Production Technical Operations Specialist I

Rockville, MD
August 20 2021
Organization Type
Site Name: USA - Maryland - Rockville Posted Date: Aug 20 2021 GSK currently has a opening for a Production Technical Operations Specialist I in Rockville, MD. In this role you'll be maintaining/improving/drafting GMP documentation (BRs, SOPs, WIs, TRPs), assist with CAPAs/MCs, assist with delivering training (Production new hire & general/refreshers), some Training matrices maintenance, and maintain critical M-ERP data to support Production to be a more agile/flexible work force. Key Responsibilities: Manage Production documents such as BRs, SOPs, WIs, and TRPs by working with SMEs to develop and/or update documents to be safe, compliant, efficient, and continuously improve including in the digital space (eBR), for new product introductions (NPIs), or new equipment. Assist with MERP Process Data, SAP Software Operating System, and CAPAs/MCs execution. Assist in review of human factor related incidents to determine the need for additional/modified training or documentation improvements. Assist the Production New Hire Training Program & some general training as needed. Assist with maintenance and revision of area specific training matrices/curricula as needed. Assist in GEMBAs, RCAs, problem solves, or continuous improvement initiatives as needed. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Associates Degree or 1+ years of experience in a pharmaceutical manufacturing facility 1+ years of experience as a qualified trainer and/or facilitating classes. 1+ years of experience in production control systems (Delta-V, CCDARTS, Unicorn, or similar) 1+ years of experience authoring and/or revising technical documents. Experience in current Good Manufacturing Practices environment and Enterprise training systems (i.e. MyLearning). Preferred Qualifications: If you have the following characteristics, it would be a plus: • Proven ability to work effectively in cross-functional teams and implement project plans on time • Good knowledge of written and oral English. • Must be flexible, adaptable and a strong team player. • Excellent communicator across multiple mediums (IM, email, face to face, etc.). • Ability to work well under high pressure and deadlines. • Ability to adapt to changing technologies (MERP, eBR, AR/VR, etc.). • Excellent organizational skills. • Strong attention to detail. • Must be willing to work modified shifts to support customers on shift as needed. Why GSK? Our values and expectations are 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. 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