{"id":3323091,"url":"https://alion.io/job/onequva-sterility-assurance-specialist-1st-shift","title":"Sterility Assurance Specialist 1st Shift","company":{"id":3832669,"name":"Onequva","domain":"onequva.com","url":"https://alion.io/company/onequva","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"UltiPro","truth_index":null},"role":"MedTech","role_family":"MedTech","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Bloomsbury, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":66000,"max_usd":160000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":31},"experience_years_min":2,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"Microsoft Excel","optional":false}],"status":"live","first_seen_at":"2026-09-29T14:49:47Z","employer_posted_date":"2026-09-29","last_verified_at":"2026-10-27T22:42:25Z","board_verified":true,"closed_at":null,"days_open":28,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":28},"description":"Our Sterility Assurance Specialist plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include the oversight and performance of the Quality Assurance aspects of Sterility Assurance, including Environmental/Personnel Monitoring teams to ensure compliance within the facility. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.\nThis is a full-time role for our 1st shift, working Monday through Friday from 6:00am to 2:30pm. This is a set, consistent schedule based on site in our Bloomsbury, NJ location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws.\nWhat the Sterility Assurance Specialist Does Each Day: \nEnsures company compliance to Quva Pharma’s Standard Operating Procedures (SOPs) and Quality Management System (QMS)\nSchedule & Proctor Media Fills\nPerforms reading of media aseptic process simulations and Environmental/Personnel Monitoring (EM/PM) plates and accounting of all units\nPerforms EM/PM sampling; Maintains EM/PM records\nPeriodically reviews Environmental/Personnel monitoring data to identify any potential trends\nProviding training support for personnel on appropriate aseptic techniques and gowning techniques including execution of Compounder Competency Assessments\nProvides support for sterility investigations including EM/PM excursions and review of deviations and investigations\nWorks in accordance with area Supervision to provide quality assurance oversight where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs)\nDemonstrates a high level of discretion in the timely identification, and resolution of events potentially impacting the Quality of products and processes\nProvides an established technical expertise for current processes and oversees training of department personnel on new processes\nReviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products\nEvaluation of batches / product for compliance with defined specifications\nSampling, inspection, and control of commercial product labels\nReview and approval of shipping documentation for commercial products\nOur Most Successful Sterility Assurance Specialists:\nWork to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout facility\nAre detail-oriented with strong verbal and written communications skills\nSupport the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards\nAct decisively with purposeful pursuit of goals or objectives, and thinks strategically in terms of solutions\nDrive achievement, expresses energy, shows accountability, ability to multi-task and work in a fast-paced, quality-rich environment\nMotivate others, share knowledge, build high performing teams, show respect towards others, and give constructive feedback\nMinimum Requirements for this Role:\nA High School diploma or equivalent\nAble to successfully complete a drug and background check\nStrong Microsoft Word and Excel skills\nMust be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas\nKnowledge of sterile pharmaceutical manufacturing technologies and FDA and other applicable GMP regulations for Sterile Product\nAny of the Following Will Give You an Edge: \nBachelor’s Degree in life science or related field\nAt least 1 year experience at Quva Pharma\nAt least 2 years’ experience in Quality Assurance, Sterile Compounding and/or GMP production facility\nAt least 2 years’ experience with FDA-regulated operations (cGMP processes)\nBenefits of Working at Quva:\nSet, full-time, consistent work schedule\nComprehensive health and wellness benefits including medical, dental and vision\n401k retirement program with company match\n17 paid days off plus 8 paid holidays per year\nNational, industry-leading high growth company with future career advancement opportunities\nPay range $18.85- $27.34 based on experience \nAbout QuVa:\nQuva Pharma is a national, industry-leading, FDA registered 503B outsourcing services company that provides hospitals with essential medications in ready-to-administer injectable formats that are critical for effective patient care. We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide. As a leader in sterile compounding, we continue to invest in automation and integrated technologies to improve our production processes, safety, consistency, and product quality.\nAs part of our team, you'll experience being at the forefront of groundbreaking solutions, collaborating with brilliant minds, and making a tangible impact in healthcare delivery.\nQuva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. 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