Quality Analyst I, Bioassay (Overnight Shift Sun 10p-10a, Tues & Wed 1a-1p)
US-GA-Union City
Job ID: 2024-3032 Type: Regular Full-Time # of Openings: 1 Category: Quality Control Mfg Union City
Overview
Who we are.
Dendreon is making the battle against cancer personal. PROVENGE® (sipuleucel-T), Dendreon's flagship product, 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, come join our team. Headquartered in Seal Beach, CA and with locations in Union City, GA and Seattle, WA, we have a diverse offering of exciting opportunities.
Core Values:
PutPatients 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
Job Summary:
Dendreon seeks as Quality Analyst I, Bioassay. This individual will be responsible for performing daily lab operations with the assigned functional area related various assays for qualifying raw materials and reagents as well as complete other assigned duties.
Responsibilities
Perform various release tests for in-process and finished products. These tests include flow cytometry, ELISA (Bead Identity), endotoxin, complete blood count (CBC), viability, gram stain, etc.
Perform various assays for qualifying raw materials and reagents.
Receives and maintains traceability and integrity of test samples, reagents and materials used in the cGMP laboratory per approved procedures.
Performs routine laboratory equipment
Revises and updates standard operating procedures.
Adheres to cGMP good documentation practices to ensure data integrity and traceability.
Train on stability tests including cell culture and immunoassay methods when requested.
Performs testing in support of method validation studies as assigned.
Able to perform laboratory investigations for invalid assays and initiate non-conformance reports for out-of-specification test results as well as perform impact assessment and root cause investigation.
Able to organize and provide analytical data with some supervision upon request.
Be a fully trained and dependable analyst in Bioassay
Uses professional concepts and company policies and procedures to solve a variety of problems.
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.
Normally receives general instructions on routine work, detailed instructions on new assignments.
Qualifications
Education Requirement:
Bachelor’s degree in a scientific discipline or equivalent.
Job Requirements:
Typically, 5+ years related experience in cGMP/FDA regulated industry.
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
