Quality assurance manager jobs in Allentown, PA - 114 jobs

Quality Assurance Operations Supervisor Essential Duties and Responsibilities Overall responsibility for coordinating the disposition of API and drug product Coordinates batch documentation review with Operations groups to ensure GMP compliance and timely delivery of products to customers Ensures all documentation and API/drug product batches produced meet the requirements of GMPs and other regulatory health authority requirements Supervises day-to-day functions of the QA Operations team Mentors/coaches and provides succession planning for direct reports Ensures batches meet GMP requirements and all production and QC documentation has been reviewed prior to disposition If any errors or data integrity issues occur during the manufacturing, packaging, labelling, and testing of API/drug product, that they have been investigated according to internal procedures. Ensures QC data meets specifications and any OOSs are investigated per internal procedures Provides QA presence on API/drug product filling/packaging line through documented walkthroughs to ensure GMP compliance Works with global partners in EU/UK QA to ensure batches are dispositioned and records provided in a timely manner Manages drug product complaint program ensuring samples are received in a timely fashion and investigations meet established internal procedural requirements and reports back to customer service team through approved software programs Prepares metrics for weekly, monthly and quarterly Management meetings Key Competencies (knowledge, skills, and abilities every person must possess to be successful), i.e. Critical Thinking skills using “Risk Based” logic and reasoning to identify the strengths and weaknesses in QMS, recommend and institute solutions, conclusions, and approaches to problems Demonstrated ability to evaluate quality matters by leveraging GMP experience, analyzing data, while using FDA Risk Based type approaches Attention to detail/ sense of urgency- ability to act quickly and escalate issues Excellent customer service skills and professional demeanor always to interface effectively with all internal and external customers Excellent verbal and written communication skills Energetic, enthusiastic, and motivational disposition Education/Experience Bachelor's degree required with Bachelor of Science preferred 5+ years' experience in Pharmaceutical/Biotech industry Experience in TrackWise, EDMS, LMS or other such software tools for managing the QMS Working knowledge of 21 CFR part 210/211, and part 11, FDA guidance. Knowledge of 21 CFR part 820 Medical Device Regulations preferred.

Bethlehem, PA $60,000-$70,000 base + bonus No C2C | No Sponsorship | No Relocation Assistance A growing pharmaceutical manufacturing site has a full-time opportunity for a Quality Assurance Compliance Specialist to join a friendly, collaborative QA team. Job Summary: Support GMP operations with a strong focus on batch record review, documentation control, and product release activities. This is a hands-on QA role in a regulated manufacturing environment with strong visibility and growth potential. Key Responsibilities Review manufacturing and packaging batch records (paper & electronic) for product release Review laboratory data and generate Certificates of Analysis (C of A) Release product in SAP and generate quality reports as needed Support documentation control, archiving, and QA record management Review calibration records and support quality systems compliance Assist with deviations, investigations, APRs, CRNs, BOMs, and MBR updates Support internal and regulatory audits (FDA and other agencies) Support packaging line inspections as needed Train new QA team members and provide cross-coverage within QA Assist with new product launches and special QA projects Qualifications Bachelor's degree in a science or technical field (Chemistry preferred) or equivalent experience 5+ years of experience in a regulated industry (pharmaceutical or medical device) Strong knowledge of FDA regulations, GMPs, GDPs, and GLPs Experience in manufacturing and/or packaging environments Familiarity with quality systems and documentation control Microsoft Office proficiency; SAP, TrackWise, and EDMS experience a plus Strong communication, problem-solving, and critical-thinking skills

Remote: No About the Job Arencibia is the leading provider of gas monitoring, analytics, and recovery solutions. We help the world's largest manufacturers in metals, aerospace, automotive, semiconductors, and other industries transform the economics, reliability, and predictability of their gas supply chain while delivering significant environmental benefits. We own and operate industrial gas recovery systems and our proprietary Monitoring, Analytics, and Recovery Service (MARS) to reduce gas supply costs, increase predictability, and provide unprecedented insight into manufacturing operations. Arencibia's operating and maintenance function is based in Quakertown, PA. As an R&D Manager Semiconductor Systems, you will lead and support research and development activities focused on semiconductor related gas systems, testing platforms, and advanced process gas technologies. This role combines hands on technical leadership with strategic planning, experimental design, and resource management to enable effective semiconductor focused testing and development. You will work closely with internal R&D, Process Engineering, and Controls teams to design experiments, evaluate equipment and systems, and mature new technologies from concept through validated performance. Responsibilities Include: Lead semiconductor focused R&D initiatives related to process gas delivery, gas monitoring, purification, and scrubbing technologies. Support the design, build, and operation of laboratory and pilot scale test systems for semiconductor gas applications. Define experimental objectives, test plans, and validation strategies for semiconductor related testing activities. Manage laboratory resources, equipment utilization, and testing schedules to ensure efficient execution of R&D programs. Collaborate with internal R&D and Process Engineering teams to evaluate equipment specifications, system designs, and performance data. Support technical evaluations of process equipment, including gas analyzers, flow meters, compressors, pumps, valves, purification modules, and associated instrumentation. Coordinate with equipment vendors to review technical documentation, evaluate system capabilities, and support equipment selection and integration. Maintain clear, accurate, and well organized technical documentation, including test protocols, experimental results, specifications, and design records. Participate in technical reviews, root cause analyses, and data driven decision making to guide development priorities. Travel to customer or vendor sites as needed for testing support, equipment evaluation, or technical coordination. Occasionally lift and or move up to 40 pounds. Strong Candidates Will Have: PhD, Master's, or Bachelor's degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, or a related technical discipline. More than five years of experience in the semiconductor industry, with hands on involvement in process gas systems, gas scrubbing, gas monitoring, or related technologies. Strong understanding of semiconductor process gas requirements, contamination control, and system reliability considerations. Experience designing and executing laboratory or pilot scale experiments for gas or semiconductor related systems. Ability to interpret and evaluate P&IDs, process flow diagrams, equipment specifications, and technical drawings. Demonstrated ability to manage technical resources, testing priorities, and complex development activities. Strong analytical skills with the ability to interpret experimental data and translate results into actionable insights. Excellent written and verbal communication skills, with the ability to clearly document and present technical information. Detail oriented and structured approach to experimental design, documentation, and process improvement. Experience with cryogenic systems, inert gas handling, or high purity gas applications is a plus. Benefits: 401(k) Dental insurance Health insurance Paid time off Vision insurance

Title: Inventory Quality Specialist About Midea Midea Group is one of the world's largest home appliance brand, offering the most comprehensive selection of products in the world to fully serve the needs of day-to-day living at home, at work, or anywhere else you go. We strive to aim high, put the customer first, transform and innovate the marketplace, utilizing our commitment, dedication, inclusion and partnership with our teams. Midea is a global company operations in more than 195 countries. As a publicly listed company, we are also ranked #245 as a Fortune Global 500 company and offers one of the most comprehensive ranges in the home appliance industry. Midea America is a subsidiary of Midea Group in the US. Job Summary Midea America is seeking a highly organized, detail-oriented Warehouse Inventory Controller to support inventory accuracy, quality, and control within our regional distribution center in Pennsylvania. This role is critical to ensuring system integrity, physical inventory accuracy, and compliance with customer, financial, and operational requirements. The Inventory Controller owns inventory governance across the DC-overseeing audits, discrepancy resolution, rework and returns, aged inventory management, and WMS execution. This role partners closely with Warehouse Operations, Finance, Quality, Reverse Logistics, Compliance, and third-party logistics providers (3PLs) to ensure inventory accuracy, accountability, and continuous improvement. Essential Job Responsibilities Inventory Accuracy & Control Lead and oversee physical inventories and cycle counts; plan, schedule, and execute mid-year and year-end inventory audits. Investigate, reconcile, and resolve inventory discrepancies (shorts, overages, damages, loss) in a timely and accurate manner. Ensure all inventory adjustments are supported by root cause analysis and properly executed in the WMS. Monitor shrink-related incidents (damaged product, dropped pallets, losses) and ensure real-time system updates while holding 3PLs accountable per contractual terms. Review and correct inventory imbalances using systematic in-house transfers. Quality, Compliance & Rework Oversee isolation and disposition of returned, recalled, quarantined, and rework inventory. Direct warehouse staff on corrective actions leading to final stock resolution (A-Stock, liquidation, scrap). Conduct inventory quality audits, including inventory accuracy, damaged product segregation, and outbound quality standards (pallet integrity, overhang, wrapping, strapping, and load securement). Partner with Midea Compliance and customer portals to reduce chargebacks and compliance penalties. Ensure DC teams follow SOPs for receiving discrepancies, shortages, and damage documentation. WMS & Master Data Management Ensure proper WMS execution to maintain inventory accuracy and visibility. Manage item master attributes including TI-HI, stack height, pallet configuration, inventory grade, and demand type. Recommend optimal placement strategies for seasonal, e-commerce, rework, and quarantined inventory. Generate and manage RMAs to support reverse logistics and systematic receiving processes. Operational Support & Reporting Respond promptly to inventory-related inquiries from Operations, Order Management, Sales, Procurement, Quality, Reverse Logistics, Finance, and Senior Leadership. Monitor and report on inventory turns, aged inventory, seasonal readiness, and high-velocity e-commerce SKUs. Communicate rework timelines, costs, and quality issues to Finance and cross-functional stakeholders. Monitor productivity of quality and rework labor to ensure value-added work is completed on time and within budget. Safety & Supply Management Communicate and enforce all safety policies; conduct self-audits to ensure compliance. Maintain warehouse supply inventory (pallets, stretch wrap, labels, etc.) and track usage levels. Required Qualifications Bachelor's degree in Logistics, Supply Chain Management, or a related field (required). Minimum of 5 years of experience in a warehouse or distribution environment (preferred). At least 5 years of supervisory or lead-level experience (preferred). Strong working knowledge of Warehouse Management Systems (WMS); YMS experience preferred. Advanced proficiency in Microsoft Excel; strong skills in PowerPoint and Word. Excellent written and verbal communication skills with the ability to collaborate cross-functionally. Strong planning, organization, and problem-solving capabilities. Ability to operate effectively under pressure in a fast-paced, changing environment. Customer-focused mindset with a high level of ownership and accountability. Ability to spend extended periods on the warehouse floor while adhering to all safety requirements. Must be authorized to work in the United States. Featured benefits Insurance package. 401(k). Work life balance. Comprehensive benefit package, to learn more, please visit Careers Page (midea.com) Midea America Corp. is an equal opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics

Primary Duties & Responsibilities Lead SiC LLC Quality Function Build strong organization quality talent in SiC LLC plants. Actively engage in resolving customer quality issues and prepare for customer audits. Drive total customer satisfaction. Coach the plants towards a culture of prevention. Establish strategic quality direction within the plants. Teach advanced Quality classes at the plants. Establish a culture of intelligent risk-taking and guide the plants in choices to help exploit strategic opportunities. Lead in strategic decision-making, and in tactical decision making within important risk-saturated areas. Ensure Quality systems are aligned with identified best-practices. Lead and manage the quality functions at SiC LLC plants. Design and lead production of various dashboards accurately depicting quality product and process status in all plants. Create and Maintain QMS Alignment with the Coherent Global Quality System Ensure Quality Manual aligns with Coherent Corporate Global Quality manual. Establish and maintain a process for “Preventive Action Efficiency” to drive mistake-proofing in the factories. Implement and maintain Coherent Global COQ process. Implement and maintain coherent Global KPI process. Implement and maintain Coherent Global QBR. Implement and maintain Coherent Global Risk Assessment process. Implement and maintain the Coherent Global QAT-based assessment QMS effectiveness. Implement and maintain Coherent Global Purge process. Implement and maintain Coherent Global Quality Stop process. Implement and maintain Coherent Global NPI process. Implement and maintain Coherent Global PCN process. Lead the Development and Implementation of IAFT 16949 QMS Conceive, design, develop, implement, and continually improve an IATF 16949 certified QMS. Lead efforts to identify, develop, proceduralize, and implement best quality AIAG practices in all SiC LLC plants. Guide best practice design and deployment of processes for PPAP, SPC, MSA, APQP, and FMEA. Implement Coherent Corporate Global internal quality audit process to ensure continual compliance and improvement of the automotive QMS. Design and implement periodic Management Review processes to drive continual improvements. Implement the Coherent Corporate Global 8D corrective action database and ensure its optimum usage. Develop and maintain a Quality Manual. Implement and maintain key complimentary processes within SiC LLC Export compliance is maintained. Ensure implementation and maintenance of Coherent Lean process. Implement and maintain necessary ESD processes. Implement and maintain necessary ESG processes. A quality work environment consistent with 6S practices is maintained. Assure regulatory compliance in product-related areas such as RoHS, REACH, and Conflict Minerals. Education & Experience M.S. in technical field, preferably Statistics, Mathematics, or Industrial Engineering. Extensive experience with Quality Sciences and Quality Management. 20 years Quality Engineering, Quality Management, or Quality Consulting. 15 years of experience electronics or semiconductor manufacturing. 20 years of experience in internal quality audit. 10 years of experience managing tier-1 or tier-2 customer audits. 10 years of experience in using structured techniques to solve complex problems. Awareness of PPAP, FMEA, MSA, Control Plan, and SPC techniques. Awareness of lean manufacturing techniques. Due to ITAR compliance, this position requires candidates to be a U.S. Citizen, Permanent Resident Alien, or Protected Individual per 8 U.S.C. 1324b(a)(3). Skills & Other Requirements Expert Knowledge of the ISO 9001 criteria. Awareness and understanding of the IATF 16949 criteria. Process characterization and control techniques. Able to balance financial and quality objectives. Statistical expertise including FMEA, SPC, DOE, MSA, Process Capability. Able to understand AIAG process control plans. Able to facilitate cross-functional Kaizen Events. Solve complex problems using intuition, induction, deduction, analysis of data, and advanced quality tools, and structured problem-solving methods. Effectively work in cultures throughout North America, Europe, and Asia. Able to think critically and to reengineer all elements of an Automotive Quality System to remove waste of time and dollars, while increasing Quality performance. Willing to take intelligent risks to gain opportunities for quality innovation. Excellent interpersonal, communication and presentation skills and ability to comprehend and communicate at a high level with executives, senior managers, and global customers, suppliers, and principals at different sites. Able to relate well and work collaboratively with all levels within a site, from senior leaders to production operators. Ability to deal effectively with differences of opinion, to influence, to draw ideas from others, and to negotiate and mediate. Ability to anticipate and handle multiple priorities and complex/abstract issues involving external and internal priorities. Ability to excel in a cross-organizational, cross-cultural, global team environment and to easily adjust in the face of challenge and change. Handle special assignments promptly and professionally. Maintain a high standard of ethics, professionalism, leadership, and competency. Proven ability to lead and motivate people. Demonstrates and promotes the Coherent ICARE Worldwide Values. Knowledgeable in worldwide ESG norms. Working Conditions Office Environment Manufacturing Plant Environment, on occasion Physical Requirements Ability to work at computer Safety Requirements All employees are required to attend scheduled training, follow the site EHS procedures and Coherent Corporate EHS standards. This includes the use of proper protective equipment (PPE) as required by the job responsibilities. Managers will ensure that all safety and environmental procedures are followed consistently. They will ensure that risk assessments are performed, proper training, work instructions, required PPE is available, and will monitor compliance. Quality & Environmental Responsibilities Depending on location, this position may be responsible for the execution and maintenance of the ISO 9000, 9001, 14001 and/or other applicable standards that may apply to the relevant roles and responsibilities within the Quality Management System and Environmental Management System. Culture Commitment Ensure adherence to company's values (ICARE) in all aspects of your position at Coherent: Integrity - Create an Environment of Trust Collaboration - Innovate Through the Sharing of Ideas Accountability - Own the Process and the Outcome Respect - Recognize the Value in Everyone Enthusiasm - Find a Sense of Purpose in Work

The Senior Manager of QA leads one or more QA teams supporting designated functional areas of Packaging Operations or Central functions (i.e., Facilities, Warehouse, Project and Account Management, Engineering, IT, Incoming Inspection and Documentation) in a contract pharmaceutical packaging facility. The position provides quality oversight, regulatory and cGMP guidance to designated areas within Sharp US Commercial Sites. Responsibilities include, but are not limited to, supervision of quality related activities, troubleshooting quality related issues, making quality decisions regarding issue resolution, and driving continuous quality improvements. This position is responsible for ongoing contact with customer QA representatives regarding quality non-conformances, investigations, change controls, CAPAs, documents, quality metrics, customer quarterly business reviews, audits and audit follow-up related to their designated functional areas. This position is responsible to assist the Sharp audit team and help prepare area owners to lead discussions and tours relevant to their designated areas during customer and/or regulatory agency inspections and work with internal partners to lead and/or drive subsequent actions. The Senior Manager Quality is responsible to ensure both internal and external customers receive the appropriate level of quality support and will serve as the second level of escalation for customer issues or concerns. The scope of the position includes Allentown, Macungie and/or Conshohocken. The impact of decisions relating to customer interface, quality issues and documentation requirements could expose the company to significant risk or economic loss. ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of minimum responsibilities related to the Senior Manager QA position. Other duties may also be assigned. Leads one or more QA teams associated with designated functional areas of Packaging Operations or Central functions (i.e., Facilities, Engineering, Warehouse, Packaging Services, Incoming Inspection, Documentation, etc.) Responsible for ensuring products and processes meet customer, company and regulatory requirements/standards and participating in internal, regulatory and customer audits as required. Responsible for delivering internal and customer quality KPIs and standards for assigned areas. Responsible for leading and coaching teams through problem-solving initiatives and impact assessments associated with change management and non-conformances as well as the review and approval of quality related documentation. Serve as an escalation point for customers and serve as backup for the site Quality lead during absences. Summarize data, draw conclusions, and turn recommendations into clear actions which can be effectively communicated across all levels of the organization. Identify and lead implementation of continuous improvement opportunities of broader impact (i.e., site or division level). Support designated area to ensure compliance to processes and products and ensure testing, inspection and monitoring programs meet all requirements. Responsible for implementation of initiatives related to quality systems gap resolutions as well as quality improvements. Responsible for contributing to and driving attainment of the short- and long-term quality strategy by understanding the future needs, relative to the required skills and resources needed, to successfully support the business. Responsible to work across the broader quality organization to meet future needs through succession planning, training, development and mentoring of personnel. Responsible to effectively communicate a variety of personnel actions, including but not limited to, employment, termination, performance, discipline, scheduling, and salary review. Performs other related duties as required. by management. QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. SUPERVISORY RESPONSIBILITIES: Direct supervision of quality managers and professionals at the local site. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE: Bachelor's degree in science is preferred with seven to ten years of related experience or Associate's degree with ten to fifteen years of related experience or a minimum of fifteen years of related experience. Knowledge of current FDA regulations and current industry practice Thorough knowledge of quality and/or operations required. Knowledge of DEA regulations desired. Broad knowledge of current pharmaceutical industry including packaging practices Above average written and oral communication skills required. Above average organizational and planning skills required. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions. Approximately 5-10 percent auto travel between sites. Travel to customers on an as needed basis. DISCLAIMER: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Quality Assurance Job Category: People Leader All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: Johnson & Johnson is currently recruiting for Director of Sterility Assurance! This position will be located in Raritan, NJ. Position Summary: The Director of Sterility Assurance is a leadership role responsible for overseeing all microbiological and virological control aspects of cell and gene therapy product manufacturing at the Raritan facility. This role ensures the safety, quality, and compliance of our products and processes through the development, implementation, and management of robust testing programs, risk assessments, and quality systems. The Director will provide technical expertise and strategic direction in microbiology and virology. The candidate will consult with JNJ manufacturing facilities, Global and Site Quality and Global Sterility Assurance and other functions to educate on the Sterility Assurance program requirements and proactively ensure compliance of the JNJ Sterility Assurance program with various country agency standards, industry trends and scientific principles. Key Responsibilities: Raritan Site Quality Management Responsibilities (80%) Develop, and maintain oversight of comprehensive microbiology and virology programs, including environmental monitoring, incoming material testing, in-process testing, lot release testing, and stability testing. Serves as primary point of contact and decision maker for internal policies, procedures, and strategy documents governing Sterility Assurance and Contamination Control related topics. Support in knowledge advancement beyond the Quality organization to build, maintain, and develop capabilities across the JNJ network for the Sterility Assurance space. Development of knowledge-based programs to advance company education and training programs. Provide mentoring leadership to stakeholder SMEs to build capability for new and existing sites or where gaps in technical expertise have been identified. Sponsor and oversee activities focused on driving process improvements and harmonization projects across the JNJ network for Sterility Assurance and Contamination Control. Serve as the SME leadership role for topics associated with Sterility Assurance and Contamination Control across the network, representing on network teams and other appropriate governance forums. Provide technical support to during new process design and facility change activities to ensure Sterility Assurance programs and product requirements are supported at the sites. Engage in providing support during regulatory submissions and on-site inspections. Define and execute the process for managing observations and commitments related to Sterility Assurance for the Raritan. Accountable for transformation of sterility assurance global standards across Engineering, MSAT and Quality and ensuring that they are in use across all sites. Set vision for the future to proactively meet regulatory expectations. Accountable for program management for execution / implementation to global standards Deliver Annex 1 compliance through standardized global policies. Implement KPI dashboards for contamination control. Define clear project and governance frameworks to clarify roles and responsibilities between global and local teams. Drive continuous improvement and proactive inspection readiness with storyboard creation and coaching/mentoring. Lead the uplift in capability building and leadership development across functions. External network/advocacy with industry forums and regulators to keep pace with evolving regulatory expectations and emerging technology. Leadership Team Responsibilities (20%) Sets and manages targets and objectives for the Raritan site ensuring alignment with overall company strategy. Drives the achievement of annual goals, guided by Our Credo and leadership principles. Builds and sustains strong relationships with internal and external stakeholders, including Global Quality teams, Manufacturing, Quality Control, Facilities and Engineering, and partners. Coordinates quality-related activities across departments, sites, and organizations to proactively support and optimize business processes. Ensure the Sterility Assurance department has a clear organizational structure, with robust formation and succession plans to support long-term stability. Provides leadership to build a high-performing, collaborative team through hiring, mentoring, and talent development. Champions a culture of quality compliance, diversity, inclusion, and continuous improvement. Manages professionals within the Quality team, fostering ongoing talent development and succession planning. Collaborates with the VP, IMSC Quality, and other site Quality Heads as part of the Advanced Therapies Quality Leadership Team (ATQLT) to ensure harmonization and standardization across sites. Partners with cross-functional leaders to support continuous improvement and lifecycle management of GMP policies and the QMS. Represents Raritan in the planning, development, and execution of corporate Quality initiatives. Establishes effective partnerships across business units, sites, and functions to ensure integrated and efficient business processes. Qualifications: Education: A minimum of a Bachelors or equivalent University degree is required with a focus in pharmacy, engineering, chemistry, microbiology or related scientific / engineering discipline preferred. Masters or advanced degree preferred. Required: Minimum of 10 years of Quality Assurance / Quality Systems experience related to manufacturing Comprehensive knowledge of vaccines, biological manufacturing and related Quality management processes and systems Proven people management and Quality leadership experience Strong people leadership skills and a proven track record in attracting, developing and retaining talent in the organization Comprehensive regulatory cGMP and technical knowledge to develop sterility assurance strategies necessary to maintain the desired level of inspection readiness Experience hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory reviewers Experience with implementing and overseeing cGMP operations in a commercial manufacturing facility Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control teams Extensive knowledge of chemical, biochemical and microbiological concepts Knowledge of cGMP regulations and FDA/EU guidance Fluent in English (written and spoken) Preferred: Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is highly preferred Strategic thinking with the ability to manage/master complexity and to act as a sponsor for change Ability to prioritize and guide the organization in coping with the demands of a rapidly changing environment Ability to apply appropriate risk assessment strategies to manage business & compliance priorities Effective negotiation and influencing skills and lead with a mindset of continuous improvement Balanced decision-making skills and ability to effectively resolve conflict, when needed Business acumen; develop and control budgets Ability to communicate effectively with different levels in the organization and with health authorities Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource Required Skills: Preferred Skills: Aseptic Processing, Clean Room Manufacturing, Contamination Control, Risk Assessments The anticipated base pay range for this position is : $150,000.00 - $258,750.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Quality Assurance Job Category: People Leader All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: Johnson & Johnson is currently recruiting for Director of Sterility Assurance! This position will be located in Raritan, NJ. Position Summary: The Director of Sterility Assurance is a leadership role responsible for overseeing all microbiological and virological control aspects of cell and gene therapy product manufacturing at the Raritan facility. This role ensures the safety, quality, and compliance of our products and processes through the development, implementation, and management of robust testing programs, risk assessments, and quality systems. The Director will provide technical expertise and strategic direction in microbiology and virology. The candidate will consult with JNJ manufacturing facilities, Global and Site Quality and Global Sterility Assurance and other functions to educate on the Sterility Assurance program requirements and proactively ensure compliance of the JNJ Sterility Assurance program with various country agency standards, industry trends and scientific principles. Key Responsibilities: Raritan Site Quality Management Responsibilities (80%) Develop, and maintain oversight of comprehensive microbiology and virology programs, including environmental monitoring, incoming material testing, in-process testing, lot release testing, and stability testing. Serves as primary point of contact and decision maker for internal policies, procedures, and strategy documents governing Sterility Assurance and Contamination Control related topics. Support in knowledge advancement beyond the Quality organization to build, maintain, and develop capabilities across the JNJ network for the Sterility Assurance space. Development of knowledge-based programs to advance company education and training programs. Provide mentoring leadership to stakeholder SMEs to build capability for new and existing sites or where gaps in technical expertise have been identified. Sponsor and oversee activities focused on driving process improvements and harmonization projects across the JNJ network for Sterility Assurance and Contamination Control. Serve as the SME leadership role for topics associated with Sterility Assurance and Contamination Control across the network, representing on network teams and other appropriate governance forums. Provide technical support to during new process design and facility change activities to ensure Sterility Assurance programs and product requirements are supported at the sites. Engage in providing support during regulatory submissions and on-site inspections. Define and execute the process for managing observations and commitments related to Sterility Assurance for the Raritan. Accountable for transformation of sterility assurance global standards across Engineering, MSAT and Quality and ensuring that they are in use across all sites. Set vision for the future to proactively meet regulatory expectations. Accountable for program management for execution / implementation to global standards Deliver Annex 1 compliance through standardized global policies. Implement KPI dashboards for contamination control. Define clear project and governance frameworks to clarify roles and responsibilities between global and local teams. Drive continuous improvement and proactive inspection readiness with storyboard creation and coaching/mentoring. Lead the uplift in capability building and leadership development across functions. External network/advocacy with industry forums and regulators to keep pace with evolving regulatory expectations and emerging technology. Leadership Team Responsibilities (20%) Sets and manages targets and objectives for the Raritan site ensuring alignment with overall company strategy. Drives the achievement of annual goals, guided by Our Credo and leadership principles. Builds and sustains strong relationships with internal and external stakeholders, including Global Quality teams, Manufacturing, Quality Control, Facilities and Engineering, and partners. Coordinates quality-related activities across departments, sites, and organizations to proactively support and optimize business processes. Ensure the Sterility Assurance department has a clear organizational structure, with robust formation and succession plans to support long-term stability. Provides leadership to build a high-performing, collaborative team through hiring, mentoring, and talent development. Champions a culture of quality compliance, diversity, inclusion, and continuous improvement. Manages professionals within the Quality team, fostering ongoing talent development and succession planning. Collaborates with the VP, IMSC Quality, and other site Quality Heads as part of the Advanced Therapies Quality Leadership Team (ATQLT) to ensure harmonization and standardization across sites. Partners with cross-functional leaders to support continuous improvement and lifecycle management of GMP policies and the QMS. Represents Raritan in the planning, development, and execution of corporate Quality initiatives. Establishes effective partnerships across business units, sites, and functions to ensure integrated and efficient business processes. Qualifications: Education: A minimum of a Bachelors or equivalent University degree is required with a focus in pharmacy, engineering, chemistry, microbiology or related scientific / engineering discipline preferred. Masters or advanced degree preferred. Required: Minimum of 10 years of Quality Assurance / Quality Systems experience related to manufacturing Comprehensive knowledge of vaccines, biological manufacturing and related Quality management processes and systems Proven people management and Quality leadership experience Strong people leadership skills and a proven track record in attracting, developing and retaining talent in the organization Comprehensive regulatory cGMP and technical knowledge to develop sterility assurance strategies necessary to maintain the desired level of inspection readiness Experience hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory reviewers Experience with implementing and overseeing cGMP operations in a commercial manufacturing facility Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control teams Extensive knowledge of chemical, biochemical and microbiological concepts Knowledge of cGMP regulations and FDA/EU guidance Fluent in English (written and spoken) Preferred: Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is highly preferred Strategic thinking with the ability to manage/master complexity and to act as a sponsor for change Ability to prioritize and guide the organization in coping with the demands of a rapidly changing environment Ability to apply appropriate risk assessment strategies to manage business & compliance priorities Effective negotiation and influencing skills and lead with a mindset of continuous improvement Balanced decision-making skills and ability to effectively resolve conflict, when needed Business acumen; develop and control budgets Ability to communicate effectively with different levels in the organization and with health authorities Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource Required Skills: Preferred Skills: Aseptic Processing, Clean Room Manufacturing, Contamination Control, Risk Assessments The anticipated base pay range for this position is : $150,000.00 - $258,750.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

We are currently on a hunt for a Quality Manager to join our client's team in Bethlehem, PA. What you'll be doing: You will lead the overall quality direction of this World Wide Food company and will be involved in every aspect of overseeing quality. Will lead the development and execution of all Quality Assurance programs and activities that ensure compliance with company policies, food safety standards, government regulations, and industry best practices including GMP, SQF and HACCP. Will edit and develop HACCP plans and strategies for new products. Maintain current library for all GMPs, SOPs, SQF. Qualifications We would love to hear from you if : 4+ years of experience in QA food processing and packaging experience. You must have SQF experience. BS/Masters in Food Science, Microbiology, engineering Must have extensive experience with FDA. PS:Excellent Base Pay + Great Benefits + Relocation Pay. We embrace diversity and equal opportunity in a serious way. Additional Information All your information will be kept confidential according to EEO guidelines.

Job Description: Quality Assurance and Training Manager Element Risk Management 's Core Values: Proactive Stewardship. We manage and protect the relationships and resources entrusted to us with the utmost care. Confident Humility. We approach our work with self-assurance and expertise, while remaining open to learning and valuing the insights of others. Unshakable Integrity. We commit to honesty, transparency, and doing what is right even when faced with adversity or no one is watching. Continuous Improvement. We seek opportunities to enhance our skills, processes, and services while fostering a spirit of excellence, innovation, and growth. Relentless Perseverance. We embrace challenges with tenacity, discipline, and endurance. Position Overview: This role is pivotal in ensuring our products/services meet the highest standards of quality, compliance, and customer satisfaction. The ideal candidate will play a key role in driving continuous improvement initiatives, support employee training, leveraging technology to optimize processes, and leading internal audits to maintain operational excellence. This position demands a blend of technical experience, leadership skills and a keen eye for detail to maintain standards of quality and customer satisfaction. KEY RESPONSIBILITIES AND DUTIES: At all times, the Quality Assurance and Training Manager shall: Quality Oversight & Compliance Works with department managers to develop QA procedures and standards Ensure compliance with agency standards and process adherence, through internal audits Assist in the reporting of key quality metrics and KPIs Training & Development Quarterback training programs across Small Business and Personal Lines teams to enhance quality awareness and best practices for new and existing employees Manages and trains VAs (virtual assistants) Responsibility in identifying areas for process improvement and quality issues, recommends solutions in support of a culture of continuous improvement Lead cross-functional initiatives to improve operational efficiency, reduce errors, and enhance product/service quality. Evaluates SOPs Internal Audits & Risk Management Assists with planning and developing internal audits Coordinate with relevant teams to address audit findings JOB REQUIREMENTS and QUALIFICATIONS: College degree or equivalent is desired. Must be organized with demonstrated skills for effective communication both verbal and written with the ability to influence others. Should be familiar with all operations with a thorough understanding of the agency system. OTHER RELEVANT REMARKS: This position description describes the general nature and level of work performed. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this position. This position description is not intended as and does not create a contract of employment between the Agency and any individual employee. The Agency reserves the right to change this position description at any time within its sole discretion.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description: The correct title for this position is Clinical Quality Manager. Role Description The Clinical Quality Manager (CQM) is responsible for driving Asset and Study level quality management for specific assets primarily in the Alliance Partner (AP) model by maintaining 'quality' line-of-sight from Asset to Clinical Investigator Site level. • With this focus, the CQM role brings deep knowledge for asset- and study-level quality across clinical trial business process areas. In partnership with the Dev Ops Asset Lead and BU Clinical Lead, the CQM will ensure study level quality oversight, manage relevant Asset and Study level quality issues, and will be instrumental in ensuring that Asset and Study level information is appropriately incorporated within the GCP QMS. Act as point person to stakeholders and asset teams for asset and study quality risk management and quality issues management. • CQM may also continue to provide additional centralized services as described below as necessary. Responsibilities As CQMs are assigned to specific Asset, responsibility includes: Facilitate IQMP Development and Oversight of IQMP (Integrated Quality Management Plan) at study and asset level including integration within the Quality Management System (QMS) Facilitate study-level quality risk management activities (including IQMP activity) • Drive consistent implementation of IQMP across study-teams Facilitate IQMP development to ensure that study teams: Identify factors that are critical to quality and pre-specify appropriate quality metrics Identify high priority risks to quality and prospectively implement appropriate mitigation plans • Facilitate IQMP implementation, via participation on the asset clinical operations team, by ensuring that quality metrics are monitored and that quality deviations are identified and addressed in a timely and appropriate manner. Utilize QMS information, and integrate findings back into QMS, share learnings across assets and across CQM team Provide feedback to IQMP BPO to continuously improve IQMP approach Quality Gate and/or Quality Compliance Assessments Perform quality gate assessments (e.g. quality, completion or compliance assessment of key quality elements (e.g. prior to study start-up, during conduct phase, and study closeout) • Perform asset or study-focused quality compliance assessments Track compliance or performance against expectations, and manage outcomes Asset Clinical Quality Management Facilitate study-level quality risk management activities (including IQMP activity) Maintain comprehensive portfolio of quality issues across Asset Provide quality management / operational expertise Review quality reports and metrics for asset/study implications and remediation needed; to identify useful knowledge to apply/share cross-functionally IQMP PSQRV visit information for trends across asset Significant deviations/qualifying quality issues (QQI) across asset • Audit/Inspection Metrics Audit and/or CAPA Trend reports Protocol Deviations Metrics and Trends Guide asset/study team on appropriate quality remediation actions, facilitates remediations, and tracks/ensures completion in close collaboration with DevOps Asset Lead and BU Clinical Lead (e.g. remediation for pervasive cross-asset protocol deviation issues) • Ensure timely progress and completion for quality activities for which study teams/Alliance Partner are responsible per Clinical Trial Process Quality Standards (CTPQS): (e.g. Audit CAPA completion, study level quality issue action tracking, inspection readiness) Participates on QQI teams to provide guidance on actions to address quality issues (e.g. issuance of Protocol Deviation Alert Letters (PDAL), or actions to address QQI) May attend governance meetings and provide knowledge/trend information as appropriate • Perform Root Cause Analysis (RCA) for ad hoc asset quality issues Participate and guide team with Inspection conduct and response activity Maintain line-of-sight to asset quality issues where studies within asset are in multiple models (e.g. AP model, Maintained portfolio) Escalation, Communication, and Governance Guides asset/study team on appropriate escalation pathways Communicates/Escalates Asset / Study quality issues to: Asset-level roles (e.g. DevOps Asset Lead, Clinical Lead) Governance committees as necessary (e.g. QCC, QOC) BPOs for process level issues Alliance Partner Quality group/roles for potential qualifying quality issues as applicable Communicates study team continuous improvement feedback on business processes to BPOs Communicates key quality information (e.g. inspection/audit learnings) across asset/study teams and may serve as asset quality expert and liaison to relevant governance meetings • Lead or participate in quality-focused meetings for Asset Teams Perform other quality management related or oversight tasks as assigned CQMs may be responsible to provide other CQM centralized services which may include: Quality Compliance Assessments Lead / Contribute to Quality and Compliance Assessments (QCA) planning, conduct and report-out Line Compliance and SOP Review Coordinate and may manage the DevOps Compliance Plan (ADM02); ensure CTPQ training compliance Contribute to the review of new and revised SOPs to determine impact on DevOps business and compliance capability Audit Coordination Point of contact within DevOps and for internal audit groups for process audit planning, conduct and response support; may serve as DevOps/Clinical Audit Coordinator; track Dev Ops / Clinical process audit CAPAs; provide Audit Schedule Root Cause Analysis Facilitation May lead or participate in Root Cause Analysis for ad hoc requests Inspection Readiness Develop and lead strategy for and/or provide Study Team Inspection Readiness (IR) guidance and support; leads teams through pre-submission IR deep-dive Act as CQM Inspection Readiness contact for study teams via the CPM line Inspection • Support Acts as lead point of contact or supports the lead/main CQM point of contact within DevOps and for MQA when regulatory inspections are announced Coordinates or supports coordination of resources within DevOps/Clinical to ensure successful inspection outcomes and CAPA management for inspection commitments, communicates inspection progress and needs to DevOps/Clinical stakeholders QQI/CAPA Management: Acts and/or supports CAPA Mgmt lead as business line quality group for CAPA Management of Dev Ops / Clinical CAPAs . • Ensures or supports compliance with CAPA process QQI Case Management o Will or may function as QQI Case Lead: management for Significant Deviations, including investigation/root cause analysis and action development, tracking, and documentation Qualifications Training & Education Preferred: Degree in one of the disciplines related to drug development or business. Advanced or comprehensive knowledge, experience and expertise in clinical trial development, and operational quality management disciplines such as, quality and compliance assessments, quality assurance, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process, and/or inspection readiness. • Prior Experience Preferred Advanced or comprehensive clinical trials experience, especially operational processes and/or systems. Advanced or comprehensive Quality Management experience including use of metrics to drive quality and compliance Excellent understanding of Pharmaceutical processes and SOPs Skilled in project management Strong influencing skills with ability to influence a broad range of global stakeholders. Strong interpersonal skills and ability to build and maintain excellent working relationships across lines in a matrix organization Experience of drug development across one or more business lines Experience of working on global initiatives or project teams. Appreciation of diverse needs of different regulatory requirements of different sites and countries Ability to work successfully with internal and external partners • Excellent communication skills adaptable to meet the needs of diverse stakeholder groups Experience of conducting, managing or participating in an audit and/or inspection process Record of achievement and delivery for personal and team goals Ability to balance and prioritize a diverse and demanding workload Works independently and proactively set own work agenda with minimum guidance Competencies: Advanced or comprehensive knowledge in clinical trial development Able to use metrics and related data to determine where quality issues may exist and address appropriately Advanced or comprehensive experience in Quality areas such as: Quality management, quality compliance assessments, audit, inspection, compliance, CAPA management, and inspection readiness fields Knowledge of Pharmaceutical process in these areas • Project Management skills/experience Ability to provide guidance and instruction in Inspection Readiness and consultation for audit responses Knowledge of ICH GCP and regulations in order to assess GCP situations and coordinate resolution activities across partner lines Knowledge of Pharmaceutical SOPs and processes Ability to implement strategies using coordinated and transparent metrics to track and manage compliance Ability to lead cross-line global initiatives or root-cause analysis for quality related process improvement"Facilitate IQMP • Development and Oversight of IQMP (Integrated Quality Management Plan) at study and asset level including integration within the Quality Management System (QMS) " Quality Gate and/or Quality Compliance Assessments Asset Clinical Quality Management " Advanced or comprehensive clinical trials experience, especially operational processes and/or systems. Qualifications Advanced or comprehensive Quality Management experience including use of metrics to drive quality and compliance Excellent understanding of Pharmaceutical processes and SOPs Skilled in project management " Skills Skills Skills:Category Name Required Experience Areas of Expertise Compliance Yes 6 + Years Technical Skills Quality Audit Reports Yes 6 + Years Additional Skills:Advanced knowledge of Clinical Trial development required. Minimum of Bachelors Degree required. Advanced degree preferred. Additional Information Sneha Shrivastava Technical Recruiter (Clinical/Scientific) Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Connect with us on - LinkedIn | Facebook | Twitter

Line of Business: Cement & White About Us Heidelberg Materials is one of the world's largest suppliers of building materials. Heidelberg Materials North America operates over 450 locations across the U.S. and Canada with approximately 9,000 employees. What You'll Be Doing Lead and implement quality control programs to ensure product compliance with internal and external standards Monitor production processes and conduct audits to identify areas for improvement Collaborate with operations and technical teams to resolve quality issues and drive continuous improvement Train and support plant personnel on quality procedures and best practices Analyze data and prepare reports to communicate quality performance and trends What Are We Looking For Demonstrated ability to lead quality initiatives in a manufacturing or industrial environment Bachelor's degree or equivalent experience in Chemistry, Chemical Engineering, or related field Strong analytical and problem-solving skills with a focus on continuous improvement Effective communication and collaboration across cross-functional teams Proficiency in quality systems, standards, and tools (e.g., ISO, Six Sigma, SPC) Capability to manage multiple priorities and adapt to changing business needs Work Environment This role operates in a plant environment with exposure to industrial equipment, materials, and processes. Occasional travel to other facilities may be required. What We Offer Competitive base salary ($95,330 - $119,160) and participation in our annual incentive plan 401(k) retirement savings plan with an automatic company contribution as well as matching contributions Highly competitive benefits programs, including: Medical, Dental, and Vision along with Prescription Drug Benefits Health Saving Savings Account (HSA), Health Reimbursement Account (HRA) and Flexible Spending Account (FSA) AD&D, Short- and Long-Term Disability Coverage as well as Basic Life Insurance Paid Bonding Leave, 15 days of Paid Vacation, 40 hours of Paid Sick Leave and 10 Paid Holidays Equal Opportunity Employer - Minority / Female / Veteran / Disabled

Dometic is a global market leader in the mobile living industry. Millions of people around the world use Dometic products in outdoor, residential, and professional applications. Our Marine organization is a trusted provider of innovative solutions for the worldwide boating and boat building industry, and we recently expanded our scope to lead the boating industry into an electrified future. Dometic has won numerous NMMA Innovation Awards over the years and we are always striving for new ways to make boating easier, safer, and more enjoyable. We are a journey of continuous growth - now looking for our next star - a passionate Quality Manager. This position reports to the General Manager and will work in Limerick, PA Dometic Marine's facility in Limerick, PA develops and manufactures mechanical steering control systems along with shift and throttle cables. As a Quality Manager in the Limerick, PA team, you will be involved in managing the overall quality control for manufactured products and compliance with the quality management system. Your main responsibilities Promote quality achievement and performance improvement across the organization. Lead and organize formal/informal problem solving in areas of scrap, process capability, warranty, etc., using; 8D, Shanin Red X, 3L5W and A3 reporting formats as examples. Develop and measure quality goals, KPI's and targets in the global and local organization's strategic plan. Establishes and implements metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions. Assess product specifications and customer requirements. Ensure compliance with national and international standards. Partner with engineering, manufacturing and purchasing to formulate and agree on comprehensive quality procedures. Liaise with other managers and staff, particularly in areas such as design, production and purchasing. Work closely with purchasing employees to establish supplier quality performance criteria and monitor supplier performance. Assess suppliers' product specifications and quality plans. Define processes and procedures in conjunction with operating employees. Supervise internal auditing and continual improvement to product or services. Work methodically to establish a clearly defined quality management system. Lead and coach technical employees in carrying out tests/checks, in a laboratory environment. Ensure tests and procedures are properly understood, carried out, evaluated and that product modifications are investigated if necessary. Act as key contact with customers' auditors and being responsible for ensuring the execution of corrective actions and ongoing compliance with customers' specifications. Write technical and management system reports that predict trends that will affect improvement of quality. Pinpoint relevant quality-related training needs. Consider application of environmental and health and safety standards. Customer and Executive level presentation experience is paramount. Complete additional job duties and assignments. What do we offer? You are offered an interesting role in a dynamic, fast paced and global environment with great opportunities to grow and take on new challenges. The growth at Dometic is continuous - which gives you great possibilities to evolve with the company. Medical/Dental/Vision Insurance Employee Assistance Program (EAP) Disability insurance (STD/LTD) 401 (k) with company match PTO Company defined holidays and two floating holidays for you to use as you choose Paid maternity/paternity leave Tuition assistance Membership reimbursement (wholesale club and gym) Employee discounts on our incredible products Opportunities to make an impact

OVERALL RESPONSIBILITIES: Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts. DUTIES: • Responsible and accountable for on-time submission and accuracy of regulatory reports • Review and complete determination associated Medical Device Report and/or Vigilance Report • Knowledge of and familiarity with global regulations for reporting • Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events • Interact positively with internal, external business partners and colleagues • Adhere and comply to work instructions, standard operating procedures, and regulations • Expedite investigations by collaborating with internal/external business partners • Achieve productivity targets • Fully trained within three months of hire • Achieve accuracy targets for complaint documentations • Participate in projects and events • Complaint determination • Reportability assessments • Conduct follow-ups with complainant, reporters • Checking your own work • Updating SharePoint • Tracking complaints in the process for closure • All other duties as assigned Qualifications • Bachelor's Degree or equivalent experience • Generally requires 2-4 years of related work experience • RAC or ASQ certifications a plus Additional Information All your information will be kept confidential according to EEO guidelines.

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QA Shop Floor Specialist III as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations. Schedule: Wed-Sat 1 st Shift Key Responsibilities Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process. Support manufacturing activities for cGMP compliance through spot checks/internal audits. Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation, in accordance with Good Documentation Practices (GDP). Review, revise, or draft Standard Operating Procedures (SOPs) Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised. Support batch review & material release in SAP for In-house reagents. Support Floor Spot-check, audit trail review. Strive to reduce non-conformances in supported areas by proactively driving compliance. Support Investigations team by providing quality and compliance input for continuous improvement and remediations. Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor. Utilize multiple electronic quality systems, batch records and SAP. Work in a team based, cross-functional environment to complete tasks required to meet business objectives. Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas. Provide QA shop floor support for extended periods of time. Responsibilities will include but not limited to tasks mentioned above. Support regulatory inspections and audits as needed. Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements. Other duties will be assigned, as the need arises. Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses Color Perception both eyes 5 slides out of 8. Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning Requirements Bachelors degree required in Life Sciences or Engineering. 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy. Experience with quality support in clinical manufacture is preferred. Flexible to work on weekends, as needed. Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position. Is frequently required to communicate with coworkers. While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms. Ability to lift 20 lbs. Report to work on-time. Duties are required to be performed on-site at manufacturing facility. Perform other duties as assigned. Attend departmental and other scheduled meetings. Practice good interpersonal and communication skills. Demonstrate positive team-oriented approach in the daily execution of procedures. Promote and work within a team environment. Learn new skills, procedures and processes as assigned by management and continue to develop professionally. Support and contributes to projects. Assist in troubleshooting issues related to manufacturing. Technical knowledge within functional units Demonstrate an understanding of the process in order to properly perform the assigned tasks. Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems. Utilizes tools within MS Office and other systems to improve business effectiveness. Read and interpret documents such as safety rules, operating instructions, and logbooks. Review and provide feedback for SOPs. Interpret a variety of instructions furnished in written, oral, or diagram. Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process. Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals, Aseptic processing in ISO 5 clean room and biosafety cabinets. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices. Great attention to detail and ability to follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. Good written and verbal communication skills are required. Ability to summarize and present results, and experience with team-based collaborations is a must. Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk. Ability to collaborate well with stakeholders, customers and peers. Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Must be able to discern the criticality of issues and to communicate to management regarding complex issues. Ability to manage conflict and issues that arise with internal or external customers. #LI-RP1 #LI-Onsite The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Performance-based bonus and/or equity is available to employees in eligible roles. The anticipated base pay range is:$75,972-$99,713 USD Benefits Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Please note: These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. For information related to our privacy policy, please review: Legend Biotech Privacy Policy.

Delta Mission and Values Delta's Mission: To enrich the lives of individuals and families through outstanding community-based support and mutually rewarding relationships. Values: Customer Focus, Performance Excellence, Learning and Growth Position Summary The Quality Assurance Coordinator is responsible for monitoring the systematic operations of the residential and vocational programs. This person will serve as a liaison between the local office and the national office. This person will be held accountable for ensuring the appropriate implementation of policies and procedures and ensuring programs are completely in compliance with state rules, regulations and agency policies. Reports to: The Director of Quality Assurance Principal Duties and Responsibilities To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The duties listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Schedule and conduct Quality Assurance audits of individual financial records and personnel files to include training records, medication administration records, medical records. Conduct comprehensive record reviews. Conduct physical site inspections of homes and program locations. Submit a quarterly report card to the Quality Assurance Director and Regional/State Director. Conduct a 30-day initial audit of all new homes and programs. Audit individuals' in-house accounts to verify that required documentation is maintained, accounts are monitored by the designated staff and balances are correct Communicate findings of audits to the State Director, RegionalDirector and Quality Assurance Director. Recommends any necessary changes in current policy and procedures. Conduct staff training as needed. Complete required training to become a Certified Investigator. Conduct investigations as required. Maintain a master file of all audit findings. Cooperate with the Department of Human Services staff in any investigation or inspection. Cooperate with all internal or external audits or investigations as a condition of continued employment. Maximize the development and capacity of staff to advance the mission and values of Delta. Ensure the full capacity of programmatic resources. Promote and demonstrate ethical and professional conduct at all times ensuring employees conduct. themselves in an ethical and professional manner. Promote continuous quality improvement projects and ongoing performance measures. Promote and address Delta's Risk Management Program for the health and safety of individuals and employees. Perform other duties as assigned. Qualifications Requirements Ability to form collaborative working relationships with diverse populations, including working with individuals of diverse cultures, ethnicities, gender, age, sexual orientation, socioeconomic status, religion, education background, etc. Ability to develop knowledge of, respect for, and skills to engage with those of other cultures or backgrounds. Demonstrated commitment to diversity, equity and inclusion. Aptitude for balancing multiple priorities with strong organization, time management and prioritization skills. Ability to self-direct, self-pace, multi-task and function well under the pressure of deadlines and conflicting priorities. Ability to work effectively with people, facilitating their growth and development. Ability to use acquired knowledge of supervisory and administrative principles and methods. Ability to read, write and speak English and communicate effectively with all constituencies of a diverse community; perform arithmetic calculations. Ability to use telephone, voice mail, copier, facsimile machine, calculator, computer and other office equipment. Fully proficient in Microsoft Office, software applications and the ability to learn new and emerging technologies. Ability to operate vehicles with a valid driver's license in accordance with applicable state laws, insurance provider requirements and company policies and procedures. Position Qualifications Bachelor's degree from an accredited college or university. Associates degree or sixty (60) credit hours from an accredited university or college and four (4) years' experience working with persons with intellectual disabilities may be substituted for Bachelor's degree. Two (2) years' work experience working directly with persons with intellectual disabilities Two (2) years' work experience using electronic health records and database management. Valid driver's license in the state of residence with a satisfactory driving record. Commitment to and knowledge of community-based support for persons with disabilities Working knowledge of management of an effective Quality assurance program Ability to present facts and recommendations effectively in oral and written form Independent judgment is required to plan, prioritize, and organize diversified workload Knowledge and understanding of local regulatory agency operations

Primary Duties & Responsibilities * Lead SiC LLC Quality Function * Build strong organization quality talent in SiC LLC plants. * Actively engage in resolving customer quality issues and prepare for customer audits. Drive total customer satisfaction. * Coach the plants towards a culture of prevention. * Establish strategic quality direction within the plants. * Teach advanced Quality classes at the plants. * Establish a culture of intelligent risk-taking and guide the plants in choices to help exploit strategic opportunities. * Lead in strategic decision-making, and in tactical decision making within important risk-saturated areas. * Ensure Quality systems are aligned with identified best-practices. * Lead and manage the quality functions at SiC LLC plants. * Design and lead production of various dashboards accurately depicting quality product and process status in all plants. * Create and Maintain QMS Alignment with the Coherent Global Quality System * Ensure Quality Manual aligns with Coherent Corporate Global Quality manual. * Establish and maintain a process for "Preventive Action Efficiency" to drive mistake-proofing in the factories. * Implement and maintain Coherent Global COQ process. * Implement and maintain coherent Global KPI process. * Implement and maintain Coherent Global QBR. * Implement and maintain Coherent Global Risk Assessment process. * Implement and maintain the Coherent Global QAT-based assessment QMS effectiveness. * Implement and maintain Coherent Global Purge process. * Implement and maintain Coherent Global Quality Stop process. * Implement and maintain Coherent Global NPI process. * Implement and maintain Coherent Global PCN process. * Lead the Development and Implementation of IAFT 16949 QMS * Conceive, design, develop, implement, and continually improve an IATF 16949 certified QMS. * Lead efforts to identify, develop, proceduralize, and implement best quality AIAG practices in all SiC LLC plants. * Guide best practice design and deployment of processes for PPAP, SPC, MSA, APQP, and FMEA. * Implement Coherent Corporate Global internal quality audit process to ensure continual compliance and improvement of the automotive QMS. * Design and implement periodic Management Review processes to drive continual improvements. * Implement the Coherent Corporate Global 8D corrective action database and ensure its optimum usage. * Develop and maintain a Quality Manual. * Implement and maintain key complimentary processes within SiC LLC * Export compliance is maintained. * Ensure implementation and maintenance of Coherent Lean process. * Implement and maintain necessary ESD processes. * Implement and maintain necessary ESG processes. * A quality work environment consistent with 6S practices is maintained. * Assure regulatory compliance in product-related areas such as RoHS, REACH, and Conflict Minerals. Education & Experience * M.S. in technical field, preferably Statistics, Mathematics, or Industrial Engineering. * Extensive experience with Quality Sciences and Quality Management. * 20 years Quality Engineering, Quality Management, or Quality Consulting. * 15 years of experience electronics or semiconductor manufacturing. * 20 years of experience in internal quality audit. * 10 years of experience managing tier-1 or tier-2 customer audits. * 10 years of experience in using structured techniques to solve complex problems. * Awareness of PPAP, FMEA, MSA, Control Plan, and SPC techniques. * Awareness of lean manufacturing techniques. * Due to ITAR compliance, this position requires candidates to be a U.S. Citizen, Permanent Resident Alien, or Protected Individual per 8 U.S.C. 1324b(a)(3). Skills & Other Requirements * Expert Knowledge of the ISO 9001 criteria. * Awareness and understanding of the IATF 16949 criteria. * Process characterization and control techniques. * Able to balance financial and quality objectives. * Statistical expertise including FMEA, SPC, DOE, MSA, Process Capability. * Able to understand AIAG process control plans. * Able to facilitate cross-functional Kaizen Events. * Solve complex problems using intuition, induction, deduction, analysis of data, and advanced quality tools, and structured problem-solving methods. * Effectively work in cultures throughout North America, Europe, and Asia. * Able to think critically and to reengineer all elements of an Automotive Quality System to remove waste of time and dollars, while increasing Quality performance. * Willing to take intelligent risks to gain opportunities for quality innovation. * Excellent interpersonal, communication and presentation skills and ability to comprehend and communicate at a high level with executives, senior managers, and global customers, suppliers, and principals at different sites. * Able to relate well and work collaboratively with all levels within a site, from senior leaders to production operators. * Ability to deal effectively with differences of opinion, to influence, to draw ideas from others, and to negotiate and mediate. * Ability to anticipate and handle multiple priorities and complex/abstract issues involving external and internal priorities. * Ability to excel in a cross-organizational, cross-cultural, global team environment and to easily adjust in the face of challenge and change. * Handle special assignments promptly and professionally. * Maintain a high standard of ethics, professionalism, leadership, and competency. * Proven ability to lead and motivate people. * Demonstrates and promotes the Coherent ICARE Worldwide Values. * Knowledgeable in worldwide ESG norms. Working Conditions * Office Environment * Manufacturing Plant Environment, on occasion Physical Requirements * Ability to work at computer Safety Requirements All employees are required to attend scheduled training, follow the site EHS procedures and Coherent Corporate EHS standards. This includes the use of proper protective equipment (PPE) as required by the job responsibilities. Managers will ensure that all safety and environmental procedures are followed consistently. They will ensure that risk assessments are performed, proper training, work instructions, required PPE is available, and will monitor compliance. Quality & Environmental Responsibilities Depending on location, this position may be responsible for the execution and maintenance of the ISO 9000, 9001, 14001 and/or other applicable standards that may apply to the relevant roles and responsibilities within the Quality Management System and Environmental Management System. Culture Commitment Ensure adherence to company's values (ICARE) in all aspects of your position at Coherent: Integrity - Create an Environment of Trust Collaboration - Innovate Through the Sharing of Ideas Accountability - Own the Process and the Outcome Respect - Recognize the Value in Everyone Enthusiasm - Find a Sense of Purpose in Work

OVERALL RESPONSIBILITIES: Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts. DUTIES: • Responsible and accountable for on-time submission and accuracy of regulatory reports • Review and complete determination associated Medical Device Report and/or Vigilance Report • Knowledge of and familiarity with global regulations for reporting • Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events • Interact positively with internal, external business partners and colleagues • Adhere and comply to work instructions, standard operating procedures, and regulations • Expedite investigations by collaborating with internal/external business partners • Achieve productivity targets • Fully trained within three months of hire • Achieve accuracy targets for complaint documentations • Participate in projects and events • Complaint determination • Reportability assessments • Conduct follow-ups with complainant, reporters • Checking your own work • Updating SharePoint • Tracking complaints in the process for closure • All other duties as assigned Qualifications • Bachelor's Degree or equivalent experience • Generally requires 2-4 years of related work experience • RAC or ASQ certifications a plus Additional Information All your information will be kept confidential according to EEO guidelines.

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Specialist, QA Process Excellence as part of the Quality team based in Raritan, NJ. Role Overview The QA Process Excellence Specialist III role is an exempt level position with responsibilities for providing quality oversight for the manufacturing process and associated technical activities within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical operations activities including data or document review, risk assessments, CAPAs, and continuous improvement activities. They will be a subject matter expert for the manufacturing process and provide quality oversight for technical teams. Key Responsibilities Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing Teams in support of technical activities. Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for manufacturing operations. Provide expertise related to investigations and deviations occurring during routine manufacturing and protocol-driven activities such as tech transfer and process validation. Assist in the development of process, operational, and quality improvements for manufacturing. Assist in the review and development of process-related protocols and documentation. Provide technical quality oversight for electronic batch records. Support manufacturing and technical operations teams in trouble shooting and resolving complex scientific / technical problems. Evaluates quality processes and system standards to ensure compliance with applicable internal standards, industry standards, and global regulations. Provide Quality Oversight for batch records, change controls, SOPs, non-conformances, risk assessments, and CAPAs associated with manufacturing and technical operations and ensure effectiveness of related actions. Ability to handle multiple priorities daily while being flexible and responsive to frequently shifting priorities. Ability to work independently perform assigned tasks. Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements. May support CSV activities as needed. May support equipment qualification activities as needed. Drive continuous improvement. Requirements A minimum of a Bachelor's Degree in Science or equivalent technical discipline is required. 5+ years relevant work experience or equivalent. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A portion of the 5 years must include quality assurance experience. Strong knowledge of cell therapy processes strongly preferred. Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred. Experience with Computer System Validation (CSV) is a plus. Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals. Experience reviewing/auditing GMP documentation. Strong interpersonal and written/oral communication skills. Ability to quickly process complex information and make critical decisions with limited information. Ability to work independently and escalate to management when required. Detail-oriented and able to follow procedures closely. Ability to identify and assess possible gaps and work collaboratively to address such issues. Must be highly organized and capable of working in a team environment with a positive attitude. Strong proficiency with using Microsoft Office applications. #Li-RP1 #Li-Onsite The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Performance-based bonus and/or equity is available to employees in eligible roles. The anticipated base pay range is:$75,972-$99,713 USD Benefits Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Please note: These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. For information related to our privacy policy, please review: Legend Biotech Privacy Policy.