Quality Assurance Associate
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Job Title: Quality Assurance Associate
Location (On-site, Remote, or Hybrid?): Chapel Hill, NC (onsite)
Contract Duration: 1 year Job description
The person in this position will be responsible for supporting QA Systems in conjunction with the Quality Assurance Manager.
Location (On-site, Remote, or Hybrid?): Chapel Hill, NC (onsite)
Contract Duration: 1 year Job description
The person in this position will be responsible for supporting QA Systems in conjunction with the Quality Assurance Manager.
- This person provides direction on the execution of quality processes for ACT facility employees, providing guidance and expectations on how those systems are to be followed.
- This person will help manage the critical document control system. Ensuring all facility documents are revised, made effective, and archived in a controlled manner according to appropriate governing policies.
- The person will also track QA System progress either through internal auditing or the use of metrics.
- Person will help direct others who are executing validation work, review executed work, ensure work is completed against plan.
- Person will be responsible for the review of executed batch records, identify corrections, and help resolve issues
- Based upon QA system usage the person will investigate occurrences and deviations and identify potential corrective and preventive actions to improve processes.
- This person will support the use of electronic quality management system.
- Batch Record Issuance
- Assists in the process of creating batch records and forms needed to support the process.
- Batch Review
- Completes initial review of batch records
- Initiates and investigates deviations related to the manufacturing and release of products.
- Responsible for tracking and trending manufacturing errors and other metrics for KPIs.
- Support Material Release, inspecting incoming materials and ensuring they meet specifications for use within manufacturing.
- Technical Writer and resource for policies, Standard Operating Procedures, forms, worksheets, and job aids in support of quality and manufacturing operations.
- Assists and supports manufacturing in identifying needed policies, Standard Operating Procedures, and other required documents.
- Be a liaison for manufacturing to support projects.
- Maintain annual competencies in required quality functions and remain up to date in required EHS LMS modules.
- Assist in training other QA/QC members in ACT Quality Systems.
- Assist in the maintenance of quality electronic systems.
- Experience with MasterControl is beneficial.
- Responsibilities may be modified or added as needed and discussed with the QA Manager and/or Directors.
Vacancy posted 4 days ago
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