{"id":3482940,"url":"https://alion.io/job/cordenpharma-deviation-investigator-associate","title":"Deviation Investigator Associate","company":{"id":2014421,"name":"CordenPharma","domain":"cordenpharma.com","url":"https://alion.io/company/cordenpharma","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":{"grade":"B","score":84,"open_postings":4,"ghost_share":0,"stale_share":0.5,"repost_share":0.25,"time_to_fill_p50_days":51,"computed_at":"2026-11-05T05:54:30Z"}},"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":["Boulder, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":76500,"max":95500,"currency":"USD","period":"year","gross":null,"usd_annual":95500},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-29T20:43:34Z","employer_posted_date":"2026-10-29","last_verified_at":"2026-11-05T00:13:36Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"CordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.\nOur network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.\nOur People Vision\nWe strive for excellence. We share our passion. Together, we make a difference in patients' lives.\nSUMMARY\nResponsible for on time completion and writing of deviations, laboratory investigations, and/or assigned corrective/preventative actions. Can lead manufacturing or laboratory investigations with minimal guidance. Works directly with supervisors, operators, or other Corden staff to collect data to support root cause analysis and CAPA identification. Participates in Operational Excellence Program.\nESSENTIAL DUTIES AND RESPONSIBILITIES\nInclude the following. Other duties may be assigned.\nResponsible for initiation, completion, drafting, and on time closure of investigations assigned\nWork closely with cross functional teams to collect data and conduct interviews immediately following a deviation; including working with technical teams to identify and document deviation impact\nLead and perform root cause analysis to determine most likely root cause/ contributing factors for a deviation \nGather and interpret data to ensure the deviation includes a documented justification for impact on materials, product, or system within scope of the deviation\nFacilitation and/or participation in meetings to drive internal alignment between the review team/area subject matter expert(s) on an investigational path forward\nIdentification and communication of observed trends to drive effective and sustainable system process improvements\nAble to progress multiple projects and deviations simultaneously\nCollaborate internally and with customers for correction resolution on deviation drafts\nParticipation in the Corden Operational Excellence Program to drive continuous improvement\nCollaborate and/or update procedures/documentation to address identified CAPAs\nPerform investigation in compliance with applicable CordenPharma procedures\nLEADERSHIP & BUDGET RESPONSIBILITIES\nProvides guidance and leadership where appropriate, based upon the results of deviations. Leads efforts for investigations assigned and process improvements identified.\nSAFETY & ENVIRONMENTAL RESPONSIBILITIES\nEvery individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.\nQUALITY RESPONSIBILITIES\nCorden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.\ncGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.\nQUALIFICATIONS\nTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nEDUCATION and/or EXPERIENCE\nBachelor’s Degree (BS) from a college or university in a technical field (Engineering, Chemistry, Science); and 2 years Pharmaceutical Manufacturing experience in a technical support; or equivalent combination of education and experience.\nLANGUAGE SKILLS\nAbility to read, analyze, and interpret procedures, technical data, and governmental regulations. Ability to write reports, business correspondence, and procedures/technical documents. Ability to effectively present information and respond to questions from other employees, managers, customers, and regulatory auditors. Ability to speak, read and write in English.\nMATHEMATICAL SKILLS\nAbility to apply mathematical operations to tasks such as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, factor analysis, etc.\nREASONING ABILITY\nAbility to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.\nCERTIFICATES, LICENSES, REGISTRATIONS\nNone.\nPHYSICAL DEMANDS\nThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nWhile performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and ability to adjust focus.\nWORK ENVIRONMENT\nThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nWhile performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions, moving mechanical parts, and outside weather conditions. The noise level in the work environment is usually moderate.\nCORE COMPETENCIES\nThese are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.\nTechnical writing for the educated, but uninformed reader. Able to translate very complex and challenging scientific or technical information into a brief and complete report\nWork well on a team and be able to trouble shoot and problem solve in a cross functional team setting\nProven logic and decision-making abilities, critical thinking skills\nStrong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with cGMP Quality Systems\nInvestigator/initiators are expected to work in a Good Manufacturing Practice (cGMP) environment and have familiarity with cGMP quality systems\nThe ability to manage multiple ongoing projects concurrently\nHave excellent meeting facilitation and conflict resolution skills\nProfessional and proficient technical writing capability\nAbility to work in a fast-paced environment\nStrong written and verbal communication skills are required\nKnowledge of common investigative tools (6M, 5Whys, etc.)\nSALARY\nActual pay will be based on your skills and experience.\nBENEFITS\n401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service \nAccident Plan\nCritical Illness Insurance\nDental Insurance\nDisability Insurance\nEmployee Assistance Program\nFlexible Spending Account\nHealth Insurance PPO/HSA\nHospital Indemnity Plan\nID Theft Protection\nLife Insurance\nPaid Maternity/Paternity Leave\nTuition Reimbursement\nWellness Program\nVacation - Three Weeks 1st Year\nVision Insurance\nEQUAL OPPORTUNITY EMPLOYER\nCorden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.\nThis post will expire November 23, 2026","description_format":"text","description_chars":9170,"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":[{"language":"English","level":"All levels","optional":false}]},"benefits":["Dental insurance","Health insurance","Life insurance","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-29T20:43:34Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":6,"expected_fill_days":51,"reasons":["conf:5","win:early","comp:junior"],"computed_at":"2026-11-05T05:54:30Z"},"pay":{"stated_usd_annual":95500,"is_top_pay":true},"html_url":"https://alion.io/job/cordenpharma-deviation-investigator-associate","json_url":"https://alion.io/job/cordenpharma-deviation-investigator-associate.json","meta":{"generated_at":"2026-11-05T11:54:38Z","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":15161,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-06T00:00:00Z"}},"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":2014421},"rest":"https://alion.io/mcp/rest/get_company?id=2014421"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcordenpharma-deviation-investigator-associate"},{"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%2Fcordenpharma-deviation-investigator-associate"},{"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%2Fcordenpharma-deviation-investigator-associate"},{"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/cordenpharma-deviation-investigator-associate\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcordenpharma-deviation-investigator-associate"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3482940}},{"tool":"search_jobs","arguments":{"company":"cordenpharma.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3482940},"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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