DEA Manager

Warehouse Technician

Chemist Data Reviewer

Production Technician I

Manager Continuous Improvement

Java Backend Engineer

Specialist, DEA Compliance

QC Chemist I

Role Description: <ul><li>The DEA Manager is responsible for ensuring the company maintains strict compliance with all DEA regulations and applicable state-level controlled substance laws.</li><li>This role manages the day-to-day requirements for handling-controlled substances, including quota management, licensing, ARCOS reporting, Suspicious Order Monitoring (SOM), material movement, and maintaining accurate records to ensure audit readiness at all times.</li></ul> Responsibilities: <ul><li>Manages a team supporting State Licensing, Suspicious Order Monitoring (SOM) and DEA.</li><li>Manages and submits DEA procurement quota applications.</li><li>Maintains and renews DEA, State, and Board of Pharmacy licenses and registrations for all company facilities.</li><li>Oversees the generation and execution of DEA 222 forms for the transfer and procurement of Schedule II controlled substances.</li><li>Acts as the primary point of contact during DEA and State Board of Pharmacy inspections and audits.</li><li>Liaises with Procurement and the DEA regarding the import/export of control substances and completes required documentation.</li><li>Prepares, reviews, and submits accurate and timely ARCOS reports to the DEA; Ensures accurate reporting of year-end and biennial inventories across all facilities.</li><li>Conducts internal audits of controlled substance vaults, cages, and manufacturing areas to ensure physical security and record-keeping compliance.</li><li>Drafts, reviews, and updates Standard Operating Procedures (SOPs) related to the handling, storage, and distribution of controlled substances.</li><li>Monitors federal and state legislative changes regarding controlled substances; advises management on the impact of new regulations and implement necessary operation shifts.</li><li>Coordinates all controlled substance destruction with the warehouse and the Environmental, Health &amp; Safety department.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in science, PharmD preferred.</li><li>5+ years of relevant work experience.</li><li>Strong knowledge of DEA and FDA regulations.</li></ul> Physical Requirements <ul><li>Ability to stand, walk, or climb stairs/ladders for extended periods while performing duties within the plant.</li><li>Occasional lifting or moving of materials or equipment (generally up to 25–40 lbs)</li><li>Frequent use of hands and eyes for computer work, and documentation.</li><li>Ability to wear required personal protective equipment (PPE) such as safety glasses, gowns, gloves, or respirators when entering manufacturing areas.</li><li>Capacity to work in cleanroom, environments, which may involve temperature variations, or noise.</li><li>Must be able to travel between facilities as needed</li></ul>

Role Description: <ul><li>The Warehouse Technician will be responsible for executing material handling, inventory management, and warehouse operations in support of a sterile pharmaceutical manufacturing facility producing injectable IV bag products, including high potent APIs and controlled substances.</li><li>This role will ensure materials are received, stored, issued, and shipped in compliance with cGMP, DEA, and site safety requirements.</li><li>The Warehouse Technician will play a key role in maintaining accurate inventory records, supporting production schedules, and ensuring the cleanliness, organization, and security of the warehouse.</li></ul> Responsibilities: <ul><li>Receive, inspect, and verify incoming materials, components, and supplies against purchase orders and specifications.</li><li>Ensure proper storage of raw materials, packaging components, and controlled substances in compliance with cGMP, DEA, and safety requirements.</li><li>Accurately issue and deliver materials to production areas based on production schedules and work orders.</li><li>Operate warehouse equipment such as forklifts, pallet jacks, and material handling devices in a safe and compliant manner.</li><li>Perform cycle counts, physical inventory counts, and reconciliation of discrepancies in coordination with Inventory Control.</li><li>Maintain warehouse cleanliness, organization, and environmental conditions per site procedures and regulatory requirements.</li><li>Document all material transactions in the inventory management system, ensuring data accuracy and adherence to data integrity principles.</li><li>Prepare shipments of materials, components, or finished products in compliance with applicable regulations, including hazardous material handling requirements.</li><li>Support material sampling activities, including coordination with Quality Control for testing.</li><li>Assist in warehouse procedure creation, updates, and continuous improvement initiatives.</li><li>Ensure DEA security and access control measures are followed for controlled substances.</li><li>Collaborate with Production, Quality, Planning, and Procurement to ensure timely material availability for manufacturing operations.</li></ul> Requirements: Qualifications/Experience: <ul><li>High school diploma or equivalent required; Associate’s degree preferred.</li><li>Minimum of 2 years of warehouse or material handling experience in a cGMP-regulated pharmaceutical, biotechnology, or related manufacturing environment.</li><li>Experience handling controlled substances and/or high potent APIs preferred.</li><li>Knowledge of cGMP, DEA, and OSHA requirements for material handling and storage.</li><li>Experience operating forklifts and other warehouse equipment; forklift certification preferred.</li></ul> Skills/Competencies: <ul><li>Strong attention to detail and accuracy in documentation and inventory management.</li><li>Familiarity with inventory management systems and ERP software.</li><li>Ability to work effectively in a fast-paced, highly regulated environment.</li><li>Strong organizational skills with the ability to prioritize tasks.</li><li>Good communication and teamwork skills.</li><li>Commitment to safety, compliance, and maintaining a secure warehouse environment.</li><li>Ability to lift and move materials in accordance with safety guidelines.</li></ul>

Job Summary: <ul><li>This position is dedicated to the review, verification, and assessment of analytical data generated within the Quality Control laboratory.&nbsp;</li><li>The role ensures that all laboratory documentation meets cGMP, regulatory, and internal quality standards.&nbsp;</li><li>Responsibilities do not include performing laboratory testing, operating instruments, or releasing materials or products.</li></ul> Responsiblities: <ul><li>Review complete analytical data packages generated from a wide range of QC laboratory instrumentation, including HPLC, UPLC, GC, UV?Vis, FT?IR, Dissolution, X?Ray Diffraction (XRD), pH meters, Karl Fischer, ICP-MS, and other compendial or platform - specific systems.</li><li>Verify calculations, chromatographic integrations, peak assignments, system suitability criteria, and instrument audit trails across software platforms such as Empower, ChemStation, LabSolutions, ICP?MS data systems, and dissolution software.</li><li>Assess data for compliance with approved analytical methods, compendial requirements, SOPs, and cGMP expectations, ensuring consistency across diverse analytical techniques.</li><li>Evaluate raw data outputs such as chromatograms, spectra (UV, IR), dissolution profiles, XRD patterns, elemental analysis reports, pH logs, and mass spectrometry data for accuracy and scientific soundness.</li><li>Identify discrepancies, atypical trends, integration anomalies, missing data, or potential data integrity concerns and escalate findings promptly.</li><li>Confirm that all raw data, worksheets, logbooks, electronic records, and metadata comply with ALCOA+ principles and meet internal documentation standards.</li><li>Review LIMS entries for accuracy, completeness, and proper linkage to supporting raw data and metadata.</li><li>Ensure instrument-specific parameters (e.g., wavelength accuracy for UV, calibration curves for ICP?MS, dissolution run conditions, GC column performance) are appropriately documented and meet acceptance criteria.</li></ul> Requirements: Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years’ relevant analytical laboratory experience OR</li><li>Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experience</li></ul> Knowledge: <ul><li>Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports</li><li>Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.</li><li>Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS</li><li>Has demonstrated competence in conducting chemical analyses</li><li>Strong knowledge of wet chemistry techniques</li><li>Competency in Microsoft Office Suite</li></ul> Skills &amp; Abilities: <ul><li>Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management</li><li>Ability to display and analyze data in a logical manner</li><li>Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information</li><li>Ability to display and analyze data in a logical manner</li><li>Strong verbal and written communication skills as well as good computer skills</li><li>Strong attention to details and accurate record keeping</li><li>Establish and maintain cooperative working relationships with others</li><li>Solid organizational skills</li><li>Ability to coach less senior staff and develop laboratory skills and ability</li><li>Ability to take initiative, set priorities and follow through on assignments</li></ul> Physical Requirements: <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel.&nbsp;</li><li>Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods</li></ul>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment used for formulation, filling, and packaging of IV bag products in compliance with cGMP and SOPs.</li><li>Perform routine preventive maintenance on production equipment to ensure operational readiness and minimize downtime.</li><li>Support equipment and process qualifications, including execution assistance, documentation support, and adherence to qualification protocols.</li><li>Act as first-line troubleshooting support for mechanical or operational equipment issues, escalating to Engineering or Maintenance as required.</li><li>Assist with isolator technology operations, including cleaning, sterilization, and environmental control procedures.</li><li>Participate in line clearance, changeover, and cleaning activities to maintain continuous production operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity and cGMP requirements.</li><li>Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.</li><li>Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.</li><li>Contribute to continuous improvement initiatives focused on safety, efficiency, and product quality.</li><li>Work closely with cross-functional teams, including Engineering, Validation, and Quality, to support operational readiness.</li><li>Comply with all Environmental Health &amp; Safety (EHS) standards and maintain a clean and safe work environment.</li></ul> Key Stakeholders Internal <ul><li>Production Supervisor and Production Manager</li><li>Engineering and Maintenance</li><li>Validation and Quality Assurance</li><li>Materials and Warehouse Teams</li><li>Environmental Health &amp; Safety (EHS)</li></ul> External <ul><li>Equipment vendors and service technicians (as required)</li></ul> Requirements: Qualifications &amp; Experience <ul><li>High school diploma or equivalent required; Associate degree or technical certification in mechanical, engineering, or life sciences preferred.</li><li>Minimum 2 years of experience in pharmaceutical or other regulated manufacturing environments, including compounding, filling, inspection, or secondary packaging.</li><li>Prior experience with sterile products or IV bag manufacturing strongly preferred.</li><li>Strong mechanical aptitude with the ability to perform routine maintenance and troubleshoot equipment issues.</li><li>Experience operating automated production equipment using HMI or SCADA interfaces required.</li><li>Working knowledge of cGMP, aseptic processing, and controlled substance regulations preferred.</li><li>Ability to read, understand, and follow SOPs, maintenance procedures, and qualification protocols.</li></ul> Skills &amp; Competencies <ul><li>Strong technical and mechanical problem-solving skills</li><li>High attention to detail with a commitment to quality and data integrity</li><li>Ability to work effectively in a fast-paced, highly regulated environment</li><li>Strong verbal and written communication skills</li><li>Team-oriented mindset with a collaborative approach</li><li>Comfortable working in cleanroom environments with PPE requirements</li></ul>

Responsibilities: <ul><li>Implement and champion company OA principles (company Continuous Improvement System) and tools across Operational and Supply Chain Planning processes.</li><li>Identify areas for improvement and lead projects to enhance operational efficiency and effectiveness.</li><li>Collaborate with cross-functional teams to develop and implement best practices in operational and supply chain planning.</li><li>Conduct process mapping, root cause analysis, and develop innovative solutions to complex problems.</li><li>Provide coaching on LEAN activities and Lead Kaizen events and other continuous improvement initiatives within the operational and supply chain planning domain.</li><li>Develop and track key performance indicators (KPIs) to measure the success of LEAN initiatives.</li><li>Provide training and mentoring to team members on company OA methodologies and tools.</li><li>Create and maintain documentation of best practices and standard operating procedures.</li><li>Regularly report on project progress and outcomes to senior management.</li></ul> Requirements:﻿﻿ <ul><li>Bachelors degree in Supply Chain Management, Business Administration, Industrial Engineering, or a related field</li><li>5+ years of experience manufacturing added advantage form Semicon, medical line, EE manufacturing, automation or operations management.</li><li>3 years people manager skill are desirable.&nbsp;</li><li>Good engagement, communication, and hands on skills on handling of Continuous Improvement principles and their application in operational and supply chain processes.</li><li>Proven track record in implementing continuous improvement methodologies (e.g., Lean, Six Sigma).</li></ul>

Responsibilities: <ul><li>Collaborate with team, high availability, concurrent and fault tolerant software systems.</li><li>Significantly contribute to development of Aladdin’s global, multi-asset trading platform.</li><li>Work with product management and business users to define the roadmap for the product.</li><li>Design and develop innovative solutions to complex problems, identifying issues and roadblocks.</li><li>Apply validated quality software engineering practices through all phases of development.</li><li>Ensure resilience and stability through quality code reviews, unit, regression and user acceptance testing, dev ops and level two production support.</li><li>Be a leader with vision and a partner in brainstorming solutions for team productivity, efficiency, guiding and motivating others.</li><li>Drive a strong culture by bringing principles of inclusion and diversity to the team and setting the tone through specific recruiting, management actions and employee engagement.</li><li>For VP Level: In addition to above, a VP level candidate should be able to lead individual projects priorities, deadlines and deliverables using AGILE methodologies.</li></ul> Requirements: Qualifications: <ul><li>B.S. / M.S. degree in Computer Science, Engineering, or a related subject area</li><li>For VP Level: 8+ years of proven experience</li><li>For Associate Level: 4+ years of experience</li></ul> Skills and Experience: <ul><li>A proven foundation in core Java and related technologies, with OO skills and design patterns</li><li>Track record building high quality software with design-focused and test-driven approaches</li><li>Good hands-on object-oriented programming knowledge in Java, Spring, TypeScript, JavaScript, Microservices, Angular (2.0+), React.</li><li>Strong knowledge of Open-Source technology stack (Spring, Hibernate, Maven, JUnit, etc.).</li><li>Experience with relational database and/or NoSQL Database (e.g., Apache Cassandra)</li><li>Great analytical, problem-solving and communication skills</li><li>Some experience or a real interest in finance, investment processes, and/or an ability to translate business problems into technical solutions.</li><li>For VP Level: In addition to the above, a VP level candidate should have experience leading development teams, projects or being responsible for the design and technical quality of a significant application, system, or component. Ability to form positive relationships with partnering teams, sponsors, and user groups.</li></ul> Nice to have and opportunities to learn: <ul><li>Exposure to building microservices and APIs ideally with REST, Kafka or gRPC.</li><li>Experience working in an agile development team or on open-source development projects.</li><li>Experience with optimization, algorithms or related quantitative processes.</li><li>Exposure to high scale distributed technology like Kafka, Mongo, Ignite, Redis</li><li>Experience with Cloud platforms like Microsoft Azure, AWS, Google Cloud</li><li>Experience with DevOps and tools like Azure DevOps</li><li>Experience with AI-related projects/products or experience working in an AI research environment.</li><li>A degree, certifications or opensource track record that shows you have a mastery of software engineering principles.</li></ul>

Role Description:The DEA Compliance Specialist, under general supervision, is knowledgeable on all matters of the DEA as it pertains to pharmaceutical testing, manufacturing and distribution of controlled substances.Those matters include licenses, procurement, and movement of material, production, shipment and destruction.Incumbent should also have the ability to interface with governmental agencies and represent the company as needed.Responsibilities:DEA coordinator for CII –CV controlled substances: manages/coordinates all DEA-related actives at siteReviews and releases daily orders through Suspicious Order Monitoring System (SOMs) and assures compliance with Suspicious Orders Reporting (SORS)Maintains Know your Customer (KYC) informationConducts year‐end and biennial inventory and report ARCOS quarterly reporting & cycle count inventory via DEA websiteCoordinates all movement of controlled substances from manufacturing through analytical testingLiaises with Procurement and DEA regarding import/export of controlled substance and completes necessary paperworkMaintains compliance of all DEA, State, and Board of Pharmacy registrationsCoordinates all controlled substance destruction with QC, Environmental, Health & Safety and Logistic departmentsWorks with Security department to maintain facility upgrades to security systemsPower of Attorney to sign DEA 222 form, responsible for completing, maintaining and tracking all DEA 222 formsResponsible for submitting CII quota applications to DEA; maintain organized DEA files on related activitiesCoordinates and documents DEA audits for sites and issues audit reports to management upon completionRemains current on DEA regs in order to address organization business needsCreates all destruction reports and coordinates pick ups for controlled destruction from MRB, line waste and lab waste.SOPs:Updates associated SOP’s related to job functionsSupporting responsibilities: Back up to State Licensing associateParticipates and represents department at project meetings as requiredRequirements:Education & Experience:Bachelor’s degree in a relevant field required2+ years’ relevant work experienceExperience with IQVIA SOM software preferredWorking knowledge of GMP regulations and compliance issuesStrong knowledge of DEA and FDA regulationsKnowledgeable of production and production planning processes

Responsibilities:The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.May participate in investigations.Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses.Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeepingCleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.Under close supervision, learns to troubleshoot basic instrument problems.With guidance, participates in OOS/OOT/NOE and other investigations.Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor.May assist in drafting, editing, and reviewing SOPs and laboratory investigations.Maintains assigned training records current and in-compliance.May assist in the training of less senior laboratory staff.Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.Follows internal processes related to controlled substances continuous.Follows EH&S procedures to ensure a safe work environment.Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous.Requirements:Minimal acceptable level of education, work experience and certifications required for the job.Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. Some pharmaceutical laboratory experience preferred.Proficiency in a body of information required for the job.e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Basic knowledge of wet chemistry techniques.Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.Competency in Microsoft Office Suite.Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.Ability to display and analyze data in a logical manner.Good verbal and written communication skills as well as good computer skills.Attention to details and accurate record keeping.Establish and maintain cooperative working relationships with othersSolid organizational skills.Ability to take initiative, set priorities and follow through on assignments.Physical & mental requirements e.g., lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicalsMust occasionally lift and/or move up to 15-25 lbs.Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision.Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.

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8 dea form 222 Jobs found

DEA Manager

Warehouse Technician

Chemist Data Reviewer

Production Technician I

Manager Continuous Improvement

Java Backend Engineer

Specialist, DEA Compliance

QC Chemist I

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8 dea form 222 Jobs found

DEA Manager

Warehouse Technician

Chemist Data Reviewer

Production Technician I

Manager Continuous Improvement

Java Backend Engineer

Specialist, DEA Compliance

QC Chemist I

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