Quality assurance specialist jobs in Allentown, PA - 84 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.

Piramal Pharma Solutions is seeking an experienced Manager, Quality Systems & Compliance to lead and maintain robust quality systems and ensure compliance with global regulatory requirements at our Sellersville site. This role is critical in supporting cGMP and regulatory compliance across manufacturing, testing, warehousing, and distribution operations for pharmaceutical drug products. The successful candidate will ensure quality systems are effectively implemented, aligned with company quality policies, and continuously improved to meet evolving regulatory and business needs. Key Responsibilities Quality Systems Leadership Serve as system administrator for electronic Quality Management Systems (eQMS), including ComplianceWire, TrackWise, Ensur, eBMR, and eForms. Ensure effective use of quality systems to support site compliance and continuous improvement initiatives. Review and approve quality system records, including deviations, CAPAs, change controls, and training records. Training Program Management Oversee all site training activities and ensure compliance with regulatory and internal requirements. Partner with department heads and SMEs to develop, implement, and maintain training curricula. Provide guidance and training to end users on quality systems and processes. Document Control Manage the site SOP program and overall document control lifecycle. Oversee document management activities, including Master Batch Records and protocols. Compliance & Governance Lead Quality System Committees (QSCs) and review boards, including Deviation, CAPA, and Change Control Review Boards. Provide quality system metrics on a weekly, monthly, and quarterly basis. Manage Annual Product Reviews (APRs). Oversee complaint, FAR, and recall management processes. Manage Quality Technical Agreements (QTAs). Audit & Supplier Management Lead the Supplier Management Program. Manage internal, external, client, and regulatory audits. Actively support regulatory inspections and client audits. Data Integrity & Computer Systems Serve as Site Data Integrity Compliance Officer (DICO). Manage the site Data Integrity Program. Oversee the Computer System Validation (CSV) program. Support implementation and upgrades of electronic systems. Continuous Improvement Collaborate with the corporate quality team to implement global policies and procedures. Support site quality improvement initiatives and special projects. Ensure adherence to site safety standards. Perform additional Quality Systems & Compliance activities as assigned. Required Qualifications Education Bachelor's degree or higher in a scientific, quality assurance, or technical discipline. Experience Minimum of 10+ years in a manufacturing environment with QA, Quality Systems, and/or Compliance experience in a cGMP/FDA-regulated industry. At least 5 years in a supervisory or managerial role. Technical & Functional Skills In-depth knowledge of global pharmaceutical regulations (FDA, EMA, PDMA, ANVISA, TGA, DEA). Strong understanding of Quality Management Systems for non-sterile pharmaceutical manufacturing. Hands-on experience with eQMS platforms (DMS, LMS, eBMR). Proven experience in audits, supplier management, and data integrity. Excellent organizational, communication, and cross-functional collaboration skills. Proficient in Microsoft Office and standard business systems. Ability to manage multiple projects and priorities simultaneously.

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

Under the direction of the Audit Manager, the Quality Auditor has the responsibilities for hosting customer audits, conducting supplier audits, and conducting internal cGMP compliance audits for the company. This role encompasses the entire audit process including support in regulatory and third-party audits. The Auditor responsibilities encompass Sharp Packaging Services, LLC commercial US facilities (Allentown, Conshohocken, and Macungie). The impact of decisions relating to customer interface, supplier interface and regulatory agency interface 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 Q.A. Auditor position. Other duties may also be assigned. Host customer audits. Write responses to customer audit observations. Support the supplier audit program, including auditing suppliers and writing of supplier qualifications, routine and for cause audit reports. Support site specific internal audit program, including performing and documenting internal audits. Review and evaluate the appropriateness of supplier and internal audit responses to ensure effective CAPAs and effectiveness checks are in place. Participate in regulatory agency inspections. Coordinate the Root Cause and Corrective Action / Preventative Action (CAPA) process as it relates to all audits and inspections. Identify areas for continuous improvement as part of audit process. Remain current with FDA inspectional trends and current industry standards for cGMP compliance. Follow Sharp SOPs governing internal and supplier audit programs. Follow ISO 13485, principles of cGMPs and industry guidance documents. Assist in appropriate problem-solving initiatives to address customer or regulatory cGMP issues as requested by management. Other duties may be assigned as appropriate. 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: None PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE: A minimum of one year of experience conducting cGMP compliance audits or comparable industry experience preferred. Knowledge of FDA cGMPs regulation required specifically 21 CFR 210/211, 820, Part 4 Knowledge of ISO 13485 required Knowledge of ICH08, 09 and 10 desired. Knowledge of DEA regulations, ISO 9001 and ISO 15378 desired. Above average written and oral communication skills required. Above average organization 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 accommodation 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 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 or periodically go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions. Approximately 30 percent travel between sites. Approximately 15 percent travel to supplier sites is required. A valid driver's license is required. 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.

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

+ 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"

Cleveland Steel Container, an Employee Owned and World Class Steel Pail Manufacturing company, is seeking an enthusiastic, responsible, and customer-oriented individual that has a positive attitude and shares the values of our company culture, which is built around teamwork, family, honest communication and producing desirable results for our Quakertown, PA manufacturing facility. INDUSTRY LEADING BENEFIT PROGRAM THAT INCLUDES LOW EMPLOYEE PREMIUMS FOR MEDICAL INSURANCE, UNMATCHED RETIREMENT PROGRAMS AS AN EMPLOYEE OWNER. DENTAL, VISION, LIFE AND DISABILITY INSURANCES. NEW EMPLOYEES ARE ELIGIBLE FOR 15 DAYS OF PAID VACATION PER CALENDAR YEAR AND 11 PAID COMPANY HOLIDAYS. SIGN ON BONUS OF $2,000 PAID OUT IN FIVE INSTALLMENTS OVER THE COURSE OF ONE YEAR. $1,000 REFERRAL BONUS FOR ANYONE THAT IS REFERRED THAT GETS HIRED BY THE COMPANY This Quality Assurance Technician position is responsible to ensure company and customer quality standards are being achieved. Duties and Responsibilities: Test and conduct routine and non-routine in-process inspection of production output, measure samples of finished product and check production quality verifications for completeness, timeliness and tolerances as well as complete product testing of finished goods Assist with incoming inspections for internal / external suppliers as directed. Confirm discrete job special instructions are being followed or met Member of daily audit team for various product and process audits per checklist Participant in the revision and update of standard operating procedures. Conduct and complete Internal Quality audits and may be involved in the development of testing methods Ensure employees adhere to safety and quality standards Skills and qualifications: 1-3 years manufacturing experience: required (metal, paint/finishing industries: a plus) High School Diploma or GED: required ISO 9000 and 5S Program knowledge and experience Customer focused mindset Proven hands-on shop floor experience; forklift experience Working knowledge Microsoft Office (Word, Excel, PowerPoint) Good work record; Strong work ethic Strong communication and interpersonal skills Good teamwork and time management skills Experience in a high volume fast paced environment Cleveland Steel Container was founded in 1963 to provide customers with a dependable steel pail. Currently, we have four pail plants located strategically throughout the United States to support our customers. At our Streetsboro facility, we have a metal stamping plant to provide component parts for our pails. Our goal is to continuously provide our customers with quality pails through excellent service at an outstanding value. Finally, we make good pails and deliver them on time! Cleveland Steel Container offers a competitive salary based on commensurate experience and a comprehensive benefits program that includes medical, dental, and vision insurance, flexible spending accounts, 401k with company contribution, profit sharing, paid holidays and vacations, life insurance and short & long-term disability coverages along with an Employee Stock Ownership Plan (ESOP).

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

Business: Critical Care Department: Quality Assurance Provides continuous oversight of all daily Quality activities to assure compliance with internal procedures and regulatory requirements. Provide proper control, review, and management of site documentation to ensure GMP and regulatory compliance. Key Stakeholders: Internal Quality Assurance Team, Site Management, All Departments Key Stakeholders: External FDA or other health organizations Reporting Structure Directly reports to Quality Assurance Supervisor Essential Duties and Responsibilities * Responsible for the review, approval, and disposition of finished product for the site and final CoA signature * Facilitates client project management as required ensuring "quality on time and in full" * Coordinates the investigation and closure of non-conformances ensuring appropriate corrective and preventive actions (CAPA) and change controls are initiated and deviations are closed * Leads or participates in focused deviation cross-functional investigations, improvement projects * Reviews and approves laboratory investigations in a timely manner and ensures appropriate root cause is identified * Provides assistance to other QA associates and assist with department trainings * Provides support to QA management during regulatory audits * Reviews BOMs, inspection plans, pallet patterns, calibration records and SOPs * Performs internal audits and assist in writing reports for audits * Maintains and revises procedures related to the quality assurance activities. Supports Annual Product Review (APR) reports by collecting batch record data, creating and maintaining data bases * Maintain the vendor complaint process * Maintain, monitor and provide trend analysis of DIs, LIs, CAPAs, customer complaints and change controls * Performs special projects and/or assignments as indicated by Quality Management * Oversee and review of Obsolete material destruction * Perform Quality inspections on packaging line as needed * Maintain supplier approval program * Support/Maintain site Document Control System * Review, approve and close out Document Change Requests * Tracking of changes using DCC spreadsheet and supporting actions through closure * Maintain original documentation archive and Archival of documents offsite * Printing of new and revised documents, Issuance of forms, logbooks * Review documentation submitted for routing in eDMS for proper formatting and accuracy. * Load documents into an electronic Documentation Management System (eDMS) * Route documents for approval in the eDMS * Recall documentation for audits in a timely manner * Performs external audits and assist in writing reports for audits * Responsible for maintenance and revision procedures related to document control * May require up to 25% travel. Key Competencies (knowledge, skills, and abilities every person must possess to be successful) * Critical Thinking - using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems * Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers * Excellent verbal and written communication skills * Energetic, enthusiastic, and motivated disposition * Attention to detail with strong organizational skills * Ability to explain problems, solutions and make recommendations, and the ability to manage various urgent requests in a professional manner * Ability to analyze data/trends to make sound regulatory interpretation while preparing metrics and reports * The ability to drive projects in relation to implementation of new workflows and updates to new systems Education / Experience * Bachelor's degree in relevant scientific quality assurance / technical field * 5+ years of experience * Strong understanding of pharmaceutical cGMP, industry standards, and regulations * Strong verbal and written communication skills with the ability to interact across functions, departments, and seniority levels * Expert level user for Quality computer systems * Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems * Thorough understanding of computer system validation and GAMP requirements

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 vacation days, personal days, sick time, 11 company 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. Please note: These benefits are offered exclusively to permanent 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. Legend Biotech maintains a drug-free workplace.

Job Details Primary Function: Assist in facilitating the work of Quality Assurance, review and improve accuracy of Front End Revenue Cycle which includes front end billing edits, front end denials, zero accounts and any other front end related revenue opportunity. Participate in and coordinate the implementation of strategies and processes. Participation and coordination of creation of payor update guides. Participate and create training manuals. Provide training and mentoring to new registrars on all shifts and current registrars in front end denial and edit findings. Identify and report ongoing issues and possible resolutions. Provide statistics to management. Responsible for presenting standard training programs, prepares course materials, establishes lesson plans and administers qualifying tests. Provides office support for all computer applications, office procedures and protocols. Run detailed statistics to determine what areas need improvement, where denials are happening, determine how to correct processes to prevent, bring information to denial meetings. Work with internal and external customers. Job Description Education/Training/Experience: BA or BS in related field preferred OR 3-5 years in Patient Access and/or Patient Accounting Experience. Strong verbal and written communication skills required. 1-3 years lead or supervisory experience preferred. Patient Registration, third party billing, precertification, insurance verification experience required. Working knowledge of registration and billing regulatory requirements including EMTALA. Ability to prioritize tasks. Excellent PC literacy skills required. Candidate must have a positive and strong work ethic. EPIC AND CERNER EXPERIENCE STRONGLY PREFERRED Work Shift Rotating (United States of America) Worker Sub Type Regular Employee Entity Albert Einstein Medical Center Primary Location Address 559 W. Germantown Pike, East Norriton, Pennsylvania, United States of America Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years. Jefferson is committed to providing equal educa tional and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status. Benefits Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance. For more benefits information, please click here

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.

PeopleShare is currently looking for a 3rd Shift Quality Control Inspector in the Hatfield, PA area. 1-3 years experience preferred, but in depth training is provided! Great room for growth with a busy manufacturing company. 3rd Shift Quality Job Details: Schedule: 11pm-7a Pay Rate: $25/hour Selling Points about 3rd Shift Quality:1. Training provided2. Room to grow3. Competitive Pay Rate 3rd Shift Quality Job Description:• Carries out written and verbal instructions to support quality processes. • Reads work orders, SPC charts, and schedules. Reads and interprets detailed prints, sketches, layouts, specifications, SPC results, and manuals to determine specifications, testing procedures, adjustment methods, and certification processes. • Inspects and examines parts to identify product or equipment defects. • Observes and reads instruments, gauges, dials, etc. to determine operating conditions. • Measures dimensions of products to verify conformance to specifications. Compares colors, shapes, texture and grades of product/materials with color charts, templates or samples to verify conformance to standards. • Notifies supervisor or other production personnel of production problems. • Records inspection or test data. Calculates results. Writes test or inspection reports. • Works independently or as part of a team. 3rd Shift Quality Job Requirements:• Works independently with instructions from supervisor and computerized work order system. • Communicates well with all levels of personnel in writing and orally (in English). Good interpersonal skills. • Works well with others: team-oriented. • Understands quality control analysis methods and processes. • Demonstrates knowledge in the use of measuring instruments (e.g., calipers, micrometers, calibrated resistance monitoring equipment, etc.). • Possesses good math and excel skills and aptitude. • Understands statistical process control data collection and process control methods. • Demonstrates strong analytical and critical thinking skills. PeopleShare is the leading Staffing Agency in the region and has temporary to hire and permanent jobs across 8 states. Our openings include receptionist, data entry, customer service, collections, office managers, call center, administrative assistant, accounts payable clerk, accounts receivable clerk, file clerk, warehouse, assembly, production, pickers, packers, forklift, machine operators, and maintenance mechanics. PeopleShare provides equal opportunities to all employees and applicants for employment without regard to race, religion, color, age, sex, national origin, sexual orientation, gender identity, genetic disposition, neurodiversity, disability, veteran status, or any other protected category or class under federal, state, and/or local laws. This policy applies to all locations and all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. IND##IND7IND7

Job DescriptionDIRECT HIRE: A great opportunity for a Quality Assurance Assistant to join a dynamic team in the Allentown, PA. area. Hourly Rate: $19hr - $23hr Benefits: Medical, dental, vision, PTO, 401K, short-term disability, employee life Schedule: M-F, 40hrs +OT Roles & Responsibilities: Test and conduct routine and non-routine in-process inspection of production output, measure samples of finished product and check production quality verifications for completeness, timeliness and tolerances as well as complete product testing of finished goods Assist with incoming inspections for internal / external suppliers as directed Confirm discrete job special instructions are being followed or met Member of daily audit team for various product and process audits per checklist Participant in the revision and update of standard operating procedures Conduct and complete Internal Quality audits and may be involved in the development of testing method Ensure employees adhere to safety and quality standards Skills and qualifications: 1-3 years manufacturing experience: required (metal, paint/finishing industries: a plus) High School Diploma or GED: required ISO 9000 and 5S Program knowledge and experience Measuring tools knowledge and experience Customer focused mindset Proven hands-on shop floor experience; forklift experience Working knowledge Microsoft Office (Word, Excel, PowerPoint) Good work record; Strong work ethic Strong communication and interpersonal skills Good teamwork and time management skills Experience in a high volume fast paced environment Once you apply, please text "QAA" to ************ for a faster reply. INDH Powered by JazzHR za964VIUsY

Title: ICQA Associate Hours/Shift: 1st Shift Mon - Fri 8:00 am - 4:30 pm at $20.25hr or 2nd Shift Sat - Wed 3:00pm to 11:30pm at $21.25hr If you're looking to be at the forefront of disrupting the ecommerce industry, wanting to make your mark and be continuously challenged to grow, your time has come. ShipBob is recognized as #1 on Crain's 2020 "Fast 50" list of the fastest-growing companies in Chicago & Inc.5000 top 500 companies with the most proven track records. With this growth, we are looking for top talent to help us reach the next level. Role Description: This is an incredibly important position that helps to monitor inventory activities of all clients at each fulfillment center while allowing all existing operations team members to remain focused on their day-to-day responsibilities. As ShipBob continues to grow, it is imperative to provide a great experience in serving our clients' needs while maintaining sustainable growth and scalability from an operations perspective. About Us: ShipBob is a cloud based logistics platform that partners with over 5,200+ e-commerce businesses to help them be more successful online. We offer a full suite of fulfillment solutions for our merchants, including the ability to improve their transit times, shipping costs and deliver best in class experience to their customers. With almost 100% accuracy rate in fulfilling orders and orders shipped on time, our merchants can count on us to deliver excellent service. ShipBob's growing fulfillment network is powered by our proprietary technology and acts as a back office for logistics, providing merchants with full visibility into orders, inventory levels in real time, and access to advanced analytics, over 27 integrations and data reporting. As one of the fastest growing tech companies in Chicago with over $330M+ raised from blue-chip investors like Menlo Ventures, Bain Capital Ventures, Hyde Park Venture Partners and SoftBank Vision Fund 2, our goal is to continue to be the #1 best fulfillment technology in the industry. To help us meet this standard, we are scaling our entire team and looking for people who share our core values and have an entrepreneurial mindset About You: At ShipBob, we're looking for individuals who embody our core values: * Be Mission-Driven. We want team members that are passionate about helping entrepreneurs improve their business, and bring that passion every day. * Be Humble. We have ambitious goals, and our team members understand that success or failure depends on us working together and leaving egos at the door. * Be Resilient. Logistics is a complicated business. So is software. We value team members that never give up and keep iterating until a problem is solved. * Be a Creative Problem Solver. As a startup, we value smart, innovative solutions to complex problems. We fall in love with the problem, not our "favorite" solution. * Be Safety Minded. It's not just talk; it's the way you work. What You'll Do: * Investigate inventory discrepancies reported by the Operations team. * Perform physical inventory cycle counts, and reconcile inventory variances. * Communicate updates and relay important operational information about clients directly to ICQA Lead. * Play a pivotal role in understanding the root cause of inventory adjustments and participate in efforts to correct. * Vocalize concerns around inventory practices to ICQA Lead, helping to identify areas of opportunity in day to day processes. Expectations: * Proficient in cycle counting and inventory control processes according to written SOP's. * Perform Root Cause Analysis around inventory discrepancies and review findings with ICQA Lead. * Ensure inventory variances are researched and resolved in a timely manner, allowing fulfillment of outbound orders. * Ensure timely communications to MC team for any orders not able to be fulfilled due inventory discrepancies. What You'll Bring To The Table: * Demonstrates the ability to quickly adapt to changing conditions and solve problems immediately. * Ability to determine inventory discrepancies, perform physical inventory cycle counts, and reconcile inventory variances. * Possesses effective written and verbal communication skills; displays reading comprehension skills. * Displays the ability to multitask and handle multiple issues at the same time without stress. * Displays attention to details. * Ability to lift 40lbs without any health limitations. * Able to stand and walk continuously during and up to an 8-10hr shift. * Able to bend, stoop, reach above, and push/pull frequently. * May be required to flex into other departments for support as needed. We recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. Diversity of experience and skills combined with passion is a key to innovation and excellence; therefore, we encourage people from all backgrounds to apply to our positions. Perks and Benefits: * Medical, Dental, Vision & Basic Life Insurance * 401K Match * Variety of voluntary benefits, such as: short term disability * Weekly paychecks & Wage Progression Program * KinderBob Daycare Stipend program * Paid Time Off & Sick Time Off * Referral Bonus Program * Fun Culture >>> Check us out on Instagram Reports to: ICQA Area Manager Classification: Hourly/Non-Exempt ShipBob provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

🧪 Quality Assurance Operations Supervisor | Bethlehem, PA Join a well-established, FDA-regulated pharmaceutical manufacturing site in Bethlehem, PA that produces acute care drug products used in hospitals worldwide. This team is known for its strong quality culture, long-term stability, and investment in people. Competitive salary, bonus eligibility, and excellent benefits starting day one! 🔍 Job Summary The Quality Assurance Operations Supervisor oversees GMP quality activities supporting manufacturing and packaging operations. This role plays a critical part in batch record review and disposition, deviations and CAPAs, OOS investigations, QC data review, and drug product complaint management to ensure regulatory compliance and product quality. 🛠 Key Responsibilities Coordinate batch documentation review with manufacturing and packaging teams to support timely product release. Ensure API and drug product batches comply with GMP and regulatory requirements. Supervise daily activities of the QA Operations team. Mentor and coach team members while supporting succession planning. Review production and QC documentation prior to batch disposition. Ensure deviations, data integrity issues, and errors are investigated per internal procedures. Oversee QC data review and OOS investigations. Perform documented QA walkthroughs of manufacturing and packaging operations. Collaborate with global QA partners to support batch release activities. Manage the drug product complaint program, including investigations and reporting. Prepare QA metrics for weekly, monthly, and quarterly management meetings. ✅ Skills & Competencies Strong risk-based decision-making and critical thinking skills Ability to evaluate quality issues using GMP knowledge and data analysis High attention to detail with a proactive sense of urgency Strong customer service mindset and professional communication style Excellent written and verbal communication skills Motivated, energetic, and people-focused leadership approach 🎓 Education / Experience Bachelor's degree preferred or equivalent experience 10+ years of pharmaceutical or biotech industry experience Experience with QMS tools such as TrackWise, EDMS, LMS, or similar Working knowledge of 21 CFR Parts 210, 211, and Part 11; Part 820 familiarity preferred.

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 Change Control Specialist II as part of the Quality team based in Raritan, NJ. Role Overview The QA Change Control Specialist II role is an exempt level position with responsibilities for providing quality oversight over the change control process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will be responsible for managing change control activities throughout the lifecycle. Key Responsibilities Support and streamline the site change control process. Participate in change control process from initiation through completion. Schedule and participate in the site change control review board meetings. Manage change control metrics reporting. Collaborate with functional departments to resolve issues. Support drafting of standard operating procedures. Support cross-functional projects with many stakeholders. Participate in the training program for new members. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Review change controls, SOPs, and other documentation. Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes. Drive continuous improvement. Have advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge. Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Quality Control, and Operations Technical Support. Requirements A minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required. Minimum of 2 years relevant work experience is required. It is preferable that the candidate has experience working in a cGMP manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. GxP Quality System knowledge, including relevant regulations and guidances (e.g. 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA). Operational experience with electronic quality systems. Familiarity with core Quality Management System processes. Strong written and verbal communication skills, and analytical problem solving and conflict resolution skills. IT system lifecycle knowledge including requirements gathering, change management, implementation and continuous support is a plus. Flexible, highly motivated, with strong organization skills, ability to multi task with attention to detail. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment. Effective interpersonal skills with the ability to communicate across all levels of the organization. Ability to work independently with a high degree of accountability. Proficient knowledge of Microsoft Office. Experience in quality metrics reporting, analysis and process improvement techniques is a plus. Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint). #Li-BZ1 #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 vacation days, personal days, sick time, 11 company 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. Please note: These benefits are offered exclusively to permanent 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. Legend Biotech maintains a drug-free workplace.

DIRECT HIRE: A great opportunity for a Quality Assurance Assistant to join a dynamic team in the Allentown, PA. area. Hourly Rate: $19hr - $23hr Benefits: Medical, dental, vision, PTO, 401K, short-term disability, employee life Schedule: M-F, 40hrs +OT Roles & Responsibilities: Test and conduct routine and non-routine in-process inspection of production output, measure samples of finished product and check production quality verifications for completeness, timeliness and tolerances as well as complete product testing of finished goods Assist with incoming inspections for internal / external suppliers as directed Confirm discrete job special instructions are being followed or met Member of daily audit team for various product and process audits per checklist Participant in the revision and update of standard operating procedures Conduct and complete Internal Quality audits and may be involved in the development of testing method Ensure employees adhere to safety and quality standards Skills and qualifications: 1-3 years manufacturing experience: required (metal, paint/finishing industries: a plus) High School Diploma or GED: required ISO 9000 and 5S Program knowledge and experience Measuring tools knowledge and experience Customer focused mindset Proven hands-on shop floor experience; forklift experience Working knowledge Microsoft Office (Word, Excel, PowerPoint) Good work record; Strong work ethic Strong communication and interpersonal skills Good teamwork and time management skills Experience in a high volume fast paced environment Once you apply, please text "QAA" to ************ for a faster reply. INDH

Title: ICQA Associate Hours/Shift: 1st Shift Mon - Fri 8:00 am - 4:30 pm at $20.25hr or 2nd Shift Sat - Wed 3:00pm to 11:30pm at $21.25hr If you're looking to be at the forefront of disrupting the ecommerce industry, wanting to make your mark and be continuously challenged to grow, your time has come. ShipBob is recognized as #1 on Crain's 2020 “Fast 50” list of the fastest-growing companies in Chicago & Inc.5000 top 500 companies with the most proven track records. With this growth, we are looking for top talent to help us reach the next level. Role Description: This is an incredibly important position that helps to monitor inventory activities of all clients at each fulfillment center while allowing all existing operations team members to remain focused on their day-to-day responsibilities. As ShipBob continues to grow, it is imperative to provide a great experience in serving our clients' needs while maintaining sustainable growth and scalability from an operations perspective. About Us: ShipBob is a cloud based logistics platform that partners with over 5,200+ e-commerce businesses to help them be more successful online. We offer a full suite of fulfillment solutions for our merchants, including the ability to improve their transit times, shipping costs and deliver best in class experience to their customers. With almost 100% accuracy rate in fulfilling orders and orders shipped on time, our merchants can count on us to deliver excellent service. As one of the fastest growing tech companies in Chicago with over $330M+ raised from blue-chip investors like Menlo Ventures, Bain Capital Ventures, Hyde Park Venture Partners and SoftBank Vision Fund 2, our goal is to continue to be the #1 best fulfillment technology in the industry. To help us meet this standard, we are scaling our entire team and looking for people who share our core values and have an entrepreneurial mindset About You: At ShipBob, we're looking for individuals who embody our core values: Be Mission-Driven. We want team members that are passionate about helping entrepreneurs improve their business, and bring that passion every day. Be Humble. We have ambitious goals, and our team members understand that success or failure depends on us working together and leaving egos at the door. Be Resilient. Logistics is a complicated business. So is software. We value team members that never give up and keep iterating until a problem is solved. Be a Creative Problem Solver. As a startup, we value smart, innovative solutions to complex problems. We fall in love with the problem, not our “favorite” solution. Be Safety Minded. It's not just talk; it's the way you work. What You'll Do: Investigate inventory discrepancies reported by the Operations team. Perform physical inventory cycle counts, and reconcile inventory variances. Communicate updates and relay important operational information about clients directly to ICQA Lead. Play a pivotal role in understanding the root cause of inventory adjustments and participate in efforts to correct. Vocalize concerns around inventory practices to ICQA Lead, helping to identify areas of opportunity in day to day processes. Expectations: Proficient in cycle counting and inventory control processes according to written SOP's. Perform Root Cause Analysis around inventory discrepancies and review findings with ICQA Lead. Ensure inventory variances are researched and resolved in a timely manner, allowing fulfillment of outbound orders. Ensure timely communications to MC team for any orders not able to be fulfilled due inventory discrepancies. What You'll Bring To The Table: Demonstrates the ability to quickly adapt to changing conditions and solve problems immediately. Ability to determine inventory discrepancies, perform physical inventory cycle counts, and reconcile inventory variances. Possesses effective written and verbal communication skills; displays reading comprehension skills. Displays the ability to multitask and handle multiple issues at the same time without stress. Displays attention to details. Ability to lift 40lbs without any health limitations. Able to stand and walk continuously during and up to an 8-10hr shift. Able to bend, stoop, reach above, and push/pull frequently. May be required to flex into other departments for support as needed. We recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. Diversity of experience and skills combined with passion is a key to innovation and excellence; therefore, we encourage people from all backgrounds to apply to our positions. Perks and Benefits: Medical, Dental, Vision & Basic Life Insurance 401K Match Variety of voluntary benefits, such as: short term disability Weekly paychecks & Wage Progression Program KinderBob Daycare Stipend program Paid Time Off & Sick Time Off Referral Bonus Program Fun Culture >>> Check us out on Instagram Reports to: ICQA Area Manager Classification: Hourly/Non-Exempt ShipBob provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.