What are the responsibilities and job description for the Qa Associate I position at ProQualityNetwork?
Job Description
Job Description
Job Title : QA Associate I (Biotech Industry)
Location : Winchester, KY
Position Type : Onsite, Temp-to-Hire
Shift : SundayThursday, 10 PM6 AM
Duration : 3 months
Summary
This opportunity is offered through a contract with ProQuality Network. The role requires relocation to Winchester, KY, with no relocation expenses covered. It is a temp-to-hire position, providing an excellent chance to contribute to a dynamic manufacturing environment within the biotech industry.
Position Overview
The QA Associate I is responsible for providing quality support to ensure compliance with cGMP, CFR, and internal SOPs during the manufacturing of solid oral dosage products. This role involves oversight of manufacturing operations through document review, real-time monitoring, and testing of in-process and finished product samples.
Key Responsibilities
- Documentation and Records :
- Recommend and review SOP and batch record revisions as needed.
- Perform real-time audits of batch records in production suites for accuracy, completeness, and adherence to critical process parameters.
- Manufacturing Oversight :
- Monitor production areas to ensure compliance with cGMP, SOPs, batch records, and safety requirements.
- Perform room and equipment clearances after cleaning is completed by production teams.
- Conduct microbial swabbing of equipment and room surfaces for environmental monitoring.
- Testing and Quality Control :
- Perform routine testing of in-process and finished product samples, including particle size, bulk density, moisture analysis, appearance, and AQL testing.
- Manage quality status of materials in physical inventory and inventory systems (e.g., JD Edwards).
- Deviation Management :
- Initiate deviation reports in TrackWise and provide detailed incident documentation for investigations.
- Assist in root cause analysis and data gathering for deviations.
- Training and Process Improvement :
- Provide training and coaching to manufacturing staff as needed.
- Support site process improvements, including CAPA implementation and efficiency projects.
- Customer Support :
- Assist in customer complaint investigations by inspecting retains and complaint samples.
Required Qualifications
Education and Experience :
Knowledge and Skills :
Preferred Competencies
