QC Analyst I/II - Environmental Monitoring

Company: MacroGenics, Inc.
Location: Rockville
Posted on: August 3, 2022

Job Description:

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.Our team of400+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceuticaland biotechnologycompanies around the globe.The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.Summary of PositionThis position is responsible for performing activities in support of the microbiology and environmental monitoring testing programs including monitoring of the manufacturing cleanrooms. This individual will guide and partner with lower level QC analysts and provide ongoing feedback and information to the QC supervisors to ensure accurate documentation, timely completion of all EM and microbiological related testing, and timely review of data, while adhering to standard operating procedures and cGMPs.Responsibilities and Job Duties:Collects environmental monitoring (EM) samples and water samples on a daily basis in accordance with all protocols and procedures. Conducts plate incubation, enumeration and microbial identification, as needed.Conducts testing such as Bioburden, Endotoxin, and TOC for utilities, raw materials, in-process and final formulation samples in accordance with standard operating procedures.Enters and reviews data into laboratory data system to ensure data integrity and adherence to standard operating procedures and GMPs.Conducts investigation when there are out of specification results from sampling and testing, and reports to supervisor.Initiates and monitors progress of microbiology related quality event records (e.g., Deviations and CAPAs) and conducts investigations to identify root cause and possible resolution.Develops, revises and updates standard operating procedures as needed.Collaborates with Senior QC team members to participate in development, transfer and validation of microbial testing methods, and conducts training on microbial test methods to other QC Analysts as needed.Overseas the lab equipment calibration and maintenance processes as required for testing per standard operating procedures, and raises any concerns about equipment to supervisor for resolutionIdentifies microbiology data trends and reports findings and provides recommendation to supervisors for review and consideration.Performs special projects related to problems encountered with microbial testing and instruments, and makes recommendations for solutions that will minimize future issues.Mentor lower lever analysts, as needed.QualificationsEducation, Experience, & CredentialsQC Analyst IHigh School Diploma and minimum of one year experience in performing Environmental Monitoring and Microbiology testing.Bachelor's Degree in a scientific disciplineQC Analyst IIHigh School Diploma and minimum of four years of experience in performing Environmental Monitoring and Microbiology testing.Associate's degree in a scientific area of study with three years of related experience;Bachelor's Degree in a scientific discipline and minimum of two years' related experienceExperience in one or more of the following areas required: Environmental Monitoring, Quality Control, Microbiology, and/or GMP production.Knowledge, Skills and AbilitiesWorking knowledge of good laboratory practices.Good understanding of GMPs and have previous experience working within highly regulated pharmaceutical /biotech facilities.Ability to organize and prioritize daily activities to meet internal customer needs in a fast-paced environment.Ability to work on extremely complex problems in which analysis of situation or data requires an in-depth evaluation of intangible variables.Ability to act independently to determine methods and procedures on new assignments.Demonstrate the confidence to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.Demonstrating ability to coach and train others.Be able to work in a team environment in a cooperative and respectful manner.Ability to stand for periods of time when performing tasks on the floor.Ability to work a varied schedule including off shift and weekends.Ability to lift up to 50 pounds.Supervisory ResponsibilitiesNoneStatementMacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.Equal Opportunity Employer/Veterans/DisabledWe do not accept non-solicited resumes or candidate submittals from search/recruiting agencies. To promote the health and well-being of our employees and ensure business continuity, MacroGenics requires all new hires to be fully vaccinated for COVID-19 by his/her start date. A new hire will need to either (a) establish that they have been fully vaccinated or (b) obtain an approved exemption as an accommodation.

Keywords: MacroGenics, Inc., Rockville , QC Analyst I/II - Environmental Monitoring, Professions , Rockville, Maryland