Site Name: Cambridge Binney Street Posted Date: Dec 16 2024 Are you energized by a quality documentation role that allows you to enhance your technical skills and drive efficiency in quality standards? If so, the Documentation QA Staff role could be an ideal opportunity to explore. This on-site position is for M-F 11 am to 7pm shift and requires flexible schedule as necessary. As Documentation QA Staff, you will issue and manage key documentation such as Manufacturing Master Batch Records to consistently deliver based on Manufacturing schedule, create, and update Standard Operating Procedures or Work Instruction to consistently ensure compliance with defined requirements. This position provides the opportunity to work directly with Manufacturing, Supply Chain, Warehouse, QA Operations, and QC EM team members. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Key Responsibilities: Responsible for organization, management, and control of site cGXP documents and records in QA Document Control to established quality standards. Drive continuous Quality and Compliance mindset within QA Document Control to ensure compliance with cGMP and GSK requirements. Develop and update local procedures or work instructions to ensure compliance with GSK requirements and maintain audit readiness. Manage master batch record issuance, tracking, reconciliation, scanning and archival to support site manufacturing operations. Manage logbook issuance, tracking, reconciliation, and archival for the site. Perform Management Monitoring (MM) Champion audit role for QA Document Control. Perform site administration role in Veeva Quality Documentation, as required. Provide real time issue identification and resolution, collaborating with other team members including active involvement in problem-solving activities to understand concerns to develop solutions to accelerate performance in QA Document Control. Active participation in QA documentation Business Excellence continuous improvement projects. Collaborate with cross-site and cross-functional Single Point of Contact (SPOC) to identify and implement best practices and accelerate efficiencies. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree and 3+ years of cGXP/cGMP documentation experience., OR Associate degree and 4+ years of cGXP/cGMP documentation experience, OR High School diploma and 6+ years of cGXP/cGMP documentation experience. Experience resolving cGMP compliance issues and participating on continuous improvement teams. Experience with quality processes and activities, Environmental Health & Safety (EHS) and computerized systems such as ERP, Veeva Vault, SmartSheets, Microsoft Office, preferred. Preferred Qualifications: If you have the following characteristics, it would be a plus: Able to respond to changing priorities and expectations with a composed demeanor and foster effective cross-functional relationships. Excellent communication, writing and presentation skills for interfacing with internal and external organizations. Strong collaboration and team skills Able to think through the process and accurately apply and adapt GSK and regulatory standards. Helpful to understand the QA function in a start-up entity and ability to make decisions on go/no go criteria. Able to work effectively within a variety of situations and adapt enthusiastically to changes in job demands. Pursue tasks with energy, drive, and initiative; even in a fast-paced environment. Comfortable in a results-driven, highly accountable environment where you can make an impact. Builds productive working relationships across key groups. Ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. 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). 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