Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact – one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry — our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.
Quality Control Analyst II (Environmental Monitoring)
Gaithersburg, MD
Your Tasks:
This position is primarily responsible for the development, qualification and performance of environmental monitoring and clean utility sampling to support GMP manufacturing operations. Responsibilities include assisting in the development, execution and qualification of environmental monitoring and clean utility processes, and the review and development of SOPs and other controlled documents.
Essential Duties and Responsibilities:
- Develop and execute environmental monitoring and clean utility sampling in Grades A-D clean room.
- Adhere to all applicable SOPs for clean rooms, quality control and quality assurance.
- Development of GMP documentation such as SOPs, EMRs, Training documents and forms.
- Perform plate reading and data entry.
- Assist in investigating OOLs and implementing CAPAs as appropriate.
- Ensure adherence to schedule and that quality standards are always met or exceeded.
- Work with QA, Manufacturing, MSAT and others to troubleshoot issues.
- Develop and ensure adherence to schedule and that quality standards are always met or exceeded.
- Develop and implement training plans for QCEM Analyst I.
Requirements:
- Bachelor's Degree in life sciences or relevant discipline; Minimum of 5 years’ experience in environmental monitoring and clean utility sampling; or equivalent combination of education and experience.
- Knowledge of cGMP and GLP regulations and GDP are essential.
- Previous experience working in a QC department of a Biotech Company is preferred and comprehensive GMP EM experience is required.
- Impeccable aseptic and gowning technique is required.
- Intermediate level experience with Word, Excel, electronic data management systems.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a controlled biological manufacturing cleanroom and microbiology laboratory, using such equipment as particle counters, air samplers, biosafety cabinets, incubators, plate readers and computers. While performing the duties of this job, the employee is exposed to viruses and bacteria. Employees entering the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.
As a global team of over 3,000 diverse innovators, we are united by a shared vision to advance research and improve patient care worldwide. Our mission transcends mere scientific discovery; we are on a quest to unravel the complexities of biology and transform them into tangible solutions that propel research to unprecedented heights. These developments have led to cutting-edge cell and gene therapies – transformative methods that mobilize the body’s own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow. Here, you will contribute to work that is breaking barriers, blending the wonders of biological discovery with the pursuit of well-being for all. Every day presents a chance to make a tangible impact and play a key role in accelerating the journey of research from the lab to the market.
Join Miltenyi Biotec and immerse yourself in an environment where your efforts are significant, your contributions are valued, and your work truly matters.
Miltenyi Biotec is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
Miltenyi Biotec, Inc. participates in E-Verify.
