Quality assurance specialist jobs in Bethlehem, PA - 118 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.

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

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).

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.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: Johnson & Johnson is currently seeking three Quality Assurance Incoming Specialist II. This position will be located in Raritan, NJ! At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/. Johnson & Johnson Innovative Medicine, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment. In this role, you will be providing quality releases of materials related to the production of CAR-T and viral vectors in a controlled cGMP environment. You will act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns. Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity! Main Responsibilities will include, but are not limited to: Responsible for incoming inspection/release of materials related to manufacturing of autologous CAR-T products and viral vectors for clinical trials and commercial operation Reviews, inspection, and disposition of all incoming materials for use of CAR-T and viral vector product manufacturing per inspection plan and record results to complete receipt process Review inspection documentation (C of A or other Material Certifications) for inbound materials. Review and inspect documentation in support of Final Product Shipments Generates inspection reports and non-conformances for failures Ensures non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented Track investigations to ensure timely closure Provide Quality Oversight to Warehouse for cGMP compliance through spot checks/internal audits Support execution of technical protocols Participate in departmental or multi-functional, interdepartmental teams and meetings Support External/Internal Audits Provide quality oversight for incoming shipments of raw materials, working cell banks and consumables and outgoing shipments of viral vector drug substance. Author and revise Quality departmental documents. Review and approve controlled documents including standard operating procedures, master batch records, work instructions, protocols and reports, and technical studies. Participate in continuous improvement activities. Other duties may be assigned as necessary. Qualifications Education: A minimum of a Bachelor's Degree is required, with a focused degree in Engineering, Science or equivalent technical field preferred. Skills & Experience: Required: Minimum 2 years of industry experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry. Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) regulations and FDA/EU guidance Ability to be organized and capable of working in a team environment with a positive demeanor. A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills. Ability to work independently on routine tasks. Ability to maintain written records of work performed in paper-based and computerized quality systems. Preferred: Experience with quality support in clinical or GMP manufacturing or support of QC laboratories is preferred. Experience with the manufacture of cell and gene therapy products as well as knowledge of Good Tissue Practices is preferred. Other: Requires ability and flexibility to work 8-hour shifts 1st shift Tuesday-Saturday, and provide occasional off shift or weekend support, as needed. This position is located primarily in Raritan, NJ, and may require up to 5% local travel. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource. #car-t Required Skills: Preferred Skills: The anticipated base pay range for this position is : $65,000.00 - $104,650.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations. Schedule: Wed-Sat, 2 nd Shift Key Responsibilities Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process. Support manufacturing activities for cGMP compliance through spot checks/internal audits. Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation, in accordance with Good Documentation Practices (GDP). Review, revise, or draft Standard Operating Procedures (SOPs) Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised. Support batch review & material release in SAP for In-house reagents. Support Floor Spot-check, audit trail review. Strive to reduce non-conformances in supported areas by proactively driving compliance. Support Investigations team by providing quality and compliance input for continuous improvement and remediations. Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor. Utilize multiple electronic quality systems, batch records and SAP. Work in a team based, cross-functional environment to complete tasks required to meet business objectives. Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas. Provide QA shop floor support for extended periods of time. Responsibilities will include but not limited to tasks mentioned above. Support regulatory inspections and audits as needed. Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements. Other duties will be assigned, as the need arises. Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses Color Perception both eyes 5 slides out of 8. Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning Requirements Bachelors degree required in Life Sciences or Engineering. 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy. Experience with quality support in clinical manufacture is preferred. Flexible to work on weekends, as needed. Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position. Is frequently required to communicate with coworkers. While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms. Ability to lift 20 lbs. Report to work on-time. Duties are required to be performed on-site at manufacturing facility. Perform other duties as assigned. Attend departmental and other scheduled meetings. Practice good interpersonal and communication skills. Demonstrate positive team-oriented approach in the daily execution of procedures. Promote and work within a team environment. Learn new skills, procedures and processes as assigned by management and continue to develop professionally. Support and contributes to projects. Assist in troubleshooting issues related to manufacturing. Technical knowledge within functional units Demonstrate an understanding of the process in order to properly perform the assigned tasks. Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems. Utilizes tools within MS Office and other systems to improve business effectiveness. Read and interpret documents such as safety rules, operating instructions, and logbooks. Review and provide feedback for SOPs. Interpret a variety of instructions furnished in written, oral, or diagram. Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process. Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals, Aseptic processing in ISO 5 clean room and biosafety cabinets. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices. Great attention to detail and ability to follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. Good written and verbal communication skills are required. Ability to summarize and present results, and experience with team-based collaborations is a must. Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk. Ability to collaborate well with stakeholders, customers and peers. Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Must be able to discern the criticality of issues and to communicate to management regarding complex issues. Ability to manage conflict and issues that arise with internal or external customers. #LI-BG1 #LI-Onsite The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Performance-based bonus and/or equity is available to employees in eligible roles. The anticipated base pay range is:$75,972-$99,713 USD Benefits Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Please note: These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. For information related to our privacy policy, please review: Legend Biotech Privacy Policy.

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.

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 vUfAsB0Vzo

Established in 2000, A Minority Business Enterprise (MBE), LanceSoft Inc. is a pioneer in providing premium end-to-end Professional IT/Non-IT Contingent Workforce Solutions and IT Services to diverse clients across various domains. Core Service Offerings We offer a gamut of services across diverse domains, categories, skill sets with varying lengths of assignments, that include, but are not just limited to: - Temporary Staffing - Permanent Staffing - Payrolling - Recruitment Process Outsourcing (RPO) - Back-office Services - Application Design and Development - Website Design and Development - Program/Project Management Our Domain Strength With currently over 1000+ staff serving over 49 clients worldwide including “Fortune” companies, LanceSoft serves a wide array of industries including Healthcare/Pharma, Clinical/Medical Devices, Technology, Telecom, Retail and Distribution, Energy & Utilities, Banking, Finance, Insurance, Manufacturing, Automobile, Media, Transportation, and Government Sectors. Geographic Coverage LanceSoft is headquartered in Herndon, Virginia and has a network of branch offices across the US in Chicago (IL), Irving (TX), Basking Ridge (NJ), Atlanta (GA) and San Diego (CA). We also have an International footprint with two country offices in Canada (ON and BC) along with three delivery centers in India- Bangalore, Indore and Hyderabad to further help serve our clients better. We currently operate and recruit in 49 US states catering to diverse Contingent Workforce needs of our clients. Awards and Accolades Following are some of our awards and accolades in the US Contingent Workforce space: - Manpower “Premier Vendor” - 2014 - Kelly's “Supplier Innovation Award” - 2012 - Kelly's “Supplier of the Year” Award - 2012 and 2011 - Kelly's “Service Excellence Award” - 2010 and 2009 - “Stewardship Recognition” from Johnson & Johnson's (J&J) Kelly Work sense program Specialties IT/Non-IT Contingent Workforce Services, Creative Solutions, Temporary/Permanent Staffing, Recruitment Process Outsourcing, Payrolling, Application Design and Development, Back-office Services, Program/Project Management, Website Design and Development Job Description Title: Document Control Specialist-III Location: Horsham- PA PV Controlled Documents is a member of the Training & Document Control Center of Excellence (TDC CoE) group within Compliance Strategy and Analytics and is responsible for development and delivery of Global Medical Organization (GMO), Office of Consumer Medical Safety (OCMS) and Dual-sector medical safety procedural documents. The Senior Associate, PV Documents is responsible for assigned deliverables to promote regulatory compliance with respect to pharmacovigilance. This involves procedural document development on GMO, OCMS, and Dual-Sector Pharmacovigilance (PV) processes and pharmacovigilance-focused regulations. The Senior Associate, PV Controlled Documents identifies and supports improvement activities for a document management department of the highest standards that may be leveraged to support other Client's organizations and sectors as appropriate by actively interacting with Client colleagues. The Senior Associate, PV Documents supports projects that ensures document development requirements are identified and aligned to overall strategic objectives. The Senior Associate, PV Controlled Documents may participate on functional teams for projects in order to support achieving program deliverables. Support the development and delivery of assigned procedural documents by actively partnering with GMO/OCMS functional areas, other partners and Medical Safety Organizations as needed to ensure that desired outcomes and deliverables are met. Support procedural document initiatives and projects of moderate complexity. Facilitates Cross-pharma Reviews and Impact Assessments as needed. Provide Audits and Inspections support and litigation request support. Facilitate Procedural Document Committee meetings. Other duties as assigned. Qualifications The position requires the ability to: · Manage multiple, moderately complex procedural document assignments within timeframes with minimal guidance. · Communicate, both verbal and written, and collaborate effectively and professionally with internal colleagues and external parties · Lead committee meetings and projects/initiatives professionally · Foster consensus and make decisions independently appropriate to subject matter and responsibilities · Experience in procedural document development or quality role for a minimum of 5 years preferably in pharmaceutical industry · Demonstrated experience in Electronic Document Management System(s) · Proficient in Microsoft Word, PowerPoint, Excel, and Visio. · Pharmacovigilance knowledge or experience preferred. · Demonstrated strong Credo values. · Excellent oral and written communication skills, including formal presentation skills. · Commitment to providing excellent customer service. · Ability to work independently and successfully manage multiple priorities simultaneously. · Ability to establish successful working relationships with staff at all levels within the organization during the development of procedures. Additional Information Thanks and Regards Dishant Nagar ************

The employee is responsible for maintaining the quality procedures on production lines. They are responsible for handling material using appropriate equipment and processes, while making sure the department complies with company safety requirements, contributes to the quality improvement process and interfaces and communicates within their department. _________________________________________________________________________ Essential Job Requirements: Employee is required to be on the production line thirty, prior to shift startup. Check daily schedules to assure that no changes have taken place Read all work order information prior to start up Review all printed material for accuracy and appropriateness for use Match batch approval to work order signing if information is correct Inspect all codes on lines, jars, bottles, labels, folding cartons, packers, and shippers. Any mechanical problems found at this time should be conveyed to the Mechanic and Line Leader and QC Inspector. All issues concerning paperwork, components or batching will be reported to your Lead. Make sure all information is correct and sign the paperwork. If the information is not correct call your Lead. The Quality Assurance Auditor will be responsible after the shift start up for: The Auditor will insure that the cap is being sealed once an audit. If torques do not meet spec, inform line leader and inspector. Do not leave until the inspector signs your audit paperwork. If weights do not meet spec. inform line leaded and inspector. Do not leave until the inspector signs your audit paperwork. Aesthetics of the line are to be inspected. This will include label placement, dirt on containers, grease on bottom, etc. Any problems inform the line leader, inspector and call your lead if needed. At the end of the shift the job order duties are as follows: Employee will place all paperwork into the designated area. Employee will complete all paperwork for the next day before their departure. The Auditor will question the Quality Control Lead if they do not understand the requirements of the task to be performed. The employee reports to the Quality Control Lead and their work is reviewed or directed by this Lead, with monitoring of major job duties. Receiving this supervision is necessary, but not critical for successful job performance. Requirements Physical Requirements/Working Conditions • Employee is required to pass a drug and/or alcohol test. • While performing the job the employee must be able to stand and walk constantly during shift. • While performing the job the employee must be able to sit, push/pull, climb, stoop/crouch, crawl/kneel, twist, balance and reach occasionally during shift. • While performing the job the employee must be able to lift and carry 25 to 50 lbs frequently during shift. • To perform this position, the employee must be able to read and write English and do mathematical calculations. Hours: 6:00am - 3:00pm

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

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.

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations. Schedule: Wed-Sat, 2nd Shift Key Responsibilities * Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process. * Support manufacturing activities for cGMP compliance through spot checks/internal audits. * Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues. * Review of all documentation, in accordance with Good Documentation Practices (GDP). * Review, revise, or draft Standard Operating Procedures (SOPs) * Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised. * Support batch review & material release in SAP for In-house reagents. * Support Floor Spot-check, audit trail review. * Strive to reduce non-conformances in supported areas by proactively driving compliance. * Support Investigations team by providing quality and compliance input for continuous improvement and remediations. * Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor. * Utilize multiple electronic quality systems, batch records and SAP. * Work in a team based, cross-functional environment to complete tasks required to meet business objectives. * Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas. * Provide QA shop floor support for extended periods of time. * Responsibilities will include but not limited to tasks mentioned above. * Support regulatory inspections and audits as needed. * Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements. * Other duties will be assigned, as the need arises. * Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. * Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses * Color Perception both eyes 5 slides out of 8. * Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning Requirements * Bachelors degree required in Life Sciences or Engineering. * 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience * Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy. * Experience with quality support in clinical manufacture is preferred. * Flexible to work on weekends, as needed. * Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position. * Is frequently required to communicate with coworkers. * While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms. * Ability to lift 20 lbs. * Report to work on-time. * Duties are required to be performed on-site at manufacturing facility. * Perform other duties as assigned. * Attend departmental and other scheduled meetings. * Practice good interpersonal and communication skills. * Demonstrate positive team-oriented approach in the daily execution of procedures. * Promote and work within a team environment. * Learn new skills, procedures and processes as assigned by management and continue to develop professionally. * Support and contributes to projects. * Assist in troubleshooting issues related to manufacturing. * Technical knowledge within functional units * Demonstrate an understanding of the process in order to properly perform the assigned tasks. * Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems. * Utilizes tools within MS Office and other systems to improve business effectiveness. * Read and interpret documents such as safety rules, operating instructions, and logbooks. * Review and provide feedback for SOPs. * Interpret a variety of instructions furnished in written, oral, or diagram. * Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process. * Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. * Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals, * Aseptic processing in ISO 5 clean room and biosafety cabinets. * Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices. * Great attention to detail and ability to follow the procedures. * The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. * Good written and verbal communication skills are required. * Ability to summarize and present results, and experience with team-based collaborations is a must. * Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk. * Ability to collaborate well with stakeholders, customers and peers. * Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality. * Must be able to discern the criticality of issues and to communicate to management regarding complex issues. * Ability to manage conflict and issues that arise with internal or external customers. #LI-BG1 #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

Established in 2000, A Minority Business Enterprise (MBE), LanceSoft Inc. is a pioneer in providing premium end-to-end Professional IT/Non-IT Contingent Workforce Solutions and IT Services to diverse clients across various domains. Core Service Offerings We offer a gamut of services across diverse domains, categories, skill sets with varying lengths of assignments, that include, but are not just limited to: - Temporary Staffing - Permanent Staffing - Payrolling - Recruitment Process Outsourcing (RPO) - Back-office Services - Application Design and Development - Website Design and Development - Program/Project Management Our Domain Strength With currently over 1000+ staff serving over 49 clients worldwide including “Fortune” companies, LanceSoft serves a wide array of industries including Healthcare/Pharma, Clinical/Medical Devices, Technology, Telecom, Retail and Distribution, Energy & Utilities, Banking, Finance, Insurance, Manufacturing, Automobile, Media, Transportation, and Government Sectors. Geographic Coverage LanceSoft is headquartered in Herndon, Virginia and has a network of branch offices across the US in Chicago (IL), Irving (TX), Basking Ridge (NJ), Atlanta (GA) and San Diego (CA). We also have an International footprint with two country offices in Canada (ON and BC) along with three delivery centers in India- Bangalore, Indore and Hyderabad to further help serve our clients better. We currently operate and recruit in 49 US states catering to diverse Contingent Workforce needs of our clients. Awards and Accolades Following are some of our awards and accolades in the US Contingent Workforce space: - Manpower “Premier Vendor” - 2014 - Kelly's “Supplier Innovation Award” - 2012 - Kelly's “Supplier of the Year” Award - 2012 and 2011 - Kelly's “Service Excellence Award” - 2010 and 2009 - “Stewardship Recognition” from Johnson & Johnson's (J&J) Kelly Work sense program Specialties IT/Non-IT Contingent Workforce Services, Creative Solutions, Temporary/Permanent Staffing, Recruitment Process Outsourcing, Payrolling, Application Design and Development, Back-office Services, Program/Project Management, Website Design and Development Job Description Title: Document Control Specialist-III Location: Horsham- PA PV Controlled Documents is a member of the Training & Document Control Center of Excellence (TDC CoE) group within Compliance Strategy and Analytics and is responsible for development and delivery of Global Medical Organization (GMO), Office of Consumer Medical Safety (OCMS) and Dual-sector medical safety procedural documents. The Senior Associate, PV Documents is responsible for assigned deliverables to promote regulatory compliance with respect to pharmacovigilance. This involves procedural document development on GMO, OCMS, and Dual-Sector Pharmacovigilance (PV) processes and pharmacovigilance-focused regulations. The Senior Associate, PV Controlled Documents identifies and supports improvement activities for a document management department of the highest standards that may be leveraged to support other Client's organizations and sectors as appropriate by actively interacting with Client colleagues. The Senior Associate, PV Documents supports projects that ensures document development requirements are identified and aligned to overall strategic objectives. The Senior Associate, PV Controlled Documents may participate on functional teams for projects in order to support achieving program deliverables. Support the development and delivery of assigned procedural documents by actively partnering with GMO/OCMS functional areas, other partners and Medical Safety Organizations as needed to ensure that desired outcomes and deliverables are met. Support procedural document initiatives and projects of moderate complexity. Facilitates Cross-pharma Reviews and Impact Assessments as needed. Provide Audits and Inspections support and litigation request support. Facilitate Procedural Document Committee meetings. Other duties as assigned. Qualifications The position requires the ability to: · Manage multiple, moderately complex procedural document assignments within timeframes with minimal guidance. · Communicate, both verbal and written, and collaborate effectively and professionally with internal colleagues and external parties · Lead committee meetings and projects/initiatives professionally · Foster consensus and make decisions independently appropriate to subject matter and responsibilities · Experience in procedural document development or quality role for a minimum of 5 years preferably in pharmaceutical industry · Demonstrated experience in Electronic Document Management System(s) · Proficient in Microsoft Word, PowerPoint, Excel, and Visio. · Pharmacovigilance knowledge or experience preferred. · Demonstrated strong Credo values. · Excellent oral and written communication skills, including formal presentation skills. · Commitment to providing excellent customer service. · Ability to work independently and successfully manage multiple priorities simultaneously. · Ability to establish successful working relationships with staff at all levels within the organization during the development of procedures. Additional Information Thanks and Regards Dishant Nagar ************

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.

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