{"id":3295009,"url":"https://alion.io/job/leiters-operations-document-coordinator","title":"Operations Document Coordinator","company":{"id":3799549,"name":"Leiters","domain":"leiters.com","url":"https://alion.io/company/leiters","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":null},"role":"Administrative","role_family":"Administrative","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":["Englewood, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":63936,"max":79920,"currency":"USD","period":"year","gross":null,"usd_annual":79920},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-26T21:31:26Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-10-29T00:57:29Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"This position reports to the Visual Inspection, Labeling & Packaging (VILP) or Manufacturing Manager. The Operations Document Coordinator is responsible for performing Manufacturing, and VILP Batch Record (BR) initial review and assisting Manufacturing and VILP leadership in making the necessary BR corrections to facilitate the QA BR final review performed prior to product release. This position will also be responsible for conducting less complex investigations for any manufacturing/VILP discrepancies that may occur during product manufacturing and/or inspection, labelling and packaging. The candidate should have an excellent understanding of cGMP requirements. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, manufacturing and VILP experience, attention to detail, and excellent communication with other functional areas.\nWhy Join Leiters Health?\nAre you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further - Leiters Health is seeking talented individuals like you to join our dynamic team!\nAt Leiters Health, we're not just another pharmaceutical company - we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.\nInnovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.\nMeaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.\nProfessional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.\nCutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.\nCollaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.\nWho We're Looking For:\nWe're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today!\nEssential Functions:\nReview executed batch records and other relevant information to ensure documentation meets the ALCOA principles: Attributable, Legible, Contemporaneous, Original, Accurate\nFacilitates batch record corrections prior to the QA BR review team.\nAssists with BR corrections identified by the QA Specialists during the QA BR review process.\nTracks and trends corrections by department and by employee to identify areas for improvement (employee retraining, BR instructions that may need to be clarified, etc.)\nConduct less complex investigations related to manufacturing and VILP discrepancies.\nOther duties as assigned.\nSUPERVISORY RESPONSIBILITIES:\nNone\nEXPERIENCE AND NECESSARY SKILLS:\nBachelor’s degree (in a scientific discipline desired) or equivalent experience.\nAt least 2 years of experience in a cGMP environment, preferably in a pharmaceutical manufacturing organization. \nKnowledge and experience with the cGMPs requirements, especially regarding Good Documentation Practices (GDP).\nDetail oriented and able to identify potential adverse issues.\nExcellent organization and documentation skills.\nProficient with computer skills, including Microsoft Word and Excel.\nProficient written, verbal and oral English communication skills.\nPhysical Requirements:\nAbility to stand or sit for extended periods of time.\nAbility to stoop, crawl, bend, walk for extended periods of time, if applicable. \nAbility to lift, push and pull up to 25 pounds periodically. \nBenefits:\nSmart healthcare coverage options that rewards wellness (and puts money back in your pocket!)\nFlexible Spending & Health Savings Accounts (FSA & HSA) available\nDental & Vision insurance \nEmployer Paid Life Insurance & Employee Assistance Program\nShort Term & Long-Term Disability Insurance\nUp to 4% 401K Matching (100% vested on day one!)\nGenerous Paid Time Off Options - vacation, sick, paid leave and holidays!\n$5,250 Annual Tuition Reimbursement after 6 months\n$1,000 Referral Bonus Program with no limit\nEligible for annual bonus program \nTimeline: We will be accepting applications on an ongoing basis until position is filled.\nWe are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.\n*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.","description_format":"text","description_chars":5461,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[{"language":"English","level":"Upper-Intermediate (B2)","optional":false}]},"benefits":["401k plan","Growth opportunities","Life insurance","Professional development","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-26T21:31:26Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":0,"green_card_filings_12m":0,"median_offered_wage_usd":92500,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":95,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.946,"p_room":1,"age_days":1,"expected_fill_days":36,"reasons":["conf:3","urgency","win:early","comp:junior"],"computed_at":"2026-10-28T05:59:10Z"},"pay":{"stated_usd_annual":79920,"is_top_pay":true},"html_url":"https://alion.io/job/leiters-operations-document-coordinator","json_url":"https://alion.io/job/leiters-operations-document-coordinator.json","meta":{"generated_at":"2026-10-29T03:55:16Z","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":5977,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"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":3799549},"rest":"https://alion.io/mcp/rest/get_company?id=3799549"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fleiters-operations-document-coordinator"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"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%2Fleiters-operations-document-coordinator"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"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%2Fleiters-operations-document-coordinator"},{"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/leiters-operations-document-coordinator\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fleiters-operations-document-coordinator"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3295009}},{"tool":"search_jobs","arguments":{"company":"leiters.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3295009},"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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