Staff Advanced Quality Engineer (Software)

Inspection Technician

Warehouse Technician

Buyer/Planner

Maintenance Engineer

Production Technician I

Compounding Technician

Filling Technician

QC Lab Sample Coordinator

Environmental Health and Safety (EHS) Manager

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: <ul><li>Purpose Statement The Inspection Technician is responsible for sterile pharmaceutical inspection operations, with additional expectations for technical troubleshooting, routine maintenance, and active support of qualification activities.</li><li>This position operates in an isolator-based manufacturing environment, works with high potent APIs and controlled substances, and plays a key role in ensuring compliance with cGMP, safety, and site procedures.</li><li>The Inspection Technician serves as a technical resource within the production team and supports continuous improvement of manufacturing processes.</li><li>This position will include cross training for support of formulation, IV Bag filling, leak inspection, dispensing and packaging.</li></ul> Responsibilities: <ul><li>Operate, monitor, and adjust IV Bag inspection equipment and direct 100% inspection of filled IV-bags of various sizes and configuration.</li><li>Secondary responsibilities will include operating manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform visual inspection of final product to ensure conformance with quality standards and specifications.</li><li>Perform AQL testing manually to verify integrity of the automated inspection system.</li><li>Serve as first-line troubleshooting support for equipment and GMP manufacturing issues, escalating to engineering or maintenance as required.</li><li>Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.</li><li>Assist in the creation, revision, and implementation of SOPs and production-related procedures.</li><li>Provide training, guidance, and on-the-job support to other production personnel.</li><li>Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.</li><li>Review documentation completed by fellow members of the production team.</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>Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications/Experience <ul><li>High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.</li><li>Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of product post fill inspection.</li><li>Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with skills including the ability to concisely describe problems to mechanics.</li><li>Knowledge of cGMP, and aseptic processing, requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI required. Experience with a supervisory controller and data acquisition system (SCADA) interface will be a plus.</li><li>Experience with isolator-based manufacturing strongly preferred.</li><li>Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols</li></ul> Skills/Competencies <ul><li>Precise skills for inspecting finished product effectively.</li><li>Demonstrated problem-solving and troubleshooting skills.</li><li>Ability to mentor and train less experienced technicians.</li><li>Excellent attention to detail and documentation accuracy.</li><li>Effective communication and teamwork skills.</li><li>Commitment to safety, quality, and data integrity.</li><li>Comfortable working in cleanroom environments with PPE requirements.</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>

Responsibilities: <ul><li>Develop and execute purchase orders for raw materials, packaging components, consumables, and services in accordance with approved supplier lists and site requirements.</li><li>Maintain optimal inventory levels by balancing material availability with cost-effective order quantities.</li><li>Collaborate with Production Planning and Supply Chain to align material purchases with manufacturing schedules.</li><li>Participate and represent the site in the routine S&amp;OP meeting.</li><li>Monitor supplier performance, including on-time delivery, quality, and responsiveness, and drive corrective actions as needed.</li><li>Negotiate pricing, terms, and contracts with suppliers to achieve cost savings and value-added agreements.</li><li>Maintain accurate purchasing and planning data in the ERP system, ensuring alignment with master data and inventory control requirements.</li><li>Identify and qualify alternative suppliers to mitigate supply risks and ensure business continuity.</li><li>Coordinate with Quality Assurance and Quality Control to ensure incoming materials meet specifications and quality standards.</li><li>Support new product introduction by sourcing and securing materials in alignment with project timelines.</li><li>Generate and track Production Orders through release to ensure on time, in full deliveries to customers.</li><li>Track and report key procurement and planning metrics, such as supplier on-time delivery, inventory turns, and purchase price variance.</li><li>Ensure compliance with all cGMP, DEA, and regulatory requirements for the procurement and handling of controlled substances and high potent materials.</li><li>Participate in cross-functional process improvement initiatives to enhance supply chain efficiency and reliability</li></ul> Requirements: Qualifications / Experience: <ul><li>Bachelor’s degree in Supply Chain Management, Business Administration, or related field preferred; equivalent work experience considered.</li><li>Minimum of 3 years of procurement, planning, or supply chain experience in a cGMP-regulated pharmaceutical, biotechnology, or related manufacturing environment.</li><li>Experience with controlled substances, high potent APIs, and regulated material handling preferred.</li><li>Strong knowledge of ERP/MRP systems, purchasing processes, and inventory control principles.</li><li>Familiarity with cGMP, DEA, and FDA requirements related to materials management.</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>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform routine preventive maintenance and minor repairs on production equipment to maintain optimal operating conditions.</li><li>Serve as first-line troubleshooting support for equipment and process issues, escalating to engineering or maintenance as required.</li><li>Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.</li><li>Assist in the creation, revision, and implementation of SOPs and production-related procedures.</li><li>Provide training, guidance, and on-the-job support to Production Technician I personnel.</li><li>Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.</li><li>Review documentation completed by fellow members of the production team.</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>Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.</li><li>Operate isolator technology, including performing and verifying sanitization steps, and supporting advanced troubleshooting.</li><li>Ensure controlled substances are handled, documented, and stored per DEA and site requirements.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications / Experience <ul><li>High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.</li><li>Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of compounding, filling, inspection, and secondary packaging. Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with hands-on equipment troubleshooting and maintenance skills.</li><li>Knowledge of cGMP, aseptic processing, and controlled substance handling requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI or SCADA interface required.</li><li>Experience with isolator-based manufacturing strongly preferred.</li><li>Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols</li></ul> Skills / Competencies <ul><li>Demonstrated problem-solving and mechanical troubleshooting skills.</li><li>Ability to mentor and train less experienced technicians.</li><li>Excellent attention to detail and documentation accuracy.</li><li>Effective communication and teamwork skills.</li><li>Commitment to safety, quality, and data integrity.</li><li>At home working in cleanroom environments with PPE requirements.</li></ul>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform routine preventive maintenance and minor repairs on production equipment to maintain optimal operating conditions.</li><li>Serve as first-line troubleshooting support for equipment and process issues, escalating to engineering or maintenance as required.</li><li>Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.</li><li>Assist in the creation, revision, and implementation of SOPs and production-related procedures.</li><li>Provide training, guidance, and on-the-job support to Production Technician I personnel.</li><li>Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.</li><li>Review documentation completed by fellow members of the production team.</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>Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.</li><li>Operate isolator technology, including performing and verifying sanitization steps, and supporting advanced troubleshooting.</li><li>Ensure controlled substances are handled, documented, and stored per DEA and site requirements.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications / Experience&nbsp; <ul><li>High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.</li><li>Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of compounding, filling, inspection, and secondary packaging. Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with hands-on equipment troubleshooting and maintenance skills.</li><li>Knowledge of cGMP, aseptic processing, and controlled substance handling requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI or SCADA interface required.</li><li>Experience with isolator-based manufacturing strongly preferred.</li><li>Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols</li></ul> Skills/Competencies <ul><li>Demonstrated problem-solving and mechanical troubleshooting skills.</li><li>Ability to mentor and train less experienced technicians.</li><li>Excellent attention to detail and documentation accuracy.</li><li>Effective communication and teamwork skills.</li><li>Commitment to safety, quality, and data integrity.</li><li>At home working in cleanroom environments with PPE requirements.</li></ul>

Responsibilities: Sample Management <ul><li>Performs QC sample/reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC sample reconciliation and disposal.</li><li>Tracks inventory of product samples, stability samples, and test materials in the lab.</li><li>Uses laboratory software for sample, reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with samples.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Send samples for outside testing. Submit samples to the appropriate labs for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the submission of samples.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting sample processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li></ul> Investigations&nbsp; <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any sample and reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance&nbsp; <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendia requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.</li></ul> Safety <ul><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.</li></ul> Requirements: Education &amp; Experience <ul><li>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computer savvy.</li></ul> Skills &amp; Abilities <ul><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>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 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.</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>

Responsibilites: <ul><li>Develop and implement site-wide EHS programs aligned with federal, state, and local regulations, including OSHA, EPA, and DEA requirements for controlled substances.</li><li>Lead risk assessments, job hazard analyses (JHAs), and containment evaluations, particularly in areas handling high-potent and controlled substances.</li><li>Serve as the primary liaison for EHS-related aspects of DEA compliance, supporting controlled substance handling protocols in collaboration with Quality, Security, and Operations.</li><li>Oversee the environmental and safety controls for controlled substances, ensuring proper ventilation, storage, access restrictions, spill response, and waste disposal procedures in compliance with DEA and EPA regulations.</li><li>Develop and maintain physical and procedural controls related to controlled substance areas (e.g., vaults, restricted labs, destruction processes) in partnership with Security and Regulatory Affairs.</li><li>Lead the investigation and root cause analysis of all incidents, near-misses, and controlled substance discrepancies, and implement corrective/preventive actions.</li><li>Ensure training and education of site personnel in EHS best practices, with a focus on potent compound safety, exposure monitoring, and controlled substance handling protocols.</li><li>Implement industrial hygiene programs, including monitoring of airborne concentrations and potential operator exposure to potent and hazardous compounds.</li><li>Establish robust programs for emergency preparedness, including chemical spills, fires, security threats, and controlled substance incidents.</li><li>Maintain all required permits, records, and documentation related to hazardous waste, emissions, safety incidents, and controlled substance EHS compliance.</li><li>Partner with Engineering, Validation, and Operations to incorporate EHS and security standards into facility, utility, and equipment design and commissioning.</li><li>Foster a strong culture of safety, accountability, and environmental stewardship at all levels of the organization.</li></ul> Requirements: <ul><li>Bachelor’s degree in Environmental Science, Occupational Health &amp; Safety, Chemical Engineering, or related field (Master’s preferred).</li><li>Minimum of 7–10 years of progressive EHS experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.</li><li>Direct experience managing EHS compliance for controlled substances (DEA Schedules II–V) and high-potency APIs strongly preferred.</li><li>In-depth knowledge of OSHA, EPA, DEA, NJDEP, and global EHS regulations and guidelines.</li><li>Familiarity with industrial hygiene, containment technologies, and safe handling procedures for potent compounds</li><li>Experience leading EHS activities during greenfield/startup site development and qualification is a plus.</li></ul>

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20 dea controlled substances Jobs found

Staff Advanced Quality Engineer (Software)

Inspection Technician

Warehouse Technician

Buyer/Planner

Maintenance Engineer

Production Technician I

Compounding Technician

Filling Technician

QC Lab Sample Coordinator

Environmental Health and Safety (EHS) Manager

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20 dea controlled substances Jobs found

Staff Advanced Quality Engineer (Software)

Inspection Technician

Warehouse Technician

Buyer/Planner

Maintenance Engineer

Production Technician I

Compounding Technician

Filling Technician

QC Lab Sample Coordinator

Environmental Health and Safety (EHS) Manager

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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TALENT

COMPANY

Contact Us

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.