Highlights
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Maintain compliance with applicable SOPs, cGMP requirements, and CFR guidance for solid oral dosage pharmaceutical manufacturing.
Numbers & Facts
| Location | Winchester, KY |
| Industry | Staffing/Employment Agencies |
| Company Size | 500 to 999 employees |
| Website | https://www.thefountaingroup.com/ |
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:
Quality Assurance Associate
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
About Company
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.