{"id":2937014,"url":"https://alion.io/job/gsk-operational-quality-specialist","title":"Operational Quality Specialist","company":{"id":6649,"name":"GSK","domain":"gsk.com","url":"https://alion.io/company/gsk","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":86,"open_postings":60,"ghost_share":0,"stale_share":0.733,"repost_share":0.017,"time_to_fill_p50_days":16,"computed_at":"2026-11-10T06:52:35Z"}},"role":"Operations","role_family":"Operations","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Marietta, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":64000,"max_usd":133000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2645},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-08-25T00:00:00Z","employer_posted_date":"2026-08-25","last_verified_at":"2026-11-10T02:52:13Z","board_verified":true,"closed_at":null,"days_open":77,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":77},"description":"Business Introduction:\nWe manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.\nPosition Summary:\nYou will provide operational quality oversight at a United States manufacturing site. You will work closely with production, laboratories, engineering and quality teams to keep processes compliant, safe, and reliable. To ensure adherence to cGxP standards and procedures through the independent oversight of GxP processes. To improve the effectiveness of quality in preventing, identifying and addressing quality issues by encouraging proactive quality culture and continuous improvement. To maintain presence and be accountable for batch record review and approval, key quality decision-making, and quality escalations. To be a liaison between operations and the site QA Systems, QA Compliance and QA Product Release (QAPR) departments. We value practical problem solvers who make clear decisions and coach others. This role offers hands-on learning, visible impact on product quality, and growth opportunities that align with our mission of uniting science, technology and talent to get ahead of disease together.\nResponsibilities:\nEnsure that all GMP processes and operational personnel adhere to current GMP, applicable regulatory requirements, and procedures, minimizing risk of non-compliance and maintaining inspection readiness at all times.\n\nMaintain shopfloor oversight across area of responsibility and be the first line of contact to support initial management of quality issues, demonstrate quality decision-making, and provide quality escalations as needed.\n\nProvide guidance during GMP activities to proactively detect potential quality issues through active observation in real-time, allowing for timely interventions to prevent deviations and defects.\n\nPerform a spot-check of activities across production and laboratory areas to ensure compliance with quality standards that includes production, testing, cleaning and maintenance activities.\n\nCarry out review of cGMP documentation and records ensuring that the content meets defined criteria, exceptions have been appropriately addressed, and Good Documentation Practice (GDP) is being maintained following ALCOA+ principles for data integrity, audit and traceability. Review and final approve batch records and batch related documentation.\n\nProvide review, initial impact approval, and final approval of deviations and associated CAPA plans. Provide review and approval of documentation which may include procedural revisions, logbooks, PQRs, customer complaint investigations, change controls, validation documents, etc.\n\nEnsure all GMPs, validation, quality, safety and environmental regulations are met. Adhere to all safety guidelines and procedures.\n\nRole model by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the why and the impact non-compliance can have on product quality and patient safety.\n\nProvide on-the-floor quality oversight, perform regular shopfloor walk-throughs, and detect early quality risks. Review executed and master batch records, deviations, and CAPA plans for completeness and compliance.\n\nMake or recommend disposition decisions and support lot release activities following defined procedures. Support and perform self-inspections, internal audits, and inspection readiness activities.\n\nReview and approve GMP documentation including change controls, validation summaries, and procedural updates. Investigate quality issues, support root cause analysis, and help implement corrective and preventive actions.\n\nWhy You?\nThis role is on-site at a United States manufacturing location and requires regular presence in production and laboratory areas. We are building a team that values collaboration, clarity, and continuous learning. We are committed to inclusion and want colleagues who help create a respectful, supportive workplace.\nBasic Qualifications:\nWe are seeking professionals with the following required skills and qualifications to help us achieve our goals:\nBachelor’s degree in biology, chemical engineering, life sciences field or a bachelor's degree in another discipline is acceptable if technical depth has been achieved from professional experience.\n\n2 + years of experience in regulated industry. Strong quality assurance background. Experience in biologics manufacturing is strongly preferred. Experience working in pharmaceutical facilities, equipment, and quality systems.\n\n1+ years of experience with GMP’s, NIH Guidelines, FDA and other regulatory agency compliance requirements sufficient to apply to quality operations and compliance.\n\nExperience with validation principles, aseptic processing, quality systems and FDA regulations. Experience with training in DMAIC root cause analysis methodology. Experience reviewing batch records and GMP documentation.\n\nPreferred Qualifications:\nIf you have the following characteristics, it would be a plus:\nExperience in biologics or pharmaceutical manufacturing environments with deviations, CAPA, change control, and validation activities. Training or experience in root cause analysis methods such as DMAIC or similar.\n\nFamiliarity with inspection readiness and regulatory agency expectations. Demonstrated ability to influence cross-functional teams and coach others on quality behaviors. Comfortable working in a fast-paced environment and prioritizing competing demands.\n\nWell-developed interpersonal skills and decision-making capabilities with the ability to influence different levels of the Site and Quality organization. Ability to deliver clear communications (written and verbally), coaching, foster a ‘Quality Starts With Me’ culture and work with a spirit of continuous improvement.\n\nAbility to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal quality solutions and implement decisions. Time management skills and ability to prioritize and respond to operational needs and issues within high paced environment. Be a team player prepared to work in and embrace a multi-skilled team-based culture.\n\nHow to apply:\nIf this role matches your skills and ambitions, we encourage you to apply. Tell us how your experience aligns with the responsibilities and qualifications. Share examples of quality improvements you have delivered and how you supported teammates. We look forward to hearing from you and exploring how you can help make a real difference for patients.\nSkills\nData Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Technical WritingPlease visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.\nWhy GSK?\nUniting science, technology and talent to get ahead of disease together.\nGSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.\nPeople and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.\nIf you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - \nGSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.\nImportant notice to Employment businesses/ Agencies\nGSK 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.\nPlease 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 the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/","description_format":"text","description_chars":10723,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Continuous learning","Growth opportunities"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Vaccines","Oncology Therapeutics","Infectious Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-20T16:21:09Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 65 · green card filings: 1","filings_12m":65,"filings_prev_12m":42,"green_card_filings_12m":1,"median_offered_wage_usd":101515,"route":null,"cap_exempt":false,"checked_at":"2026-11-10T11:34:35+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":5,"band":"cold","label":"Long shot","p_open":1,"p_active":0.161,"p_room":0.28,"age_days":77,"expected_fill_days":16,"reasons":["conf:4","stale_co","velocity","win:tail","crowd:junior,brand"],"computed_at":"2026-11-10T06:52:35Z"},"pay":null,"html_url":"https://alion.io/job/gsk-operational-quality-specialist","json_url":"https://alion.io/job/gsk-operational-quality-specialist.json","meta":{"generated_at":"2026-11-10T13:14:55Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":30819,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-11T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":6649},"rest":"https://alion.io/mcp/rest/get_company?id=6649"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fgsk-operational-quality-specialist"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fgsk-operational-quality-specialist"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fgsk-operational-quality-specialist"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/gsk-operational-quality-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgsk-operational-quality-specialist"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2937014}},{"tool":"search_jobs","arguments":{"company":"gsk.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2937014},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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