Quality Control Technician

Position Title: Quality Control Technician

Work Location: Worcester, MA 01604

Assignment Duration: 12 Months (possible extension- performance based)

Work Schedule:

• Training: Monday-Friday for the first 6-12 weeks, 8:30 AM - 4:30 PM
• Post-Training: One position will work Sunday-Wednesday and the other will work Wednesday-Saturday, generally 8:30 AM - 4:30 PM

Position Summary: The Primary function would be to : Performs sample retain discard per GMP procedures. Performs routine Environmental Monitoring testing within a GMP environment.

Key Responsibilities:

* 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. 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.

* Should be willing to work on weekends and holidays.

Qualification & Experience:

* BS in Biology or other life science required

* 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

* Should have good 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.