Quality Control Analyst I

1 month ago

Gaithersburg, United States LGC Clinical Diagnostics Full time
Job DescriptionJob DescriptionCompany Description

LGC Clinical Diagnostics Business Unit is comprised of LGC Clinical Diagnostics, Inc. (formerly SeraCare Life Sciences & Maine Standards), Technopath Clinical Diagnostics, the Native Antigen Company, LGC Proficiency Testing & Thistle QA. Our 400+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), an ISO 9001- accredited facility in Oxford, UK and ISO 17043 facilities in Michigan (USA) and Johannesburg, South Africa. LGC Clinical Diagnostics is owned by LGC Group, a UK-headquartered life sciences measurement and testing business with >$510m of annual revenue and >3,500 employees globally.

Job Description

The Quality Control Analyst I will support manufacturing activities, perform routine laboratory maintenance, and conduct routine sample preparations and analyses. Work environments will include typing/computer work at a desktop workstation, sitting and/or standing at laboratory bench, and working in biosafety cabinets and chemical exhaust hoods. 

Key Responsibilities:

  • Support product dispense and kitting operations as necessary:
    • Verify fill weight and cap tightness of dispensed liquid product.
    • Verify correctness of applied product labels.
  • Maintain laboratory and equipment according to standard operating procedures.
  • Prepare samples for submission to external laboratories as required.
  • Conduct analyses of finished and intermediate products and raw materials according to standard operating procedures, including:
    • Immunoassays - ELISA, Dot Blotting and Immunohistochemical staining.
    • Nucleic acid extractions, quantitation and PCR.
    • Wet chemistry - pH, conductivity and spectrophotometry.
  • Review data for compliance to specifications and report non-conformances.
  • Prepare data and documentation to support product release.
  • Exercise Good Laboratory Practices and maintain data integrity and traceability.
  • Support overall company policies and procedures.
Qualifications

Knowledge and Technical Skills:

  • Competent with basic laboratory equipment, pipetting and preparation of dilutions. 
  • Analyses and proofreads results for validity and accuracy.
  • Maintains documentation for traceability.
  • Exercises judgement within generally defined practices and policies.
  • Proficient in written and verbal communication, including the ability to communicate technical issues in a clear, concise manner.
  • Ability to work independently or in a team, as the situation demands.
  • Flexibility to adapt to changing priorities, as required.

Education and/or Experience:

  • Requires a Bachelor's degree in a scientific discipline or equivalent with a minimum of 1 - 3 years of relevant experience.
  • Hands-on experience with immunoassays (ELISA, protein immunoblotting) is preferred.
  • Working experience in a regulated laboratory environment (GLP/GMP) is a plus.


Additional Information

Physical Requirements:

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.  Physical demands are normal for a laboratory/office environment as defined below.

Working Conditions: 
•    Work environment – Primarily an office/lab/warehouse/workshop setting with manufacturing exposure. 
•    Extreme Conditions – The noise level in the work environment is usually moderate. 
•    Protective Clothing Required – Steel-toe shoes, hearing or eye protection may be required.
•    Potential injuries or illnesses - will work in a biosafety level 2 environment and will be required to work with potentially infectious pathogens and human source materials, but with appropriate lab or personal protection.
•    Handling of hazardous waste – employee receives initial hazardous waste management training when hired to a position that requires managing hazardous waste. Annual refresher training is provided every year he or she remains in that position.
•    Work environment involves exposure to hazards or physical risks, which require following safety precautions and specific personnel training for employees working with hazardous materials and hazardous waste.

All your information will be kept confidential according to EEO guidelines.

  • Quality Control Analyst I

    3 weeks ago

    Gaithersburg, United States LGC Group Full time

    Company DescriptionLGC Clinical Diagnostics Business Unit is comprised of LGC Clinical Diagnostics, Inc. (formerly SeraCare Life Sciences & Maine Standards), Technopath Clinical Diagnostics, the Native Antigen Company, LGC Proficiency Testing & Thistle QA. Our 400+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine (USA),...

  • Quality Assurance Analyst I

    1 week ago

    Gaithersburg, Maryland, United States LGC Clinical Diagnostics Full time

    Job OverviewThe Quality Control Analyst I plays a vital role in supporting production processes, ensuring the integrity of laboratory operations, and performing essential sample preparations and analyses. The work environment encompasses a mix of computer-based tasks at a workstation, hands-on activities at laboratory benches, and operations within biosafety...

  • APD Business Analyst

    1 month ago

    Gaithersburg, United States 10000454 - Business Analyst Full time

    Job Title: APD Business AnalystIntroduction to Role:Are you ready to power the business to have a bigger impact on patients' lives? Embrace the novel opportunity to work at a business that puts patients first. In Early Science, we have highly skilled scientists in our labs who experiment and support complex drug projects. The environment is driven by...

  • Analyst, Quality Control Environmental Monitoring, Cell Therapy

    7 days ago

    Gaithersburg, United States AstraZeneca Pharmaceuticals LP Company Full time

    Introduction to roleAre you ready to make a difference in the world of healthcare? We are seeking a QC Environmental Monitoring Analyst to join our Operations team. This role is essential in performing microbial environmental monitoring and testing, ensuring the highest quality of our cell therapy products. If you have a strong background in GMP, quality...

  • Laboratory Quality Control Technician

    1 week ago

    Gaithersburg, Maryland, United States LGC Clinical Diagnostics Full time

    Job OverviewThe Quality Control Analyst I plays a crucial role in supporting production processes, ensuring the integrity of laboratory operations, and performing essential sample preparations and evaluations. The work environment includes a mix of computer-based tasks at a desk, hands-on activities at laboratory benches, and operating within specialized...

  • Quality Assurance Specialist I

    1 week ago

    Gaithersburg, Maryland, United States LGC Clinical Diagnostics Full time

    Job OverviewCompany Overview:LGC Clinical Diagnostics is a leading entity in the life sciences sector, operating under the umbrella of LGC Group. Our facilities are recognized for their compliance with FDA regulations and ISO standards, ensuring the highest quality in clinical diagnostics.Position Summary:The Quality Control Analyst I plays a crucial role in...

  • Senior Quality Control Manager

    7 days ago

    Gaithersburg, Maryland, United States Cartesian Therapeutics Full time

    Job OverviewPosition SummaryCartesian Therapeutics is on the lookout for a Senior Scientist/Associate Director of Quality Control to manage the analytical testing laboratories at our facility. This role involves overseeing both in-process testing and lot release quality control assessments. The ideal candidate will possess substantial experience in quality...

  • Analytical Scientist

    1 week ago

    Gaithersburg, Maryland, United States Kaztronix Full time

    Kaztronix is seeking a highly motivated and experienced Analytical Scientist to join our growing Quality Control team in Gaithersburg, MD. In this role, you will play a crucial part in ensuring the quality and integrity of our products by providing technical expertise across various analytical processes. Responsibilities: Contribute to the development and...

  • Associate Director, Quality Control

    2 months ago

    Gaithersburg, United States Cartesian Therapeutics Full time

    Job DescriptionJob DescriptionSummaryCartesian Therapeutics is seeking a Senior Scientist/Associate Director, QC for the company's Quince Orchard facility. You will oversee QC analytical testing laboratories, including in-process testing and lot release QC testing. The Associate Director, QC will have both quality control and method validation...

  • Quality Control Lab Technician

    4 weeks ago

    Gaithersburg, United States Eurofins USA PSS Insourcing Solutions Full time

    Job DescriptionJob DescriptionCompany DescriptionEurofins Scientific is a global leader in life sciences, offering a comprehensive range of analytical testing services that ensure the safety, authenticity, and accuracy of products across various industries. From food and water to pharmaceuticals and cosmetics, Eurofins partners with some of the world's...

  • Quality Assurance Analyst

    5 days ago

    Gaithersburg, Maryland, United States i360technologies Full time

    Job OverviewRole Summary: The Quality Assurance Analyst will be responsible for ensuring the highest quality of software products through meticulous testing processes.Key Responsibilities:Test Planning: Create comprehensive test plans tailored for each software release.Testing Design: Formulate high-level and detailed testing designs based on user...

  • Oracle Cerner PharmNet Clinical Information System Analyst I, Day Shift, Clinical Informatics

    1 month ago

    Gaithersburg, Maryland, United States Adventist HealthCare Full time

    Adventist Healthcare seeks to hire an experienced Oracle Cerner PharmNet Clinical Information System Analyst I for our Support Center who will embrace our mission to extend God's care through the ministry of physical, mental, and spiritual healing.As an Oracle Cerner PharmNet Clinical Information System Analyst I, you will: •Builds, tests, and verifies...

  • Oracle Cerner PharmNet Clinical Information System Analyst I, Day Shift, Clinical Informatics

    2 months ago

    Gaithersburg, United States Adventist HealthCare Full time

    Adventist Healthcare seeks to hire an experienced Oracle Cerner PharmNet Clinical Information System Analyst I for our Support Center who will embrace our mission to extend God's care through the ministry of physical, mental, and spiritual healing.As an Oracle Cerner PharmNet Clinical Information System Analyst I, you will: •Builds, tests, and verifies...

  • Associate Scientist, Quality Control

    2 months ago

    Gaithersburg, United States Cartesian Therapeutics Full time

    Job DescriptionJob DescriptionSummaryThe Associate Scientist, Quality Control (QC) reporting into the Senior Director, QC will execute QC operations in support of manufacturing and will have technical lab experience and have strong industry experience. The role requires advanced ability to set priorities, manage timelines and represent the interest of the...

  • Communications Analyst

    3 months ago

    Gaithersburg, United States IMSolutions, LLC Full time

    Job DescriptionJob DescriptionIMSolutions seeks an experienced Communications Analyst Designer to fill an exciting opportunity working in federal government contracting supporting BPA Call Orders.This will be a remote, hybrid, or in-office role depending on the Task Order assigned.As the Communications Analyst, you will be responsible for defining,...

  • Quality Assurance Specialist I

    6 days ago

    Gaithersburg, Maryland, United States LGC Clinical Diagnostics Full time

    Job OverviewThe Quality Assurance Specialist I will assist in production processes, perform routine laboratory upkeep, and carry out standard sample preparations and evaluations. The work environment will encompass computer tasks at a desktop workstation, standing or sitting at laboratory benches, and operating within biosafety cabinets and chemical fume...

  • Financial Analyst

    2 months ago

    Gaithersburg, United States National Institute Of Standards And Technology Full time

    To provide technical expertise in reviewing funding applications, perform baseline reviews for affiliations with malign entities, export control entity listing, and patterns of concern. Serves as the Liaise with the CHIPS R&D and Incentives Offices, NIST Research Security Team, and NIST International Affairs and Academics Office. The individual's work...

  • Quality Documentation Specialist

    2 months ago

    Gaithersburg, United States Xometry Full time

    Job DescriptionJob DescriptionXometry (NASDAQ: XMTR) powers the industries of today and tomorrow by connecting the people with big ideas to the manufacturers who can bring them to life. Xometry's digital marketplace gives manufacturers the critical resources they need to grow their business while also making it easy for buyers at Fortune 1000 companies...

  • Financial Analyst

    2 months ago

    Gaithersburg, Maryland, United States National Institute Of Standards And Technology Full time

    To provide technical expertise in reviewing funding applications, perform baseline reviews for affiliations with malign entities, export control entity listing, and patterns of concern. Serves as the Liaise with the CHIPS R&D and Incentives Offices, NIST Research Security Team, and NIST International Affairs and Academics Office. The individual's work...

  • Administrative Quality Assurance Associate

    2 weeks ago

    Gaithersburg, Maryland, United States Xometry Full time

    Job OverviewXometry (NASDAQ: XMTR) is at the forefront of connecting innovative thinkers with manufacturers capable of realizing their visions. Our digital platform equips manufacturers with essential resources to expand their operations while facilitating seamless access for buyers from leading corporations to global manufacturing capabilities.We are in...