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This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
location: Round Lake, Illinois
job type: Contract
salary: $35.00 - 47.31 per hour
work hours: 9 to 5
- Perform non-conformance (NCR) investigations within the Track Wise 8 Management System.
- Execute implementation of CAPAs associated with NCR investigations.
- Maintains a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements. Maintains audit ready status for assigned areas and assists other areas within the facility in maintaining compliance with local procedures as well as US & International Regulatory and Company corporate quality requirements.
- Provide guidance and coaching on performance of DMAIC problem solving and process improvement projects for less experienced individuals within the plant.
- BS/BA (4 years of university level education) in science, engineering or related field.
- 0-2 years relevant work experience in cGMP related industry or in a clinical setting.
- Greenbelt certification or equivalent experience using Six Sigma or other Lean Manufacturing tools is a plus.
- Candidate must not be allergic to Penicillins or Cephalosporins
- Understanding of the product's intended use and manufacturing process
- Ability to prioritize multiple tasks to ensure compliance with regulations and standard operating procedures.
- Strong problem solving and analytical skills.
- Consultation and facilitation skills.
- Understanding of statistics in support of fact based decision making.
- Excellent written/verbal communication and organizational skills
- Ability to make independent decisions with minimum oversight
- Customer sensitivity / acumen and ability to interact with all levels of management.
- Experienced user of TrackWise preferred.
- Working knowledge of FDA Regulations and International Regulatory requirements.
- Understanding of risk management tools.
- Available to work during off-shift or weekends as appropriate to support investigations and training
skills: FDA, Quality Assurance, CAPA, GMP (Good Manufacturing Practice)
Equal 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).
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.