SMS Solutions Inc is Hiring Immediately.

We are looking for skilled Quality Assurance Specialists in the Lake County, IL (Gurnee) Area. Come join the SMS team! It takes more than top-notch facilities, modern equipment, and innovative technologies to become our customer’s most trusted supplier. It takes people who are committed to our customer’s success and who are willing to go the extra mile to get the job done right. 

Job Title: Quality Assurance Specialist

Location: Gurnee, IL, US

Job Type: Contract, 2 months 

Pay: $29.00 - $30.94/Hr.

Shift Structure:

• Monday to Friday
• 2:30 PM to 10:30 PM (B Shift)
• 40 hours per week
• Onsite

About the Client Company:

• A global healthcare leader, creating breakthrough science to improve people’s health. Our client is always looking towards the future, anticipating changes in medical science and technology.

Job Description:

Performs data and document audits to ensure application integrity, accuracy, consistency and completeness. Prepares and issues final audit reports summarizing findings and noting corrective action.

About the Role:

• Reviews production batch records (DHR's) for accuracy and completeness in order to approve intermediate products for use in production. Reviews finished goods batch records. Reports all deviations in these records and assures these have been addressed and resolved prior to issuing approval.
• Conducts spot-check inspections/audits of production operations
• Participates in the internal audit program
• Writes, reviews and approves Standard Operating Procedures (SOPs) as necessary
• Assists with and may write validations/test protocols as necessary
• May assist in testing of complaint samples and stability samples and reports results out of acceptance limits
• Provides backup to other Quality Specialists
• May administer the Quality Records program and assist and act as backup to the Document Control Specialist (with administrator rights in Agile).

Qualifications and Skills:

• Bachelor’s degree, or the equivalent 1-2 years’ experience in an FDA controlled environment.
• Bachelor’s degree in a related technical field is preferred but not required
• One to two years’ experience working in a professional environment where compliance was of vital importance.
• Knowledge of the QSR or ISO 13485 is a plus. 
• Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic.
• Knowledge of MS Office.
• Excellent organization skills
• Attention to detail 
• Excellent writing skills 
• Effective interpersonal skills 
• Excellent critical analytical skills 

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