Sr QA Specialist 2nd shift

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.