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QA Associate 1 Job Opening In Winchester – Now Hiring Confidential


Job description


Job Title: QA Associate
Location: Winchester, KY

Duration: Months on w (Temp to Hire)

SHIFT: SUN-THURS - PM - :AM -

TRAINING ON ST SHIFT MON-FRI AM - :PM.




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 years of relevant work experience.

Minimum: High School Diploma plus + 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.

  • Required Skill Profession

    Other Production Occupations


    • Job Details

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    Unlock Your QA Associate Potential: Insight & Career Growth Guide


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