Quality Analyst II, Lab Operations at Dendreon Pharmaceuticals, LLC in Seal Beach, California

Job Description:

Dendreon Pharmaceuticals, LLC


Quality Analyst II, Lab Operations

US-CA-Seal Beach

Job ID: 2024-3000
Type: Regular Full-Time
# of Openings: 1
Category: Quality Control Mfg
Seal Beach

Overview

Who we are.

Dendreon is making the battle against cancer personal. Our flagship product PROVENGE® (sipuleucel-T), was the first FDA approved immunotherapy for the treatment of metastatic castrate resistant prostate cancer and is made from the patient's own immune cells.

If you are looking to positively impact the lives of patients, we want you to join our team. We have Immunotherapy Manufacturing Facilities located in Seal Beach, CA and Union City, GA. A sizeable Research & Development group based out of Seattle, WA, and a highly skilled Commercial team countrywide.

Core Values:

• Put Patients First. Every day is a new opportunity to improve the lives of patients living with cancer
• Act with Integrity. Be honest, transparent, and committed to doing what’s right in every situation.
• Build Trust. Building trust takes time. Engage teammates, be candid and transparent. Over communicate and seek feedback.
• Raise the Bar. Harness continuous improvement, foster innovation and elevate our people.
• Drive Results. Be accountable and execute – we win together when everyone performs.

Your Role:

Responsible for supporting the department lab operations within the assigned functional area related to management of laboratory equipment and instrument systems to ensure for the timely release of product, as well as complete other assigned duties.

Responsibilities

Your Work:

• Manages QC equipment maintenance with vendors and department staff. This includes working with vendors on service contracts, initiating requisitions, managing on-demand work orders and performing routine equipment maintenance as needed.
• Coordinates with Procurement to maintain service agreements, blanket purchase orders.
• Perform basic troubleshooting of instrument systems to assist with identifying issues and implementing proper corrective actions to minimize the downtime of instruments and to ensure ability for timely patient testing is not impacted.
• Oversees projects that involve QC instrumentation, including initiating and owning quality change controls, and working cross-functionally and across sites to validate and implement new systems.
• Initiates non-conformances and conducts investigations as needed to address issues
• Ensure timely assessment and closure of NCs and Change Control requests
• Ensure timely assessment and closure of Laboratory Investigations
• Participate in audits of site operations
• Gathers metric information for use in continuous improvement of area of responsibility. Assist in interpretation of metric data.
• Revises and updates standard operating procedures
• Performs validation testing as needed to support implementation of new instruments or changes in instrument software.
• Reviews and approves equipment calibration reports.
• Adheres to good documentation practices to ensure data integrity and traceability.
• System administrator for all QC laboratory systems (MetOne, WinKQCL, Myla/BacT, NC-200, NC-202, CytoFlex/CytExpert and others as required).
• Uses professional concepts and company policies and procedures to solve a variety of problems.
• Accountable for security administration of a large variety of software systems under increasing data integrity requirements
• Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.
• Perform other duties as required.

Qualifications

Education Requirements:

• Bachelor’s degree in a scientific discipline or equivalent.

Job Requirements:

• 4+ years related experience in cGMP/FDA regulated industry.
• Knowledge of basic lab testing techniques.
• Analytical skills to evaluate and interpret data to arrive at logical conclusions.
• Attention to detail, quality and compliance with strict adherence to test procedures and protocols.
• Ability to learn new technologies and processes quickly and to understand the operational concepts of each equipment used in the laboratory.
• Knowledge of cGMP/QSR/ICH and FDA device/drug/biologics regulations preferred.
• Proficient in MS Office applications.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Able to adjust workload based on changing priorities.

Working Conditions and Physical Requirements:

• Ability to sit or stand for extended periods of time
• Intermittent walking to gain access to work areas
• Finger dexterity sufficient to use a computer and to complete paperwork activities
• Vision sufficient to use a computer, to read written materials and to complete paperwork activities;
• Hearing sufficient to communicate with individuals by telephone and in person
• Ability to lift up to 25 Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (- 196ºC) areas.
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50
• May be required to work alternate shifts
• Ability to gown aseptically for work in Clean Room environments
• Job performed in a lab, office, or utility (noisy) environment
• Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.

PI249581856

Salary:

$72,334.00

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