Aditi Consulting
QA Associate 1
Aditi Consulting, Winchester, Kentucky, us, 40392
Tasks, Duties and Responsibilities:
Recommend SOP and batch record changes as neededReview proposed SOP revisions and provide feedback to managementReal-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parametersPerform room and equipment clearances per procedure following cleaning conducted by production.Perform microbial swabbing of equipment and room surfaces for environmental monitoring.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 analysisEnforcement of GMP Compliance.Promotes team work and good communication.Provide training and coaching to manufacturing staff as neededSupport site process improvements (training, efficiency projects, implementation of CAPAs)Supports customer complaint investigation by performing inspection of retains and complaint samples
III. Essential Skills and 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.
Compensation:The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
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.
Recommend SOP and batch record changes as neededReview proposed SOP revisions and provide feedback to managementReal-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parametersPerform room and equipment clearances per procedure following cleaning conducted by production.Perform microbial swabbing of equipment and room surfaces for environmental monitoring.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 analysisEnforcement of GMP Compliance.Promotes team work and good communication.Provide training and coaching to manufacturing staff as neededSupport site process improvements (training, efficiency projects, implementation of CAPAs)Supports customer complaint investigation by performing inspection of retains and complaint samples
III. Essential Skills and 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.
Compensation:The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
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.