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Production Specialist Manager

Company: GSK
Location: Rockville
Posted on: June 24, 2022

Job Description:

Site Name: USA - Maryland - RockvillePosted Date: May 26 2022GSK currently has an opening for a Production Specialist Manager in Rockville, MD. The Production Specialist Manager will be part of a high performing team responsible for delivering the supply of GSK products to the One Biopharm supply chain. They will demonstrate GSK Values (ambitious for patients, accountability for impact, and do the right thing) on a daily basis by engaging positively with team members and production support groups. The Production Specialist Manager with support Manufacturing and Site Management by leading a talented team responsible for troubleshooting process deviations, developing and executing of CAPAs, supporting start-up/product changeover activities, supporting editing and approving documentation changes (i.e. batch records and standard operating procedures (SOPS), and champion of continuous improvement of site systems and processes.Key Responsibilities:Demonstrate GSK Values - ambitious for patients, accountability for impact, and do the right thing - in every interaction, in every work task, and with every responsibility of the job role to achieve high performing behaviors in the workplace. Adhere to safety procedures and training requirements in accordance with site, GSK, and federal regulations including the proper use of controls, personal protection equipment, and waste handling practices. Follow ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) principles for all documentation of performed tasks.Line Manager to the Production Specialist who lead deviation investigations (DE), create or execute corrective action and preventative actions (CAPAs), create or execute change controls (MCs), or manage Batch Records) with the main responsibility to coach the Production Specialist in enhancing their technical capability and navigating through the various production systems and processes (i.e. MERP, deviation process, CAPA process, MC process, and Veeva process). If applicable, can also perform Production Specialist duties. Understand biopharmaceutical production processing and SAP MERP quality systems (DE, CAPA, MC, Batch Records), Veeva). Serve as subject matter experts (SME) in these systems and can be a delegate for the Production Specialist Associate Director in decision making and signature authority.Responsible for implementing and ensuring compliance to GSK employment policies by proactively addressing performance, coaching individuals and team on GSK processes and practices, participating in talent management and recruitment, conducting frequent 1:1s with team members, participating in the site escalation ladder, and demonstrating recognition and celebration for success.Manage team's workload against production schedule, trainings, development, and system accesses to ensure an equal spread of work amongst the entire Specialists team and a successful recruitment/on-boarding for the new hires.Engage in cross functional teams and use operational knowledge and project management skills to prioritize improvements that simplify both technical processes and business systems (quality systems, logistics, etc.). As a leader, ensure the team has appropriately prioritized these initiatives and is developing the capabilities to execute them, specifically in technical writing. Responsible for measuring/improving KPIs related to training, performance management with quality notifications (DE, CAPA, and or MC), production team health, and other inspection readiness metrics.Support and interact with agency (FDA, EMEA, etc.) auditors if required and help drive inspection readiness (i.e. creating and/or presenting story boards, conducting L1 audits against Audit Universe, execute audit CAPAs, etc). If applicable, will be available as on-call personnel representing the Production Specialist team (i.e. some weekends and night coverage) to support deviations management.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:BS or BA Degree3+ years of GMP production or pharmaceutical experiencePreferred Qualifications:If you have the following characteristics, it would be a plus:5+ years of GMP experience preferredUnderstanding of DeltaV, eBR, MERP, IP21Project management experienceLeadership experience-Lead and performance manage a small teamDemonstrated continuous improvement behaviors including problem solvingDemonstrated flexibility, ability to adapt and accommodate different/ multiple work demands.Why GSK?At GSK, we have already delivered unprecedented change over the past four years, improving R, 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 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 isambitious 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 For the Record site.

Keywords: GSK, Rockville , Production Specialist Manager, Professions , Rockville, Maryland

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