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Quality Specialist - I (Assistant)

Elkton, VA 22827

Posted: 06/11/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 608131 Is job remote?: No Country: United States

Job Description

Target Pay Rate: 30-39.92/hr **salary will be commensurate with experience 

Job Description:

The individual carries out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations.
The role will support the review and approval of qualification activities, change controls, batch records, auxiliary forms, investigations, procedures, and other quality related documentation.
The successful candidate will support aseptic operations on shift, including auditing of classified (Grades A/B/C) areas which also includes getting certified for Grade A/B gowning.
May perform quarantine functions and accountability reviews.
Supports special projects as assigned.
The role follows cGMP and routinely makes decisions using cGMP/process knowledge.
May work with customers to resolve problems and to satisfy quality and production needs.
Follows site safety requirements.
Authors, reviews, and approves data/ documents such as methods, procedures, and/ or protocols.
Performs all work and completes assignments in a timely manner and is an active member of 1 or more teams.
The individual tracks/reports metrics as needed.
May provide training/ presentations as needed.
May help with regulatory inspections.

Education Minimum Requirement: Bachelor's Degree in Science, Health Science, Engineering, or related discipline with 1-3yrs industry experience. Required Experience and Skills: Previous Experience in the pharmaceutical industry. Preferred Experience and Skills: Previous experience supporting aseptic operations or sterile product, experience in Quality Assurance/Engineering role or Technical role. Previous experience in food or pharmaceutical environment in regulatory/inspection role. Previous experience in project management, process data analysis. Lean Six Sigma Certification Previous Experience with SAP,MEDS, etc. Additional: Beta Lactam screening required for this role. Shift Requirements: 8am-5pm. The successful candidate will support aseptic operations.
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About Elkton, VA

Unlock your potential in Elkton, Virginia! Nestled in the picturesque Shenandoah Valley, Elkton offers a perfect blend of natural beauty and career opportunities. With proximity to Shenandoah National Park, Massanutten Resort, and the historic Luray Caverns, this charming town provides a vibrant community for professionals seeking a fulfilling lifestyle. Explore job listings in this area to experience the local cuisine, art galleries like the Warehouse Art Gallery, and the captivating performances at Court Square Theater. Join us in Elkton, VA, and embark on an exciting career journey surrounded by scenic wonders and rich cultural experiences!

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