at Randstad US in waukegan, Illinois, United States
Job Description
quality engineer.
+ waukegan , illinois
+ posted 6 days ago
job details
summary
+ $30.66 – $42.93 per hour
+ contract
+ bachelor degree
+ category computer and mathematical occupations
+ reference1056003
job details
job summary:
A Quality Engineer is needed for a research-driven biopharmaceutical company in the Waukegan, IL area. This role requires a technically educated professional with extensive experience in pharmaceutical GMP/GDP environments, proficient in writing technical reports and quality procedures, managing qualification/validation activities, and providing regulatory guidance and training in a global R&D setting.
location: Waukegan, Illinois
job type: Contract
salary: $30.66 – 42.93 per hour
work hours: 8am to 4pm
education: Bachelors
responsibilities:
+ Provide interpretation, guidance, and training for clients on qualification and validation requirements in GLP, GCP, and GMP regulated areas within an R&D organization.
+ Review and approve various qualification/validation plan documents, test strategies, test documents, summaries, and certification packages with minimal supervision.
+ Compile, review, and approve quality documents including policies, processes, procedures, templates, and formats.
+ Support Corrective and Preventive Actions (CAPA) activities related to validation and qualification.
+ Provide guidance, direction, and support to peers and collaborate effectively in global and virtual team environments.
Education and Experience Requirements:
+ Minimum of a 4-year college degree, preferably a BS in Chemistry, Biology, Engineering, Pharmacy, or Microbiology.
+ 4-7 years of experience in Quality Assurance or related fields such as regulated GxP environments in qualification/validation, documentation, or compliance.
+ Sound knowledge of current regulatory requirements such as 21 CFR Part 11, EU GMP Annex 11 / 15, ICH, and PIC/S, as well as Best Practices (GAMP5, etc.).
qualifications:
+ Experience level: Experienced
+ Education: Bachelors
skills:
+ Quality
+ GMP
+ GDP
+ PharmaceuticalEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Pay offered to a successful candidate will be based on several factors including the candidate’s education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).Applications accepted on ongoing basis until filled.
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