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Fda Inspector Jobs in Schenectady, NY (NOW HIRING)

Curia, Inc.

Production Technician

Rensselaer, NY · On-site

$28.60/hr

Learn how to; properly weigh and scale operations, review batch records, inspect equipment, drum ... Ability to follow FDA manufacturing guidelines * Communication skills Preferred * Knowledge and ...

AMRI

Production Technician

Rensselaer, NY

$28.60/hr

Learn how to; properly weigh and scale operations, review batch records, inspect equipment, drum ... Ability to follow FDA manufacturing guidelines * Communication skills Preferred * Knowledge and ...

AMRI

Production Technician

Rensselaer, NY

$28.60/hr

Learn how to; properly weigh and scale operations, review batch records, inspect equipment, drum ... Ability to follow FDA manufacturing guidelines * Communication skills Preferred * Knowledge and ...

AMRI

Production Technician

Rensselaer, NY

$28.60/hr

Learn how to; properly weigh and scale operations, review batch records, inspect equipment, drum ... Ability to follow FDA manufacturing guidelines * Communication skills Preferred * Knowledge and ...

Curia, Inc.

Production Technician

Rensselaer, NY · On-site

$28.60/hr

Learn how to; properly weigh and scale operations, review batch records, inspect equipment, drum ... Ability to follow FDA manufacturing guidelines * Communication skills Preferred * Knowledge and ...

Curia, Inc.

Production Technician

Rensselaer, NY · On-site

$28.60/hr

Learn how to; properly weigh and scale operations, review batch records, inspect equipment, drum ... Ability to follow FDA manufacturing guidelines * Communication skills Preferred * Knowledge and ...

Curia, Inc.

Customer Quality Lead (QA)

Rensselaer, NY · On-site

... g., FDA, ICH). * Knowledge of pharmaceutical manufacturing operations. * USFDA inspection experience (e.g., participant or has interacted with Investigators) * Excellent communication and ...

Sysco

Outbound Warehouse Supervisor

Albany, NY · On-site

$64K - $96K/yr

... inspections. * Makes recommendations for disciplinary action and/or behavior modification where ... OSHA, AIB, FDA, USDA, etc.) QUALIFICATIONS Education * High school diploma or general education ...

AMRI

LIMS Master Data Specialist III

Rensselaer, NY

$100K - $125K/yr

Ensure compliance with global corporate policies and regulatory standards (e.g., FDA 21 CFR Part 11 ... Support internal and external regulatory audits and inspections by providing LIMS documentation and ...

Curia, Inc.

LIMS Master Data Specialist III

Rensselaer, NY · On-site

$100K - $125K/yr

Ensure compliance with global corporate policies and regulatory standards (e.g., FDA 21 CFR Part 11 ... Support internal and external regulatory audits and inspections by providing LIMS documentation and ...

AMRI

Customer Quality Lead (QA)

Rensselaer, NY · On-site

... g., FDA, ICH). * Knowledge of pharmaceutical manufacturing operations. * USFDA inspection experience (e.g., participant or has interacted with Investigators) * Excellent communication and ...

AMRI

Site Quality Head

Rensselaer, NY

$170K - $225K/yr

... and FDA quality requirements. Essential job duties * Site Head of Quality provides technical ... Drive robust site inspection readiness program, assess risks and provide guidance on compliant ...

Sysco Corporation

Outbound Warehouse Supervisor

NY · On-site

$64K - $96K/yr

... inspections. * Makes recommendations for disciplinary action and/or behavior modification where ... OSHA, AIB, FDA, USDA, etc.) QUALIFICATIONS Education * High school diploma or general education ...

Curia, Inc.

Site Quality Head

Rensselaer, NY · On-site

$170K - $225K/yr

... and FDA quality requirements. Essential job duties * Site Head of Quality provides technical ... Drive robust site inspection readiness program, assess risks and provide guidance on compliant ...

Curia, Inc.

Senior Specialist LIMS

Rensselaer, NY · On-site

$81K - $112K/yr

Ensure compliance with global corporate policies and regulatory standards (e.g., FDA 21 CFR Part 11 ... Support internal and external regulatory audits and inspections. * Lead QC ongoing LIMS ...

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All JobsFda Inspector JobsFda Inspector Jobs in Schenectady, NY

Fda Inspector information

See Schenectady, NY salary details

$23.7K

$53.2K

$95.8K

How much do fda inspector jobs pay per year?

As of Aug 20, 2026, the average yearly pay for fda inspector in Schenectady, NY is $53,155.00, according to ZipRecruiter salary data. Most workers in this role earn between $37,200.00 and $61,400.00 per year, depending on experience, location, and employer.

What does an FDA inspector do?

An FDA Inspector is responsible for ensuring that companies comply with federal regulations related to food, drugs, medical devices, and other products overseen by the U.S. Food and Drug Administration. They conduct inspections, review records, collect samples, and assess manufacturing practices to ensure public health and safety. Inspectors may also investigate complaints, issue compliance notices, and recommend enforcement actions if violations are found.

What skills and qualifications are needed to be an FDA inspector?

To thrive as an FDA Inspector, you need a solid background in science or public health, attention to detail, and thorough knowledge of regulatory standards, often supported by a relevant degree. Familiarity with inspection protocols, laboratory testing equipment, and digital reporting systems is commonly required, along with potential USDA or FDA certifications. Strong analytical thinking, effective communication, and integrity are important soft skills for this role. These competencies ensure accurate inspections, compliance with safety regulations, and clear reporting essential to public health and organizational accountability.

What types of facilities or products do FDA inspectors review, and what does a typical inspection process involve?

FDA Inspectors routinely examine a variety of facilities, such as food processing plants, pharmaceutical manufacturers, medical device companies, and cosmetic production sites, to ensure compliance with federal safety and quality regulations. A typical inspection involves reviewing operational procedures, examining production environments, sampling products, and interviewing staff to identify potential violations or risks. Inspectors often work onsite, sometimes with travel required to cover multiple locations within their region, and collaborate closely with facility management to explain findings and recommend corrective actions. This role offers the opportunity to make a significant impact on public health and provides clear advancement pathways into specialized inspection or supervisory roles within regulatory agencies.

How do you become an FDA inspector?

To become an FDA inspector, candidates typically need a bachelor's degree in a relevant field such as biology, chemistry, or food science, along with experience in food safety, pharmaceuticals, or related areas. They must pass a written exam and a background check, and often undergo specialized training at the FDA's training center. Certification or licensing is not required but can enhance prospects in the field.

What cities near Schenectady, NY are hiring for Fda Inspector jobs?

Cities near Schenectady, NY with the most Fda Inspector job openings:

Fda Inspector jobs near you
Infographic showing various Fda Inspector job openings in Schenectady, NY as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 14% Part Time, 4% Contract, and 1% Nights. Highlights an 87% Physical, 3% Hybrid, and 10% Remote job distribution, with an average salary of $53,155 per year, or $25.6 per hour.

Staff External Manufacturing Specialist (Clinical Drug Product)

Regeneron Pharmaceuticals, Inc.

Rensselaer, NY • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 22 days ago

Regeneron rating

8.4

Company rating: 8.4 out of 10

Based on 43 frontline employees who took The Breakroom Quiz

22nd of 86 rated pharmaceutical

Job description

Build our future together:
We are currently looking to fill a Staff External Manufacturing Specialist as the technical and operational authority for clinical contract drug product (DP) filling operations at CMO and business partner sites. Owns the tech transfer process end-to-end, drives active batch management from pre-production through lot disposition, and is a key GMP decision-maker. Provides technical mentorship and leadership to mid-level specialists, and collaborates with management on compliance strategy and CMO performance in the clinical operations space.
When & where:
  • Rensselaer, NY
  • Monday-Friday

Discover your role:
Drug Product Filling - Technical Expertise
  • Apply deep technical knowledge of aseptic filling unit operations: sterile filtration (bioburden reduction and sterilizing-grade filters), filling (time-pressure, peristaltic, rotary piston), stoppering, capping, and lyophilization cycle development and scale-up.
  • Interpret environmental monitoring (EM) data, airborne particulate results, and media fill (APS) outcomes; assess implications for batch disposition and process adequacy.
  • Partner with DP MSAT to evaluate and apply lessons learned across the network as it relates to CCI, APS, filling operations, CMO assessments, etc.
  • Assess cleanroom design and equipment suitability (ISO 5/Grade A filling zones, Grade B/C support areas) relative to product contamination control requirements.
  • Support extractables and leachables (E&L) risk assessments for product-contact materials and container closure system selection.

Technical Transfer:
  • Own and lead end-to-end operations of tech transfer to CMO filling sites, gap assessments, risk evaluations and assessments, facility/equipment readiness, engineering run execution.
  • Approve Technical requirements document (TRD), Master Batch Records (MBR), validation reports, summary reports, etc
  • Oversee tech transfer, qualification, and validation of filling lines and critical equipment: isolator/RABS, vial/syringe filling systems, lyophilizers, and component prep (depyrogenation tunnels, washers, autoclave).
  • Coordinates/oversees DP manufacturing at CMO as dictated by project tech transfer and clinical operations.
  • Liaises between various departments within Regeneron including, but not limited to Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments, Legal, Regulatory, Strategic Sourcing and contract manufacturers or business partners.

Technical Mentorship & Leadership
  • Serve as the primary technical resource for mid-level EM Specialists; provide hands-on guidance on aseptic filling operations, batch record review, deviation management, and CMO oversight.
  • Coach Specialists on interpreting in-process data, applying GMP regulations to real-world filling scenarios, and escalating issues appropriately.
  • Lead sub-teams on continuous improvement initiatives, filling technology upgrades, and CMO performance management.
  • Collaborate with management to communicate CMO operational status, proactively, surface risks, and shape external manufacturing strategy.

Active Batch Management:
  • Serve as Regeneron's primary technical contact for all active clinical batches at CMO sites - track filling status, in-process results, and lot disposition milestones in real time.
  • Monitor in-process data: fill weight/volume checks, filter integrity test results, visual/automated inspection outcomes, and lyophilization cycle data.
  • Lead deviation investigations and drive CAPA closure for events occurring during or after filling operations; assess impact on batch and filing.
  • Track cycle times, yield trends, and reject rates across batches; analyze data for process drift and drive continuous improvement actions with the CMO.
  • Lead sub-teams in continuous process improvements, system/equipment implementation and/or strategy development.
  • Ensures product integrity and company reputation monitoring of cGMP compliance at external manufacturing contract manufacturers and business partners.

Regulatory & GMP Compliance
  • Key GMP decision-maker for external DP filling operations; apply FDA 21 CFR, EU GMP Annex 1, and USP/EP/JP compendia requirements.
  • Ensure CMO change controls are appropriately evaluated for regulatory impact; coordinate post-approval change strategies with Regulatory Affairs.
  • Review CMC sections of regulatory submissions (IND, BLA/NDA, MAA) related to DP manufacturing and filling as required.
  • Support GMP audits of CMO sites; identify compliance gaps, assess risk

This role requires:
  • A Bachelor's degree or advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or related discipline and 10+ years in pharmaceutical/biopharmaceutical DP manufacturing, with significant direct experience in sterile filling and CMO oversight.
  • Hands-on technical experience with sterile drug product filling operations (aseptic filling, lyophilization, CCI, inspection) in a GMP environment.
  • Demonstrated experience leading or executing tech transfer of DP filling processes to CMO sites, including MBR/TRD approval, PPQ, and process validation.
  • Experience leading deviation investigations and CAPA development for sterile filling operations.
  • Demonstrated ability to mentor and develop technical staff; experience providing guidance in a team or lead capacity.
  • Strong analytical, communication, and cross-functional collaboration skills; ability to influence and make decisions in ambiguous situations.
  • Willingness to travel domestically and internationally up to 25%+ as required.

May substitute proven experience for education requirement.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$108,000.00 - $176,000.00

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