Quality Assurance Associate
Aditi Consulting - Winchester, KY
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Payrate: $24.00 - $24.00/hr. Responsibilities: 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 to SOP/cGMP/batch record and safety requirements in order 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 Trackwise 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 of customer complaints Other duties as required in support of Pharma Solutions' high performance Demonstrates mastery of all tasks listed above. In addition to the following: Performs investigation, writes reports, conducts root cause analysis and implements CAPA for deviations assigned to QA Supervises the training of new QA employees Performs historical trends and provides awareness training to QA on documentation errors in that could potentially be missed during audit Provides QA representation as required for projects and meetings. Participates and assists in the Regulatory group in internal audits of other functional areas. Serves as a customer facing contact when needed Develop new procedures as required Other duties as required in support of Pharma Solutions' high performance Requirements: Bachelor's degree Associates with 1 year of related work experience High School Diploma/GED with 2 years of related work experience Pay Transparency: The typical base pay for this role across the U.S. is: $24.00 - $24.00 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, denmatch, lifeion benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary. You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. 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Created: 2026-03-10