What are the responsibilities and job description for the Quality Assurance Associate position at Golden Technology?
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The Role: Quality Assurance Associate
Location: Chapel Hill, NC
Type: Contract
What You Ll Do
Quality Assurance Associate will be responsible for supporting QA Systems in conjunction with the Quality Assurance Manager. This role will provide direction on the execution of quality processes for ACT facility employees, providing guidance and expectations on how those systems are to be followed; 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; track QA System progress either through internal auditing or the use of metrics; help direct others who are executing validation work, review executed work, ensure work is completed against plan; Review executed batch records, identify corrections, and help resolve issues; Investigate occurrences and deviations and identify potential corrective and preventive actions to improve processes based upon QA system usage; and support the use of electronic quality management system.
Why Golden Technology?
Founded in 1997, Golden Technology has grown from a two-person vision into a trusted partner for Fortune 500 clients nationwide. Along the way, we ve built a culture centered on family, professional growth, and giving back to our communities through our Golden Community initiatives.
Here s What Sets Us Apart
Apply today and let s build your brighter future together.
The Role: Quality Assurance Associate
Location: Chapel Hill, NC
Type: Contract
What You Ll Do
Quality Assurance Associate will be responsible for supporting QA Systems in conjunction with the Quality Assurance Manager. This role will provide direction on the execution of quality processes for ACT facility employees, providing guidance and expectations on how those systems are to be followed; 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; track QA System progress either through internal auditing or the use of metrics; help direct others who are executing validation work, review executed work, ensure work is completed against plan; Review executed batch records, identify corrections, and help resolve issues; Investigate occurrences and deviations and identify potential corrective and preventive actions to improve processes based upon QA system usage; and 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.
- Participate in 5 hours of continuing education annually in cellular therapy or quality topics.
- Responsibilities may be modified or added as needed and discussed with the QA Manager and/or Directors.
Why Golden Technology?
Founded in 1997, Golden Technology has grown from a two-person vision into a trusted partner for Fortune 500 clients nationwide. Along the way, we ve built a culture centered on family, professional growth, and giving back to our communities through our Golden Community initiatives.
Here s What Sets Us Apart
- Family-first culture that values balance and support.
- Career development through mentorship, opportunities, and investment in our people.
- Community impact by dedicating time, talent, and resources to the places we live and work.
- Exciting opportunities with innovative companies.
- Guidance from a recruiting team with decades of experience.
- A professional, supportive culture built on trust and collaboration.
Apply today and let s build your brighter future together.