Quality Control Technician

Position Title: Quality Control Technician

Work Location: Worcester, Massachusetts, USA(01604)

Assignment Duration: 6 Months

Work Schedule: M-F, 7am to 3:30pm, OT on weekends may be required on rare occasions

Work Arrangement: On-site

Position Summary: Performs routine Environmental Monitoring testing within a GMP environment.

Background & Context:

• No Masters Degree or Research candidates.

Key Responsibilities:

• 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.
• Experience Level = 3-5 Years.
• 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.
• MUST be flexible working weekends and holidays.
• 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.
• Must be comfortable standing for most of their shift. Shuttling between buildings is required.