2 years of Manufacturing, Quality, QC experience or similar
• Some knowledge of cGMP's and other Regulatory requirements
• Demonstrate initiative and analytical problem-solving skills
• Ability to organize and prioritize work as needed
• Some knowledge and application of the principles of Quality Management Systems (QMS
• Must be flexible, adaptable, and a strong team player that fosters and promotes GSK Values, Behaviors and Strategies.
• Good verbal and written communication skills.
• Conflict resolution and interaction management skills

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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