Job added in hotlist
Applied job
Contract job
90-day-old-job
part-time-job
Recruiter job
Employer job
Expanded search
Apply online not available
View more jobs in Seal Beach, CA
View more jobs in California

Job Details

Quality Specialist I - Supplier Quality

Location
Seal Beach, CA

Apply for this job






Profile


Dendreon

US-CA-Seal Beach

Job ID 2018-1336
Category Quality Control


Overview

The Quality Specialist I, Supplier Quality is responsible for performing a wide variety of Supplier Quality activities to ensure compliance with applicable regulatory requirements.

Responsibilities

Responsibilities:

  • Assists with GMP internal and external audits
  • Assists with Supplier Quality training programs
  • Assists with Supplier Quality risk management
  • Assists with Supplier annual audit schedule
  • Performs batch records review for CMO raw materials
  • Perform release of CMO raw materials
  • Coordinates data and documentation review and analysis for suppliers
  • Processes deviations and non-conformances of raw materials
  • Coordinates supplier related change management
  • Authors documents, standard operating procedures and reports
  • Represents department in cross-functional teams, projects and supplier-related issue resolution

Scope:

  • 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

Job Requirements:

  • Typically 1 year related experience in cGMP/FDA regulated industry
  • Bachelor's degree in a scientific discipline or equivalent
  • Proficient in MS Office applications
  • Ability to gown aseptically for work in Clean Room environments


Working Conditions and Physical Requirements:
  • Ability to sit or stand for extended periods of time
  • 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
  • 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) environment


Dendreon is an EEO/AA employer M/F/D/V.****

Company info

Sign Up Now - BiotechCrossing.com

Similar Jobs:
Research Bioinformatician - I
Location : Los Angeles, CA
Location: Los Angeles, California Salary: Open Discipline: Academic / Research Cedars Sinai's Biomedical Sciences is looking for a Research Bioinformatician to join the Genomics Core. Under close supervision, the Research Bio...
Clinical Laboratory Divisional QA Manager
Location : Los Angeles, CA
Divisional Quality Manager -- National Genetics Institute Los Angeles, California The Divisional Quality Manager position will provide quality management oversight for clinical diagnostic and biological donor testing performed at ...
EmploymentCrossing was helpful in getting me a job. Interview calls started flowing in from day one and I got my dream offer soon after.
Jeremy E - Greenville, NC
  • All we do is research jobs.
  • Our team of researchers, programmers, and analysts find you jobs from over 1,000 career pages and other sources
  • Our members get more interviews and jobs than people who use "public job boards"
Shoot for the moon. Even if you miss it, you will land among the stars.
BiotechCrossing - #1 Job Aggregation and Private Job-Opening Research Service — The Most Quality Jobs Anywhere
BiotechCrossing is the first job consolidation service in the employment industry to seek to include every job that exists in the world.
Copyright © 2018 BiotechCrossing - All rights reserved. 168