Quality Assurance Associate

The Fountain Group; Winchester (KY); On-site; USD 30,000 - 43,000; Full time

Job summary

The Fountain Group is actively seeking a Quality Assurance Associate for our prominent client. This onsite role is located in Winchester, KY, and offers a 6-month temp-to-hire arrangement with a pay rate of $26.38 per hour.

The position requires real-time QA auditing of batch records and collaboration on SOP changes, with emphasis on cGMP compliance. The ideal candidate will hold a Bachelor’s degree (or an Associate with 1 year of related experience, or a high school diploma with 2 years) and

Qualifications

• Bachelor's degree required; or Associate's degree with 1 year of related experience; or High School Diploma/GED with 2 years of related experience.
• Experience with cGMP and CFR requirements in pharmaceutical manufacturing.
• Proficiency in batch record review and real-time QA auditing.
• Familiarity with SOP and batch record change control.

Responsibilities

• Perform real-time QA audits of batch records for completeness, documentation accuracy, calculations, and critical process parameter compliance.
• Review and recommend changes to SOPs and batch records; provide feedback on revisions.
• Conduct room and equipment clearances following production cleaning procedures.
• Perform environmental monitoring via microbial swabbing of equipment and room surfaces.
• Execute in-process and finished-product testing including particle size, bulk density, moisture, appearance, and AQL testing.
• Monitor areas for SOP, cGMP, batch record, and safety compliance; identify deviations in real time.
• Support deviation assessments, investigations, data gathering, and root cause analysis.
• Initiate deviation problem reports in TrackWise and support CAPA implementation.
• Manage quality status of WIP and finished goods in physical inventory and JD Edwards.
• Provide GMP-related training and coaching to manufacturing personnel.
• Complete customer complaint investigations.
• Maintain compliance with SOPs, cGMP requirements, and CFR guidance for solid oral dosage manufacturing.

Skills

cGMP compliance

Batch record review

Environmental monitoring

In-process testing

TrackWise deviation reporting

JD Edwards quality status

SOP change control

GMP quality assurance

Education

Bachelor's degree

Associate degree +1 year experience

High School Diploma/GED +2 years experience

Job description

The Fountain Group is currently seeking a Quality Assurance Associate for a prominent client of ours. This position is located in Winchester, KY. Details for the position are as follows:

Location: Onsite

Pay Rate: $26.38/hour

Duration: 6 months, Temp-to-Hire

Shift: Friday, Saturday, Sunday, 6:00 PM–6:00 AM + 1 additional day every other week; mandatory overtime

Job Description

• Perform real-time QA audits of batch records for completeness, documentation accuracy, calculations, and critical process parameter compliance.
• Review and recommend changes to SOPs and batch records; provide feedback on proposed revisions.
• Perform room and equipment clearances following production cleaning procedures.
• Conduct microbial swabbing of equipment and room surfaces for environmental monitoring.
• Perform in-process and finished-product testing, including particle size, bulk density, moisture, appearance, and AQL testing.
• Monitor manufacturing areas for SOP, cGMP, batch record, and safety compliance and identify potential deviations in real time.
• Support deviation assessments, investigations, data gathering, and root cause analysis.
• Initiate deviation problem reports in TrackWise and support CAPA implementation.
• Manage quality status of WIP and finished goods in physical inventory and JD Edwards.
• Provide GMP-related training and coaching to manufacturing personnel.
• Complete customer complaint investigations.
• Maintain compliance with applicable SOPs, cGMP requirements, and CFR guidance for solid oral dosage pharmaceutical manufacturing.

Education

• Bachelor's degree; OR
• Associate's degree with 1 year of related experience; OR
• High School Diploma/GED with 2 years of related experience.

Required Skills

• cGMP and CFR requirements for pharmaceutical manufacturing.
• Solid oral dosage pharmaceutical manufacturing.
• Batch record review and real-time QA auditing.
• SOP and batch record change control/review.
• Environmental monitoring and microbial swabbing.
• In-process and finished-product testing.
• TrackWise for deviation/problem reporting.
• Deviation investigation and root cause analysis.
• JD Edwards inventory/quality status management.
• GMP compliance and manufacturing quality assurance.

Preferred Skills

• Experience with CAPA implementation and process improvement initiatives.
• Experience conducting customer complaint investigations.
• Experience with pharmaceutical manufacturing quality systems.
• Experience with particle size, bulk density, moisture, appearance, and AQL testing

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