QA Specialist

LancesoftWinchester, KY

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Overview

Remote

On-site

Job Description

ONSITE POSITION - SHIFT - MON-FRI 2PM - 10: 30PM + MANDATORY OVERTIME.Recommend SOP and batch record changes as neededReview proposed SOP revisions and provide feedback to managementReal-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parametersPerform 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 analysisEnforcement of GMP Compliance.Promotes teamwork and good communication.Provide training and coaching to manufacturing staff as neededSupport site process improvements (training, efficiency projects, implementation of CAPAs)Completes investigations of customer complaintsEducation or Equivalent Requirements:

Minimum education and experience required to perform the job:

Quality Assurance AssociateBachelors degree;ORAssociates with 1 year of related work experience;ORHigh School Diploma/GED with 2 years of related work experience

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FAQs About QA Specialist Jobs at Lancesoft

What is the work location for this position at Lancesoft?

This job at Lancesoft is located in Winchester, KY, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at Lancesoft?

Candidates can expect a pay range of $24.

What employment applies to this position at Lancesoft?

The employer has not provided this information. This may be discussed during the hiring process.

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