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16 days old

Quality Control Associate

Kelly Services
Thousand Oaks, CA 91358
**QC Associate**


The QC Associate Operations position is responsible for executing sample management activities, which includes control, receipt, and distribution of product, intermediates, raw materials samples, sample retention, reference samples, and stability samples. The QC Associate Operations position will interact regularly with FDBC QC Operations, QC laboratories, Quality Assurance, Supply Chain and Manufacturing, as well as FDBCs External contract manufacturers and contract test laboratories.


**Reports to** Manager, Quality Control


**Work Location** Thousand Oaks, CA


The QC Associate is expected to carry out all their activities in compliance with FDBCs Quality processes, the requirements of the Quality Management System, and in compliance with regulation requirements governing laboratory testing and manufacturing.


**Primary Responsibilities:**


+ Performs sample transfer for testing of the product samples at all internal and external testing laboratories.

+ Work on LIMS system to support sample and data management activities.

+ Responsible for receipt and entry of samples in the inventory management system.

+ Performs any combination of sample management tasks, including label and document preparation, prepare for shipping, transfer to labs, inventory, and disposal.

+ Reviews and verifies sample documents against samples and source information to ensure accuracy and communicate discrepancies. Distributes sample information and documents.

+ Verifies data entry completed by others.

+ Assists with management of samples in stability studies as needed and directed. Including removal of samples from stability and verification of information.

+ Properly handles, stores, and disposes of hazardous materials according to FDBC procedures.

+ Ensures all work performed strictly adheres to cGMP and FDBC documents.

+ Performs and documents equipment management tasks to maintain QC equipment, which include but not limited to LN2 freezers, refrigerators, and freezers.

+ Performs document management tasks for sample documents, such as uploading of data reports/data packets into the document management system (Veeva).

+ Performs document maintenance tasks for writing procedures and work instructions.

+ Attends work center team meetings and provides project updates.

+ Perform review of logbook data which includes overall documentation.

+ Supports internal and external inspections and audits.

+ Maintains a customer-centric mindset.


Qualifications


+ Bachelors degree preferred in Biochemistry, Molecular and Cellular Biology, Immunology, or Biology.

+ 1-2+ years of experience or an equivalent combination of education and experience.

+ Experience working in laboratory environment.

+ Experience with cGMP and QC Sample Management in the pharmaceutical industry preferred.

+ Knowledge of cell-based bioassay and cell culture is a plus.

+ Experience working in LIMS application.

+ Working in flexible shift schedules. (Mostly Morning/Afternoon shifts)

+ Working in a flexible and dynamic environment.

+ Excellent verbal and written communication skills; good interpersonal skills.

+ Role model for FDBC TRAIT values (Transparency, Respect, Accountability, Integrity, Trust)


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


Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the worlds most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, were here to guide you to the next step in your engineering career.


**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.

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Posted: 2022-09-12 Expires: 2022-10-13

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Quality Control Associate

Kelly Services
Thousand Oaks, CA 91358

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