QA Associate 1 in Winchester

Job Title: QA Associate 1

Location: Winchester, KY

Duration: 6 Months on w2 (Temp to Hire)

Shift: SUN-THURS – 10PM – 6:30AM

Training On: 1ST SHIFT MON-FRI 6AM – 2:30PM

Overview

The QA Associate is responsible for quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. Key responsibilities include oversight of manufacturing operations (per 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.

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 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

Essential Skills and Experience

Preferred: Bachelor’s Degree in a related science or technical field plus 2 years of relevant work experience.

Minimum: High School Diploma plus 4+ years of relevant work experience in a regulated GMP manufacturing environment.

Additional qualifications desired: Lean Six Sigma, ASQ certification, or other professional certifications.

Knowledge / Skills Requirements

• Familiarity with basic laboratory instrumentation
• Safe work habits
• Basic math and computer skills
• Good communication skills
• Ability to follow written and verbal instructions
• Ability to work with limited supervision for routine tasks
• Excellent documentation and handwriting skills
• Proficient reading and comprehension skills
• Sound decision-making, technical, and problem-solving skills
• Good time management skills
• Expert technical writing and problem-solving skills
• Good laboratory practices
• Experienced with continuous improvement techniques
• Demonstrates initiative