Quality assurance manager jobs in Bethlehem, PA - 101 jobs

Join a fast-growing Pharmaceutical Manufacturing site in a long-term contract role as a Quality Assurance Associate. In this position, you'll play a vital role in driving compliance, elevating operational standards, and supporting the production of critical care products that impact patients worldwide! Job Summary: Strive to proactively drive the Quality culture at the site and promote cGMP activities. This person will work hands-on with the responsibility of ensuring compliance, improving practices, and qualifying/validating new processes with company strategic goals as a guide. Essential Duties & Responsibilities Provide documentation and compliance support to meet Global Regulatory Requirements for licensed products. Partner with cross-functional departments to address GMP requirements in validation, investigations, complaints, procedure updates, and change control. Manage multiple priorities while providing leadership, guidance, and feedback to team members. Drive packaging OEE (Overall Equipment Effectiveness) initiatives. Support qualifications, deviations, customer complaints, investigations, and systems compliance. Maintain oversight of the PAS-X system and ensure 24/7 audit readiness. Support regulatory audits with thorough preparation and follow-through. Lead document control activities to ensure accuracy, consistency, and compliance. Education & Experience Bachelor's degree or higher in a scientific, quality assurance, or technical field. 0-2 years of experience in the pharmaceutical or related regulated industry, including compliance and project management. Deep understanding of cGMPs, regulatory standards, and industry best practices. Ability to conduct investigations, interpret regulations, and make sound quality decisions. Exceptional verbal and written communication skills with the ability to collaborate across departments and leadership levels. Proficiency in Microsoft Outlook, Excel, Word, and other web-based systems. Strong problem-solving skills with the ability to lead projects and deliver timely results. Job Types: Contract, Temp-to-hire

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 Quality Assurance Manager- leads a team of quality professionals that provide quality oversight, GMP guidance and support and make quality related decisions for the designated functional areas within the Sharp Commercial sites. Responsibilities include but are not limited to the supervision of quality activities, assessment for new and ongoing projects, provide direction for cGMPs to direct reports and make recommendations on resolutions and/or path forward for quality related issues. The Quality Assurance Manager is responsible for ensuring all customers receive the appropriate level of quality support and partnership. The QA Manager and their team will work closely with customers on a routine basis and the QA Manager will serve as the first level of escalation for all 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 for the QA Manager. Other duties may also be assigned: Directly supervise the work activities of employees engaged in quality related tasks on the floor to ensure that products and processes meet customers, company, and regulatory requirements/standards. Participate in internal, regulatory and customer audits at the discretion of management. Review and investigate nonconformances and complaints as needed. Create, review and revise SOPs on a designated basis to ensure accuracy. Assist in appropriate problem-solving initiatives to address customer or regulatory quality issues as requested by senior management. Effectively communicate a variety of personnel actions, e.g., employment, termination, performance and salary reviews, disciplinary actions, scheduling and/or approving overtime. Represent Sharp Quality Operations as the main point of contact / SME for customer meetings and calls. Support training department to identify new opportunities for training program. Serve as the alternate for the Head of Quality during he/her absences. Summarize data, draw conclusions, and turn recommendations into clear communications to be distributed to all levels of the organization. Support the manufacturing team to ensure the compliance of processes and products and ensure testing and inspection meet all requirements. Track and monitor internal and customer KPIs related to quality control and implement programs designed to increase employee's awareness and knowledge of product nonconformities. Assure efficient and economical utilization of materials and continuous improvement of methods to eliminate wasteful practices within the department. Identify and implement quality system improvements when gaps are identified through audits, investigations, and departmental reviews. Responsible for training, development, motivating and counseling of subordinate staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies. Work with the team of training specialists to develop processes and best practices for building, managing, and continually improving GMP training program for new and existing staff according to cGMP's and in alignment with Sharp's Global Training Standard. 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 accommodation may be made to enable individuals with disabilities to perform the essential functions. SUPERVISORY RESPONSIBILITIES: Direct supervision of quality 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 five to seven years of related experience or Associate's degree with seven to ten years of related experience or a minimum of ten years' 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. Knowledge of statistical concepts, methods, and software (knowledge of Minitab is a plus). Strong data gathering and analytical skills using statistical software. Strong root cause analysis skills, and the ability to apply rigorous structured problem-solving techniques. 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 accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to handle or write and to speak and hear. 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 accommodation 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 and routinely go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions. 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.

Job Description HoverTech International, a medical device company and leader in the safe patient and handling and movement is seeking a Director of Quality Assurance & Regulatory Affairs to join their team. This opportunity is in Allentown, PA, has one direct report and requires 10% international travel. The Director of Quality Assurance & Regulatory Affairs will lead the company's quality system and regulatory compliance activities. This role is responsible for ensuring that the Quality Management System meets FDA, ISO 13485, and global regulatory requirements, while also serving as the company's primary regulatory contact for the U.S., Canada, U.K., and EU. The ideal Director of Quality Assurance & Regulatory Affairs candidate has solid experience with Class II devices, understands global regulatory frameworks, and is comfortable in a hands-on leadership role in a growing organization. HoverTech International offers… Competitive compensation 100% employer paid benefits (for employee and family) Medical, dental, vision 401K plan Life insurance Tuition reimbursement Laid-back dress code and is dog friendly! The Director of Quality Assurance & Regulatory Affairs will be responsible for: Quality Assurance (QA) Maintain and continually improve the Quality Management System in compliance with FDA 21 CFR 820, ISO 13485, and applicable global standards. Oversee CAPA, complaint handling, non-conformances, internal audits, and supplier quality. Serve as the Supplier Quality Contact, managing supplier evaluations, audits, and ongoing performance monitoring. Lead document control, change control, training systems, and production quality processes. Oversee risk management activities in accordance with ISO 14971. Serve as the Management Representative during audits and inspections. Regulatory Affairs (RA) No 510(k) submissions required, but responsible for all ongoing global regulatory maintenance. Serve as the company's: FDA Registration Owner and primary FDA contact, US Agent for applicable products, EU PRRC (Person Responsible for Regulatory Compliance) for EUDAMED, Canada Regulatory Contact (e.g., MDEL maintenance) and UK Responsible Person / PRRC. Maintain device listings, establishment registrations, and regulatory documentation for all markets. Coordinate with distributors, authorized representatives, and regulatory bodies. Review and approve labeling, IFUs, marketing content, and product changes for regulatory compliance. Monitor regulatory changes and communicate impacts to leadership. Leadership Work closely with Engineering, Operations, and Executive Leadership to embed quality and regulatory requirements across the organization. Provide clear, practical regulatory guidance for sustaining products and new initiatives. Represent QA/RA during leadership meetings, audits, and customer visits. Director of Quality Assurance & Regulatory Affairs Qualifications: Bachelor's degree in engineering, science, quality, regulatory, or related field. 5-10+ years of regulatory and quality experience in medical devices. 5+ year's experience with a QMS (Greenlight Guru preferred). Strong understanding of Class I/ Class Il medical device requirements. Experience with FDA QSR, ISO 13485, and global regulatory frameworks. Experience managing establishment registrations and serving as a regulatory contact. Background in supplier quality, audits, and QMS compliance. Excellent organizational, documentation, and communication skills. Must be open to 10% international travel.

Step into a pivotal leadership role at Clemens Food Group, where your impact on food safety, people leadership, and product quality will be seen daily. Internally, this role is called a Superintendent, but externally we're seeking an Assistant FSQA Manager-a role often known in other organizations as a Food Safety Manager, Quality Assurance Manager, or FSQA Manager. In this role, you'll lead a team of QA supervisors and technicians in a USDA-regulated meat processing facility, ensuring compliance with HACCP, SSOPs, GMPs, and audit readiness. As the senior-most FSQA authority on second shift, you'll balance hands-on floor leadership with root cause analysis, corrective actions, and continuous improvement projects in one of our largest protein production plants. Shift Details Shift starts at 3:00 PM and runs for 9 hours As a management-level position, flexibility is expected-shifts may start or end an hour earlier or later based on operational needs On-call approximately one out of every four weekends The Impact You'll Make You'll own the shift. Literally. From running handoffs and leading root cause investigations to coaching your team and making critical decisions during audits or equipment failures-this role gives you end-to-end visibility and influence. Your leadership will drive our KPIs around safety, first pass quality, and regulatory compliance. What You'll Do Lead and develop a second-shift FSQA team (multiple supervisors and techs) Be the point of contact for USDA, customer complaints, and urgent investigations Review and act on trend data to improve quality and reduce CPMs Collaborate cross-functionally with Ops, R&D, and Sanitation Manage issue resolution, floor presence, audits, and on-call response (1 in 4 weekends) Prioritize food safety and people leadership at every turn What Makes This Role Exciting? You're the top FSQA decision-maker on your shift Gain experience in a high-capacity, 1.3M sq. ft. protein facility Every day brings new projects, challenges, and growth moments Room to grow-this role is a stepping stone to FSQA Manager What We're Looking For Proven FSQA leadership, meat/poultry/seafood industry required Proven ability to lead teams and manage performance Strong background in USDA, HACCP, audits, and corrective actions Comfortable with ambiguity, fast pace, and solving complex floor issues Skills & Mindset High initiative: confident in making decisions without constant direction Project-focused: can organize chaos into action plans and results People-first: builds trust, holds people accountable, and develops others Strong communicator: connects across functions, listens well, and presents data clearly Your Future at Clemens This isn't just a shift job-it's a career-building leadership role. We'll support your onboarding, help you get grounded in our culture, and give you visibility that sets the stage for broader advancement within FSQA. Application Note: Clemens Food Group is not accepting unsolicited resumes from search or staffing firms. All resumes submitted by search or staffing firms to any employee at Clemens Food Group via email, the Internet, or directly without a valid written search agreement for this role, and without having been asked to participate in this by Talent Acquisition, will be deemed the sole property of Clemens Food Group, and no fee will be paid in the event the candidate is hired. Firms not authorized to submit candidates will not be eligible for any fee or ownership claim. #LG-AG1 Keywords Food Safety, Quality Assurance, Food Safety Supervisor, FSQA Manager, Assistant Food Safety Manager, Meat Processing QA, USDA Compliance, HACCP, SQF, Food Manufacturing, Protein Industry, QA Team Leader, Quality Systems, Food Safety and Sanitation, Second Shift Food Safety, Regulatory Compliance, Food Plant QA, FSQA Superintendent, Assistant QA Manager. #LI-AG1

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

+ The ideal candidate will have 5+ years of QA experience specifically involving raw materials in a GMP-regulated environment such as pharmaceutical, biotech, or other life sciences industries. + A bachelor's degree is strongly preferred; master's candidates may be considered. + This role is physically active and requires passing an eye exam, lifting materials (~40 lbs), and consistent gowning (jumpsuit, scrubs, goggles). + Strong attention to detail, comfort in a warehouse environment, and GMP compliance experience are essential. **Responsibilities:** + Ensure that all operations comply with relevant regulations and requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Documentation Practices + Conduct sampling and inspection of incoming raw materials, assess documentation, and determine disposition + Compile and review documentation associated with receipt, storage, incoming inspection, and distribution + Perform routine Quality Assurance assessments and provide direct operational oversight + Provide expert advice on quality matters to operational teams and cross-functional groups + Ensure staff complete necessary training related to client's business operations + Approve GMP processes, procedures, documents, and records, addressing deviations, CAPAs, change controls, risk assessments, and validation records as required + Achieve established metric targets and develop standardized approaches for tracking progress + Collaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancement + Represent the Quality Unit during audits and inspections, directly interacting with regulatory agencies + Support internal and external audits and inspections as a member of the audit/inspection team + Perform additional duties as assigned by management **Preferred Qualifications:** + Proven ability to communicate effectively with cross-functional teams and diverse cultures, both verbally and in writing + Academic background in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies + Prior experience overseeing QA in distribution, warehousing, manufacturing, validation, and engineering functions + Expertise in managing deviations, change controls, and CAPAs + Proficiency in Veeva, SM LIMS, and ERP systems + Knowledge of industry standards (GMP, GDP, Import/Export) + Commitment to exemplifying client's core values + Demonstrated self-leadership and motivation + Strong strategic thinking skills + Ability to evaluate compliance issues and engage with regulatory inspectors + Experience managing multiple priorities within a dynamic environment + Direct experience with drug substances and/or drug products + Advanced problem-solving abilities and capacity for scientific, risk-based decision-making + Track record of representing an organization during regulatory interactions + High proficiency in Microsoft Excel, Word, and PowerPoint. **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** . "US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"

Title: Quality Assurance Compliance Technical Specialist Department: Quality Assurance Job Type: Regular Full Time Shift: Monday through Friday - 1st NMS Labs has developed an extensive menu of more than 2,500 Clinical and Forensic toxicology tests to support clients in healthcare, public health, and public safety fields. For over 50 years, our clients have relied on NMS Labs for unique testing solutions that demonstrate our company core values of Quality, Integrity, Service, Innovation and Engagement. As we work to increase the company's positive impact on the diverse markets we serve, we are seeking talented professionals to join us for the journey! We invite you to learn more about our company by visiting NMSLabs.com. Job Summary: Under limited supervision, the Quality Assurance Compliance Technical Specialist will assist in monitoring regulated work conducted at NMS Labs for compliance with study protocols, internal processes, procedures, company contracts, company quality standards, and company-controlled documents. This Quality Assurance Compliance Specialist will report directly to the Quality Assurance Compliance Supervisor and will be completely independent of any laboratory operations. Requirements: * Bachelor's degree in a chemical, physical or biological science with a minimum of 3+ years diverse laboratory experience * Or * Master's degree in chemistry, physical or biological science with 1-year diverse laboratory experience * 3 years' experience in QA auditing involvement. Preferred: * Experience with leading a project. Major Duties and Responsibilities: * Participate in activities designed to assure regulatory compliance with licensing/accrediting agencies such as personnel licenses (tracking and submission to agency), external proficiencies (tracking, data submission, data entry for grading), and/or document control within the compliance software. * Perform scheduled internal audits at a frequency to assure compliance with applicable processes and procedures. * Observe work practices and report any deviations from protocol, method, SOP, or regulations. Notify Supervisor and appropriate personnel of the audit findings by documenting the scope of audit and findings in a written report. * Perform follow-up audits as necessary to verify that appropriate corrective action has been completed. * Participates in Continuous Quality Improvement efforts. * Approved to be a lead auditor in the NMS Labs Internal Audit Program. Writes reports of audit findings and makes recommendations to technical staff on corrective actions for findings. * Participate in updates to the audit matrix and/or design and scheduling of internal audits. * Reviews proficiency data prior to submission. * Reviews and grades proficiency survey results and issues reports for management review. * Assist project managers and testing supervisors (as needed) in setup and continuation of laboratory procedures in compliance with established laboratory processes and procedures. * Attend professional meetings and/or conferences on QA activities and relay information gained to the QA group. * Remains current in compliance trends for those areas of responsibility. * Participates/presents in laboratory continuing education program as needed. * Ensure that pertinent information is entered into and maintained in the appropriate QA files. * Assists QA Regulatory with external audits/inspections, as applicable. * Other duties as assigned. Knowledge, Skills, and Abilities: * Ability to define and resolve problems, collect data, establish facts, and draw valid conclusions. * Ability to read and audit complex technical data and procedures to determine compliance with established processes and procedures. * Ability to make effective and persuasive speeches and presentations to peers and management for the purpose of effecting changes necessary for regulatory compliance. * Ability to identify operationally efficient strategies to adhere to quality compliance requirements. * Ability to effectively present information and respond to questions from all co-workers. * Ability to effectively prioritize assignments to meet long and short-term deadlines. * Strong organization, documentation skills, attention to detail, and able to prioritize assignments to meet deadlines. * Possess good computer skills (to include Excel and Word) and internet usage. * Ability to travel, including out of state. * Maintains regular and reliable attendance. Physical Demands: * Ability to talk, hear, stand, reach with hands and arms, and use hands and fingers to manipulate computer keyboard, objects, tools, or controls. Specific vision abilities (with correction) include close and distance vision. * Walking and carrying objects from one work location to another and sitting and standing sometimes for periods of time. Offers of employment are made contingent upon a nationwide background investigation and urine drug screen with results satisfactory to standards of employment at NMS. We are an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, creed, sexual orientation, color, religion, sex, national origin, age, marital status, citizenship status, otherwise qualified disability, or protected veteran status (disabled Armed Forces Service medal, recently separated, active duty or campaign badge), domestic violence victim status, arrest record, or predisposing genetic characteristics.

Our client is looking to add a Quality Assurance Specialist to their team on a contract basis. This role will be onsite in Easton, PA, and contract term is 18 months. Responsibilities: Ensure that all operations comply with relevant regulations and Amgen requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Documentation Practices Conduct sampling and inspection of incoming raw materials, assess documentation, and determine disposition Compile and review documentation associated with receipt, storage, incoming inspection, and distribution Perform routine Quality Assurance assessments and provide direct operational oversight Provide expert advice on quality matters to operational teams and cross-functional groups Ensure staff complete necessary training related to Amgen business operations Approve GMP processes, procedures, documents, and records, addressing deviations, CAPAs, change controls, risk assessments, and validation records as required Achieve established metric targets and develop standardized approaches for tracking progress Collaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancement Represent the Quality Unit during audits and inspections, directly interacting with regulatory agencies Support internal and external audits and inspections as a member of the audit/inspection team Perform additional duties as assigned by management Requirements / Qualifications: Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience Proven ability to communicate effectively with cross-functional teams and diverse cultures, both verbally and in writing Academic background in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies Prior experience overseeing QA in distribution, warehousing, manufacturing, validation, and engineering functions Expertise in managing deviations, change controls, and CAPAs Proficiency in Veeva, SM LIMS, and ERP systems Knowledge of industry standards (GMP, GDP, Import/Export) Commitment to exemplifying Amgen's core values Demonstrated self-leadership and motivation Strong strategic thinking skills Ability to evaluate compliance issues and engage with regulatory inspectors Experience managing multiple priorities within a dynamic environment Direct experience with drug substances and/or drug products Advanced problem-solving abilities and capacity for scientific, risk-based decision-making Track record of representing an organization during regulatory interactions High proficiency in Microsoft Excel, Word, and PowerPoint

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. Let's do this! Let's change the world! This onsite position provides critical support for the Raw Material Center (RMC) warehouse, based in Easton, Pennsylvania. The RMC represents an advanced logistics solution designed to optimize the raw material network, serve additional manufacturing sites, and facilitate inventory pooling and bulk purchasing. RMC services encompass direct supplier receipt, incoming quality inspection and sampling, environmental monitoring, storage, and transportation. Responsibilities: Ensure that all operations align with relevant regulations and Amgen requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Documentation Practices Conduct sampling and inspection of incoming raw materials, assess documentation, and determine disposition Review documentation associated with receipt, storage, and distribution Approve GMP processes, procedures, documents, and records, addressing deviations, CAPAs, change controls, risk assessments, and validation records as required Perform routine Quality Assurance assessments and provide direct operational oversight Offer leadership, guidance, mentorship, and training to staff and partner organizations Manage oversight of logistic and transportation service providers Provide expert advice on quality matters to operational teams and cross-functional groups Ensure staff complete necessary training related to Amgen business operations Achieve established metric targets and develop standardized approaches for tracking progress Collaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancement Participate in quarterly business and quality reviews and address any service failures with LSPs Present updates on LSP Quality Management System health and initiatives at management reviews Represent the Quality Unit during audits and inspections, directly interacting with regulatory agencies Support internal and external audits and inspections as a member of the audit/inspection team Implement business continuity plans for services and processes Form strategic partnerships with internal customers and external vendors to ensure operational success Integrate risk management strategies into overall supply chain management Lead initiatives, programs, and projects targeting operational improvements Develop solutions that are comprehensive, practical, and align with functional goals Perform additional duties as assigned by management Additional Qualifications/Responsibilities We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications. Basic Qualifications: Doctorate degree OR Master's degree and 2 years of quality assurance experience OR Bachelor's degree and 4 years of quality assurance experience OR Associate's degree and 8 years of quality assurance experience OR High school diploma / GED and 10 years of quality assurance experience Preferred Qualifications: Proven ability to communicate effectively with cross-functional teams and diverse cultures, both verbally and in writing Academic background in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies Prior experience overseeing QA in distribution, warehousing, manufacturing, validation, and engineering functions Expertise in managing deviations, change controls, and CAPAs Proficiency in Veeva, SM LIMS, and ERP systems Knowledge of industry standards (GMP, GDP, Import/Export) Commitment to exemplifying Amgen's core values Demonstrated self-leadership and motivation Strong critical thinking skills Ability to evaluate compliance issues and engage with regulatory inspectors Experience managing multiple priorities within a dynamic environment Direct experience with drug substances and/or drug products Advanced problem-solving abilities and capacity for scientific, risk-based decision-making Track record of representing an organization during regulatory interactions High proficiency in Microsoft Excel, Word, and PowerPoint What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

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 About the position 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 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 anticipated base pay range is$75,972-$99,713 USD Benefits We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating 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. EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. 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. Legend Biotech maintains a drug-free workplace.

Job DescriptionDescription: The Key Objective of the Quality Assurance Receiving Specialist is to contribute to the growth and profitability of Multi-Pak by effectively executing the functions of Quality Management while providing additional support to the other senior managers. Specifically, under the general direction of the Lead Quality Assurance Receiving Specialist, they are responsible for the following: inspection of all incoming bulk, components, primary and secondary labeling, and other packaging operating supplies per appropriate specification and/or procedure to ensure adherence to cGMPs and other regulatory requirements. He/she shall ensure that all incoming material meets the required specifications to be released for production. RESPONSIBILITIES: Essential Functions: •Ensure inspection activities are being performed not limited to verifying the quantities of all the pallets received in, performing the sampling for receiving inspection, signing off the receiving inspection report and logging into the Receiving inspection logbook. The inspection shall be performed for every incoming material - bulk, labeling material, and components. •Ensure receiving reports are created and documented correctly as per the SOPs and work instructions and are consistent with the product description detailed in the Inventory Checklist. •Assures material meets the appropriate specifications through appropriate inspection methods as described in the SOP and/or specification. •Responsible for managing the entire label issuance procedure including the inspection, label verification, issuance to the Label Room and verifying the returns from the production. •Responsible for intimating the Client services department and required personnel of the receiving inspection discrepancies. •Ensure the Transfer tags are created and documented correctly for the label transfers from Chapin warehouse to Clinton warehouse and vice versa. •Ensure samples are correctly stored and managed in the Chapin warehouse. •Manage the Quarantine area in both Chapin and Clinton warehouse. •Responsible for verifying the disposition of materials and signing the documentation for the same. •Responsible for maintaining accurate records and following good documentation practices for all materials inspected. •Maintain and manage all Component Specifications and Color Standards as required and provided by the client. Nonessential Functions/Demands: •Assists QA Department with documentation and QC Inspection when required. •A person in this position may occasionally be required to work in outdoor weather conditions. Requirements: •Associate's/Bachelor's Degree (preferred). •1-2 years in related experience (especially in pharmaceutical industry). •Ability to demonstrate strong organizational skills. •Exercise judgment within defined procedures and practices. •Must be a strong team player with good problem solving, and good verbal and written communication skills. •Knowledge of GMP documentation and FDA required. •General knowledge of quarantine and warehouse operation. •Good knowledge of Microsoft Office programs. PHYSICAL/MENTAL DEMANDS: •Must be able to lift-up to 30 pounds frequently and 50 pounds on occasion. •Must be able to remain in the stationary position for up to 40% of the time. •Must be able to walk or stand up to 90% of the time. •The person in this position will need to occasionally move about inside the office to access office machinery, file cabinets, etc. •The person in this position will need to frequently move about inside the warehouse requiring them to position themselves through pallets and warehouse locations. •The person in this position is required to function in narrow aisles or passageways. •The person in this position will need to occasionally kneel, climb, crawl, climb and/or reach to perform inspections. •The person in this position is required to communicate to all other departments and must be able to exchange accurate information in these circumstances.

Title: Quality Assurance Compliance Technical Specialist Department: Quality Assurance Job Type: Regular Full Time Shift: Monday through Friday - 1st NMS Labs has developed an extensive menu of more than 2,500 Clinical and Forensic toxicology tests to support clients in healthcare, public health, and public safety fields. For over 50 years, our clients have relied on NMS Labs for unique testing solutions that demonstrate our company core values of Quality, Integrity, Service, Innovation and Engagement. As we work to increase the company's positive impact on the diverse markets we serve, we are seeking talented professionals to join us for the journey! We invite you to learn more about our company by visiting NMSLabs.com. Job Summary: Under limited supervision, the Quality Assurance Compliance Technical Specialist will assist in monitoring regulated work conducted at NMS Labs for compliance with study protocols, internal processes, procedures, company contracts, company quality standards, and company-controlled documents. This Quality Assurance Compliance Specialist will report directly to the Quality Assurance Compliance Supervisor and will be completely independent of any laboratory operations. Requirements: Bachelor's degree in a chemical, physical or biological science with a minimum of 3+ years diverse laboratory experience Or Master's degree in chemistry, physical or biological science with 1-year diverse laboratory experience 3 years' experience in QA auditing involvement. Preferred: Experience with leading a project. Major Duties and Responsibilities: Participate in activities designed to assure regulatory compliance with licensing/accrediting agencies such as personnel licenses (tracking and submission to agency), external proficiencies (tracking, data submission, data entry for grading), and/or document control within the compliance software. Perform scheduled internal audits at a frequency to assure compliance with applicable processes and procedures. Observe work practices and report any deviations from protocol, method, SOP, or regulations. Notify Supervisor and appropriate personnel of the audit findings by documenting the scope of audit and findings in a written report. Perform follow-up audits as necessary to verify that appropriate corrective action has been completed. Participates in Continuous Quality Improvement efforts. Approved to be a lead auditor in the NMS Labs Internal Audit Program. Writes reports of audit findings and makes recommendations to technical staff on corrective actions for findings. Participate in updates to the audit matrix and/or design and scheduling of internal audits. Reviews proficiency data prior to submission. Reviews and grades proficiency survey results and issues reports for management review. Assist project managers and testing supervisors (as needed) in setup and continuation of laboratory procedures in compliance with established laboratory processes and procedures. Attend professional meetings and/or conferences on QA activities and relay information gained to the QA group. Remains current in compliance trends for those areas of responsibility. Participates/presents in laboratory continuing education program as needed. Ensure that pertinent information is entered into and maintained in the appropriate QA files. Assists QA Regulatory with external audits/inspections, as applicable. Other duties as assigned. Knowledge, Skills, and Abilities: Ability to define and resolve problems, collect data, establish facts, and draw valid conclusions. Ability to read and audit complex technical data and procedures to determine compliance with established processes and procedures. Ability to make effective and persuasive speeches and presentations to peers and management for the purpose of effecting changes necessary for regulatory compliance. Ability to identify operationally efficient strategies to adhere to quality compliance requirements. Ability to effectively present information and respond to questions from all co-workers. Ability to effectively prioritize assignments to meet long and short-term deadlines. Strong organization, documentation skills, attention to detail, and able to prioritize assignments to meet deadlines. Possess good computer skills (to include Excel and Word) and internet usage. Ability to travel, including out of state. Maintains regular and reliable attendance. Physical Demands: Ability to talk, hear, stand, reach with hands and arms, and use hands and fingers to manipulate computer keyboard, objects, tools, or controls. Specific vision abilities (with correction) include close and distance vision. Walking and carrying objects from one work location to another and sitting and standing sometimes for periods of time. Offers of employment are made contingent upon a nationwide background investigation and urine drug screen with results satisfactory to standards of employment at NMS. We are an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, creed, sexual orientation, color, religion, sex, national origin, age, marital status, citizenship status, otherwise qualified disability, or protected veteran status (disabled Armed Forces Service medal, recently separated, active duty or campaign badge), domestic violence victim status, arrest record, or predisposing genetic characteristics.

Quality Specialist * No C2C or sponsorship available for this job. $65-75k Potential Contract-to-Direct for the right person! Join a fast growing Pharmaceutical Manufacturing site in a long-term contract role as a Quality Specialist. In this position, you'll play a vital role in driving compliance, elevating operational standards, and supporting the production of critical care products that impact patients worldwide! Job Summary: Strive to proactively drive the Quality culture at the site and promote cGMP activities. This person will work hands-on with the responsibility of ensuring compliance, improving practices, and qualifying/validating new processes with company strategic goals as a guide. The role may also serve as a liaison between the Operations group and the QA/QC department for day-to-day activities, capital projects, and process improvements. Essential Duties & Responsibilities Provide documentation and compliance support to meet Global Regulatory Requirements for licensed products. Partner with cross-functional departments to address GMP requirements in validation, investigations, complaints, procedure updates, and change control. Manage multiple priorities while providing leadership, guidance, and feedback to team members. Drive packaging OEE (Overall Equipment Effectiveness) initiatives. Support qualifications, deviations, customer complaints, investigations, and systems compliance. Maintain oversight of the PAS-X system and ensure 24/7 audit readiness. Support regulatory audits with thorough preparation and follow-through. Lead document control activities to ensure accuracy, consistency, and compliance. Education & Experience Bachelor's degree or higher in a scientific, quality assurance, or technical field. 1+ years of experience in the pharmaceutical or related regulated industry. Knowledge/understanding of cGMPs, regulatory standards, and industry best practices. Ability to assist in investigations, interpret regulations, and make sound quality decisions. Exceptional verbal and written communication skills with the ability to collaborate across departments and leadership levels. Proficiency in Microsoft Outlook, Excel, Word, and other web-based systems. Strong problem-solving skills with the ability to lead projects and deliver timely results.