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Actalent Quality Control Technician II in Worcester, Massachusetts

Description:

Shift: Tuesday-Saturday 8am-4:30pm

  • Monday thru Friday availability will be needed during first few months of training. Some weekends or Holiday coverage needed will know in advance.

    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.

  • Should be willing to work on weekends and holidays.

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:

o BS in Biology or other life science required

What are the top 3-5 skills requirements should this person have?

o QC Micro experience- -Hands- on experience with lab testing and EM.

o Attention to detail while running assays/ tasks in the lab and while performing EM is required

o Should have good organizational skills ability to prioritize workload and extremely thorough with excellent attention to detail.

o Should perform tasks with supervision guidance taking responsibility for complying with GMP requirements.

o MUST be flexible working weekends and holidays.

o Strong interpersonal / communication skills. Maintaining good working relationships within and outside the department.

o Adjusting quickly to new situations. Reprioritizing to meet schedule demands in continually changing work environment.

o **Must be comfortable standing for most of their shift. Also must be flexible to work some weekends and holidays pre-scheduled.

What is a nice to have but not required regarding skills requirements experience education or certification?

o Knowledge of applicable regulations and standards affecting Pharmaceutical Products e.g. USP EP JP pharmacopoeias ICH guidelines cGMP is preferred.

o GMP and/or Clean-Room experience

Clean-Room Gowning

Experience with cGMP documentation and record maintenance is required

Experience Level:

Intermediate Level

If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent

  • Maintaining an inclusive environment through persistent self-reflection

  • Building a culture of care, engagement, and recognition with clear outcomes

  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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