Quality Control Specialist Iii - Santa Monica, United States - Kite Pharma

Kite Pharma

Verified Company

Santa Monica, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

At Gilead, we're creating a healthier world for all people.

For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.

We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations.

Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite.

As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.

Join Gilead and help create possible, together.

Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission

Kite is seeking a highly motivated individual to join Kite as a QC Specialist III, Global Quality Control, to provide Quality Control support of Global Raw Materials and Reagents Center of Excellence (GRM&R CoE).

In this role you will be responsible for the testing, release, and characterization of raw material and reagents, within a Good Manufacturing Practices (GMP) environment.

Responsibilities:

Independently performs routine Raw Materials release testing by following established procedures as written.
Participates as needed in the testing of raw materials by following analytical methods compendial methods and/or analytical procedures such as, pH, Osmolality, Conductivity, LAL, Identity, ELISA, Gel/Western Blot, FT-IR, HPLC, LC-MS, PCR, UV and Fluorescence spectroscopy, enzyme assays, microbiological assays, and other applicable methods for the testing of Raw Materials and Reagents.
Responsible for equipment lifecycle, maintenance, and calibration, is performed in a timely manner, as assigned.
Responsible for the investigation and evaluation of nonconformances related to laboratory testing, laboratory OOS investigations, deviations, CAPAs and change controls, as assigned.
Responsible for QC Testing Training program, as assigned.
Supports Audits.
Provides data analysis and trending.
Provides technical solutions to a wide range of difficult problems.
Leads/coordinates Quality Control and crossfunctional projects with limited direction.
Training and crosstraining of junior employees,
Drive department goals/objectives.
Authors and revises Standard Operating Procedures.
Compile data for trending or investigation purposes or conduct research in regulatory guidance and peerreviewed journals.
Performs GMP documentation with attention to detail.
Gathering of documentation and data entry.
Documentation and test record review.
Keeps laboratory area clean and ensures waste is properly disposed.
Keeps laboratory reagent and supply inventory.
Supports the department with other duties as assigned.

Basic Qualifications:

Master's Degree and 3+ years' experience in the biotech/biopharmaceutical setting OR
Bachelor's Degree and 5+ years' experience in the biotech/biopharmaceutical setting OR
Associate and 7+ years' experience in the biotech/biopharmaceutical setting OR
High School Diploma/GED and 9+ years' experience in the biotech/biopharmaceutical setting

Preferred Qualifications:

Thorough understanding and experience operating within an GMP environment.
Working knowledge and understanding of analytical techniques to include HPLC, LC-MS, FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, Gel/ Western Blot, enzyme assays, microbiological assays, and other applicable methods to the testing of Raw Materials and Reagents within an GMP environment.
Experience leading OOS's, CAPAs, change controls, deviations, and laboratory investigations.
Knowledge of current Good Manufacturing Practices (cGMPs), GxP, pharmacopoeia, and regulatory requirements for testing pertaining to the pharmaceutical industry.
Preferred, Knowledge of aseptic technique and previous experience with cell culture.
Exceptional attention to detail and ability to keep track of multiple ongoing projects.
Experience writing, reviewing, or executing standard operating procedures, protocols, and reports.
Ability to independently perform duties and be adaptable to a dynamic and fastpaced environment.
Excellent interpersonal and organizational skills.
Strong project and time management skills.
Excellent oral and written communication skills