Market Manager, Food Service & Specialty

Mechanical Maintenance Engineer - Automation Technology

QA Associate II

DEA Manager

Warehouse Technician

Chemist Data Reviewer

Staff Advanced Quality Engineer (Software)

Maintenance Engineer

Production Technician I

Specialist, DEA Compliance

Responsibilities: <ul><li>Develop and execute market strategies for the Food Service and Specialty segments across Europe.</li><li>Conduct market sizing, segmentation, growth forecasting, trend analysis, and competitive intelligence to support strategic decision-making.</li><li>Develop a deep understanding of Food Service markets, including restaurants, bakeries, hotels, butcheries, and other food preparation environments.</li><li>Analyze customer requirements, purchasing behaviors, and market dynamics to identify growth opportunities and strategic priorities.</li><li>Investigate emerging Specialty applications, including pharmaceutical storage and other temperature-controlled technology markets.</li><li>Identify and evaluate new opportunities that support expansion into adjacent market segments.</li><li>Gather and translate Voice of Customer and market insights into recommendations that influence business strategy, investment priorities, and product roadmaps.</li><li>Monitor industry developments, regulatory changes, competitive activity, and emerging technologies across Europe.</li><li>Partner with Product Management, Portfolio Marketing, Engineering, and Commercial teams to develop and execute growth initiatives.</li><li>Support long-range planning and business strategy through data-driven market analysis.</li><li>Present market intelligence, business cases, and strategic recommendations to senior leadership and executive stakeholders.</li></ul> Requirements: <ul><li>Bachelors degree in Business, Marketing, Economics, Engineering, or a related discipline.</li><li>3-5 years of experience in Market Management, Strategy, Product Marketing, Business Analysis, Consulting, or a similar market-focused role.</li><li>Strong experience in market sizing, forecasting, trend analysis, and strategic planning.</li><li>Excellent analytical, critical-thinking, and problem-solving skills.</li><li>Experience working with large datasets and translating insights into clear business recommendations.</li><li>Strong communication and presentation skills with the ability to confidently engage senior leadership and executive stakeholders.</li><li>Experience influencing cross-functional teams and driving strategic initiatives.</li><li>International or pan-European business experience.</li><li>Fluent English.</li><li>Ability to travel up to 30%.</li></ul>

Responsibilities: This position is responsible for mechanical maintenance and assembling automation systems in the manufacturing. <ul><li>Maintenance work on mechanical, electronic and pneumatic systems, including inspections, cleanings and lubrications.</li><li>Creation of machine safety concepts and machine data concepts.</li><li>Design and optimization of automation solutions for production plants using PLC controllers, robotics, industrial image processing, drive technology, testing technology, safety technology and other automation technologies.</li><li>Programming and commissioning of PLC controllers, safety controllers and HMI systems.</li><li>Mechanical design, assembly and wiring of machines and plants.</li><li>Integration of robotic systems and other automated components into existing production processes.</li><li>Functional tests and performance tests on automation systems, troubleshooting and optimization of control programs.</li><li>Preparation of technical documentation, operating instructions and training material.</li><li>Collaboration in planning and implementing projects for modernization and expansion of our production facilities.</li><li>Support in training of new employees in using new automation technologies.</li><li>Introduction of Industry 4.0 technologies (such as 3D printing, AMR, predictive maintenance, simulation, ).</li></ul> Requirements: <ul><li>Bachelors Degree in preferably mechanical engineering, automation engineering, mechatronics or a similar qualification.</li><li>Min 3 years of experience in industrial automation.</li><li>Knowledge of Cam-controlled machines like: Bihler (prefered), Wafios, Finzer.</li></ul>

Role Description: <ul><li>The Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging. Quality activities include product sampling and inspection, area clearance to confirm process readiness, non-conforming event support to resolve in-process issues, and process validation and qualification activities.</li><li>Communicates to multiple departments and supervision to provide timely process and issue updates.&nbsp;</li><li>Identifies and escalates issues or problems to appropriate supervision.</li><li>Participates as a team member on cross-functional teams. Participates in reviews and structured processes for continuous improvement</li></ul> Responsibilities: <ul><li>Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule.</li><li>Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements.</li><li>Is competent in all relevant processes (weighing, compounding, mixing, packaging, granulation, compression, coating, Liquids Mfg. and Batch Transfer, Creams &amp; Ointments Mfg. and Batch Transfer, Packaging, etc.) Follows internal processes related to controlled substances.</li><li>Performs GMP-related verifications including area, equipment and line clearances, cleaning, room inspection, material verification, etc. according to procedures</li><li>Actively participates in process validation and equipment qualification activities.</li><li>May execute computer data entries in SAP, Leucine, LIMS, and department databases.</li><li>Sampling and inspection of raw materials, packaging components, in-process, bulk, and finished drug product during manufacturing and packaging operations of commercial and non-commercial processes.</li><li>Performs manufacturing/packaging stage reviews of batch records.</li></ul> Requirements: <ul><li>High school diploma or equivalent with 4-7 years’ relevant experience OR</li><li>AA/AS degree with 3-6 years’ relevant experience OR</li><li>BA/BS degree with 2 -5 years’ relevant experienceRelated discipline and certification in assigned area a plus.</li><li>Experience with statistical sampling methods a plus.</li></ul> Knowledge &amp; Skills <ul><li>Attention to detail.</li><li>Strong documentation skills.</li><li>Ability to read and interpret SOPs and function within the scope of procedures.</li><li>Proficiency with basic math skills and basic experience with computers and software applications required.</li><li>Ability to learn new processes and procedures.</li><li>Able to communicate effectively with other departments, management and operational personnel.</li><li>Customer/Stakeholder focused (understands impact of daily work to compliance and overall business).</li><li>Proof-reading skills; ability to identify errors.</li><li>Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs).</li><li>Experience with Enterprise Resource Planning (ERP) system is a bonus.</li><li>Ability to work overtime as needed, including occasional weekend shifts.</li></ul> Physical Requirements <ul><li>Lift 15 lbs.</li><li>Walk across plant/warehouse.</li><li>Wear appropriate gowning as required.</li><li>Ability to read for extended periods of time.</li></ul>

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: QMS Ownership for Deliverable Software <ul><li>Translate AS9115 Rev A and AS9100:2016 requirements into practical procedures, work instructions, and templates.</li><li>Establish processes covering software planning, development, integration, verification/validation, release, delivery, and post-delivery support.</li><li>Ensure the QMS supports multiple development models (Agile, Waterfall, Incremental) while enforcing required quality controls including reviews, approvals, traceability, and documentation.</li></ul> Software Planning &amp; Requirements Quality <ul><li>Lead the creation and maintenance of Software Quality Plans.</li><li>Establish standards for requirements management ensuring requirements are:</li></ul> <ul><li>Clear</li><li>Unambiguous</li><li>Testable</li><li>Maintain bidirectional traceability from:</li><li>Requirements → Design → Code → Test → Release.</li></ul> Configuration Management &amp; Change Control Define standards for Software Configuration Management (CM) including: <ul><li>Baselines</li><li>Configuration item identification</li><li>Change evaluation and approval</li><li>Configuration status accounting</li><li>Integrate software configuration management with product and system configuration processes.</li><li>Ensure CM covers software, documentation, tools, environments, and build/release artifacts.</li></ul> Supplier &amp; COTS/NDS Management <ul><li>Establish standards for evaluation and acceptance of Commercial Off-The-Shelf (COTS) and Non-Developmental Software (NDS) used in deliverable products.</li><li>Define AS9115 control applicability with both customers and suppliers.</li><li>Support supplier qualification, audits, and incoming verification for software deliverables and services.</li></ul> Verification, Validation &amp; Test Assurance <ul><li>Define verification standards within the QMS including:</li><li>Static analysis</li><li>Peer reviews</li><li>Unit testing</li><li>Integration testing</li><li>System testing</li><li>Regression testing</li><li>Security testing</li><li>Ensure independence of verification activities where required.</li><li>Maintain controlled test environments, data integrity, and objective evidence for compliance audits.</li></ul> Release, Delivery &amp; Post-Delivery Support Develop procedures for: <ul><li>Software release criteria</li><li>Delivery records</li><li>Installation documentation</li><li>Post-delivery issue management</li><li>Patching and configuration updates</li><li>Ensure all processes align with AS9115 standards.</li></ul> Audits, Metrics &amp; Continuous Improvement Lead internal and customer audits related to AS9115/AS9100 compliance. <ul><li>Manage Corrective and Preventive Actions (CAPA).</li><li>Support external and second-party audits with aerospace OEMs.</li><li>Define and track key quality KPIs, including:</li><li>Requirements volatility</li><li>Defect density</li><li>Defect escape rate</li><li>Verification coverage</li><li>Audit findings aging</li><li>Build reproducibility</li><li>Change lead time</li></ul> Requirements: Bachelor’s or Master’s degree in: <ul><li>Software Engineering</li><li>Computer Science</li><li>Systems Engineering or a related discipline.</li><li>Minimum 5 years of experience in software quality or software engineering within aerospace, defense, or other regulated industries.</li><li>Hands-on experience implementing AS9100 quality processes with working knowledge of AS9115 software lifecycle controls.</li></ul> Strong experience in: <ul><li>Requirements management</li><li>Configuration management</li><li>Verification and validation</li><li>Software release governance</li><li>Experience managing COTS/NDS software integration and supplier quality.</li><li>Proven ability to lead audit activities and corrective actions using structured problem-solving tools such as:</li><li>5 Why</li><li>Ishikawa</li><li>8D</li></ul> Preferred Qualifications <ul><li>Experience supporting AS9115 second-party audits with aerospace OEMs.</li><li>Familiarity with DO-178C concepts and coordination with DO-254/ED-80 hardware processes.</li><li>Experience with ALM/PLM and configuration management tools, such as:</li><li>Polarion</li><li>IBM DOORS</li><li>CodeBeamer</li><li>Git / GitLab</li><li>Bitbucket</li><li>Azure DevOps</li><li>Knowledge of CI/CD pipelines, static analysis tools, and unit testing frameworks.</li><li>Exposure to CMMI-DEV processes and experience aligning them with AS9115 quality objectives.</li></ul>

Role Description:&nbsp; <ul><li>To lead and manage Electrical, Electronics, PLC, and Mechanical maintenance activities across processing and packing assets.&nbsp;</li><li>The role is responsible for ensuring safe, reliable, and efficient operation of equipment by eliminating electrical, automation, mechanical, and process-related. breakdowns, improving equipment reliability and OEE, and strategically reducing unplanned downtime through effective maintenance execution and team leadership.&nbsp;</li></ul> Responsibilities: <ul><li>Lead, coordinate, and manage both Electrical and Mechanical Maintenance teams.&nbsp;</li><li>Provide hands-on technical leadership for electrical, electronics, PLC, and mechanical breakdowns.&nbsp;</li><li>Manage preventive, corrective, and condition-based maintenance activities across all processing and packing equipment.&nbsp;</li><li>Troubleshoot PLC-controlled systems including fault diagnostics, I/O checks, sensors, actuators, and basic logic analysis.&nbsp;</li><li>Oversee mechanical maintenance activities including rotating equipment, conveyors, gearboxes, bearings, and drive systems.&nbsp;</li><li>Guide maintenance teams in root cause analysis (RCA), loss analysis, and implementation of permanent corrective actions.&nbsp;</li><li>Ensure effective maintenance planning, execution, and reporting through SAP PM.&nbsp;</li><li>Own and maintain electrical, automation, and mechanical spare parts inventories, ensuring availability of critical spares.&nbsp;</li><li>Develop maintenance standards, work instructions, and OPLs for electrical, PLC, and mechanical activities.&nbsp;</li><li>Support technician capability development through coaching and technical training (electrical, PLC, and mechanical).&nbsp;</li><li>Ensure compliance with EHS, QFS, and machinery safety standards during all maintenance activities.&nbsp;</li><li>Maintain accurate documentation and records to support internal and external audits (EHS, QFS, KWS, FSSC, etc.).&nbsp;</li></ul> Key Performance Indicators (KPIs):&nbsp; <ul><li>Reduction of unplanned downtime.&nbsp;</li><li>Improvement of equipment reliability and OEE.&nbsp;</li><li>Preventive maintenance on-time completion rate.</li><li>Breakdown response time and MTTR.&nbsp;</li><li>Maintenance cost control and spare parts availability.&nbsp;</li><li>Electrical and Mechanical team capability development.&nbsp;</li></ul> Requirements: <ul><li>Bachelor’s degree in Electrical &amp; Electronics Engineering or Mechatronics Engineering.&nbsp;</li><li>Minimum 5 years of maintenance experience in manufacturing or FMCG environments.&nbsp;</li><li>Proven experience in leading both electrical and mechanical maintenance teams.&nbsp;</li><li>Strong knowledge of industrial electrical, electronic, automation, and mechanical systems.&nbsp;</li><li>Mandatory PLC knowledge : - Fault finding and diagnostics - I/O modules, field devices, and communication basics - Ability to read and analyze PLC logic&nbsp;</li><li>Solid mechanical knowledge including rotating equipment, gearboxes, bearings, conveyors, and power&nbsp;transmission systems.&nbsp;</li><li>Experience with motors, inverters, servo drives, sensors, actuators, and control systems.&nbsp;</li><li>Experience with SAP PM or similar CMMS systems.&nbsp;</li><li>Strong leadership, problem-solving, communication, and decision-making skills.</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>

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

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11 dea controlled substances Jobs found

Market Manager, Food Service & Specialty

Mechanical Maintenance Engineer - Automation Technology

QA Associate II

DEA Manager

Warehouse Technician

Chemist Data Reviewer

Staff Advanced Quality Engineer (Software)

Maintenance Engineer

Production Technician I

Specialist, DEA Compliance

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11 dea controlled substances Jobs found

Market Manager, Food Service & Specialty

Mechanical Maintenance Engineer - Automation Technology

QA Associate II

DEA Manager

Warehouse Technician

Chemist Data Reviewer

Staff Advanced Quality Engineer (Software)

Maintenance Engineer

Production Technician I

Specialist, DEA Compliance

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