Operational Quality Specialist

Company: GlaxoSmithKline
Location: Rockville
Posted on: May 16, 2022

Job Description:

Site Name: USA - Maryland - RockvillePosted Date: Apr 4 2022GSK is currently looking for an Operational Quality Specialist to join our team in Rockville, MD. The purpose of this role is to be the first line of contact for operational quality advice and support for Production and other site operational areas. - Drive for early detection and help prevent potential quality issues. Review of Batch Records for product that is manufactured in compliance with regulatory agencies' requirements and company standardsKey Responsibilities:

• Provides a Quality Oversight for the production areas including Manufacturing, Warehouse, Laboratories, Facilities and Engineering.
  • Perform rapid response, walk throughs, process assessments, and change over walk-throughs
  • Review GMP related documentation such as SOPs, MC, Deviation/CAPAs, executed solution batch records and executed BDS process batch records Master Batch Records, Glass Wash and Autoclave records, cleaning logs, temperature charts, equipment alarms and Technical Reports. Approves any changes associated with these documents.
  • Review EM and water data for facility and EM for bulk fills
  • Review executed protocols and summary reports for GMP laboratory equipment, manufacturing equipment, facility utilities, process controllers, IT systems and process validation
  • Support/Perform L1 and L2 audits and Inspection Readiness efforts making sure that area logbook and documentation is accurate and reviewed in a timely manner
  • Review Validations documents.
  • Work across multiple value streams to drive continuous improvement and promote quality culture. Utilizes and continuously improves 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.
  • Performs other functions as necessary or as assigned.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:
    • Associates degree in Technical/Scientific disciplinePreferred Qualifications:If you have the following characteristics, it would be a plus:
      • Bachelor's degree preferred
      • 3+ years' experience in Manufacturing, Quality, QC environment preferred. - -
      • Knowledge of cGMP's/FDA and other Regulatory requirements such as ICH Guidelines 8, 9, 10, 11. -
      • Demonstrate initiative and analytical problem-solving skills - ability to use and interpret data to drive decision making at both tactical and strategic level. -
      • Ability to work well under high pressure and deadlines -
      • Must be flexible, adaptable, and a strong team player and a leader that fosters teamwork and promotes GSK Values, Behaviours and Strategies. -
      • Excellent verbal and written communication skills.
      • Conflict resolution and interaction management skills.
      • Knowledge and application of the principles of Quality Management Systems (QMS)Why GSK?At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is -ambitious for patients -- so we deliver what matters better and faster; -accountable for impact -- with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead 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 , Operational Quality Specialist, Other , Rockville, Maryland