Senior Quality Control Environmental Monitoring Analyst

4 weeks ago

Gaithersburg, Maryland, United States Miltenyi Biotec Full time

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.

Your Key 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.
  • Develop and review GMP documentation such as SOPs, EMRs, Training documents, and forms.
  • Perform plate reading and data entry.
  • Lead EM investigations.
  • 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 and II.
  • Assist in audits.
  • Train manufacturing and QA team members on EM Program.
  • Data approval and protocol generation.

Requirements:

  • Bachelor's Degree in life sciences or relevant discipline; Minimum of 8 years of experience in environmental monitoring; 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.
  • Experience conducting laboratory investigations to determine root cause and identify CAPAs is required.
  • Extensive experience with GMP environmental monitoring and clean utility sampling and GDP is required.
  • Expert level experience with Word, Excel, electronic data management systems.
  • Experience with JMP and Data integrity is preferred.

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 clean laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes, 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, Inc., is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Miltenyi Biotec, Inc. participates in E-Verify.

  • Senior Business Analyst

    4 weeks ago

    Gaithersburg, Maryland, United States Diaconia LLC Full time

    Job Title: Senior Business AnalystAbout the Role:Diaconia LLC is seeking a skilled Senior Business Analyst to support the modernization and enhancement of a software system. The ideal candidate will have experience in requirement gathering, analysis, and documentation.Key Responsibilities:* Gather and analyze business requirements to identify solutions that...

  • Senior Financial Analyst

    1 week ago

    Gaithersburg, Maryland, United States Addison Group Full time

    Senior Accountant Job DescriptionOur client is seeking a highly skilled Senior Accountant to join their team. The ideal candidate will have extensive experience in accounting functions, including journal entries, account reconciliations, and preparation of supporting schedules and financial statements.Key ResponsibilitiesFinancial Statement Preparation:...

  • Construction Safety/Quality Control Specialist

    4 weeks ago

    Gaithersburg, Maryland, United States MEDC: Tribal One Full time

    Job SummaryTribal One Construction is seeking a highly skilled Safety/Quality Control Officer to oversee safety protocols and ensure quality standards on federal construction projects. This role involves implementing safety programs, conducting inspections, and ensuring compliance with federal, state, and local laws and guidelines.Key ResponsibilitiesDevelop...

  • Safety and Environmental Health Specialist

    3 weeks ago

    Gaithersburg, Maryland, United States Trinity Consultants Engineering & EHS Workforce Solutions Full time

    About this roleWe are seeking a highly skilled Safety and Environmental Health Specialist to join our team at Trinity Consultants Engineering & EHS Workforce Solutions. As a key member of our team, you will be responsible for ensuring the safety and well-being of our employees and clients.Key responsibilitiesDevelop and implement manufacturing and process...

  • Program Financial Analyst

    4 weeks ago

    Gaithersburg, Maryland, United States Connsci Full time

    We are seeking a highly skilled Program Financial Analyst to join our team at Connsci. This individual will play a key role in a large IT program related to Marketing and Regulatory Programs.Key Responsibilities:Prepare monthly and quarterly allocation and expenditure reportsPerform variance analysis reports comparing actuals to budgetReconcile financial...

  • Environmental Conservation Coordinator

    1 month ago

    Gaithersburg, Maryland, United States Jobs for Humanity Full time

    Job Title: Salt Watch CoordinatorCompany Description: Jobs for Humanity is collaborating with Upwardly Global and with Izaak Walton League Of America (National Office) to build an inclusive and just employment ecosystem. We support individuals coming from all walks of life.Job DescriptionThe Izaak Walton League of America (IWLA) is seeking a highly motivated...

  • Senior Fraud Protection Operations Manager

    4 weeks ago

    Gaithersburg, Maryland, United States Corporation Service Company Full time

    Job OverviewThe Senior Fraud Protection Operations Manager is a critical role within our Anti-Fraud team, overseeing global team members and driving strategic vision. This position is responsible for developing the strategic vision, objectives, and goals for Fraud protection in accordance with the CTO vision set forth for the business unit.Key...

  • CPIC Portfolio Analyst

    4 weeks ago

    Gaithersburg, Maryland, United States ROC Implementation and Management, Inc Full time

    Job SummaryWe are seeking a highly skilled CPIC/Portfolio Analyst to join our team at ROC Implementation and Management, Inc. The ideal candidate will have a strong background in data analysis and portfolio management, with experience working with federal government clients.Key ResponsibilitiesAnalyze cost data and investment performance metrics to inform...

  • Safety Specialist

    4 weeks ago

    Gaithersburg, Maryland, United States Trinity Consultants Engineering & EHS Workforce Solutions Full time

    Trinity Consultants Engineering & EHS Workforce Solutions is seeking a highly skilled Safety Specialist to join our team. As a key member of our EHS workforce solutions, you will be responsible for ensuring a safe working environment for our clients and their employees.The ideal candidate will have a strong background in environmental health and safety, with...

  • Business Systems Analyst

    1 month ago

    Gaithersburg, Maryland, United States GD Resources LLC Full time

    Job OverviewGD Resources LLC is a Veteran Women-Owned Business Management and Information Technology company committed to excellence. We offer dynamic opportunities for veterans and professionals alike to contribute to innovative projects and drive success in a collaborative and supportive environment.Job Title: Business AnalystLocation: Maryland, Virginia,...

  • Senior Java Software Engineer

    4 weeks ago

    Gaithersburg, Maryland, United States Phani Full time

    Job Summary:Phani is seeking a highly skilled Senior Java Software Engineer to join our team. As a key member of our software development team, you will be responsible for designing, developing, and maintaining large-scale Java-based applications. Key Responsibilities: Collaborate with cross-functional teams to analyze and design web-based applications...

  • Data Center Infrastructure Senior Manager

    4 weeks ago

    Gaithersburg, Maryland, United States GeneDx Full time

    About the Role:We are seeking an experienced Data Center Infrastructure Senior Manager to lead the design, development, and operation of our on-premise infrastructure to support our genetic testing business.This role will be pivotal in overseeing the architecture, deployment, and ongoing management of a new state-of-the-art data center, ensuring the highest...

  • Senior Fraud Protection Operations Manager

    4 weeks ago

    Gaithersburg, Maryland, United States Corporation Service Company Full time

    Job Summary:The Senior Fraud Protection Operations Manager is a critical role within our Anti-Fraud team, overseeing global team members and driving strategic vision for Fraud protection.Key Responsibilities:Develop strategic vision, objectives, and goals for Fraud protection in accordance with the CTO vision.Align Fraud protection activities with the...

  • Senior Fraud Protection Operations Manager

    4 weeks ago

    Gaithersburg, Maryland, United States Corporation Service Company Full time

    Job DescriptionWe are seeking a highly skilled and experienced professional to join our team as a Senior Fraud Protection Operations Manager. This critical role will oversee global team members and play a key part in our Anti-Fraud operations.Key ResponsibilitiesDevelop the strategic vision, objectives, and goals for Fraud protection in accordance with the...

  • Business Analyst

    4 weeks ago

    Gaithersburg, Maryland, United States Arthur Lawrence Full time

    Job SummaryArthur Lawrence is seeking a skilled Business Analyst to join our team in Gaithersburg, MD. As a Business Analyst, you will be responsible for analyzing business needs and developing solutions to drive growth and improvement.Key ResponsibilitiesDevelop and maintain relationships with clients and stakeholdersAnalyze business needs and develop...

  • CPIC/Portfolio Analyst

    4 weeks ago

    Gaithersburg, Maryland, United States ROC Implementation and Management, Inc Full time

    Job DescriptionWe are seeking a highly skilled CPIC/Portfolio Analyst to join our team at ROC Implementation and Management, Inc. As a key member of our consulting firm, you will play a critical role in helping our clients navigate and resolve complex, mission-critical challenges.Key Responsibilities:Collect, track, maintain, consolidate, and analyze data...

  • Executive Chef Assistant

    4 weeks ago

    Gaithersburg, Maryland, United States Kisco Senior Living Full time

    Job Title: Prep CookAbout the Role:We are seeking a skilled and detail-oriented Prep Cook to join our culinary team at Kisco Senior Living. As a Prep Cook, you will play a critical role in preparing high-quality food for our residents, guests, and associates.Key Responsibilities:Assist in the production of creatively designed cuisineCook according to menus,...

  • Quality Assurance Specialist

    4 weeks ago

    Gaithersburg, Maryland, United States Caring Cross Full time

    At Caring Cross, we are accelerating the development of advanced cell and gene therapies to ensure their affordable access worldwide. As a Quality Control Scientist, you will play a crucial role in building research programs and creating access to life-saving therapeutic opportunities for people living with cancer, HIV, and genetic diseases.Key...

  • Executive Culinary Director

    4 weeks ago

    Gaithersburg, Maryland, United States Kisco Senior Living Full time

    Key Responsibilities:As a Sous Chef at Kisco Senior Living, you will be responsible for supervising and planning the preparation of high-quality food to promote an excellent restaurant-style dining atmosphere. Your daily tasks will include assisting in the production of creative and delicious meals, working closely with the Executive Chef to ensure menu...

  • CPIC/Portfolio Analyst

    4 weeks ago

    Gaithersburg, Maryland, United States ROC Implementation and Management, Inc Full time

    Job SummaryWe are seeking a highly skilled CPIC/Portfolio Analyst to join our team at ROC Implementation and Management, Inc. As a key member of our consulting firm, you will play a critical role in helping our clients navigate and resolve complex, mission-critical challenges. Key ResponsibilitiesCollect, track, maintain, consolidate, and analyze data sets...