Quality EM Technician II

Collins Consulting, Inc

Worcester, MA

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JOB DETAILS

JOB TYPE

Full-time

SKILLS

Asepsis, Assays, Biology, Cleanroom, Communication Skills, Current Good Manufacturing Practice (cGMP), Data Collection, Detail Oriented, Documentation, Environmental Monitoring, Establish Priorities, GMP (Good Manufacturing Practices), Interpersonal Skills, Laboratory, Laboratory Techniques, Laboratory Testing, Operational Support, Organizational Skills, Procedure Development, Product Support, Quality Assurance Methodology, Quality Control, Record Keeping, Testing, Time Management, Trend Analysis, Writing Skills

LOCATION

Worcester, MA

POSTED

30+ days ago

This is an onsite position. Shift: Tuesday-Saturday 8-4:30 (On occasional coming in early or staying late. Monday thru Friday availability will be needed during first few months of training. Some weekends or Holiday coverage needed, will know in advance.) Description Details The Primary function would be to : 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. Top Skills: 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 Years of experience/education and/or certifications required: BS in Biology or other life science required. (No Masters Degree or Research candidates.) What are the top 3-5 skills requirements should this person have? QC Micro experience- -Hands- on experience with lab testing and EM. 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. Must be comfortable standing for most of their shift. Shuttling between client buildings is required. What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? 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

About the Company

Collins Consulting, Inc

Collins Consulting brings over two decades of total talent solutions experience to meet your on-demand consulting needs. We have an established history of serving clients nationwide in both the public and private industries. These clients range from Fortune 100 companies within the commercial arena to supporting contracts within federal agencies.

Collins Consulting is a certified Service-Disabled Veteran Owned Small Business and a SBA Small Business. We believe in servicing our country's veterans by supporting and nurturing opportunities to join their skillsets with clients who have the same principles. These certifications coupled with Top Secret facility clearance allow us to meet category and diversity goals.

Collins Consulting is agile, innovative, and an award winning advocate in providing total talent solutions to serve your business needs. Whether you are a professional who is looking for a new career or an organization in need of experienced talent, we have the resources to help you.

COMPANY SIZE

10 to 19 employees

INDUSTRY

Staffing/Employment Agencies

WEBSITE

http://www.colcon.com

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