Quality Analyst II, MicroAt Dendreon, we're transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE (sipuleucel-T), was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient's own immune cells to fight the disease. The Quality Analyst II, Microbiology is responsible for performing daily lab operations within the assigned functional area related to the release of product, and/or monitoring of environment, in addition to other tasks related to the overall productivity and operation of the department.
SCHEDULE:
Overnight - three 12 hour shifts a week. This role requires on-site presence at our Seal Beach, CA location.
Responsibilities:- Performs routine environmental monitoring, including air viable, particulate, viable surface sampling, and purified water system sampling/testing.
- Perform in-process and final product sterility testing of Dendreon products (e.g., sterility by BacT/Alert)
- Receives and maintains traceability and integrity of test samples, reagents and materials used in the laboratory per approved procedures.
- Initiates and takes ownership as needed of laboratory investigations, invalid assays and nonconformance reports for out-of-limit samples, and of other projects and related assignments.
- Performs routine laboratory equipment maintenance.
- Participates in and initiates other projects and related assignments.
- Revises and updates standard operating procedures.
- Performs testing in support of method validation studies.
- Adheres to good documentation practices to ensure data integrity and traceability
- Assists with training of QC personnel.
- Able to organize and provide analytical data with some supervision upon request.
- Uses professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
- Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Normally receives no instructions on routine work, general instructions on new assignments.
Job Requirements:- Bachelor's (preferred) degree in a scientific discipline or equivalent.
- Typically, 5+ years related experience in cGMP/FDA regulated industry.
- Strong knowledge of basic lab testing techniques.
- Intermediate level of analysis skills required to evaluate and interpret data to arrive at logical conclusions. Understanding on how to apply, and/or experience with, problem solving tools (i.e. Fishbone diagram, IS/IS NOT, Kepnoe/Trego concept, 5Ms and 5 Whys)
- 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 technical concepts behind each assay performed.
- Knowledge of cGMP/QSR/ICH and FDA device/drug/biologics regulations preferred.
- Proficient in MS Office applications.
- 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 pounds. 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 lbs.
- 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) environmentCA Compensation Range $70,304 - $92,678 USD
