Engineering Document Control Specialist
The businesses of Merck KGaA, Darmstadt, Germany
Saint Louis, MO (In Person)
$70,720 Salary, Full-Time
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Job Description
Your Role:
In this role responsibilities include but are not limited to:Essential Job Functions:
Coordinate the preparation, execution, scanning, and filing of validation protocols, maintenance work orders, and calibration certificates. Maintain engineering, maintenance, and validation quality systems in strict adherence to cGMP and regulatory requirements such as ICH Q7. Collaborate with Validation Engineers to ensure all technical documentation is accurately completed and archived in designated locations. Develop and maintain specialized databases to track various validation activities, maintenance work orders, and equipment calibration history. Oversee the administration of temperature and humidity monitoring instruments, including tracking locations and managing deployment. Manage the end-to-end calibration cycle, ensuring instruments are sent out on schedule, documentation is verified upon return, and equipment is properly returned to service. Assist in generating comprehensive reports for periodic system reviews and specific validation test cases. Provide essential documentation support for equipment commissioning and qualification, as well as gathering necessary data for internal, customer, and regulatory audits.Who You Are:
Minimum Qualifications:
Associate's Degree in Chemistry, Biology or other Life Science discipline. 1+ years' experience supporting a GMP Manufacturing group. 1+ years' experience in Trackwise, Mango, and SAP or other QMS and CMMS systems.Preferred Qualifications:
Experience working with Validation or Quality teams in a GMP environment. Experience working with cross-functional teams. Strong oral and written communication skills. Experience with good documentation practices. Strong computer and document management skills.Pay Range for this position:
$25/hr - $43/hr The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as l ocation, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here .What we offer:
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!Similar remote jobs
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