EHS Analyst

DEA Manager

Manufacturing Team Leader

Facility Mechanic

QA Tester

Manufacturing Line Leader

Customer Account Manager

Quality Assurance Associate

Responsibilities: Planning; <ul><li>Initiate annual EHS training plan &amp; EHS internal audit plan in order to meet the department annual operating plan.</li></ul> Procedures &amp; Document Update; <ul><li>Review &amp; update EHS procedure according to internal &amp; external audit finding.</li><li>Initiate, update and execute EHS policies or procedures according to national laws and regulations or S.A.F.E or Global policies in order to fulfill company EHS system and make work efficient.</li></ul> Safety and Health Management: <ul><li>Submit application to Safety Bureau for Safety and Health Impact Assessment and other required permits or registration in order to meet the requirement of national laws and regulations.</li><li>Conduct Safety Standard Management review and follow in velocity EHS system.</li><li>Coordinate industrial hygiene monitoring, evaluation, medical surveillance in order to prevent occupational disease.</li><li>Maintain SAFE and environment tool with continuous improvement.</li><li>Follow up Incident investigation, correction and Injury Trend Analysis in order to prevent incidents.</li><li>Conduct canteen and dormitory inspection with Admin. to supervise food safety and fire safety,in order to prevent incidents.</li><li>Conduct contractor &amp; supplier EHS management, issuing non-routine high risk task permits, in order to prevent incidents.</li></ul> EHS Projects: <ul><li>Lead and follow up JSA, LOTO, Ergo, Machine Guarding,BBS, Nearhit reporting, PPE management, IH, Environmental and etc.</li><li>Coordinate the Kaizens and other EHS activities, in order to meet SAFE and 5 star requirement and prevent incidents.</li></ul> Audit; <ul><li>Implement routine EHS internal audit and examine;</li><li>Prepare necessary material or data sheet for S.A.F.E ,customer, local government, global audit;in order to ensure meet compliance requirements.</li></ul> Reporting &amp; Training: <ul><li>Prepare Monthly EHS performance report in order to present EHS performance;</li><li>Organize health and safety related training to employee in order to promote the awareness of health and safety."</li></ul> Requirements: <ul><li>Minimum 5+ years of EH&amp;S experience required;</li><li>Possesses a strong grasp of Malaysias EHS laws and regulations, EHS Greenbook,can conduct compliance assessments.</li><li>Autonomous ability in conducting audits and inspections of all aspects of EHS;</li><li>Good reading and writing in English &amp; Chinese</li><li>Skilled in leveraging Excel for data analysis, visualization, and tracking key metrics.</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>

Responsibilities: <ul><li>Assist and monitor employees in job performance, answer questions, maintain action log, and provide&nbsp;</li><li>input to Area Lead on employee’s job performance.</li><li>Maintain production schedules by ensuring that each line is set-up per the prescribed line layout, has proper equipment, fixturing, tools, proper prints, in-process inspection sheets, and work instructions at the beginning of each shift, after line changeover, and during the shift.</li><li>Ensure proper clean up.</li><li>Ensure proper operation and guarding of equipment, report any unsafe equipment and/or unsafe acts.</li><li>Set good examples for quality, attendance, confidentiality, professionalism and display a positive attitude.</li><li>Consistently apply the Quality System procedures and enforce company policies and safety regulations.</li><li>Complete all documentation as required by department work instructions.</li><li>Ensure all suspect or reject material is quarantined and handled per Quality System procedures.</li><li>Make decisions and accept responsibility on operations related to assigned lines.</li><li>Assist in performing and evaluating 1st piece inspections for products as directed.</li><li>Post quantity goals and turn goal results in to Area Lead</li><li>Promote teamwork within the Production Line</li><li>Work closely with production control to react to schedule changes.</li><li>Communicate all appropriate issues to Area Lead.</li><li>Ensures production paper work is processed in a timely and accurate manner.&nbsp;</li><li>Perform other related duties and assignments as required.</li></ul> Requirements: <ul><li>High School diploma or GED</li><li>Evidence of continued education &amp; training</li><li>3-12 months experience in production</li></ul>

Responsibilities: <ul><li>Perform preventive and corrective maintenance, troubleshooting, and repairs on facility infrastructure and critical utilities, including HVAC systems for cleanroom environment, compressed air and vacuum systems, clean utilities (WFI, purified water, clean steam), boilers, chillers, temperature control units, and effluent water treatment equipment.</li><li>Support equipment setup, calibration, qualification, and creation of maintenance plans of facility utilities and equipment.</li><li>Conduct round and inspection to monitor system performance and proactively address issues.</li><li>Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.</li><li>Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).</li><li>Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.</li><li>Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.</li><li>Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.</li><li>Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.</li><li>Provide technical support of production activities during absence of production support team members or when bandwidth is insufficient.</li></ul> Requirements:﻿ <ul><li>High school diploma or technical certificate required, Associate’s degree in a mechanical or technical field preferred.</li><li>3+ years of experience as a mechanic or technician maintaining utilities or facilities infrastructure in a pharmaceutical, biotech, or regulated manufacturing environment.</li><li>Experience with pharmaceutical manufacturing equipment and cleanroom protocols is highly desirable.</li><li>Strong troubleshooting skills for mechanical, electrical, and control system issues.</li><li>Familiarity with building management systems (BMS) and alarm monitoring systems.</li><li>Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.</li><li>Understanding of cGMP, contamination control, and safety regulations (OSHA, FDA, EU Annex 1).</li><li>Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.</li><li>Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).</li><li>Self-motivated with strong attention to detail, problem-solving skills, and the ability to work independently or in a team.</li><li>Willingness to work flexible hours, including weekends or off-shifts during production or commissioning activities.</li></ul> Work Environment: <ul><li>Hands-on role in a regulated, sterile pharmaceutical manufacturing facility with strict safety and aseptic requirements.</li><li>Requires frequent gowning, standing, and work in confined or classified areas.</li><li>Fast-paced startup environment, requiring adaptability, initiative, and a collaborative mindset.</li><li>Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.</li><li>Physical requirements include lifting climbing ladders, electrical troubleshooting, and working with hand and power tools</li></ul>

Responsibilities: <ul><li>Develop detailed test plans based on project requirements and specifications.&nbsp;</li><li>Provide feedback on quality standards, usability, and areas for improvement.</li><li>Automates test scenarios and expected outcomes.&nbsp;</li><li>Conduct regression, integration, user acceptance, and performance testing.</li><li>Conducts comprehensive testing and risk-based assessments of the testing objects.&nbsp;</li><li>He/She uses source documentation as input and contributes to the planning and implementation of testing activities.&nbsp;</li><li>Leads testing components of large and complex projects, assigns tasks, provides direction to resources, and reports progress to project stakeholders.&nbsp;</li><li>He/She creates and selects tools and methodologies for review and approval by management.</li></ul> ﻿Requirements: <ul><li>Bachelors Degree or International equivalent&nbsp;</li><li>Bachelors Degree or International equivalent in Computer Science, Information Systems, Mathematics, Statistics or related field - Preferred&nbsp;</li><li>comprehensive knowledge of technical skills, principles, practices, and procedures of testing methodologies and working knowledge in planning, designing, and conducting QA reviews and inspections.&nbsp;</li><li>He/She provides expertise for key business functions and supporting technologies.&nbsp;</li><li>Provides mentorship and expertise in technologies and processes for Information Services Management (ISM) and Quality Assurance (QA).&nbsp;</li><li>He/She maintains an awareness of emerging technologies to ensure a competitive advantage.</li><li>Experience with both web and client/server based testing</li><li>Minimum 8 Years of Relevant Experience in IT Test Automation.</li><li>Should have strong Mainframe testing [CICS, JCL, DB2, Cobol]</li><li>Must be able to test and debug batch jobs (JCL).</li><li>Must be able to perform backend testing by executing SQL queries.</li><li>Expertise in APIs &amp; Web Services testing</li><li>Hands-on experience in Selenium, TestNG and Cucumber frameworks</li><li>Good in test execution reporting skills</li><li>Expertise in Test Cases Design and Test Data management</li><li>Expertise in tools like PostMan, SOAP UI, WinSCP, Oracle, Jenkins, GitHub and AppDynamics.</li><li>Should be well versed with Agile testing and Continuous Testing</li><li>Experience with Test Management tools</li><li>Knowledge on AZURE DEVOPS&nbsp;</li><li>Understanding of SAFe Agile methodologies</li><li>Should be solution-oriented and have problem solving aptitude</li><li>Should have excellent communication and presentation skills</li><li>Knowledge on Logistics domain will be an advantage</li><li>Good to have Performance Testing experience.</li><li>Knowledge on JMeter / Performance center will be an advantage.</li><li>Any certifications in test automation</li></ul>

Responsibilities: <ul><li>Assist and monitor employees in job performance, answer questions, maintain action log, and provide input to Area Lead on employee’s job performance.</li><li>Maintain production schedules by ensuring that each line is set-up per the prescribed line layout, has proper equipment, fixturing, tools, proper prints, in-process inspection sheets, and work instructions at the beginning of each shift, after line changeover, and during the shift.</li><li>Ensure proper clean up.</li><li>Ensure proper operation and guarding of equipment, report any unsafe equipment and/or unsafe acts.</li><li>Set good examples for quality, attendance, confidentiality, professionalism and display a positive attitude.</li><li>Consistently apply the Quality System procedures and enforce company policies and safety regulations.</li><li>Complete all documentation as required by department work instructions.</li><li>Ensure all suspect or reject material is quarantined and handled per Quality System procedures.</li><li>Make decisions and accept responsibility on operations related to assigned lines.</li><li>Assist in performing and evaluating 1st piece inspections for products as directed.</li><li>Post quantity goals and turn goal results in to Area Lead</li><li>Promote teamwork within the Production Line</li><li>Work closely with production control to react to schedule changes.</li><li>Communicate all appropriate issues to Area Lead.</li><li>Ensures production paper work is processed in a timely and accurate manner.&nbsp;&nbsp;</li><li>Perform other related duties and assignments as required.</li></ul> Requirements: <ul><li>High School diploma or GED</li><li>Evidence of continued education &amp; training</li><li>1-2 years experience in production</li><li>Knowledge of personal computer</li><li>Ability to read and interpret blue prints</li><li>Attention to detail</li><li>Ability to work with MRP systems</li><li>Excellent communication and interpersonal skills.</li><li>Proven ability to motivate and lead operaotr to meet production goals.</li><li>Basic computer and math skills.</li><li>Thorough knowledge and understanding of production procedures. Ability to perform all jobs in production line</li></ul>

Responsibilities:&nbsp; <ul><li>Agrees on performance expectations with the commercial team and works with GM/Unit staff to deliver against these expectations&nbsp;</li><li>Approves (w/GM consent) specialty orders, uplifts, and responsible for invoice accuracy and timelines.&nbsp;</li><li>Works closely with the production team in order to maintain a continuous knowledge of current specifications and customer expectations through routine audits.&nbsp;&nbsp;</li><li>Ensures supply chain/purchasing has current up to date data and support purchasing requirements.&nbsp;</li><li>Ensures that all processes and procedures related to specific flights are completed, quality standards are met, and additional revenue opportunities documented on invoice.&nbsp;&nbsp;</li><li>Communicates the customer goals and represents the customer interests to the local GGI team.&nbsp;&nbsp;</li><li>Strong understanding of unit capabilities and services, and effectively communicates all offerings to the client w/GM approval.&nbsp;&nbsp;</li><li>Reports to the GM and or Account Director, providing regular input on all account activity, including service status and call reports on a weekly basis.&nbsp;&nbsp;</li><li>Provides coordination between customer and GGI on special events such as Menu Presentation (scheduling, transportation, security, specs available, tent cards, tasting equipment, unit tours, beverages, etc.).&nbsp;</li><li>Owner of T-minus schedule to facilitate changes and bringing all departments together for success.&nbsp;</li><li>Maintains a professional appearance at all times. Treats the customer with dignity and respect.&nbsp;</li></ul>&nbsp;Internal &amp; External Communication:&nbsp; <ul><li>Daily reconciliation of delays and communications need activities as required.&nbsp;</li><li>Communicates daily to the GG operations team of any spec changes, performance issues, call backs, inspections, etc from previous day. Drives root cause analysis.&nbsp;&nbsp;</li><li>Weekly recaps of delays vs. targets, FAC’s, and Update with customer on weekly basis and local station management. SR (Shared Responsibility)&nbsp;</li><li>Ensures that customer issues are dealt with in an efficient manner, informing the General Manager and Commercial leader (PAM. Local Director) of any problems that may arise.&nbsp;&nbsp;</li><li>Weekly inventory status checks. SR&nbsp;&nbsp;</li><li>Provides regular two-way communication between the client and local GGI, to provide strong team representation and set proper client expectations.&nbsp;&nbsp;</li></ul>&nbsp;Inventory Management: <ul><li>Ensures customer inventory sheet to be current and up to date par levels.&nbsp;</li><li>Manages inventory process taken accurately and on time. Results reviewed before submission to the customer. Communicate to the customer when par levels need to change. SR&nbsp;</li><li>Provides customer feedback to help customer reduce costs through inventory management.&nbsp;</li><li>Warehouse space, issue here is to not be a warehouse for obsolete or excessive inventory. SR&nbsp;</li><li>Ensures that Customs requirements, GGI Bonded policy and local Agriculture (compliance agreement) are implemented. SR&nbsp;</li></ul>&nbsp;Quality: <ul><li>Assists internal department on quality/compliance through weekly specification checks and audits (chef tables, packing diagrams, CCP’s, VSIE process, safety).&nbsp;&nbsp;</li><li>Compares FACs against goals.&nbsp;&nbsp;</li><li>Ownership of CSI and drives the process as outlined in GG policy and procedures.&nbsp;</li></ul>&nbsp;Cost Management: <ul><li>Conducts weekly documented billing checks to ensure items billed.&nbsp;</li><li>Reviews monthly service order to ensure all service items captured and aligned with CXP and Sales force.&nbsp;</li></ul>&nbsp;Targets: <ul><li>Manages to a customer-specific set of KPI’s – reports on this performance to the commercial team, agrees performance targets to these KPI’s (e.g., delays, complaints, audit results) with Commercial VP and GM&nbsp;</li><li>Annual (or quarterly) customer feedback survey on each aspect of the role – communication, inventory management, Quality cost management/invoice accuracy, and customer service orientation (does the customer view this role as representing their interests in the unit) SR&nbsp;</li></ul>&nbsp;Requirements: Education:&nbsp; <ul><li>High School Diploma or GED required&nbsp;&nbsp;</li><li>Associates degree or degree from a 4 year university or college is preferred&nbsp;</li></ul>&nbsp;Work Experience:&nbsp; <ul><li>Proven Account Management skills required in order to create, maintain, and enhance customer relationships&nbsp;&nbsp;</li><li>Minimum of 3 years of account/project management experience.&nbsp;&nbsp;</li></ul>&nbsp;Technical Skills: (Certification, Licenses and Registration)&nbsp; <ul><li>Extremely detail oriented&nbsp;&nbsp;</li><li>Technical and analytical competence (understands software, hardware, networks, etc.)&nbsp;</li><li>Motivated, goal oriented, and persistent&nbsp;&nbsp;</li><li>High level of initiative and works well in a fast paced, team environment&nbsp;</li><li>Handles stressful situations and deadline pressures well&nbsp;&nbsp;</li><li>Plans and carries out responsibilities with minimal direction&nbsp;&nbsp;</li><li>Full knowledge of any customer specific requirements in Service Agreement and delivers as listed below:&nbsp;</li><li>Delta Airlines: Full knowledge of IFX system; Owner of change notice distribution list; understands the unit performance grading system; ensures the AC Damage reporting process is followed; full knowledge of Delta build tool.&nbsp;&nbsp;</li><li>United Airlines: Full knowledge of Unimatic (aircraft operation); Full knowledge of IBSOPS (meal board location); Ensures PSS (passenger counts) is used for forecasting; Ensures AirServ/AirVision is used for flight finalization; Ensures Sky Net is used for packaging/general requirements; Full knowledge on the use of Igaps (real flight info)&nbsp;</li><li>American Airlines: Understands AA evaluation and evaluation definitions; Full knowledge of AMOS &amp; Sabre systems; Ensures food/equipment inventories in AirVision; Ensures equipment distribution is updated in AirVision; Ensures monthly IUR is documented in AirVision; understands the PMP process.&nbsp;&nbsp;</li><li>British Airlines: Knowledgeble/Ensures BA IFX tools are used in operation; Maintains chronological telex and bulletin information; Analysis TCS and BBSC sheets for BA performance; Full knowledge of AirServe and train staff on the use; Owner of TP006 accuracy for each scheduled change&nbsp;</li><li>Virgin Airlines: Take weekly photos of menu items and submit them to Virgin; Monthly review of TP006 and distribute the flight information; Must have full knowledge of Skylogistix; Must have full working knowledge of AirServ.&nbsp;&nbsp;</li></ul>&nbsp;Language / Communication Skills:&nbsp; <ul><li>Excellent written and oral communication skills&nbsp;&nbsp;</li><li>Bilingual is a plus.&nbsp;&nbsp;</li></ul>

Responsibilities:Primary responsibilities of this role include the following:With Supervision, review documents/records and provide batch release authorization to 3PL service provider for products manufactured outside of the US.Support Drug Product Complaint management; forwarding to respective drug product manufacturing site and coordinate with corporate QA for investigations.Support Drug Product Recall/Field alert management.Assist with review of Quality Agreements.For applicable products, coordinate with Contract Testing Laboratories for Analytical Method Transfer activities, Drug Product testing, any OOS results, and test method issues.With supervision, review deviations/investigations related to the company's frontend products.Assist with SOP management for the company’s US corporate office.Support with quality matters for disposition of product returns.Assist during FDA inspections and local regulatory inspections at the company’s US corporate office.Requirements:Excellent verbal and written communication skills are necessary.With supervision and direction, effectively prioritizes competing tasks in a fast-paced and dynamic environment.Motivated, results driven with attention to detail, accuracy and clarity.Qualifications: BS degree in Pharmacy, Chemistry, Biology or Microbiology is preferred. 1-2 years of Quality Assurance or related pharmaceutical industry experience is preferred.Recent graduates will be considered for this role. 

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8 inspections Jobs found

EHS Analyst

DEA Manager

Manufacturing Team Leader

Facility Mechanic

QA Tester

Manufacturing Line Leader

Customer Account Manager

Quality Assurance Associate

WhiteCrow
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8 inspections Jobs found

EHS Analyst

DEA Manager

Manufacturing Team Leader

Facility Mechanic

QA Tester

Manufacturing Line Leader

Customer Account Manager

Quality Assurance Associate

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

EMPLOYER

TALENT

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