QA Associate I (Solid Oral Dosage Pharmaceutical Environment) 3454097

ProQuality Network; Kentucky; On-site; USD 55,000 - 75,000; Full time

Job summary

ProQuality Network in Kentucky seeks a QA Associate I to provide quality support for solid oral dosage manufacturing, ensuring compliance with cGMP, CFR, and company SOPs through review of batch records, in-process testing, and real-time monitoring.

Responsibilities include SOP/batch record reviews, real-time audits, environmental monitoring, investigations, deviation reports in TrackWise, and training of manufacturing staff; requires a Bachelor’s or HS with experience.

Qualifications

• Bachelor’s degree preferred with 2+ years of relevant experience.
• Minimum high school diploma with 4+ years of GMP manufacturing experience.
• Familiar with cGMP, CFR and SOPs and able to support QA investigations.

Responsibilities

• Review SOPs and batch records for accuracy and compliance.
• Perform real-time audits of batch records and monitor critical process parameters.
• Conduct environmental monitoring and room/equipment clearances.
• Support deviation investigations and prepare problem reports in TrackWise.
• Assist in training manufacturing staff and promoting GMP compliance.

Skills

SOPs

cGMP

Quality assurance

Documentation

Environmental monitoring

TrackWise

CAPA

Investigations

Data collection

Education

Bachelor's degree

HS diploma + 4+ years GMP experience

Tools

TrackWise

JD Edwards

MS Office

Job description

QA Associate I (Solid Oral Dosage Pharmaceutical Environment) 3454097

Title: QA Associate I (Biotechnology Industry) 3454097

Location: Kentucky, USA (Open to U.S. Citizens who are local residents of Kentucky)

Positions Available: 1

Shift: Sun–Thurs, 10:00 PM – 6:30 AM (Training on 1st shift Mon–Fri, 6:00 AM – 2:30 PM)

Position Summary

Our client is seeking a QA Associate I to provide essential quality support for the manufacturing of solid oral dosage pharmaceutical products. The QA Associate ensures compliance with cGMP, CFR, and company SOPs through oversight of manufacturing operations, document review, real-time monitoring of production activities, and testing of in-process and finished product samples. This role is critical in maintaining product quality, supporting investigations, and promoting continuous process improvement.

Key Responsibilities

• Review, recommend, and provide feedback on SOPs and batch record revisions.
• Perform real-time audits of batch records to ensure completeness, accuracy, and compliance with critical process parameters.
• Conduct room and equipment clearances following cleaning procedures.
• Perform environmental monitoring via microbial swabbing of equipment and room surfaces.
• Maintain thorough knowledge of SOPs, cGMP, and CFR guidance applicable to solid oral dosage manufacturing.
• Conduct routine testing of in-process and finished product samples, including particle size, bulk density, moisture analysis, appearance, and AQL testing.
• Monitor production areas for compliance with SOP, cGMP, batch record, and safety requirements; identify and resolve routine errors to prevent deviations.
• Collaborate cross-functionally to assess potential deviations and assist in investigations when required.
• Initiate deviation problem reports in TrackWise, providing detailed documentation to support investigations.
• Manage quality status of WIP and finished goods in physical inventory and JD Edwards system.
• Assist in investigations by supporting data collection and root cause analysis.
• Enforce GMP compliance and promote teamwork and effective communication.
• Provide training and coaching to manufacturing staff as needed.
• Support process improvements, including training, efficiency projects, and CAPA implementation.
• Assist in customer complaint investigations by inspecting retains and complaint samples.

Required Qualifications

Education & Experience:

• Preferred: Bachelor’s Degree in a related scientific or technical field with 2+ years of relevant experience.
• Minimum: High School Diploma with 4+ years of relevant experience in a regulated GMP manufacturing environment.
• Additional certifications such as Lean Six Sigma or ASQ are desirable.

Knowledge & Skills:

• Familiarity with basic laboratory instrumentation.
• Strong safe work habits and adherence to SOPs.
• Basic math and computer proficiency.
• Excellent communication, documentation, and handwriting skills.
• Ability to follow written and verbal instructions and work with limited supervision.
• Strong technical problem-solving and decision-making abilities.
• Good time management and organizational skills.
• Experienced with continuous improvement techniques.
• Demonstrates initiative and accountability in completing tasks.

Additional Attributes:

• Ability to enforce and promote GMP compliance.
• Works effectively in a team-oriented environment.
• Supports site-wide quality and process improvement initiatives.

Note: This opportunity is open only to U.S. citizens who are local residents of Kentucky.