Description:
The Quality Control Analyst is responsible for Quality Control Microbiological testing of environmental monitoring sampling and microbiological testing in accordance with cGMP/FDA regulations, RLT standard operating procedures and Policies.
Perform environmental monitoring in aseptic, classified, and controlled areas.
Perform growth promotion, bioburden and biological indicators testing.
Enumerate organisms on cultured media for environmental monitoring and utility samples.
Review of routine paperwork.
Direct support of the manufacturing schedule
Incubate and read plates
Qualifications:
Entry level Bachelor's degree required with 0-2 years experience
1+ years of demonstrated relevant experience in performing Environmental Monitoring in a GMP Pharmaceutical Manufacturing facility, preferably associated with aseptic production
Demonstrated ability in performing environmental monitoring techniques including, but not limited to viable surface monitoring, viable and non-viable air monitoring, compressed air monitoring, and analysis.
Previous experience with Laboratory IT systems such as LIMs.
Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities.
Experience with cGMP requirements and regulatory compliance associated with a cGMP Manufacturing facility.
Due to the nature of the process (radioactive) this role requires moderate proficiency, of the basic quality control techniques, EM instrumentation, aseptic technique, and understanding of radiation safety standards.
Understanding of GMP and GDP highly preferred
Benefits:
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.