Senior Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at GlaxoSmithKline Consumer Healthcare, L.P. This role will be responsible for ensuring the safety, quality, and efficacy of our products by providing direct support to customers in the production value streams, Quality Control, Technical Services, and Validation teams.
Key Responsibilities- Represent operational QA to ensure the safety, quality, and efficacy of products
- Provide direct support to customers in the production value streams, Quality Control, Technical Services, and Validation teams
- Coach and mentor site personnel to promote a consistent Quality Mindset and understanding of Patient Safety and Regulatory Compliance
- Support manufacturing operations across two shifts to ensure a consistent Quality Mindset for all teams
- Support Validation and Qualification activities for new systems, equipment, processes, and infrastructure related to adjuvant manufacturing
- Bachelor's Degree in a scientific discipline and 3+ years of experience in a cGMP regulated environment
- OR, Associates degree in a scientific field with 5+ years of experience in a cGMP regulated environment with Quality Assurance experience
- OR, High School Diploma or equivalent with 7+ years of experience in a cGMP regulated environment with 3+ years as part of the Quality Assurance function
- Bachelor's Degree with specialization in Computer Validation or QA for Computerized Systems
- 5+ years of experience in cGMP pharmaceutical environment or related industry focused on quality operations
- Demonstrated experience and working knowledge of cGMPs and associated regulatory requirements and guidelines for the manufacture, testing, and release of pharmaceutical/biopharmaceutical products
- Significant understanding of US and European GMP regulations
- Strong verbal and written communication skills
- Ability to work successfully both independently and in a team environment
GSK is a global biopharma company with a special purpose - to unite science, technology, and talent to get ahead of disease together. 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).
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.
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