JOBSEARCHER

Quality Associate

SotalentRound Lake, ILApril 22nd, 2026
About the RoleAn opportunity is available for a Quality Specialist to join an aseptic pharmaceutical production facility. In this role, you will help ensure that materials, processes, and finished products meet strict quality and regulatory standards.Your responsibilities will centre on reviewing and approving documentation, supporting manufacturing operations, and maintaining compliance across quality systems. You will play a key role in safeguarding product integrity and supporting continuous improvement within the plant.This position operates on a second-shift schedule (afternoon to late evening, Tuesday through Saturday).Key ResponsibilitiesOversee shop-floor quality initiatives, including maintaining procedures, tracking quality trends, and reporting findings to leadershipReview and approve documentation related to raw materials, batch records (both paper and electronic), and production activitiesManage the receipt, release, and investigation of raw materials and bulk containers, ensuring timely resolution of any discrepanciesSupport manufacturing operations through activities such as batch record handling, sample coordination, and label controlProvide backup support for stability programmes, including monitoring sample testing and coordinating updates with global teamsMaintain and approve quality-related procedures and documentation across the facilityDevelop and deliver training materials related to quality processesLead or contribute to investigations, corrective actions, and preventive measuresReview and approve change controls to ensure compliance with established standardsApprove packaging artwork and specifications using designated systemsLead or participate in quality improvement projects and communicate progress to site leadershipInvestigate inventory discrepancies within enterprise systems and collaborate with relevant teams to resolve issuesAct as a subject matter expert during internal and external auditsYour ProfileBachelor’s degree in a scientific, engineering, or related technical fieldAt least 2 years of experience in a quality or manufacturing environmentFamiliarity with aseptic manufacturing processes such as filling, inspection, and packagingStrong understanding of regulatory requirements and Good Manufacturing Practices (GMP)Ability to collaborate across departments and influence stakeholdersStrong organisational skills and ability to manage multiple prioritiesDetail-oriented with solid analytical and problem-solving capabilitiesEffective written and verbal communication skillsProficiency in standard office software toolsWorking Environment & RequirementsWork is performed in a controlled production environment requiring protective clothing and strict hygiene protocolsRestrictions may apply to personal items such as jewellery, cosmetics, or contact lenses while on the production floorExposure to varying conditions, including temperature-controlled or high-noise areasFlexibility to work different shifts, weekends, or extended hours when neededAbility to spend significant time on the production floorMust not have sensitivities to certain pharmaceutical compounds used on-siteOccasional travel for training or collaboration may be required (up to approximately 25% initially)Role requires physical activity such as standing, walking, and handling materials up to moderate weightWhat We OfferCompetitive salary, typically within the range of approximately $71,800.00 - $112,860.00 annually, depending on experience and qualificationsPerformance-related incentives where applicableComprehensive benefits package including healthcare, retirement plans, paid time off, and professional development opportunitiesA collaborative and inclusive working environment focused on innovation and continuous improvementEqual OpportunityWe are committed to providing equal employment opportunities and fostering a diverse and inclusive workplace. All qualified applicants will be considered without regard to protected characteristics.