QA Specialist III

Job Summary

The QA Specialist III is responsible for supporting, and ensuring compliance with, quality systems related to deviations, CAPAs, change controls, and Standard Operating Procedures (SOPs) for Metrology and Facilities. This role involves thorough investigation and documentation of quality events, collaborating with cross-functional teams to drive resolutions, and ensuring compliance with regulatory requirements and site policies. The ideal candidate has extensive experience in quality assurance within a GMP-regulated environment and possesses strong analytical, problem-solving, and communication skills.

Key Responsibilities

Deviation and CAPA Management:

• Lead investigations into deviations related to Metrology and Facilities, ensuring root cause analysis and impact assessments are thorough and well-documented.
• Develop and implement corrective and preventive actions (CAPAs), ensuring timely completion and effectiveness verification.
• Work cross-functionally to drive continuous improvement in deviation and CAPA processes.

Change Control Management:

• Develop, evaluate, and process change control requests related to Metrology and Facilities equipment, systems, and procedures.
• Assess potential risks and ensure changes comply with regulatory requirements and internal policies.
• Coordinate with stakeholders to ensure smooth implementation of approved changes.

SOPs and Compliance:

• Author, review, and update SOPs related ensure alignment with industry best practices and regulatory requirements.
• Ensure that all activities and documentation comply with GxP, FDA, and other applicable regulatory standards.
• Partner with Metrology and Facilitiesteams to proactively identify quality risks and implement preventative measures.
• Support internal and external audits by providing documentation, conducting gap assessments, and ensuring corrective actions are completed.
• Monitor and analyze quality metrics to identify trends and recommend process improvements.
• Perform work safely and in compliance with EHS requirements

Education, Experience & Skills

• 3 years of experience in Quality Assurance within a GMP-regulated environment, with a focus on pharmaceutical equipment, facilities, calibrations and maintenance is preferred.
• In-depth knowledge of deviations, CAPAs, change controls, and SOPs.
• Strong understanding of GMP, FDA, and other regulatory requirements.
• Experience with quality management systems (QMS). Experience in Veeva, SAP and CMX is preferred.
• Excellent problem-solving, analytical, and communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Must be proficient in Microsoft Office Suite Products.
• Must have excellent written and oral communication abilities, including the ability to communicate clearly with and engage in dialogue with all levels of employees.

Job Type: Full-time

Pay: $40.00 - $50.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person

Salary : $40 - $50