QC Analyst I/II - Environmental Monitoring
Company: MacroGenics, Inc.
Location: Rockville
Posted on: August 3, 2022
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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
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