Quality Lab Manager
ultra, Inc., Frankfort, KY, United States
Quality Lab Manager
As a Quality Lab Manager at ULTRA, you’ll be the hands‑on engine behind our lab operations, managing day‑to‑day laboratory activities, running pilot‑scale batch production, and operating pouch machinery to push product development forward.
What You’ll Own
Laboratory Operations & Equipment Management
Own the daily operation, maintenance, calibration, and troubleshooting of all lab equipment—mixers, balances, moisture analyzers, particle size analyzers, and related instrumentation.
Build and maintain equipment maintenance schedules, calibration logs, and service records in compliance with GMP requirements.
Identify equipment malfunctions, coordinate repairs with vendors, and minimize downtime.
Keep the lab environment maintained to strict cleanliness, safety, and organizational standards.
Ingredient Inventory Management
Maintain accurate inventory of raw materials, ingredients, and lab consumables.
Coordinate purchasing requests for lab‑scale raw materials in partnership with procurement.
Run regular cycle counts and reconcile inventory records in tracking systems.
Manage incoming material documentation—including COAs—and verify compliance against internal specs.
Pilot-Scale Batch Production
Execute pilot‑scale batch manufacturing per established formulas, batch records, and SOPs.
Document all batch production activities, deviations, and observations in batch records.
Collaborate with Product Development to iterate on formulations and translate bench‑scale work into repeatable pilot‑scale processes.
Support scale‑up activities by identifying process variables and optimization opportunities.
Pilot-Scale Pouch Machine Operation
Operate and maintain pilot‑scale oral pouch manufacturing equipment.
Perform machine setup, changeovers, and adjustments to hit target fill weights, seal integrity, and pouch aesthetics.
Document machine parameters and production data for each run.
Troubleshoot mechanical and process issues and elevate as needed.
Quality Assurance – Co‑Manufacturing Site Support
Review and assess finished goods against product specifications, supporting pass/fail decisions.
Support deviation investigations, CAPA development, and closure at co‑manufacturing sites.
Assist in developing co‑manufacturing quality documentation—specifications, SOPs, and control plans.
Third‑Party Analytical Testing
Serve as the primary point of contact for third‑party analytical labs, coordinating sample submissions for testing (nicotine content, moisture, pH, heavy metals, microbial limits, etc.).
Review and interpret COAs and analytical reports, flagging out‑of‑spec results and initiating follow‑up.
Maintain a testing calendar to ensure timely submissions aligned with product launch timelines and market compliance.
Collaborate with Product Development to establish analytical testing protocols and define acceptable spec ranges.
Manage third‑party lab vendor relationships, evaluate qualifications and accreditations (e.g., ISO 17025), and onboard new lab partners as needed.
Documentation & Compliance
Maintain thorough records in accordance with GMP, FDA, and applicable regulatory requirements.
Contribute to the development, revision, and training of SOPs for lab and quality operations.
Support internal audits and assist with preparation for third‑party or regulatory inspections.
Why You’re a Fit
Bachelor’s degree
in Food Science, Chemistry, Biology, Pharmaceutical Sciences, or a related technical field.
3–5 years of experience
in a laboratory, quality, or manufacturing environment within CPG, nutraceutical, tobacco
icotine, or pharma.
You’ve got demonstrated hands‑on experience operating and troubleshooting manufacturing or lab‑scale equipment.
You’re fluent in
Good Manufacturing Practices (GMPs)
and quality systems documentation.
You’re detail‑obsessed with excellent organizational and record‑keeping skills.
You’re comfortable with travel to co‑manufacturing sites (estimated 10–25%).
Bonus:
Experience with oral pouch, nicotine pouch, smokeless tobacco, or similar oral product manufacturing.
Bonus:
Familiarity with pouch filling/sealing machinery, co‑manufacturer audits, CAPA systems, or ERP/inventory management systems.
You embody ULTRA’s values:
Move fast. Be data‑driven. Take ownership. Build with intention. Compete to win.
Benefits and Perks
Medical coverage
Dental coverage
Vision coverage
HSA access
401(k) plan
Ultra pouches
Physical Requirements
Ability to stand for extended periods during batch production and machine operation.
Ability to lift up to 50 lbs. as required for raw material handling.
Comfortable working in a manufacturing environment with exposure to nicotine‑containing materials and relevant PPE requirements.
Equal Employer Opportunity
Ultra is proud to be an equal opportunity workplace. We value a diverse workforce and an inclusive culture. We encourage applications from all qualified individuals regardless of race, color, religion, gender, sexual orientation, gender identity or expression, age, national origin, marital status, disability or veteran status. We comply with all applicable employment laws, including the NYC Fair Chance Act, and provide reasonable accommodations as required by law.
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As a Quality Lab Manager at ULTRA, you’ll be the hands‑on engine behind our lab operations, managing day‑to‑day laboratory activities, running pilot‑scale batch production, and operating pouch machinery to push product development forward.
What You’ll Own
Laboratory Operations & Equipment Management
Own the daily operation, maintenance, calibration, and troubleshooting of all lab equipment—mixers, balances, moisture analyzers, particle size analyzers, and related instrumentation.
Build and maintain equipment maintenance schedules, calibration logs, and service records in compliance with GMP requirements.
Identify equipment malfunctions, coordinate repairs with vendors, and minimize downtime.
Keep the lab environment maintained to strict cleanliness, safety, and organizational standards.
Ingredient Inventory Management
Maintain accurate inventory of raw materials, ingredients, and lab consumables.
Coordinate purchasing requests for lab‑scale raw materials in partnership with procurement.
Run regular cycle counts and reconcile inventory records in tracking systems.
Manage incoming material documentation—including COAs—and verify compliance against internal specs.
Pilot-Scale Batch Production
Execute pilot‑scale batch manufacturing per established formulas, batch records, and SOPs.
Document all batch production activities, deviations, and observations in batch records.
Collaborate with Product Development to iterate on formulations and translate bench‑scale work into repeatable pilot‑scale processes.
Support scale‑up activities by identifying process variables and optimization opportunities.
Pilot-Scale Pouch Machine Operation
Operate and maintain pilot‑scale oral pouch manufacturing equipment.
Perform machine setup, changeovers, and adjustments to hit target fill weights, seal integrity, and pouch aesthetics.
Document machine parameters and production data for each run.
Troubleshoot mechanical and process issues and elevate as needed.
Quality Assurance – Co‑Manufacturing Site Support
Review and assess finished goods against product specifications, supporting pass/fail decisions.
Support deviation investigations, CAPA development, and closure at co‑manufacturing sites.
Assist in developing co‑manufacturing quality documentation—specifications, SOPs, and control plans.
Third‑Party Analytical Testing
Serve as the primary point of contact for third‑party analytical labs, coordinating sample submissions for testing (nicotine content, moisture, pH, heavy metals, microbial limits, etc.).
Review and interpret COAs and analytical reports, flagging out‑of‑spec results and initiating follow‑up.
Maintain a testing calendar to ensure timely submissions aligned with product launch timelines and market compliance.
Collaborate with Product Development to establish analytical testing protocols and define acceptable spec ranges.
Manage third‑party lab vendor relationships, evaluate qualifications and accreditations (e.g., ISO 17025), and onboard new lab partners as needed.
Documentation & Compliance
Maintain thorough records in accordance with GMP, FDA, and applicable regulatory requirements.
Contribute to the development, revision, and training of SOPs for lab and quality operations.
Support internal audits and assist with preparation for third‑party or regulatory inspections.
Why You’re a Fit
Bachelor’s degree
in Food Science, Chemistry, Biology, Pharmaceutical Sciences, or a related technical field.
3–5 years of experience
in a laboratory, quality, or manufacturing environment within CPG, nutraceutical, tobacco
icotine, or pharma.
You’ve got demonstrated hands‑on experience operating and troubleshooting manufacturing or lab‑scale equipment.
You’re fluent in
Good Manufacturing Practices (GMPs)
and quality systems documentation.
You’re detail‑obsessed with excellent organizational and record‑keeping skills.
You’re comfortable with travel to co‑manufacturing sites (estimated 10–25%).
Bonus:
Experience with oral pouch, nicotine pouch, smokeless tobacco, or similar oral product manufacturing.
Bonus:
Familiarity with pouch filling/sealing machinery, co‑manufacturer audits, CAPA systems, or ERP/inventory management systems.
You embody ULTRA’s values:
Move fast. Be data‑driven. Take ownership. Build with intention. Compete to win.
Benefits and Perks
Medical coverage
Dental coverage
Vision coverage
HSA access
401(k) plan
Ultra pouches
Physical Requirements
Ability to stand for extended periods during batch production and machine operation.
Ability to lift up to 50 lbs. as required for raw material handling.
Comfortable working in a manufacturing environment with exposure to nicotine‑containing materials and relevant PPE requirements.
Equal Employer Opportunity
Ultra is proud to be an equal opportunity workplace. We value a diverse workforce and an inclusive culture. We encourage applications from all qualified individuals regardless of race, color, religion, gender, sexual orientation, gender identity or expression, age, national origin, marital status, disability or veteran status. We comply with all applicable employment laws, including the NYC Fair Chance Act, and provide reasonable accommodations as required by law.
#J-18808-Ljbffr