30 days old

Validation Technician

Kelly Services
Carlsbad, CA 92008
**Validation Technician - Scientific**

**Location** : San Diego

**A Day in the Life** :

+ As a QC scientist, independently perform the development, validation, transfer, and verification of plasmid content, plasmid isoform quantitation, residual DNA, residual RNA, residual host cell proteins, and final plasmid drug substance and drug product release testing.

+ Perform QC plasmid assay to support characterization, in-process, release, and stability of incoming cell banks and final products.

+ Perform investigation of non-conformance materials, recommend corrective and preventive actions in a timely manner.

+ Independently develop, revise, review regulatory analytical procedures, validation/transfer protocols, work instructions, guidance, SOPs and generate repots as per the applicable regulatory and industry standards.

+ Work closely with R D, manufacturing, quality, and project management teams to execute assays that meet customer and manufacturing needs in support of department, site, and corporate objectives.

+ Independently analyze data, present results, and conclusions to the team.

+ Independently identify areas for further innovation and support continuous improvement efforts e.g., improved sensitivity, reduced turnaround time and related task .

+ Responsible for lab management tasks and stability program. ]

+ Train and supervise junior staff members.

+ Apply principles and practice of quality improvement to ensure work performed meets the applicable compliance and customer requirements.

+ Keep current on Environment, Health Safety policies, ensure safe environmental and working conditions in the Analytical Sciences labs.

+ Use CE, real time PCR, ELISA, UV Spectrophotometry, agarose gel electrophoresis, SDS-PAGE, and other state of the art analytical tool to achieve project deliverable in a timely manner.

+ Other duties as assigned; travel as needed.

+ Changes to individual responsibilities may occur due to business needs.

+ Other duties that may be determined by the management.

**Keys to Success:**

+ Education Bachelors degree in Analytical Chemistry, Life Sciences or Chemical/Biological Engineering or closely related field .

+ 3-4+ years direct experience in a regulated biological and/or pharmaceutical industry required; 5-7+ years preferred, or equivalent combination of education and experience


+ Experience in AcccuSeq, Empower Software, LIMS, SM, eDMS, TrackWise preferred.

+ within a regulated biological and/or pharmaceutical industry.

+ Knowledge, Skills, Abilities

+ Knowledge of plasmid technology, cell biology, virology and or immunology is highly desirable.

Knowledge of USA 21 CFR, EudraLex, ICH, USP-NF, Ph. Eur, P

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (


Posted: 2022-05-27 Expires: 2022-06-27

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Validation Technician

Kelly Services
Carlsbad, CA 92008

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