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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: North Chicago, Illinois
job type: Contract
salary: $35.00 - 42.73 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Assist Validation Engineer in the validation and certification of all new process equipment and periodically review all certified systems to assure the capability of meeting quality requirements.
- Responsible for implementing and maintaining the effectiveness of the Quality System.
- Support to ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations.
- Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and places product on QA hold where appropriate.
- Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
- Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
- Approves standard operating procedures; ensures procedures comply with policy and make sense.
- Approves calibration requests and ensures that these requests have appropriate product/process limits assigned.
- Develop and implement statistical quality programs, assure all acceptance sampling is capable of meeting expected product quality confidence levels for manufactured as well as purchased materials.
qualifications:
- Bachelor's degree, preferably in Biology, Chemistry or Engineering or equivalent related experience
- 2+ years of overall experience in Manufacturing, Quality or Engineering
- Good verbal and written communication skills.
- Good problem solving and analytical skills
- Good interpersonal relations / communications skills
- Good negotiation skills
- Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.
skills: SOP, Quality Assurance, 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.
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.