27 days old

Quality Assurance Specialist II

Kelly Services
Palo Alto, CA 94301
**Quality Assurance Specialist II - Palo Alto, CA**

**Direct Hire**

Our client is seeking a Clinical Manufacturing Quality Assurance Associate II to develop and maintain effective quality system in accordance with regulations GMP and applicable guidance for the LCGM. This position will be prioritized to support Sickle Cell program QA activities. The candidate possess strong technical quality experience who can promote quality and support best quality assurance practices.

**Duties include:**

+ Develop, draft, and compile documents of clinical protocols for the Investigational New Drug (IND) and Chemistry Manufacturing and Controls (CMC) sections for submissions to Food and Drug Administration (FDA), Institutional Review Board (IRB) etc.

+ Evaluate compliance of all completed CCT CAR T manufacturing (batch records, forms, etc.) and quality control records (test/analytical results) to identify deviations. Review deviations and determine if batch record should be escalated for additional review or investigation.

+ Provide guidance to CCT Product Development/Manufacturing (PD/MFG) and Quality Control (QC) to ensure compliance with all applicable regulations and assist in resolution of issues identified.

+ Evaluate and analyze the impact of new regulations to determine how to implement within unit and make recommendations based on findings for implementation.

+ Oversee Quality Assurance contract manufacturing activities to ensure required quality standards are maintained based on cGMP (current Good Manufacturing Practice) regulations.

+ Perform independent review of documentation during and post-execution of CCT CAR T cGMP activities and manufacturing campaigns. Ensure all specifications are met and that applicable requirements are completed and acceptable.

+ Provide guidance and directives regarding remediation activities required to continue production. Continuously identify and manage issues to ensure quality control is maintained, compliant, and the issues have no impact to quality of product/process.

+ Ensure raw materials used for manufacturing and testing comply with cGMP requirements and ensure staff are trained as required.

+ Collaborate with CCT PD/MFG and QC to resolve minor and major deviations and to execute continuous compliance with quality systems, internal SOPs (Standard Operations Procedures), and regulatory requirements. Actively participate in the mitigation of risks by identifying quality issues, determining corrective actions, minimizing reoccurrence, and evaluating quality impact.

+ Generate quality metrics including but not limited to deviation trends, CAPA effectiveness, EM excursions, product lot acceptance, confirmed OOS, product complaints rate, annual product review completion, per defined interval to ensure quality attributes are maintained.

+ Develop processes that enable routine execution and achievement of product/project timelines and contribute to completion of CCT project milestones and grant milestones.

+ Participate in cGMP compliance audits of vendors, contract manufacturers, contract laboratories, and quality systems.

+ Ensure equipment qualification have been completed; preventive maintenance and calibration performed prior to due date.

_* - Other duties may also be assigned_


+ Bachelors degree in life sciences (e.g. biology, chemistry, etc.).

+ Ability to effectively work in fast pace environment with cross functional groups involved in multiple projects and timelines.

+ Flexibility to support changing priorities while maintaining collaborative approach.

+ Able to work independently with some supervision.


Bachelors degree and three years relevant experience or an equivalent combination of education and relevant experience.


+ Working knowledge of GMP/ ISO compliance and quality systems.

+ Working knowledge of federal, state and local regulations, GMP, IND, FDA, and CMC.

+ Demonstrated ability of problem-detection and problem-resolution skills.

+ Demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.

+ Must possess excellent verbal and written communication skills

**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: 2021-08-23 Expires: 2021-10-04

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Quality Assurance Specialist II

Kelly Services
Palo Alto, CA 94301

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast