Job Description
We are seeking a Laboratory Technician to join the company, a premier supplier, in Winchester KY US. While working in this clean, not climate-controlled facility you will have the opportunity to be directly involved in the evolution of the industry. Come work for a company that has been consistently recognized among the Best & Brightest Companies to Work For.
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.
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
Essential Skills and Experience:
* Education or Experience: (Minimum required to perform job)
o Bachelor’s Degree in related science or technical field in combination with 2 years prior relevant work experience.
o Minimum of High School Diploma in combination with 4+ years of relevant work experience in a regulated GMP manufacturing environment.
o Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certifications.
* Knowledge/Skills Requirements: (List unique knowledge skills, or problem-solving requirements)
o Familiarity with basic laboratory instrumentation
o Safe work habits
o Basic math and computer skills
o Good communication skills
o Ability to follow written and verbal instructions
o Able to work with limited supervision for routine tasks
o Excellent documentation and handwriting skills
o Proficient reading and comprehension skills
o Sound decision-making, technical and problem solving skills
o Good time management skills
o Expert technical writing and problem solving skills
o Good Laboratory Practices
The Company is an Equal Opportunity Employer and is committed to creating an equitable and inclusive environment for all.
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