Quality Engineer, CMS
Website Dendreon Corporation
Company : Dendreon Corporation
Country: United States
Location : Seal Beach, California
Post: Sun, 19 Sep 2021 15:48:45 GMT
Expires: Sun, 17 Oct 2021 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
Who we are.
Dendreon is making the battle against cancer personal. Founded on the belief that the immune system holds the key to the future of cancer care, Dendreon is committed to the delivery of treatments that harness the power of the body’s immune system to attack cancer cells.
If you are looking to positively impact the lives of patients, we want you to join our team. Headquartered in Seal Beach, California, and with sizable locations in Union City (Greater Atlanta), Georgia and Seattle, Washington, as well as countrywide Commercial and Medical Science Liaisons teams, we have a diverse offering of exciting opportunities.
What we do.
Vision – Pioneering the future of immunotherapy.
Mission – Making the battle against cancer personal through immunotherapy treatments that extend lives.
How we do it.
The Dendreon Way. We are a purpose-driven, value-based culture. At Dendreon, we…
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.
Raise the Bar. Harness continuous improvement, foster innovation and elevate our people.
Drive Results. Be accountable and execute – we win when everyone performs.
Foster Innovation. Building a culture of creativity and pushing past boundaries.
Are you ready?
Our high-performing organization challenges, develops, and rewards employees interested in pushing past typical career limitations. If you are passionate about helping patients and looking for a unique career opportunity, view our open positions to apply or refer a friend today.
The Quality Engineer, Manufacturing Quality Assurance, performs a wide variety of QA and engineering activities to ensure compliance with applicable regulatory requirements. Provides support in the development, implementation and maintenance of quality assurance systems. Works in collaboration with other key operational departments to resolve complex quality and operational issues.
Review and disposition of Receiving Inspection
Issue batch records and in-process product labels. Ensure a timely review for batch record disposition.
Perform Quality oversight of apheresis receipt and final product packaging
Provide disposition of raw materials and components in compliance with established requirements
Author, review and approve GMP documents such as controlled logbooks supporting manufacturing, validation protocols / reports, Standard Operating Procedures (SOPs), change control documents, non-conformance impact/risk assessments and investigations, and controlled environment recertification and equipment requalification reports.
Author, review and approve any GMP equipment, facility critical work orders, alarm reports, equipment calibration and preventive maintenance work orders
Provide effective and timely risk-based decision-making, project management, and teamwork leadership
Collaborate with manufacturing, facility and laboratory functions in addressing non-conformances and CAPA, including root cause analysis, impact and risk assessments and corrections/corrective actions.
Author, review and approve impact assessments, risk assessments, FMEAs and other risk assessment documentation.
Investigation and recall of non-conforming materials, product failures, product complaints, and BPDRs. Experienced in non-conformance management
Performs GMP internal audits, and monitors compliance to company procedures, methods and regulatory regulations
Support FDA/Regulatory Agency inspections in SME capacity
Represents the MQA department in cross-functional teams
Develop and present training materials in collaboration with Training Department
Support Product Complaints, including investigation and complaint metrics
Process lot-related non-conformances and CAPA materials.
Provides guidance to employees according to established policies and management directives. Administers company policies that directly affect staff members. Recommends changes to area policies.
Frequently interacts with outside customers and functional/cross-functional peer groups at various management levels. Interaction normally requires the ability to gain cooperation of projects/schedules and tasks.
Uses professional concepts, in accordance with company objectives and Quality System Regulations, to solve complex problems in creative and effective ways independently.
Works on complex problems in which analysis, such as six sigma and LEAN principles, of situations or data requires an in-depth evaluation of various factors.
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
Bachelor’s degree required, in Engineering specialty preferred. Additional relevant certifications preferred (ASQ and similar).
Ability to gown aseptically for work in Clean Room environments
Proficient in MS Office applications.
Experience working with ERP, PLM, and electronic non-conformance systems
5-7 years related experience in cGMP/FDA regulated industry
Effective communication and decision-making skills
Knowledge of cGMP/QSR and FDA device/drug/biologics regulations.
Ability to write technical documents such as SOPs and validations
Experience with developing and validating tooling, using a risk-based approach, in a commercial GMP facility preferred.
Experience in statistical methods and statistical application software
Support the Aseptic Media Simulation program ensuring all requirements are met.
Working knowledge of LEAN and Six Sigma principles
Experience with ASME Y14.5 mechanical drawing standards
May be required to work alternate shifts.
Some travel may be required
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