Associate Operational Quality Specialist - Batch Record Review

Company: GlaxoSmithKline
Location: Rockville
Posted on: September 22, 2022

Job Description:

Site Name: USA - Maryland - RockvillePosted Date: Sep 7 2022GSK is currently looking for an Associate Operational Quality Specialist in Rockville, MD to join our team. In this role, you'll provide support for 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 support for 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 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 assignedWhy you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:
  • Associate degree or enrolled in a degree or certificate programOR 1+ years of Manufacturing, Quality or QC experiencePreferred Qualifications:If you have the following characteristics, it would be a plus:
    • Some knowledge of cGMP's and other Regulatory requirements
    • 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, Behaviours and Strategies.
    • Good verbal and written communication skills.
    • Conflict resolution and interaction management skillsWhy GSK?We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021.We continue to modernize, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.*LI-GSKIf 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.At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting site.

Keywords: GlaxoSmithKline, Rockville , Associate Operational Quality Specialist - Batch Record Review, Professions , Rockville, Maryland