Job Title – Quality Assurance Associate
Location – Winchester, KY 40391
Duration – 6 months contract position, with TEMP TO HIRE
Shift Time – FRI, SAT, SUN 6PM - 6AM + 1 DAY EVERY OTHER WEEK + MANDATORY OVERTIME.
***Onsite Position***
Job Summary: #teami
· 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 Catalent 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
· Bachelor's degree; OR Associates with 1 year of related work experience; OR High School Diploma/GED with 2 years of related work experience
Company Overview:
· Infojini Consulting is a Staffing and Recruitment company and incorporated in Baltimore, MD.
· Infojini caters various hospitals, health & wellness centers, pharmacy, and medical facilities over fifty states across the United States
Pay: $26.00 - $26.38 per hour
Work Location: In person
