Quality Engineer job in North Chicago, USA

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Manufacturing, Design, Operations Management

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Quality Engineer with a biopharmaceutical company located in North Chicago, IL.

Job Responsibilities:

Provide interpretation and guidance regarding qualification and validation requirements in GLP-, GCP- and GMP-regulated areas of an R&D organization.
Review / approve various qualification / validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate with minimal supervision.
Compilation, review and approval of quality documents (Policies, Processes, Procedures, templates, formats etc.).
Support CAPA activities related to validation and qualification
Provide guidance, direction, and support to peers.
Provide assurance that applicable national and international regulatory requirements are adhered to in the context of validation and qualification policies, processes, and procedures.
Lead or participate on process improvement projects and assist with the development of compliance plans and strategies.
Review new / updated regulations and provide comments on and assessments of how the new / updated regulations impact the organization.
Participate in preparation and execution of authority inspections, self- inspections, vendor audits, presentation of validation concepts and system validations
Represent R&D QA in cross functional global expert teams, industrial and professional associations.

Skills and Requirements:

4-year college degree; preferably a BS in Chemistry, Biology, Engineering Pharmacy, or Microbiology.
Minimum of 5 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification / validation, documentation or compliance.
Sound knowledge of the current regulatory requirements (21 CFR Part 11, EU GMP Annex 11 / 15, ICH, PIC/S) and Best Practices (GAMP5, Data Integrity, etc.)

If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-SR2