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Qualification/Validation Specialist

Birmingham, AL 35211

Posted: 04/29/2024 Job Category: Laboratory Job Number: HH172322429

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. Candidates must relocate at their own expense.
 
The Qualification / Validation Specialist develops, executes, analyzes data, and prepares summary reports applicable to assigned projects. The specialist will work under the guidance of a senior specialist or project leader 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, and 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 safely 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 experiences 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 communicate observations and outcomes clearly and effectively to all levels of employees within the Company
  • Ability to work closely and effectively with other workgroups to successfully complete projects on time and thoroughly. 
  • Proficient in using word processing, spreadsheet, and presentation software programs. 
  • Proficient in the 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

Alicia Paslawsky
Senior Technical Recruiter

Alicia Paslawsky joined Sirius Staffing in 2017 as a Senior Technical Recruiter, bringing with her over 20 years of experience in the field. She is passionate about facilitating success for both candidates and clients by matching top talent with their specific needs. Specializing in a diverse range of roles, Alicia excels in placing professionals such as Pharmaceutical Technicians, Lab Operators, Chemists, Warehouse Associates, Packaging Technicians, Engineers, Designers, and Administrative Assistants, among others. Her commitment extends beyond mere placement; Alicia prioritizes cultivating lasting relationships with candidates and clients alike.

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