Mid Level Quality Control Scientist Jobs
Mid level quality control scientist jobs go to scientists ready to own testing protocols end to end, guide junior team members, and make technical decisions without close supervision. Roles are concentrated in Biotechnology & Pharmaceuticals and Science & Research, with a mix of on-site and hybrid settings, and employers like Amneal Pharmaceuticals, MannKind Corporation, and Arrowhead Pharmaceuticals hiring at this level now.
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Open roles6
Top stateNew York
Top employerAmneal Pharmaceuticals
Top cityBrookhaven, NY
Work type100% On-site
Top industryBiotechnology
Showing 5 of 6+ Mid Level Quality Control Scientist jobs
Scientist III, Quality Control Microbiology Sterile Operations
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Added 1w ago
MannKind Corporation
Scientist III, Quality Control Microbiology Sterile Operations
Danbury, Connecticut
Added 1w ago
Scientist I, Quality Control
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Added 3mo ago
Arrowhead Pharmaceuticals
Scientist I, Quality Control
Madison, Wisconsin
Added 3mo ago
Senior Scientist, Quality Control
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Added 4mo ago
Amneal Pharmaceuticals
Senior Scientist, Quality Control
Piscataway, New Jersey
Added 4mo ago
Scientist, Quality Control
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Added 5mo ago
Amneal Pharmaceuticals
Scientist, Quality Control
Brookhaven, New York
Added 5mo ago
Senior Scientist, Quality Control
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Added 6mo ago
Amneal Pharmaceuticals
Senior Scientist, Quality Control
Brookhaven, New York
Added 6mo ago
Added 1w ago
Scientist III, Quality Control Microbiology Sterile Operations
MannKind Corporation·Danbury, Connecticut
Job functions:
$84k - $126k/yr
5+ yrs exp.
Bachelor's degree in biology
Full Time
201-500 employees
Job Description
MannKind Corporation focuses on the development and commercialization of innovative therapeutic products and drug delivery devices that address serious unmet medical needs. We apply our formulation and device capabilities to develop convenient treatment options designed to reduce the burden of disease and improve patient care.
Position Overview
This is a hands-on laboratory and cleanroom-based position. The Scientist III, Quality Control Microbiology individual performs microbiological testing and environmental monitoring activities supporting sterile drug product manufacturing, aseptic fill-finish operations, pre-filled syringes, and the FUROSCIX® Autoinjector. The role also provides technical expertise for sterility assurance, contamination control, combination-product support, investigations, method lifecycle activities, and regulatory inspection readiness.
The individual is expected to independently execute assigned testing and monitoring activities, document results in accordance with cGMP and data integrity requirements, troubleshoot technical issues, lead or support investigations, and collaborate with Manufacturing, Quality Assurance, Engineering, Facilities, Validation, and Regulatory Affairs.
Key Responsibilities
Hands-On Microbiological Testing
- Perform all routine and non-routine microbiological tests including sterility testing, Bacterial Endotoxin Testing (BET), bioburden, microbial identification, growth promotion, and water or utility monitoring.
- Prepare samples, media, reagents, standards, controls, and laboratory equipment; incubate, examine, enumerate, and document test articles as required by approved procedures.
- Execute microbiological method transfer, verification, qualification, validation; troubleshoot associated activities.
- Lead disinfectant efficacy studies and author study report
- Review and interpret microbiological data and ensure complete, accurate, and contemporaneous documentation in laboratory records and electronic systems (LIMS).
- Operate, maintain, verify, and support qualification of microbiology laboratory equipment, including incubators, air samplers, particle counters, endotoxin systems, and sterility test equipment.
Environmental Monitoring and Contamination Control
- Perform and support routine / event-driven environmental monitoring in ISO 5 (Grade A), ISO 7, and ISO 8 areas for compounding, aseptic filling, and related operations (cleanrooms, isolators, RABS, filling suites, and other controlled areas) while following aseptic gowning and behavior requirements.
- Perform viable (active and passive) and non-viable air monitoring (active), surface monitoring (swab / contact plate), and personnel monitoring.
- Evaluate environmental monitoring results, assist with alert/action-level assessments, perform trend analyses, and support organism identification and objectionability assessments.
- Support development, implementation, and continuous improvement of the site Contamination Control Strategy.
Sterile Manufacturing and Aseptic Processing Support
- Provide direct, on-floor microbiology support during compounding, sterile filtration, aseptic filling, equipment qualification, facility qualification, process validation, and PPQ activities.
- Perform environmental and personnel monitoring during aseptic process simulations (APS – “media fills”) and support protocol execution, incubation, inspection, data review, and investigation activities.
- Support cleanroom qualification and requalification, including recovery studies and viable/non-viable monitoring activities.
- Support microbiological monitoring and qualification of clean utilities, including purified water / WFI, clean steam, and compressed gases, as applicable.
Autoinjector, Pre-Filled Syringe, and Combination-Product Support
- Provide hands-on and technical microbiology support for FUROSCIX® pre-filled syringe and autoinjector manufacturing, assembly, packaging, validation, and commercial readiness activities.
- Execute or support incoming, in-process, release, and stability-related device testing, as assigned, in accordance with approved methods and specifications.
- Support microbiological risk assessments for device components, sterile primary packaging, assembly processes, storage, and distribution.
- Collaborate with Device Development, Engineering, Manufacturing, and Quality Assurance on investigations, changes, qualifications, and validation activities affecting the combination product.
Investigations, Quality Systems, and Compliance
- Lead or support investigations involving environmental monitoring excursions, sterility or endotoxin failures, bioburden events, contamination events, objectionable organisms, deviations, OOT, and OOS results.
- Perform root cause analysis, document scientifically sound conclusions, and develop or implement corrective and preventive actions.
- Author and review SOPs, test methods, specifications, protocols, technical reports, risk assessments, change controls, and validation documents.
- Support regulatory inspections, customer audits, internal audits, and inspection readiness activities as a technical resource for microbiology and sterile operations.
- Work in accordance with applicable cGMP requirements, approved procedures, laboratory safety practices, and data integrity principles.
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Qualifications
Required
- Bachelor's degree in microbiology, Biology, Pharmaceutical Sciences, or a related life science discipline with at least 7 years of relevant experience; or a Master's degree with at least 5 years of relevant experience.
- Hands-on QC Microbiology experience in a cGMP-regulated pharmaceutical, biotechnology, or combination-product environment.
- Demonstrated practical experience with sterile drug product manufacturing, aseptic processing, and environmental monitoring in ISO 5 (Grade A) areas.
- Hands-on experience with sterility testing, BET, bioburden, microbial identification, growth promotion, and cleanroom monitoring techniques.
- Ability and willingness to routinely perform laboratory testing, cleanroom environmental monitoring, aseptic gowning, and on-floor manufacturing support.
- Working knowledge of FDA cGMP requirements, USP microbiology-related chapters, EU GMP Annex 1, contamination control, and data integrity expectations.
- Strong technical writing, investigation, problem-solving, communication, and cross-functional collaboration skills.
Preferred
- Experience with pre-filled syringes, autoinjectors, drug-device combination products, or sterile injectable products.
- Hands-on experience with Container Closure Integrity Testing and associated method validation or transfer.
- Experience supporting media fills, isolators, RABS, cleanroom qualification, smoke studies, or aseptic process validation.
- Experience supporting regulatory inspections and responding to microbiology- or aseptic processing-related observations.
- Knowledge of rapid microbiological methods, laboratory computerized systems, and LIMS.
Physical and Work Environment Requirements
- Ability to work in microbiology laboratories and controlled cleanroom environments.
- Comply with gowning, hygiene, and aseptic behavior requirements.
- Ability to stand or sit for extended periods and perform repetitive laboratory manipulations with appropriate personal protective equipment.
- Ability to support manufacturing schedules, including occasional off-shift, weekend, or holiday activities when required for aseptic operations, environmental monitoring, investigations, or time-sensitive testing.
- Ability to safely handle biological materials, laboratory chemicals, equipment, and samples in accordance with approved procedures.
Key Competencies
Sterility Assurance | Hands-On Microbiological Testing | Environmental Monitoring | Contamination Control | Aseptic Processing | Autoinjector and Pre-Filled Syringe Technologies | Container Closure Integrity | Investigation and Root Cause Analysis | Technical Writing | Cross-Functional Collaboration
Equal Employment Opportunity
MannKind Corporation is an equal opportunity employer. Employment decisions are based on business needs, job requirements, and individual qualifications, without regard to any status protected by applicable law.
MannKind Corporation
Scientist III, Quality Control Microbiology Sterile Operations
Danbury, Connecticut
Added 1w ago201-500 employees
Job functions:
$84k - $126k/yr
5+ yrs exp.
Bachelor's degree in biology
Full Time
Job Description
MannKind Corporation focuses on the development and commercialization of innovative therapeutic products and drug delivery devices that address serious unmet medical needs. We apply our formulation and device capabilities to develop convenient treatment options designed to reduce the burden of disease and improve patient care.
Position Overview
This is a hands-on laboratory and cleanroom-based position. The Scientist III, Quality Control Microbiology individual performs microbiological testing and environmental monitoring activities supporting sterile drug product manufacturing, aseptic fill-finish operations, pre-filled syringes, and the FUROSCIX® Autoinjector. The role also provides technical expertise for sterility assurance, contamination control, combination-product support, investigations, method lifecycle activities, and regulatory inspection readiness.
The individual is expected to independently execute assigned testing and monitoring activities, document results in accordance with cGMP and data integrity requirements, troubleshoot technical issues, lead or support investigations, and collaborate with Manufacturing, Quality Assurance, Engineering, Facilities, Validation, and Regulatory Affairs.
Key Responsibilities
Hands-On Microbiological Testing
- Perform all routine and non-routine microbiological tests including sterility testing, Bacterial Endotoxin Testing (BET), bioburden, microbial identification, growth promotion, and water or utility monitoring.
- Prepare samples, media, reagents, standards, controls, and laboratory equipment; incubate, examine, enumerate, and document test articles as required by approved procedures.
- Execute microbiological method transfer, verification, qualification, validation; troubleshoot associated activities.
- Lead disinfectant efficacy studies and author study report
- Review and interpret microbiological data and ensure complete, accurate, and contemporaneous documentation in laboratory records and electronic systems (LIMS).
- Operate, maintain, verify, and support qualification of microbiology laboratory equipment, including incubators, air samplers, particle counters, endotoxin systems, and sterility test equipment.
Environmental Monitoring and Contamination Control
- Perform and support routine / event-driven environmental monitoring in ISO 5 (Grade A), ISO 7, and ISO 8 areas for compounding, aseptic filling, and related operations (cleanrooms, isolators, RABS, filling suites, and other controlled areas) while following aseptic gowning and behavior requirements.
- Perform viable (active and passive) and non-viable air monitoring (active), surface monitoring (swab / contact plate), and personnel monitoring.
- Evaluate environmental monitoring results, assist with alert/action-level assessments, perform trend analyses, and support organism identification and objectionability assessments.
- Support development, implementation, and continuous improvement of the site Contamination Control Strategy.
Sterile Manufacturing and Aseptic Processing Support
- Provide direct, on-floor microbiology support during compounding, sterile filtration, aseptic filling, equipment qualification, facility qualification, process validation, and PPQ activities.
- Perform environmental and personnel monitoring during aseptic process simulations (APS – “media fills”) and support protocol execution, incubation, inspection, data review, and investigation activities.
- Support cleanroom qualification and requalification, including recovery studies and viable/non-viable monitoring activities.
- Support microbiological monitoring and qualification of clean utilities, including purified water / WFI, clean steam, and compressed gases, as applicable.
Autoinjector, Pre-Filled Syringe, and Combination-Product Support
- Provide hands-on and technical microbiology support for FUROSCIX® pre-filled syringe and autoinjector manufacturing, assembly, packaging, validation, and commercial readiness activities.
- Execute or support incoming, in-process, release, and stability-related device testing, as assigned, in accordance with approved methods and specifications.
- Support microbiological risk assessments for device components, sterile primary packaging, assembly processes, storage, and distribution.
- Collaborate with Device Development, Engineering, Manufacturing, and Quality Assurance on investigations, changes, qualifications, and validation activities affecting the combination product.
Investigations, Quality Systems, and Compliance
- Lead or support investigations involving environmental monitoring excursions, sterility or endotoxin failures, bioburden events, contamination events, objectionable organisms, deviations, OOT, and OOS results.
- Perform root cause analysis, document scientifically sound conclusions, and develop or implement corrective and preventive actions.
- Author and review SOPs, test methods, specifications, protocols, technical reports, risk assessments, change controls, and validation documents.
- Support regulatory inspections, customer audits, internal audits, and inspection readiness activities as a technical resource for microbiology and sterile operations.
- Work in accordance with applicable cGMP requirements, approved procedures, laboratory safety practices, and data integrity principles.
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Qualifications
Required
- Bachelor's degree in microbiology, Biology, Pharmaceutical Sciences, or a related life science discipline with at least 7 years of relevant experience; or a Master's degree with at least 5 years of relevant experience.
- Hands-on QC Microbiology experience in a cGMP-regulated pharmaceutical, biotechnology, or combination-product environment.
- Demonstrated practical experience with sterile drug product manufacturing, aseptic processing, and environmental monitoring in ISO 5 (Grade A) areas.
- Hands-on experience with sterility testing, BET, bioburden, microbial identification, growth promotion, and cleanroom monitoring techniques.
- Ability and willingness to routinely perform laboratory testing, cleanroom environmental monitoring, aseptic gowning, and on-floor manufacturing support.
- Working knowledge of FDA cGMP requirements, USP microbiology-related chapters, EU GMP Annex 1, contamination control, and data integrity expectations.
- Strong technical writing, investigation, problem-solving, communication, and cross-functional collaboration skills.
Preferred
- Experience with pre-filled syringes, autoinjectors, drug-device combination products, or sterile injectable products.
- Hands-on experience with Container Closure Integrity Testing and associated method validation or transfer.
- Experience supporting media fills, isolators, RABS, cleanroom qualification, smoke studies, or aseptic process validation.
- Experience supporting regulatory inspections and responding to microbiology- or aseptic processing-related observations.
- Knowledge of rapid microbiological methods, laboratory computerized systems, and LIMS.
Physical and Work Environment Requirements
- Ability to work in microbiology laboratories and controlled cleanroom environments.
- Comply with gowning, hygiene, and aseptic behavior requirements.
- Ability to stand or sit for extended periods and perform repetitive laboratory manipulations with appropriate personal protective equipment.
- Ability to support manufacturing schedules, including occasional off-shift, weekend, or holiday activities when required for aseptic operations, environmental monitoring, investigations, or time-sensitive testing.
- Ability to safely handle biological materials, laboratory chemicals, equipment, and samples in accordance with approved procedures.
Key Competencies
Sterility Assurance | Hands-On Microbiological Testing | Environmental Monitoring | Contamination Control | Aseptic Processing | Autoinjector and Pre-Filled Syringe Technologies | Container Closure Integrity | Investigation and Root Cause Analysis | Technical Writing | Cross-Functional Collaboration
Equal Employment Opportunity
MannKind Corporation is an equal opportunity employer. Employment decisions are based on business needs, job requirements, and individual qualifications, without regard to any status protected by applicable law.
See All 6 Mid Level Quality Control Scientist Jobs
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Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals
- Science & Research
Mid Level Quality Control Scientist Jobs: Frequently Asked Questions
How do I get a mid level quality control scientist job?
Position your experience around ownership, not just task completion. Highlight protocols you developed or improved, deviations you investigated independently, and any cross-functional work with manufacturing, regulatory, or R&D teams. Tailor your resume to show measurable impact, such as reduced out-of-specification rates or faster release cycles, and demonstrate familiarity with the validation and documentation standards relevant to your target industry.
Which companies hire mid level quality control scientists?
Companies hiring mid level quality control scientists right now include Amneal Pharmaceuticals, MannKind Corporation, and Arrowhead Pharmaceuticals, based on current listings on Migrate Mate as of November 2026. Hiring at this level comes from pharmaceutical and biotech manufacturers, medical device firms, food and beverage producers, and contract testing organizations that need scientists who can operate with significant autonomy.
Are there remote mid level quality control scientist jobs?
Yes, though most quality control scientist work is lab- or facility-based by nature. About 0% of mid level quality control scientist openings are remote or hybrid as of November 2026, and those roles tend to involve method development documentation, data analysis, compliance writing, or quality systems oversight rather than hands-on bench work.
How do I move up to a mid level quality control scientist role?
Moving from entry level to mid level takes deliberate depth-building over your first few years. Focus on mastering one or two analytical techniques well enough to troubleshoot them independently, volunteer to lead small projects or write SOPs, and document the outcomes of your work in quantifiable terms. Employers promoting or hiring at the mid level look for scientists who have driven results, not just followed instructions.
Which industries hire the most mid level quality control scientists?
Mid Level quality control scientist roles concentrate in Biotechnology & Pharmaceuticals and Science & Research, based on current listings on Migrate Mate as of November 2026. These sectors drive consistent hiring at this level because they operate under strict regulatory frameworks that require experienced scientists who can maintain compliance, investigate failures, and support product release without constant oversight.