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6 days old

Quality Control Analytical Associate - IMMEDIATE NEED

Kelly Services
Arcadia, CA 91007
For over 25 years Kelly Science & Clinical has been connecting scientific professionals with meaningful work with industry leading employers. Today we are excited to be hiring several **_Quality Control Analytical Associates_** for an exciting therapeutics start-up in Arcadia, CA! The **_QC Associate_** will be responsible for supporting activities for method transfer, qualification, and validation of client methods. The **_QC Analytical Associate_** role is responsible for execution of testing for cGMP samples for raw materials, in-process, lot release and stability samples in-house. The role will support and coordinate the biochemical, cell based, molecular biology and general chemical testing of raw material, in-process, final product, and stability samples submitted to external laboratories. This role will be responsible for documentation that is compliant with all applicable procedures, standards, and cGMP regulations.


**Responsibilities:**


+ Assists implementation of new methods transferred by the clients and Analytical Development lab.

+ Originates and revises QC related procedures and analytical methods.

+ Supports invalid assay, exceptions, and lab investigations.

+ Ensures compliance to all quality requirements to meet audit standards and regulatory compliance.

+ Maintains lab equipment, reagents inventory, and documentation to ensure accurate, timely, and cost-effective analysis of materials and products.

+ Assists in creating training materials.

+ Collaborates with other Functional Areas and participates in cross functional meeting.

+ Executes assays to assess various cell and gene therapy products using PCR, ddPCR, ELISA and cell-based assays.

+ Qualifies current and new pharmacopoeia methods to ensure compliance with cGMPs and other regulatory requirements.

+ Analyzes and summarizes data into reports and certificate of analysis with attention to details.

+ Participates in risk assessment, HAZOP and FMEA.

+ Assists with proposed corrective and preventive actions and improvements identified through investigations and audits.

+ Performs sample management tasks, including labeling, shipping to external labs, inventory, and disposal of samples.

+ Participates with internal audits and external audits.


**Requirements:**


+ Bachelors degree in Biochemistry, Chemistry, Molecular and Cell biology, or Biology

+ Minimum of 2 years of work experience in the Pharmaceutical, Life Sciences industry with cGMP

+ Working knowledge of Deviations, Change Controls, and CAPAs

+ Basic knowledge of cGMP and ICH guidelines. Other regulatory agencies experiences preferred

+ Experience in the qualification of cell therapy equipment a plus

+ Understanding of cGMP regulations, preferably with Cell Therapy

+ Ability to organize assigned tasks in a fast paced environment and monitor tasks / assignments that may impact timely completion

+ Strong team player, able to meet deadlines and changing priorities


**Apply for Immediate Consideration**


**Schedule and interview with Athena** https://calendly.com/athp320/interview


**Text Regan at 303-601-8303 with any questions. Please be sure to include which job you are interested in.**


**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** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-23 Expires: 2022-10-24

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Quality Control Analytical Associate - IMMEDIATE NEED

Kelly Services
Arcadia, CA 91007

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