Job Title: Quality Assurance Associate
Duration : 6 Months on W2 (Temp to Hire)
Location: Winchester, KY
Shift: Monday Friday, 6:00 AM 2:30 PM (Mandatory Overtime Required)Job Summary:
The Quality Assurance Associate is responsible for ensuring compliance with cGMP standards, SOPs, and regulatory requirements in the manufacturing of solid oral dosage pharmaceutical products. This role supports real-time quality oversight, documentation review, environmental monitoring, and cross-functional collaboration to maintain product quality and compliance.
Key Responsibilities:- Review and recommend updates to SOPs and batch records
- Provide feedback on proposed SOP revisions to management
- Perform real-time batch record audits for accuracy, completeness, and compliance
- Conduct room and equipment clearance following cleaning procedures
- Perform environmental monitoring, including microbial swabbing of equipment and surfaces
- Ensure adherence to SOPs, cGMP, and CFR guidelines
- Conduct in-process and finished product testing such as:
- Particle size
- Bulk density
- Moisture analysis
- Appearance checks
- AQL testing
- Monitor manufacturing areas for compliance with quality and safety standards
- Identify and help resolve deviations to prevent production impact
- Initiate and document deviation reports in TrackWise with detailed findings
- Manage quality status of WIP and finished goods in JD Edwards and physical inventory
- Support deviation investigations, including data collection and root cause analysis
- Enforce GMP compliance across operations
- Assist with customer complaint investigations
- Provide training and coaching to manufacturing staff as needed
- Support continuous improvement initiatives (CAPAs, training, efficiency projects)
- Collaborate cross-functionally to assess quality impacts and investigations
Qualifications:
Minimum Requirements:- Bachelor s Degree OR
- Associate s Degree with 1+ year of relevant experience OR
- High School Diploma/GED with 2+ years of relevant experience