Production Technical Operations Specialist II

Company: GlaxoSmithKline
Location: Rockville
Posted on: August 4, 2022

Job Description:

Site Name: USA - Maryland - Rockville Posted Date: Jul 22 2022 The Investigative Specialist is an integral position for our Production Organization. The Specialist reports directory to the Production Investigative Specialist Manager. The Specialist manages cross-functional deviation investigations and corrective and preventative actions. This position is responsible for ensuring thorough investigations that lead to effective CAPAs while ensuring on-time closure for product lot release. Leads cross-functional complex deviation investigations with on-time closure to ensure product batch release. Follow ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) principles for all documentation of performed tasks. Own deviations investigations and management of corrective and preventative (CAPA) actions, and product impact assessments. Develops biopharmecutical operations process knowledge and stakeholder management through their relationships with the Production team (BMAs, First Line Leaders), Quality, and supporting departments. Supports training new hire Specialists on deviations/technical writing. Leads or supports Continuous Improvement projects. Conducts data gathering, trending, and data presentation as needed to support investigations and continuous improvement activities Support internal and external audits as needed. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BA / BS in a scientific or technical discipline, and 2 years of demonstrated technical competency in biopharmaceutical manufacturing processing. 2 years of experience in a biopharmaceutical manufacturing facility (operations experience preferred) 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 budget Excellent communication and technical writing skills Ability to support and / or lead system troubleshooting efforts Participate in cross-functional teams to solve production problems 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-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. 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/ Agencies GSK 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.PDN-96d7eff9-9737-46cf-92aa-ad6e0a4ee039

Keywords: GlaxoSmithKline, Rockville , Production Technical Operations Specialist II, IT / Software / Systems , Rockville, Maryland