Senior QA Specialist at GSK in Richmond, VA

Site Name: Richmond Sherwood

Posted Date: Dec 3 2020

The Senior QA Specialistparticipates in Quality and Compliance activities for assigned projects and products during the development and product transfer from R&D to internal/external sites, as well as provide local support to the Richmond R&D site.

In this role you will have the opportunity to demonstrate your understanding of manufacturing, packaging, clinical labeling, and analytical testing requirements to identify complexities in each area and the interdependencies between them.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

Execution Powerhouse

• Key support for Quality and Compliance activities assigned during product development and transfer
• Participates in cross functional matrix project teams to provide timely quality support
• Represents quality in development and release decisions with guidance from management; receives information and distributes as appropriate

Growth Mindset

• Develops knowledge of regulations impacting areas of work (i.e., USP, EP/BP, JP, ICH, WHO, TGA, ISO, PICS)
• Identifies and shares quality requirements at local, corporate and regulatory levels to assist colleagues and Stakeholders in product development activities

Consumer and Customer-Obsessed

• Support review of CMC and non-CMC related documents, including product specification, batch records, test methods, validation protocols and reports, analytical method transfers, equipment qualification and calibration related documents, stability protocols and GTR's, process and product transfer protocols and reports and packaging documentation to escalate known issues that will impact product release
• Support of clinical supply activities; review and approval of clinical supplies, registration samples and consumer test supplies
• Quality consultant on consumer-driven activities (consumer understanding, sensory and retail study) to support business needs

Data Driven

• Assist colleagues and Stakeholders to ensure work is conducted following sound scientific practices and supporting data: Methods, Validations, Qualifications, USP water release, controlled substance maintenance, Change Controls, Deviations, and CAPAs

Agile

• Identify and understand quality strategies throughout organization that promote efficient, agile and compliant processes for product launches

Why you?

Basic Qualifications:

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

• Bachelor's Degree in Chemistry, Pharmacy, Biology or Related Science
• 2 + years experience in a scientific or manufacturing environment
• Demonstrated experience in GMP environment as relates to regulatory compliance

Preferred Qualifications:

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

• Understands applicable GMP, BOH, and Regulatory Affairs regulations and guidelines
• Analytical, manufacturing, and laboratory experience
• Capacity to work in global and multidisciplinary environments

Why GSK?

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, rigour 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.

*LI-GSK

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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