2 Validation Specialist Jobs in Raleigh, NC
Alliance Biotech Solutions is Hiring a Validation Specialist Near Raleigh, NC
Alliance Biotech Solutions (ABS) is a quality partner providing first in class solutions to the biotech and life sciences industries. While our offers are limitless, we are focused on providing Engineering, Qualification, and Compliance solutions for our clients. ABS employees are our product for the industry, and therefore our #1 priority because without them ABS cannot exist. They strengthen us in everything we do. We recognize their value as contributors (individual and/or teams) for our partners. Encouraging growth and stretching their potential is paramount to success, and achievements for all.Position Responsibilities
- Interfacing with your project manager (PM) and understanding your scope among projects.
- Must be able to work independently or in a team environment, interacting with individuals at all levels in an organization, teams, and departments.
- Familiarity and sound understanding of common Qualification documentation and practices including, but not limited to Standard Operating Procedures (SOP’s), User Requirements Specifications (URS), Risk Assessments (RA), Validation Plans (VP), Requirements Trace matrix (RTM) Data Integrity Assessment (DIA)
- Plan, initiate and implement Change Control activities
- Writing and executing, Installation Operational Qualification (IOQ) and Performance Qualification (PQ) protocols and Summary Reports including thorough resolution of protocol deviations.
- Ability to work on multiple projects simultaneously
- Provides ongoing support for equipment throughout the system lifecycle including revalidation, troubleshooting, and deviation management
Experience
- 1-5 years’ experience performing commissioning, qualification and validation activities in an cGMP manufacturing and/or laboratory environments
- Familiarity with common validation equipment and systems; data loggers and paperless validation system
- Maintaining an up-to-date knowledge of validation requirements, practices, and procedures including an understanding on GxP, GAMP5, cGMP, CFRs (Part 11, 210, and 211), FDA/EU regulatory requirements and associated guidance documents
Skills and Abilities
Good technical problem-solving and troubleshooting skills
High attention to detail
Great interpersonal and organizational skills.Ability to multi-task and take initiative to accomplish assigned tasks accurately while taking established deadlines into accountWilling and able to thrive in unusually fast paced and changing environmentsAbility to change priorities in response to company demands while continuing to deliver resultsBenefits
Industry competitive wage as a full-time employee
Flexible Paid Time OffBonus plansMedical, Dental and Vision Insurance with low employee costEmployer paid long term and short-term disability401k plan with employer contributions
Alliance Biotech Solutions does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Alliance Biotech Solutions, and Alliance Biotech Solutions will not be obligated to pay a placement fee.
All persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
Job Summary
Full Time
$54k-73k (estimate)
02/28/2024
06/15/2024
The job skills required for Validation Specialist include Problem Solving, Initiative, Troubleshooting, Change Control, etc. Having related job skills and expertise will give you an advantage when applying to be a Validation Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Validation Specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Validation Specialist positions, which can be used as a reference in future career path planning. As a Validation Specialist, it can be promoted into senior positions as a Validation Engineer II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Validation Specialist. You can explore the career advancement for a Validation Specialist below and select your interested title to get hiring information.
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