Sterile Processing

3 weeks ago

Elkton, United States AA2IT Full time
Job DescriptionJob Description

Qualifications:

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.

Responsibilities:

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.

 

Company DescriptionAA2IT is in this business to make you successful. Strategy, Execution and Value. There are too many businesses that have solid, well-thought-out strategies that sit in a drawer somewhere collecting dust. Executing on Strategy effectively and measuring what matters drives the value. We start with your business strategy, align technology strategy, and create a roadmap that gets your business value.

AA2IT is a global firm providing Staffing and IT Solutions. We are headquartered in Texas, delivering successful talent acquisition and technology services. We are fully digital organization with a people centric and a technology driven vision.Company DescriptionAA2IT is in this business to make you successful. Strategy, Execution and Value. There are too many businesses that have solid, well-thought-out strategies that sit in a drawer somewhere collecting dust. Executing on Strategy effectively and measuring what matters drives the value. We start with your business strategy, align technology strategy, and create a roadmap that gets your business value.\r
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AA2IT is a global firm providing Staffing and IT Solutions. We are headquartered in Texas, delivering successful talent acquisition and technology services. We are fully digital organization with a people centric and a technology driven vision.

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