
Quality Assurance Associate
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Overview
Remote
On-site
Compensation
$25-$25/hour
Job Description
Payrate: $25.23- $25.23/hr.Requirements:
- Recommend SOP and batch record changes as needed
- Review proposed SOP revisions and provide feedback to management
- Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters
- Perform room and equipment clearances per procedure following cleaning conducted by production.
- Perform microbial swabbing of equipment and room surfaces for environmental monitoring.
- Maintain a full understanding of all SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products.
- Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time.
- Monitor production manufacturing areas for compliance with SOP/cGMP/batch record and safety requirements to identify and resolve routine errors and prevent possible deviations that affect production real-time.
- Works cross functionally to assess impact for potential deviations and assist in identifying if an investigation is required.
- Initiate deviation problem reports in Track wise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the department responsible can be conducted.
- Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)
- Other assignments as needed within the scope of QA Associate training curriculum.
- Assist in investigations for deviations by supporting data gathering and root cause analysis
- Enforcement of GMP Compliance.
- Promote teamwork and good communication.
- Provide training and coaching to manufacturing staff as needed
- Support site process improvements (training, efficiency projects, implementation of CAPAs)
- Completes investigations into customer complaints
- Bachelor’s degree; OR Associates with 1 year of related work experience; OR High School Diploma/GED with 2 years of related work experience
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FAQs About Quality Assurance Associate Jobs at Aditi Consulting
What is the work location for this position at Aditi Consulting?
This job at Aditi Consulting is located in Winchester, KY, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Aditi Consulting?
Candidates can expect a pay range of $25.23–$25.23 per hour for this role.
What employment applies to this position at Aditi Consulting?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at Aditi Consulting?
You can apply for this role at Aditi Consulting either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.