Manufacturing - Quality Assurance Associate

Manufacturing

• Quality Assurance Associate Medvacon Life Sciences, LLC Winchester, KY Job Details Full-time 3 hours ago Qualifications Optimizing workflow processes Incident investigation techniques for hazard identification JD Edwards Quality records maintenance Defect resolution root cause analysis Environmental monitoring in sterile processing Incident management Cleanroom environmental monitoring Pharmaceutical regulatory compliance Incident report management Coaching Data quality assurance Production deviation management Production safety compliance TrackWise Good documentation practices (GDP) Corrective and preventive actions (CAPA) Mid-level Inventory management software Quality reports High school diploma or GED Manufacturing standard operating procedures Manufacturing process inspections Continuous improvement Data quality monitoring Issue tracking Staff training Quality assurance within pharmaceutical industry Quality improvement Compliance documentation Full Job Description

TEMP TO HIRE

• DURATION
• 6 MONTHS
• ONSITE

POSITION

• SHIFT
• MON-FRI 2PM
• 10:30PM + MANDATORY

OVERTIME.

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 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

Education or Equivalent Requirements:

Minimum education and experience required to perform the job: Quality Assurance Associate Bachelors degree; OR Associates with 1 year of related work experience; OR High School Diploma/GED with 2 years of related work experience

Important Notice:

Protecting Your Information Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to . xc7J6mo8jJ