What are the responsibilities and job description for the Quality Validation Specialist position at VTI Life Sciences?

Job Description

VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries.

We are looking for a Quality Validation Specialist (Contractor) to be responsible for quality oversight of validation activities at our client's Los Angeles facility. This person will have quality signatory responsibility for approval of qualification, validation, and final report documents. Ensure that the validation and compliance requirements are met according to guidelines and our client's standard operating procedures. Proficient in facility quality systems and participates as subject matter expert of validation requirements. The scope includes validation for Facility, Equipment, Critical Utility, Automation Systems, Cleaning and Process.

This 1-year project starts in March 2025 and is 100% onsite..

Essential Duties and Responsibilities :

Responsible for reviewing pertinent documents, against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc. which comprises the majority of the work performed.
Provide validation expertise and support for the development (or modification phases) of manufacturing facility, systems, process and information and Computerized System; address, include and implement all the applicable QA requirements.
Review from a quality perspective, the validation approach and documentation as required to assure compliance with procedures and regulatory submissions  Review from a quality perspective the validation documentation required to assure the proper development of a project and support regulatory submissions.
Participate in the risk assessment related to the project.  Assure requirements traceability throughout the whole project life cycle.  Evaluate, analyze, and approve protocol discrepancies and ensure that the required corrective actions are taken.
May perform other duties as assigned.

Qualifications :

BA or BS degree preferably in the engineering or science field.

5 years of related experience.

Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills. Must be able to handle multiple projects concurrently, have computer experience and have extensive knowledge of FDA Regulations and GxPs.

Must have experience in pharmaceutical / biotech validation which includes the writing and executing of protocols.

Must have experience or advanced training and demonstrate proficiency (e.g. Client’s quality systems such as validation, change control, etc., statistical methods / six sigma training, problem analysis and resolution, design of experiments and process development / pilot scale work).

The individual will have proficiency in plasma fractionation and purification processes.

Successful track record of analyzing complex technical problems.

Demonstrates good troubleshooting and decision-making abilities.

Must be self-motivating and able to handle multiple projects / systems concurrently.

Ability to design and influence in own area of expertise.

Extensive cross-functional team experience, including technical and non-technical work.

Must have the following personal attributes : integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.

Must have passion to innovate and drive for solutions.  Must display personal accountability for results and integrity.

Must have uncompromising dedication to quality.

Must have relentless focus on rapid and disciplined action.

Must have respect for individuals and the diverse contributions of all. Education and / or experience

SALARY RANGE FOR THIS ROLE IS $80,000 - $112,000 ANNUALLY FOR A W2 EMPLOYEE

VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, a matching 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.

As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time / permanent employees. www.validation.org

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Salary : $80,000 - $112,000

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