MQA (Manufacturing Quality Assurance) Associate II

Nexus employees earn 4 weeks’ vacation per year, and our benefits start on day 1!

Title: MQA (Manufacturing Quality Assurance) Associate IIFull TimeLocation: Pleasant Prairie, WI

Our CompanyNexus Pharmaceuticals, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most.

Responsibilities:Performs tasks/deviations/investigations/protocols/CAPAs of moderate and high complexity; works closely with other members of the organization during investigations to determine root cause and potential preventative/corrective actions.Responsible for the timely closure of investigations and quality recordsParticipate in change control process as necessary to maintain document audit readinessIdentify improvements/new procedures/compliance gaps based on applicable regulations for GMP operationsGenerate and issue batch records for manufacturing operationsAudit critical manufacturing processes to ensure cGMP compliance and approve critical manufacturing areas for useIdentify and respond to instances of manufacturing deviations and discrepancies or laboratory out of specification results; assess risk to product and provide recommendations to management for resolutionReview aseptic manufacturing records for batches to assure compliance with cGMP before being released for further processing, packaging or commercial release.Review logbooks for accuracy, completeness, compliance to company standard operating procedures and regulatory guidelines/regulationsEnsure compliance with DEA regulations for controlled substancesMonitor, generate, and review daily alarm reports within the Environmental Monitoring System to ensure compliance with GMP regulations.Perform internal audits according to schedule to identify areas of concern and/or process improvements based on current federal regulationsParticipates in inspection readiness activities and assists in inspections by regulatory authorities (FDA/DEA)May participate in vendor auditsModels effective and constructive communication behaviors and interactions with technical departments both orally and in writing; maintain acceptable proficiency in technical and non-technical (e.g., interpersonal) skillsOther duties as assigned

Skills and Abilities:Specific skill set: quality minded, critical thinking, technical writing, problem solving, experience in investigative techniques, highly detail oriented, and highly organizedAbility to communicate clearly and concisely when conveying information, summarizing facts, asking questions, etc.Must be able to work independentlyStrong organizational skillsAbility to set long-term goals and objectives

Education and Experience:4-year bachelor’s degree in science-related discipline3+ years of relevant experience. Pharmaceutical preferredKnowledge of Microsoft Office Suite Programs requiredFamiliarity with digital QMS systems, MasterControl preferred

Travel Requirements:5 – 20% travel required for this role (domestic and international)

Physical Requirements:Lifting requirements less than 50 pounds80% of day in manufacturing / 20% in officeOffice, manufacturing, and laboratory environment

Level of Proficiency:Must be able to work independentlyStrong organizational skills

DISCLAIMER: The list under Role Responsibilities is not exhaustive, but is merely the most accurate lists for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change.

EEOC Statement: Nexus is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Nexus participates in E-Verify.