Website Aditi Consulting
Aditi Consulting
Company : Aditi Consulting
Payrate: $26.60- $27.60/hr.
Shift: FRI, SAT, SUN (6:00 PM – 6:00 AM)
Summary:
The QA Associate is responsible for the Quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.
Responsibilities:
• Supports customer complaint investigation by performing inspection of retains and complaint samples
• Support site process improvements (training, efficiency projects, implementation of CAPAs)
• Provide training and coaching to manufacturing staff as needed
• Promotes team work and good communication.
• Enforcement of GMP Compliance.
• Assist in investigations for deviations by supporting data gathering and root cause analysis
• Other assignments as needed within the scope of QA Associate training curriculum.
• Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)
• 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.
• Works cross functionally to assess impact for potential deviations and assist in identifying if an investigation is required.
• 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.
• Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time.
• 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 microbial swabbing of equipment and room surfaces for environmental monitoring.
• Perform room and equipment clearances per procedure following cleaning conducted by production.
• Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters
• Review proposed SOP revisions and provide feedback to management
• Recommend SOP and batch record changes as needed
Education or Experience: Preferred – Bachelor’s Degree in related science or technical field in combination with 2 years prior relevant work experience.
Minimum of High School Diploma in combination with 4 years of relevant work experience in a regulated GMP manufacturing environment.
Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certifications.
Pay Transparency: The typical base pay for this role across the U.S. is: $26.60 – $27.60/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
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Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi’s use of AI technology, including calls from an AI Voice Recruiter.
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