{"id":3920726,"url":"https://alion.io/job/amgen-sr-associate-quality-assurance-pqa-2nd-shift","title":"Sr Associate Quality Assurance - PQA - 2nd Shift","company":{"id":4775,"name":"Amgen","domain":"amgen.com","url":"https://alion.io/company/amgen","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":83,"open_postings":337,"ghost_share":0,"stale_share":0.68,"repost_share":0.018,"time_to_fill_p50_days":42,"computed_at":"2026-11-11T05:49:22Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Holly Springs, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":82081,"max":111052,"currency":"USD","period":"year","gross":null,"usd_annual":111052},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":true}],"status":"live","first_seen_at":"2026-11-06T00:00:00Z","employer_posted_date":"2026-11-06","last_verified_at":"2026-11-11T22:44:15Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"Career Category\nQualityJob Description\nJoin Amgen’s Mission of Serving Patients\nAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.\nSince 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.\nOur award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.\nSR ASSOCIATE QUALITY ASSURANCE I - PQA - 2ND SHIFT\nWhat you will do\nLet’s do this. Let’s change the world. In this vital role you will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance.\n* Staff for the PQA team are on-site workers.\nThe Plant Quality Assurance team will work different shift structures to provide ongoing support to our functional teams and 24/7 operations. There are several openings for this position. The successful incumbent will be expected to transition to a shift working schedule, including weekends, and is intended to serve second-shift hours (early afternoon through late evening). Specific hours will be determined based on operational needs.\nSupport ANC facility commissioning and qualification and manufacturing Analytical Equipment Qualification and Validation activities, perform quality review and approval of documents according to project timelines.\nQuality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems. May include support on commissioning and qualification and validation activities in addition to new document support.\nProvide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.\nEnsure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.\nDrive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations.\nEnsure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.\nOversee and provide guidance during on-the-floor analytical testing.\nEnsure that changes that could potentially impact product quality are assessed according to procedures.\nEnsure that deviations from established procedures are investigated and documented per procedures.\nAlert senior management of quality, compliance, supply and safety risks.\nProvide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.\nIdentification and implementation of continuous improvement opportunities within our processes and systems.\nSupport and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.\n\nWhat we expect of you\nWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications.\nBasic Qualifications:\nHigh school/GED + 4 years of Quality,manufacturing and/or other regulated environment work experience OR\nAssociate’s + 2 years of Quality,manufacturing and/or other regulated environment work experience OR\nBachelor’s + 6 months of Quality,manufacturing and/or other regulated environment work experience OR\nMaster's \nPreferred Qualifications:\nStrong cGMP and GDP behaviors\nExperience in biotechnology or pharmaceutical plant start up\nKnowledge and process experience within a cGMP manufacturing facility or other highly regulated environment \nTechnical understanding of upstream and/or downstream manufacturing within a biotechnology production operation \nProficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems \nDemonstrated experience with deviations records\nExperience supporting GMP testing laboratories.\nStrong organizational skills and ability to manage multiple tasks at one time, ability to follow assignments through to completion and meet timelines\nStrong communication skills, both written and oral\nDemonstrated ability to work as a team player and independently\n\nWhat you can expect of us\nAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.\nThe expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.\nIn addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:\nA comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts\nA discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan\nStock-based long-term incentives\nAward-winning time-off plans\nFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.\nApply now and make a lasting impact with the Amgen team.\ncareers.amgen.com\nIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.\nApplication deadline\nAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.\n\nSponsorship\nSponsorship for this role is not guaranteed.\nAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.\nAmgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.\nWe will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.\n.Salary Range\n82,081.95USD -111,052.05 USD","description_format":"text","description_chars":8617,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"high_school","optional":false},"security_clearance":false,"languages":[]},"benefits":["Flexible schedule","Retirement plans"],"hiring_locations":[],"hiring_excludes":[{"name":"Puerto Rico","iso":"PR"}],"relocation_offered":false,"industries":["Biotechnology","Prescription Drugs","Immunology & Inflammation Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-11-07T14:49:16Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 372 · green card filings: 113","filings_12m":372,"filings_prev_12m":465,"green_card_filings_12m":113,"median_offered_wage_usd":136675,"route":null,"cap_exempt":false,"checked_at":"2026-11-11T07:38:50+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":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":5,"expected_fill_days":42,"reasons":["conf:0","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-11-11T05:49:22Z"},"pay":{"stated_usd_annual":111052,"is_top_pay":false},"html_url":"https://alion.io/job/amgen-sr-associate-quality-assurance-pqa-2nd-shift","json_url":"https://alion.io/job/amgen-sr-associate-quality-assurance-pqa-2nd-shift.json","meta":{"generated_at":"2026-11-12T00:42:51Z","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":1678,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-13T00:00:00Z"}},"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":4775},"rest":"https://alion.io/mcp/rest/get_company?id=4775"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Famgen-sr-associate-quality-assurance-pqa-2nd-shift"},{"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%2Famgen-sr-associate-quality-assurance-pqa-2nd-shift"},{"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%2Famgen-sr-associate-quality-assurance-pqa-2nd-shift"},{"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/amgen-sr-associate-quality-assurance-pqa-2nd-shift\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Famgen-sr-associate-quality-assurance-pqa-2nd-shift"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3920726}},{"tool":"search_jobs","arguments":{"company":"amgen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3920726},"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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