QC Tech II
100 Research Dr Worcester, MA 01605 US
*Depending on experience
Extension may become a possibility at any time due to business needs, however, no guarantee is provided. The Primary function would be to: • Performs routine Environmental Monitoring testing within a GMP environment. • Supports 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.
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 Nice to have:
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
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.