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QA Reserve Sample Inspector Level 1 - 1st Shift
The CKHobbie Group
- United States
- United States
Über
Responsibilities include transferring of samples to appropriate storage locations, visual inspection of finished good customer samples and completion of necessary documentation and inventory transactions. Additionally, participation in internal, external or regulatory audits will be required at the discretion of senior management. The impact of the quality inspection process directly impacts company compliance to regulatory requirements and customer satisfaction. Essential Duties and Responsibilities: Responsible to ensure and enforce GMP Compliance throughout the inspection and warehouse areas. Responsible for sampling and performing a visual inspection on all Customer Reserve Samples per the Work Instructions and/or inspection form. Responsible for packing Customer Reserve Samples in order to transfer to the final storage location. Responsible for reviewing work of peers at the discretion of QA Management. Responsible for scanning and archiving all completed inspection reports and associated documentation. Responsible for participating in internal, customer, and regulatory audits at the discretion of Senior Management. Responsible for training of designated peers at management request. Responsible for performing a physical inventory at the discretion of QA Management on all storage locations that contain Customer Reserve Samples. Qualifications: Bachelor's degree with a minimum of two years' experience and/or training. Associate's degree with two to four years' experience and/or training. High school diploma with four to six years' experience and/or training. Experience in inspection of pharmaceutical or related industry is preferred. General knowledge of FDA regulations related to cGMPs is required. General knowledge of Quality Control/Assurance is required. Good documentation and communication skills is required. Good organizational and planning skills is required. Prior experience driving a forklift is desired. Ability to multi-task when necessary is preferred. Mathematical Skills: Ability to apply simple mathematical operations to assigned tasks. Language Skills: Ability to effectively communicate (either written or verbally) with the following groups: Internal: Daily contact with Compliance, Quality, Warehouse, and Customer Service Departments for information on sample inspection issues and cGMP issues. External: Minimal contact with customer representatives related to sample inspections. Reasoning Ability: A thorough understanding of each aspect of the job is required. Ability to make rational decisions pertaining to quality compliance. Ability to resolve problems effectively and efficiently. Computer Skills: Basic Windows applications, including Microsoft Office Suite. Experience with Lotus Notes and QAD desired. Physical Demands: The employee will frequently sit to complete paperwork. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and the ability to adjust focus. Work Environment: The working environment is clean and not normally subject to a hazardous environment or conditions. The noise level in the work environment is usually moderate.
Sprachkenntnisse
- English
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