Location: 1100 Enterprise Dr, Winchester, KY 40391
Duration: 06 MONTHS.
Timings: MON - FRI 2PM - 10:30PM.
100% Onsite Role - TEMP TO HIRE
Description
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 Catalent SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.
II. Specific Tasks, Duties And Responsibilities
RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:
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 team work and good communication.
Provide training and coaching to manufacturing staff as needed
Support site process improvements (training, efficiency projects, implementation of CAPAs)
Supports customer complaint investigation by performing inspection of retains and complaint samples
Education or Experience:
Bachelor’s Degree in related science or technical field preferred with 2 years prior work experience
Minimum of High School Diploma with 4+ years of relevant experience in a regulated GMP manufacturing environment.
Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certification