Sr QA Specialist 2nd shiftHarba Solutions Limited • Indianapolis, Indiana, United States

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Sr QA Specialist 2nd shift

Harba Solutions Limited

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Über

Responsibilities Review and approve quality documentation, including raw material and component records, manufacturing batch documentation, change controls, deviations, CAPAs, and validation protocols and reports. Partner with manufacturing and operations teams to investigate equipment- and process-related deviations and support implementation of effective corrective and preventive actions. Maintain an active quality presence on the production floor to verify compliance with procedures, GMP requirements, and quality standards. Balance production schedules with quality requirements to ensure timely product disposition without compromising compliance. Perform electronic and manual release of incoming materials, sterile supplies, media, and manufacturing components. Manage the site reference sample retention program, ensuring proper collection, storage, and documentation. Oversee ancillary quality programs, including environmental and facility support activities such as pest control coordination. Conduct batch record review and support final product disposition decisions. Mentor and provide guidance to junior quality team members. Evaluate deviations in real time, determine product impact, initiate containment actions, and escalate critical issues when necessary. Contribute to cross-functional investigations using root cause analysis, risk assessments, and structured problem-solving tools. Promote a culture of safety, compliance, and continuous improvement by reinforcing adherence to SOPs, regulatory expectations, and operational goals. Utilize quality and manufacturing systems (eQMS, LIMS, SCADA, CMMS, and related software) to maintain documentation accuracy and data integrity. Analyze deviation and process data using statistical tools to identify trends, variability, and opportunities for improvement. Manage multiple priorities effectively in a dynamic, fast-paced manufacturing environment. Qualifications Bachelor’s degree in a scientific discipline such as Chemistry, Biology, Biochemistry, Microbiology, or a related field. 8+ years of experience in GMP-regulated manufacturing environments. 4+ years of quality assurance oversight experience supporting GMP manufacturing operations. 3+ years of hands-on experience with quality systems, including deviations, CAPA, document management, and change control. Strong understanding of GMP regulations, quality systems, and product disposition processes. Excellent written and verbal communication skills. Proficiency with electronic quality systems and data analysis tools, including Microsoft Office and statistical software.
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Indianapolis, Indiana, United States

Sprachkenntnisse

English

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