Job Description

Title: QA Associate

Location: Winchester KY 40391

Duration: 6 Months

Onsite Role

SHIFT - MON-FRI - 2PM - 10:30PM - TRAINING ON 1ST SHIFT MON-FRI 6AM - 2:30PM.

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 Client 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 Client 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 - 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.

Knowledge/Skills Requirements: (List unique knowledge skills, or problem-solving requirements)

• Familiarity with basic laboratory instrumentation

• Safe work habits

• Basic math and computer skills

• Good communication skills

• Ability to follow written and verbal instructions

• Able 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

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