Aditi Consulting · 9 hours ago
QA Associate
Winchester, KY
Contract
Onsite
Entry Level
$26.40/hr - $26.40/hr
4+ years expAditi Consulting is seeking a QA Associate responsible for quality support functions in the manufacturing of solid oral dosage products. The role involves oversight of manufacturing operations, document review, real-time monitoring, and testing of in-process and finished product samples.
AppsConsultingInformation TechnologySoftware Engineering
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 responsible department 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
Promotes team work and good communication
Provide training and coaching to manufacturing staff as needed
Support site process improvements (training, efficiency projects, implementation of CAPAs)
Supports customer complaint investigation by performing inspection of retains and complaint samples
Qualification
Required
Minimum of High School Diploma in combination with 4+ years of relevant work experience in a regulated GMP manufacturing environment
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 responsible department can be conducted
Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)
Enforcement of GMP Compliance
Promotes team work and good communication
Provide training and coaching to manufacturing staff as needed
Support site process improvements (training, efficiency projects, implementation of CAPAs)
Supports customer complaint investigation by performing inspection of retains and complaint samples
Preferred
Bachelor's Degree in related science or technical field in combination with 2 years prior relevant work experience
Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certifications
Benefits
Medical, dental, and vision 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
Discretionary performance or recognition bonus
Sick leave and mobile phone reimbursement provided based on state or local law.
Company
Aditi Consulting
Aditi Consulting is a firm that stays abreast of offering technological solutions, project management and digital transformation.
1001-5000 employees
H1B Sponsorship
Aditi Consulting has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (55)
2024 (44)
2023 (25)
2022 (26)
2021 (24)
2020 (30)
Funding
Current Stage
Late StageLeadership Team
Raja Narayana
President & CEO
Pradeep Singh
Chairman
Recent News
bloomberglaw.com
2025-10-16
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