MacroGenics, Inc. · 4 hours ago
QC Analyst I - Sample Handler
MacroGenics, Inc. is a biopharmaceutical company focused on developing innovative medicines for cancer and other diseases. They are seeking a QC Analyst I - Sample Handler to perform inspection, sampling, and testing of incoming raw materials, ensuring compliance with internal specifications and cGMP requirements.
BiotechnologyHealth CareManufacturing
Responsibilities
Performs inspection, sampling and testing of incoming raw materials according to internal specifications, procedures (SOPs), drawings and other applicable controlled documents, per schedule and within established turn-around times
Collaborates with Materials Management to receive and prepare shipments of raw material samples, lot release samples and stability samples for testing performed by contract laboratories
Follows established procedures and performs tasks in accordance with cGMP requirements
Prepares composite samples and aliquots using aseptic technique in ISO 5 and ISO 8 areas and in biological safety cabinets
May perform routine analytical testing including more complex methods such as cell culture and growth promotion as well as basic methods such as concentration by UV absorbance, pH, conductivity, appearance and osmolality, draeger tube gas testing, Raman IR, and environmental monitoring, in accordance with all protocols and procedures
Performs physical inspections of stored materials and maintains accurate tracing / tracking of Quality Control sample and retain inventory
Records data in LIMS and SAP, ensuring completeness and accuracy per cGMP. Compiles and reviews data ensuring data integrity and adherence to SOPs. Ensures data storage and archiving are performed per established procedures
Ensures that instruments and equipment used in inspection, sampling and testing are kept in a qualified and calibrated state and raises any concerns about equipment to supervisor for resolution
Maintains the sampling room at constant state of cleanliness, compliance and inspection readiness and ensures that sampling room and sample packaging inventory is stocked with required cleaning solutions, sample containers, labels, etc. Orders materials via SAP
Reports discrepancies and nonconforming materials to management and supports subsequent investigations and other Quality event records (e.g., Deviations and CAPAs) in electronic document management system (MasterControl), and coordinates with appropriate departments when there are issues/concerns
Prepares general lab solutions and buffers as needed and monitors expiration of these solutions and buffers
Performs other duties as assigned
Qualification
Required
High School Diploma and minimum of two years directly related experience; or
Associate's Degree and minimum of one year directly related experience; or
Bachelor's Degree in a scientific discipline
Experience in one or more of the following areas required: Aseptic technique, cell culture, ISO 5 sampling, ISO 8 sampling, GMP clean experience, Quality Control, or GMP testing
Working knowledge of good laboratory practices
Needs to be able to follow directions that are outlined in SOPs and other quality guidelines
Ability to organize daily activities to meet internal customer needs in a fast-paced environment
Knowledge of basic chemistry concepts
Ability to understand when he/she should seek advice and guidance
Data entry skills (LIMS experience a plus)
Microsoft Office skills
Ability to work in a team environment in a cooperative and respectful manner
Ability to rotate and/or fill in at Rockville, MD, sites
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
Benefits
Medical / dental / vision / prescription coverage
Employee wellness resources
401(k) plan with employer match
Access to an Employee Stock Purchase Plan, (ESPP)
Paid time off & paid parental leave benefits
Disability benefits
Company
MacroGenics, Inc.
MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.
H1B Sponsorship
MacroGenics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (4)
2022 (1)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$275.92MKey Investors
National Institutes of HealthNextech VentureVentures West
2019-02-12Post Ipo Equity· $110M
2013-10-10IPO
2011-01-31Private Equity· $12.02M
Recent News
2025-12-11
2025-11-26
MacroGenics, Inc.
2025-11-13
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