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Sirius Staffing
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Bailee Stevens
Qualification / Validation Specialist
Job Description
Sirius Staffing is seeking a Qualification/Validation Specialist for a long-term contract in Birmingham, AL.
This is a W2 contract role. Not offering C2C. This position does not offer relocation assistance, per diem, or a sign-on bonus. Candidate must relocate at their own expense.
The Qualification / Validation Specialist develops, executes, analyzes data and prepares summary reports as
applicable to assigned projects. The specialist will work under the guidance of a senior specialist or project
lead to ensure adherence to project timelines and compliance requirements. They are responsible for adhering
to GMP regulatory compliance, the site Validation Master Plan (VMP), Standard Operating Procedures
(SOP’s) and Business Line Policies/Procedures.
Responsibilities:
- Support and adhere to Validation Plans, Procedures and Projects
- Execute Validation projects, ensuring activities are on time and within budget, meet cGMP requirements
- Demonstrates quality practices, ensures projects are compliant with inspection agencies’ (FDA, EU) requirements and company practices
- Provide support to external departments for tasks that require a validation resource
- Adhere to Plans and SOPs ensuring ongoing regulatory compliance (FDA/EU) with industry standards, practices, and trends
- Maintain training on company Quality and Compliance systems
- When required for assigned projects; provide information in support of clients audits and regulatory inspections
- Maintain current Validation knowledge through review of current Pharmaceutical, Engineering, Scientific literature, and by participating in Professional events, i.e. ISPE, ASQ, PDA, etc.
- Establishes safety as the number one priority through training, actions and behaviors
- Adhere to all company safety, health and environmental policies, procedures and directives
- Conduct all testing in a safe manner by use of MSDS to establish chemical hazards; observe the appropriate laboratory procedures; and report all incidents that could threaten the safety of laboratory personnel
Qualifications:
- Bachelor’s degree preferably in Science or Engineering discipline. Other disciplines and/or equivalent job experience will be considered.
- 3 to 5 experience in validation/qualification of aseptic pharmaceutical processes and/or equipment
- Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices and cGMPs
- Knowledge and hands-on experience in at least two (2) of the following areas of expertise:
- Cleaning Verification / Validation / Autoclave / Steam sterilization
- VHP sterilization/decontamination cycle o Aseptic Process Simulations (Media Fills)
- Dry Heat Depyrogenation
- Excellent interpersonal skills, Effective written and verbal communication skills; ability to clearly and effectively communicate observations and outcomes to all levels of employee within the Company
- Ability to work closely and effectively with other workgroups in order to successfully complete projects on time and thoroughly.
- Proficient in the use of word processing, spreadsheet, and presentation software programs.
- Proficient in use of Kaye Validator AVS and Val Probe Systems
Sirius Staffing is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to characteristics such as race, color, national origin, religion, gender, age, marital status, disability, veteran status, citizenship status, sexual orientation, gender identity, or any other status protected by law.
Meet Your Recruiter
Bailee Stevens
Recruiting Manager
Bailee Stevens is a recruiter bringing a wealth of experience and a genuine passion for building relationships and helping talent find career opportunities. With 14 years’ experience in the industry, she has learned the importance of finding the perfect fit for both candidates and clients. Bailee takes pride in effectively communicating and making a meaningful impact on people’s careers and lives. She has expertise in working in many different industries from Manufacturing, Industrial, Energy, Aviation, Oil and Gas, Automotive, Government, Marine/Shipbuilding, and more. Bailee has been successful in recruiting talent for many different types of positions such as Professional, IT, Logistics, Procurement, Finance/Accounting, Administrative, Light Industrial, Engineering, Healthcare roles, and more.
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About Birmingham, AL
Discover Your Next Career Opportunity in Beautiful Birmingham, Alabama! This vibrant city nestled in the heart of the South offers a perfect blend of Southern charm and modern amenities. Known for its rich history, delicious southern cuisine, and thriving arts scene, Birmingham is a hidden gem for job seekers looking to grow their careers. Explore job opportunities near iconic landmarks like the Vulcan Park and Museum, catch a show at the Alabama Theatre, or cheer on the Birmingham Barons at Regions Field. With its lush parks, trendy galleries, and bustling cultural events, Birmingham provides an exciting backdrop for your professional journey. Start your job search today and experience the magic of Birmingham!
