QA Associate 1

Manpower Group (USA); Italia; In loco; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a detail-oriented QA Associate 1 to support the manufacturing of solid oral dosage products. This role is vital in ensuring compliance with cGMP and company SOPs by overseeing operations, performing quality audits, and conducting testing. The position offers a unique opportunity to join a high-performing team in a regulated environment with potential for full-time hire. If you are passionate about quality assurance and eager to contribute to process improvements, this could be the perfect role for you.

Competenze

• 2+ years of experience in a GMP manufacturing environment preferred.
• Strong technical and problem-solving skills required.

Mansioni

• Audit batch records for compliance and accuracy.
• Monitor production for SOP/cGMP compliance and safety.

Conoscenze

Technical Skills

Problem-Solving

Decision-Making

Communication

Documentation

Time Management

Basic Math

Computer Skills

Technical Writing

Formazione

Bachelor’s Degree in a related science

High School Diploma

Strumenti

Trackwise

JD Edwards

Descrizione del lavoro

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!