QC Technician

About the role

Performs sample retain discard per GMP procedures. Performs routine Environmental Monitoring testing within a GMP environment. Performs Environmental Monitoring (EM) during a fill operation. Supports other lab associated functions.

Responsibilities

• Perform test methods as written to support product/material release.
• Effectively perform a multitude of laboratory techniques with minimal error for which they will be trained on.
• Understand, implement, and maintain GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements.
• Accept responsibility to complete assigned tasks as committed.
• Support investigation writers and approvers to gather data.
• Effectively perform a multitude of laboratory techniques with minimal error for which they are or will be trained on.
• Writes or revises procedures with guidance.
• Works under the guidance of a supervisor but is able to manage their own time to ensure timely completion of assigned duties.
• Trends data to support trend reports.

Qualifications

• BS in Biology or other life science required.
• Microbiology and GMP internship experience can be considered.
• QC Micro experience; hands-on experience with lab testing and EM.
• Hands-on Aseptic Technique experience preferable.
• Hands-on working experience in Biosafety hoods preferable.
• Attention to detail while running assays/tasks in the lab and while performing EM is required.
• Organizational skills, ability to prioritize workload and extremely thorough with excellent attention to detail.
• Should perform tasks with supervision guidance, taking responsibility for complying with GMP requirements.
• Strong interpersonal/communication skills.
• Maintaining good working relationships within and outside the department.
• Adjusting quickly to new situations.
• Reprioritizing to meet schedule demands in continually changing work environment.
• Knowledge with the LIMS system, specifically entering results is preferred.
• Knowledge of applicable regulations and standards affecting Pharmaceutical Products (e.g. USP, EP, JP pharmacopoeias, ICH guidelines, cGMP) is preferred.
• GMP and/or Clean-Room experience.
• Clean-Room Gowning.
• Experience with cGMP documentation and record maintenance is required.

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 of the month following at least 1 calendar year after employment begins.