{"id":4204003,"url":"https://alion.io/job/hikma-pharmaceuticals-documentation-specialist","title":"Documentation Specialist","company":{"id":1843927,"name":"Hikma Pharmaceuticals","domain":"hikma.com","url":"https://alion.io/company/hikma","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Phenom","truth_index":null},"role":"Product","role_family":"Product","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":["Bedford, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":21,"max":null,"currency":"USD","period":"hour","gross":null,"usd_annual":42000},"salary_estimate":null,"experience_years_min":1,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-11-12T22:07:46Z","employer_posted_date":"2026-11-12","last_verified_at":"2026-11-12T23:07:11Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Job Title: Documentation Specialist\nLocation: Bedford, Ohio\nJob Type: Full-time\nAbout Us:\nAs a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.\nDescription: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Documentation Specialist. In this role, you will be responsible for processing and reviewing executed batch records in Operations. Batch records must be reviewed for accuracy in compliance with cGMP, FDA regulations and policies. Additional responsibilities will include assisting in update/revisions of manufacturing Standard Operating Procedures and the tracking of the document approvals through the VEEVA document system.\nKey Responsibilities:\nRegular and predictable onsite attendance and punctuality.\nAccurately review and approve executed production batch records and associated batch related documents.\nAccurately arrange the documents in a batch record.\nRevise/update Standard Operating Procedures pertaining to the Operations group. \nMaintain acceptable cGMP and Safety training level. This includes maintaining Job specific curriculum training at least 95% complete, attending and passing cGMP training sessions. \nAssist the Operations department in deviation investigation through documentation of findings\nQualifications\nWe value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:\nEducation:\nMinimum: High School diploma or equivalent is required.\nPreferred: Associate of Science\nExperience:\nMinimum:\nOne or more years’ experience in healthcare/pharmaceutical product manufacturing or quality assurance.\nStrong background in pharmaceutical documentation and strong knowledge of cGMPs/FDA regulations\nSkills\nAbility to write, revise and review SOPs\nStrong interpersonal skills and great attention to detail are necessary\nProficient in Microsoft Office applications (Word and Excel)\nGood communication skills both verbal and written\nGood time management skills and the ability to multitask and work independently\nStrong ability to cope with the stress associated with changes in the daily production schedule\nMust have history of strong documentation skills and attention to detail.\nFamiliarity with cGMPs and CFR.\nGood organizational skills and ability to multi-task and perform work in a timely manner.\nAbility to work in a team environment with good communication skills and ability to communicate effectively with peers, department management and production personnel.\nBasic knowledge of computer systems at a proficient level to navigate input and/or reference computerized data.\nAbility to read and understand documents such as production batch records, safety rules, corporate guidelines and standard operating procedures.\nCompensation\nHourly Rate: $21.00 per hour. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.\nWhat We Offer*:\nAnnual performance bonus, commission, and share potential\nAuto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute\nA generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries\n3 personal days (prorated based on hire date)\n11 company paid holidays\nComprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits\nEmployee discount program\nWellbeing rewards program\nSafety and Quality is a top organizational priority\nCareer advancement and growth opportunities\nTuition reimbursement\nPaid maternity and parental leave\n*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.\nRecruiters:\nPlease note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.\nEqual Opportunity Employer:\nHikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. 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