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Quality Assurance Associate

3 months ago

Winchester, United States Planet Pharma Full time

PAY - $26.40

Winchester, KY ONSITE

SHIFT - MON-FRI 2PM - 10:30PM WITH SOME OT HERE AND THERE ON WEEKENDS

TEMP TO HIRE - DURATION - 3-6 MONTHS TO CONVERT.


I. Position Overview:

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 internal 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:

  • 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 internal 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

III. Essential Skills and Experience:

Education or Experience: (Minimum required to perform job)

  • Preferred - Bachelors 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.