Manufacturing Technician

Job Title: QA Associate 1

Location: 1100 Enterprise Drive, Winchester, KY 40391

Duration: 6 months temp to hire

Pay Rate: $26.40/hr. on W2 (without benefits)

SHIFT: MON-FRI 10PM - 6:30AM

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 SOP) through document review/approval, real-time monitoring/approval of manufacturing activities, and testing/approval of in-process and finished product samples.

• 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
• Work 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
• Promote teamwork and good communication
• Provide training and coaching to manufacturing staff as needed
• Support site process improvements (training, efficiency projects, implementation of CAPAs)
• Support customer complaint investigation by performing inspection of retains and complaint samples

• Preferred - Bachelor’s 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

Entry level

Contract

Manufacturing, Purchasing, and Product Management

Manufacturing, Pharmaceutical Manufacturing, and Retail Pharmacies