QA Associate I Operations

JOB REQUIREMENTS: Life changing therapies. Global impact. Bridge tothousands of biopharma companies and their patients. We are PCI. Ourinvestment is in People who make an impact, drive progress and create abetter tomorrow. Our strategy includes building teams across our globalnetwork to pioneer and shape the future of PCI. Step Into Quality. StartYour Career with Purpose. Are you eager to build your career inpharmaceutical manufacturing while making a meaningful impact on productquality and patient safety? Join us at PCI as a Quality Associate I -Operations, where you'll be on the front lines of GMPproduction-supporting real-time quality oversight, solving problems asthey arise, and ensuring that every product meets the highest standardsof safety, efficacy, and compliance. This is an ideal role forearly-career professionals passionate about science, quality, andcontinuous improvement. You'll receive hands-on training, mentorship,and exposure to industry best practices while working in a fast-paced,collaborative environment.What You'll Do Provide real-time QA supporton the production floor: observe critical operations, audit procedures,and monitor compliance during GMP manufacturing Perform in-processreviews of executed batch records and documentation for completeness andaccuracy Participate in lot disposition and review of drug product andintermediates Act as a first responder to quality issues, documentinginvestigations and supporting immediate corrective actions ConductAcceptable Quality Limit (AQL) visual inspections of drug productSupport deviation documentation, root cause investigations (using toolslike 5 Whys, Fishbone), and CAPA processes Collaborate acrossdepartments and represent QA during manufacturing activities and processimprovements Contribute to SOP revisions, quality initiatives, andregulatory readinessWhat You Bring Bachelor's degree in a relevantscientific field (preferred) 0-2 years of experience in thepharmaceutical or biotech industry 1+ years of experience in QAOperations (preferred) Understanding of GMP regulations (21 CFR210/211/820); exposure to ICH guidelines and risk tools (FMEA, HACCP,ICH Q9) a plus Strong organizational and technical writing skills, withattention to detail Familiarity with Microsoft Word, Excel, and OutlookAbility to manage multiple tasks and communicate effectively acrossteams Self-starter mindset with the ability to work... For full infofollow application link. LSNE is an EEO/AA Employer and all qualifiedapplicants will receive consideration for employment without regard to,their race, color, religion, sex, age, national origin, ancestry, sexualorientation, gender identity, disability, protected genetic information,protected veteran status, military service, or other protected status.The Company's EEO policy, as well as its affirmative actionobligations, include the full and complete support of The Company. APPLICATION INSTRUCTIONS: Apply Online:ipc.us/t/CBF62133280D469C

Created: 2025-12-18