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Manufacturing Specialist (Investigative)

Company: GlaxoSmithKline
Location: rockville
Posted on: May 3, 2021

Job Description:

Site Name: USA - Maryland - RockvillePosted Date: Apr 14 2021Are you looking to develop your skills in biopharm manufacturing quality and deviations management? If so, this Manufacturing Specialist (Investigative) could be an ideal opportunity to explore.This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:Leads cross-functional deviation investigations with on-time closure to ensure product batch release.Leads investigations including key responsibilities of:Initiation and management of Quality RecordsRoot cause analysisProduct impact assessmentStakeholder managementDevelops, executes and oversees corrective action and preventive actions (CAPAs)Works with the team to monitor critical process parametersLeads or supports Continuous Improvement projectsConducts data gathering, trending, and data presentation as needed to support investigations and continuous improvement activitiesSupports Manufacturing coordination efforts such as sampling, equipment modification and maintenance, and internal inspection activities to ensure minimal interruption to routine operationsAssists with shutdown/changeover and campaign scheduling and schedule managementSupports Tech transfer and process monitoring support as neededSupport internal and external audits as neededRevision and management of manufacturing documents such as Batch Records and SOPs as neededWhy you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:BA / BS in a scientific or technical discipline2+ years of demonstrated technical competency in biopharmaceutical manufacturing processingPrevious experience in a biopharmaceutical manufacturing facility (operations experience preferred) Previous experience in production control systems (Delta-V , CCDARTS, Unicorn, or similar)Previous experience in process deviation investigations and remediationPrevious experience authoring and/or revising technical documentsKnowledge of cGMP requirements and practices and previous experience in a cGMP setting Preferred Qualifications:If you have the following characteristics, it would be a plus:Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans on time and on budgetExcellent communication and technical writing skillsAbility to support and/or lead system troubleshooting effortsInitiates change control for equipment modificationsAssist in development, execution and reporting of data from biopharmaceutical technology and tech transfer studies/protocolsParticipate in cross-functional teams to solve production problemsCollect, assess, and generate and depict conclusions from large quantities of production dataWhy 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.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.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 For the Record site.

Keywords: GlaxoSmithKline, Rockville , Manufacturing Specialist (Investigative), Other , rockville, Maryland

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