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Quality Assurance Associate

Aditi Consulting

Winchester, KY

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JOB DETAILS
SALARY
$25.23–$25.23 Per Hour
SKILLS
Analysis Skills, Artificial Intelligence (AI), Automotive Automation, Biotech and Pharmaceutical, Coaching, Code of Federal Regulations, Communication Skills, Consulting, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Collection, Documentation, Environmental Monitoring, GMP (Good Manufacturing Practices), High School Diploma, J D Edwards, Manufacturing, Messaging Technology, Physical Inventory, Process Improvement, Production Control, Purchasing/Procurement, Quality Assurance, Quality Management, Root Cause Analysis, Safety Training, Short Messaging Service (SMS), Speech Technology, Standard Operating Procedures (SOP), State Laws and Regulations, Team Player, Telephony, Testing, Training/Teaching, Training/Teaching Curriculum
LOCATION
Winchester, KY
POSTED
9 days ago
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
 
Education:
  • Bachelor’s degree; OR Associates with 1 year of related work experience; OR 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: $25.23- $25.23/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. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
 
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to messages or by contacting privacy@aditiconsulting.com.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy .
 
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Aditi Consulting