Job Title: QA Associate 1
Location: Winchester, KY 40391
Shift: Sunday–Thursday, 10 PM–6 AM
Job Type: Temp-to-Hire (3+ months)
Work Type: Onsite
Job Overview:
We are seeking a detail-oriented and experienced QA Associate 1 to support the manufacturing of solid oral dosage products. This position plays a critical role in ensuring compliance with cGMP, CFR, and company SOPs by overseeing manufacturing operations, performing quality audits, and conducting testing for in-process and finished products.
Key Responsibilities:
* Audit batch records in real-time for accuracy and compliance with critical parameters.
* Conduct room and equipment clearances following cleaning procedures.
* Perform microbial swabbing of equipment and room surfaces for environmental monitoring.
* Test in-process and finished product samples, including particle size, moisture analysis, and appearance checks.
* Monitor production for SOP/cGMP compliance and safety adherence.
* Identify, document, and resolve routine errors; initiate deviations in Trackwise when necessary.
* Manage the quality status of materials in inventory systems (JD Edwards).
* Assist in investigations by gathering data and supporting root cause analysis.
* Train and coach manufacturing staff on quality practices and compliance.
* Support process improvements, customer complaint investigations, and implementation of CAPAs.
Qualifications:
Education & Experience:
* Preferred: Bachelor’s Degree in a related science or technical field with 2+ years of relevant experience.
* Minimum: High School Diploma with 4+ years of experience in a GMP manufacturing environment.
* Certifications such as Lean Six Sigma or ASQ are a plus.
Skills & Competencies:
* Strong technical, problem-solving, and decision-making skills.
* Familiarity with laboratory instrumentation and Good Laboratory Practices (GLP).
* Excellent communication, documentation, and time-management abilities.
* Proficient in basic math, computer skills, and technical writing.
* Ability to work independently with limited supervision.
* Experience with continuous improvement techniques and safe work habits.
Why Join Us?
This is a fantastic opportunity to contribute to a high-performing team in a regulated manufacturing environment. With the potential for full-time hire, this position offers growth and development opportunities for the right candidate.
Apply Now:
If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
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