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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.

Qualifications:
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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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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!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.