Quality assurance specialist jobs in Franklin, NJ

Join a growing and trusted pharmaceutical organization dedicated to advancing quality in sterile drug production. As a QA Manufacturing Specialist, you'll provide direct quality oversight of production operations, ensuring alignment with cGMP guidelines as defined under Section 503B. This role supports compliance in compounding, filling, inspecting, and packaging processes by monitoring critical procedures and documentation. Ideal for detail-driven individuals eager to contribute to regulatory excellence and patient safety. RESPONSIBILITIES Monitor daily production floor activities including compounding, aseptic filling, visual inspection, and packaging to uphold quality standards Ensure cleaning protocols are thoroughly followed and documented in manufacturing areas Approve product labels and ensure compliance prior to use Conduct verification of line clearance, material status, aseptic techniques, and documentation during filling operations Ensure personnel follow proper gowning procedures across all production zones Identify and document quality events such as deviations, initiate CAPAs, and manage change controls Represent QA interests during audits and inspections as needed Assist with root cause investigations to drive continuous improvement Maintain detailed and accurate batch records, logs, and compliance documentation Adhere to company policies and support additional duties as needed QUALIFICATIONS Minimum 3 years of experience in quality assurance within aseptic drug manufacturing, preferably in a 503B outsourcing facility High school diploma required; BS in a scientific discipline preferred Solid understanding of cGMP, Good Documentation Practices, and pharmaceutical quality systems Knowledge of manufacturing operations, automation, and cleanroom practices Proficient in Microsoft Office (Word, Excel, PowerPoint); ability to learn new systems as required Effective communication skills with ability to work independently and under time-sensitive conditions Adaptable to rotating shifts, weekend schedules, and holiday coverage if required Physical ability to lift up to 25 pounds and wear required cleanroom attire, including scrubs, gloves, and safety footwear Comfortable working in cleanroom environments and with hazardous substances as necessary

Duration: 12 months The Quality Management Specialist II tasks include: CW shadows 3 ongoing studies and supports 7 ongoing studies (planning to reporting stage) to provide Quality oversight, to recommend best practices. Communicates and collaborates with the stakeholders (CM and FAs) partnering for cross-functional team support and attendance of project and study level meetings. With the assistance of Senior GCP Level 1 members, consults on major and critical quality issues, potential Serious Breaches, significant noncompliance, data integrity issues and protocol deviations, escalates to Senior Management, and performs periodic resolution checks for assigned studies. Supports risk assessments and risk-based approaches for the annual GQM Audit Plan, identifies the number of site audits and vendor audits based on risk-criteria with input from study teams. Provides study and site related information and documentation to the audit team, GCP Level 2 in preparation for audits. Participates in the risk assessment of preferred and active vendors utilizing risk assessment tools to prepare the annual GQM Vendor Audit Plan. Involved in CAPA review of Quality Issues, Audits, Inspections, eTMF audit responses. Participates and contributes to weekly, monthly, and quarterly GQM GCP meetings. Attends QA:QA and Quality Council meetings with CRO accompanied by a Senior Member from the GCP In-Line Quality (Level 1) Participates in the review and harmonization process of controlled documents such as protocols/ICF, CSRs, amendments, procedural documents & templates. Receives GCP training of ICH Guidelines E6 R3 and Modules from 21CFR and reads GCP Material. Team Members in training participate in weekly team support meetings. Involved in the Portfolio-wide proactive Inspection Readiness support (Sponsor, Site, CRO) - conducts Do & Don't training, participates in interview preparations/debriefs, assesses Inspection Readiness Visits and Pre-Inspection Visits outcomes. Reviews and assesses Pharmacovigilance System Master File (PSMF) and performs PV related activities as assigned. Qualifications: Bachelors Degree; preferably some Pharmaceutical background and GCP ICH E6 knowledge. 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, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Recruiter Details: Name: Vicky Email: ********************************** Internal Id: 25-54443

JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

Program Dates May 19th, 2026 - August 7th, 2026 About Wakefern Wakefern Food Corp. is the largest retailer-owned cooperative in the United States and supports its co-operative members' retail operations, trading under the ShopRite , Price Rite , The Fresh Grocer , Dearborn Markets , Fairway Markets , Gourmet Garage , and Morton Williams banners. Employing an innovative approach to wholesale business services, Wakefern focuses on helping the independent retailer compete in a big business world. Providing the tools entrepreneurs need to stay a step ahead of the competition, Wakefern's co-operative members benefit from the company's extensive portfolio of services, including innovative technology, private label development, and best in class procurement practices. Your contribution If you are a student who is pursuing an education in Supply Chain Management, Food Engineering, Quality Assurance, Quality Control Management, or other related fields, these internship opportunities may be a great fit for you! Wakefern prides itself in being the industry leader in Logistics and Distribution. Our organization currently services over 400+ retail stores throughout the northeast. The Logistics Infrastructure includes 9 warehouses in New Jersey and Pennsylvania, housing 4 million square feet of warehouse space. Wakefern's fleet of over 2000 trailers ship approximately 1.4 million cases daily while traveling 52,000,000 miles per year! This sophisticated operation utilizes state of the art technology to meet the needs of our more than 8 million customers. Quality Assurance: Product Inspector (Produce) track: This internship goes beyond a typical desk job, you'll be immersed in the core of our supply chain operations. The QA (Produce) Intern plays a hands-on role in inspecting fresh produce and other perishable items to ensure quality, safety, and compliance with Wakefern standards. This position involves physically examining inbound deliveries for grade, freshness, proper labeling, and packaging integrity, as well as monitoring temperatures and verifying weights and counts. Interns will gain first-hand experience with Wakefern's Food Safety and Quality Practices, USDA and FDA guidelines. Interns will be learning leadership skills mentored by supervisors to understand all skills required in a Quality Assurance Product Inspection department. What you will do Work in a refrigerated warehouse environment. Inspects all inbound deliveries to ensure the purchased goods conform to all established product specifications, standards, and grade requirements. Performs random organoleptic inspections of inbound goods to assure the quality, grade, and wholesomeness of the product. Inspects all inbound deliveries for cleanliness and soundness of the transportation vehicle and the absence of cross contamination. Monitors product temperatures by means of physical probing of goods and observation of time and temperature recording devices. Verifies the weights and counts of received goods. Examines all packaging for proper labeling and enforces all packaging and labeling requirements of the FDA, USDA, and USDC. Monitors products in inventory and storage for quality and safety. Performs daily sanitation inspections of all applicable facilities and warehouses. Gathers and organizes all records and documentation to comply with all regulatory requirements. Monitors all control points, critical control points, and quality control points for each of the food safety and food quality plans for the applicable perishable food facilities. Physical demands include the ability to bend, stretch, extend, tug and pull based on inspection of various products, Ability to work in cold temperatures as low as 33 °F. 5 days on site - no remote work. Wear OSHA-Compliant Steel Toe or Composite Safety Boots when in the warehouse is required. Bilingual Spanish / English is a plus, but not required. Provide coverage for the Shift Supervisors, working any 5 of the 7-days, including weekends, holidays, vacations, and peak volume periods. Interns work 40 hours per week. Various projects as assigned. Interns will be based out of one of the following warehouse locations and may work one of the following shifts: Locations/Shifts Northern Perishables - Elizabeth, NJ 5:00am-1:30pm or 6:00am-2:30pm (shift times may be later on certain days to reflect events interns are required to attend) Produce Facility - Newark, NJ 5:00am-1:30pm or 6:00am-2:30pm (shift times may be later on certain days to reflect events interns are required to attend) What we are looking for Must be at least 18 years old Must have completed 24 college credits with a 3.0 cumulative GPA or better Will be enrolled in an undergraduate or graduate school for fall Successful completion of a substance abuse test is required Successful completion of a background check is required Reliable transportation is required Strong interpersonal, analytical, and customer service skills with the ability to multitask and manage time effectively Excellent communication skills (written, oral, and presentation) Strong MS Office skills (Excel, Word, and PowerPoint required) Ability to exhibit proper business etiquette when dealing with all levels of the organization Previous work experience in a retail environment is beneficial Must have flexibility with regard to schedule which can include coverage for a 7-day work week, weekends, holidays, vacations and peak volume weeks (interns will work 40 hours per week) Company Perks Vibrant Food Centric Culture Corporate Training and Development University Collaborative Team Environment Educational Workshops Networking Opportunities Volunteer Opportunities Compensation and Benefits: First year Wakefern Supply Chain/Logistic Interns will be paid at $18.00 per hour. Master Students and Returning Wakefern Supply Chain/Logistic Interns will be paid at $19.00 per hour. Interns are not eligible for company benefits including medical, dental, and vision coverage, life and disability insurance, a 401(k) retirement plan with company match & annual company contribution, paid time off and holidays.

12-month contract Hybrid in Princeton, NJ - onsite on Wednesday Responsibilities: Shadow and support quality oversight activities for 10+ ongoing clinical studies (from planning to reporting stages), ensuring best practices are identified and followed. Partner and communicate with Clinical Managers (CMs) and Functional Area (FA) stakeholders to provide cross-functional team support and attend project/study-level meetings. With guidance from senior GCP auditors, consult on and escalate major/critical quality issues, serious breaches, data integrity concerns, and protocol deviations to senior management. Conduct periodic resolution checks and follow-ups on quality issues for assigned studies. Contribute to risk assessments and development of the annual GQM Audit Plan by recommending the number and type of site/vendor audits based on study risk. Gather and provide study-related documentation and insights to the audit team and GCP Level 2 auditors in preparation for audits. Participate in the risk evaluation of preferred and active vendors to support the annual GQM Vendor Audit Plan. Support CAPA (Corrective and Preventive Action) reviews stemming from quality issues, audits, inspections, and eTMF (electronic Trial Master File) assessments. Engage in weekly, monthly, and quarterly GQM GCP team meetings, as well as QA:QA and Quality Council meetings alongside senior audit team members. Assist in the review and harmonization of controlled documents including protocols, informed consent forms (ICFs), clinical study reports (CSRs), amendments, SOPs, and templates. Participate in ongoing GCP training, including ICH E6 R3 guidelines, 21 CFR modules, and team-led educational sessions. Provide support across portfolio-wide inspection readiness activities (sponsor, site, CRO), including delivery of Do & Don't training, interview preparation, debriefs, and findings analysis. Review and assess the Pharmacovigilance System Master File (PSMF) and conduct PV-related quality activities as assigned. Qualifications: Bachelor's degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related field. 1-2 years of experience in clinical research, clinical quality assurance, or GxP-related functions preferred. Familiarity with GCP guidelines (ICH E6) and FDA 21 CFR Part 11 and 312 regulations. Strong organizational and communication skills with the ability to work cross-functionally. Analytical mindset with the ability to identify and assess quality risks. Demonstrated ability to learn in a fast-paced, collaborative environment. Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook). Previous exposure to TMF systems, CAPA processes, or audit support is a plus. Interest in building a career in clinical quality, auditing, or compliance.

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 Sr. Manager of GLP QA as part of the Regulatory Affairs team based in Somerset, NJ. Role Overview The incumbent/appointee will be responsible for ensuring that the relevant nonclinical studies are performed in compliance with GLP regulations and Health Authorities' guidance/principles. He/she will maintain a compliant quality system to meet these requirements, and will be responsible for the overall (GLP) quality oversight of studies, from the assessment of external vendors via audits to their onboarding. The appointee will oversee the overall laboratory processes by reviewing and/or supporting the development of SOPs, and supporting the bioanalytical assays that are required for the GLP or CGLP studies. She/he may be involved in overseeing the work performed by external contract research organizations (CROs) and/or consultants. It is expected that the appointee will have a broad knowledge of GCP/ICH guidelines in order to support cross-functional teams and provide input in GCP/GLP processes; in fact, he/she will partner with the study teams in order to maintain and/or reinforce a ‘quality culture', thus contributing to Legend Biotech's inspection-readiness goal. The appointee is expected to be local (Somerset, NJ) and be on a hybrid work schedule (i.e., 2-3 days working at the Somerset, NJ, site.) The incumbent will report to the Sr. Director of Clinical Quality Assurance. Key Responsibilities Support the GLP quality compliance systems, via established policies and procedures for the GLP QA function. Manage GLP quality systems including all implementation and maintenance of procedures and standards. Perform audits and other reviews when necessary or required to ensure compliance. Support the process of GCP/GLP deviations from study protocols or standard operating procedures. Support internal and external GLP study audits and general laboratory compliance audits to ensure that laboratories, internal and external are adhering to all quality protocols and regulations. Collaborate with the GLP's relevant functions in reviewing relevant data for nonclinical and clinical studies to verity data integrity and to ensure work was performed according to protocols and complied with all relevant regulations. Provide quality oversight of contract or internal testing facilities to ensure adherence to all regulations, standard procedures and protocols. Alert the appropriate level of management with any non-compliance issues, ensure all corrective actions take place and elevate concerns when necessary. Support the development of agenda items for Early Development (EDD) team meetings to provide input and quality perspectives Provide input in the development of GLP related SOPs, and support cross-functional teams in the development of “Quality” related documentation (e.g., SOPs, training modules), and other documents as assigned. Communicate activities and feedback to core Quality management team to allow other team members to identify any issues or action items that need addressing. Contribute to GLP audits/inspections and coordinate the review of responses to regulatory agency questions resulting from these inspections, and/or from external/internal audits Requirements Bachelor's degree in biology, biochemistry, or the life sciences Must be able to communicate effectively in English A minimum of 3 years (for Sr. Manager) or 1 year (for Manager level) of related industry experience in Quality 3 years of experience in working and/or overseeing GLP Quality in laboratories testing biologics Experience performing audits of GLP testing labs is a plus Experience with participation in and hosting regulatory audits is a plus Experience working with CROs, vendors, and relationship management Experience in auditing activities Ability and desire to work well with diverse employees and customers in a cooperative and supportive manner. Must be a team player with good interpersonal skills, a forward thinker, always looking for pragmatic solutions that highlight ‘quality' while being resource-efficient Strong project management skills Ability to articulate QA-GLP perspective and the status of QA-related activities at cross-functional meetings Working knowledge of relevant FDA, ICH GCP guidelines, and GCP, GLP related regulations Results driven with demonstrated successful outcomes #Li-JR1 #Li-Hybrid The anticipated base pay range is: $142,146 - $186,567 USD Benefits: We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace.

Bond Vet is on a mission to strengthen the human-animal bond through better pet care. We offer primary and urgent care, so we're there for pets when they need us most. Our clinics are designed with pets and people in mind: warm, friendly, and highly sniffable. We balance this design with a strong focus on technology, all built in-house, which means we can easily innovate our systems to improve the veterinary team, pet, and client experience. About the Role At Bond Vet, we are passionate about pushing the boundaries of pet healthcare and redefining industry standards. We believe in innovation, creativity, and delivering exceptional value to our team, clients and their beloved pets. Our commitment to excellence has led us to create a unique opportunity for a team leader of medical programs and projects who can drive our efforts in developing groundbreaking solutions in pet healthcare. As a leader, you will play a pivotal role in aligning medical strategy with our company's strategic goals. Your responsibilities will span across operational and medical-focused programs, with an emphasis on supporting our operations team on strategic initiatives that are identified by the CVO and our Ops leadership team. As a senior leader, you will also be spending about 25% of your time spent as a DVM in an assigned shift on the floor. This is in the spirit of connecting with our teams on the ground to find areas of opportunity and test the programs and projects success that are implemented. Work Location & Flexibility At Bond Vet, we know great work can happen in different environments. This role is hybrid, with the expectation that team members are within commuting distance of one of our Bond Vet clinics. While much of your work can be done remotely, you'll have regular in-person time at a local clinic - including completing 1-2 clinical shifts per week, as all our medical leadership do - to provide vital context for the organizational work we aim to accomplish. Being close to our clinics also supports relationship-building, team support, project development, deployment, and a deeper understanding of daily operations. If you live near any Bond Vet market - including NYC, Boston, DC, Chicago, New Jersey, or Philadelphia - we welcome applicants who are excited about a flexible, hybrid work experience. Your Priorities * Leadership presence - being there for our teams * Medical Quality - setting clinical standards, program oversight * Program development, deployment planning, & execution * Medical strategy and innovation - keep us at forefront of veterinary medicine Your Strengths * Able to think strategically and execute tactically * Makes progress with imperfect information * Autonomous following strategic alignment * Detail-oriented and accountable * Solution-oriented Core Responsibilities Leadership presence & field support * Round regularly in clinics (target: each site ~2×/year) to coach, observe care, and remove blockers; host brief huddles/debriefs with MD/AMD/RMD and nursing leads. * Represent medical leadership at CEs, conferences, campus events, and community engagements; present or facilitate CE as needed. * Maintain visibility on established clinician communication channels; participate in leadership calls and cross-functional forums. * Act as a mentor and coach to team members, providing guidance and support to help them reach their full potential. * Develop well-rounded medical professionals capable of balancing employee, client, pet, and business needs. * Lead by example, promoting a high-performance culture and holding the team accountable for achieving project objectives. Medical quality & program execution * Own the medical operations teams' quarterly medical quality survey metric -define measures (e.g., access, communication, adherence), set targets, validate data, and publish a quarterly quality readout by region. * Stand up and chair a quarterly Safety Committee; lead case reviews and publish a brief safety update highlighting decisions and changes. * Plan and deliver skills laboratories (e.g., dentistry, surgery; for doctors and technicians); publish an annual training calendar and track participation and skill sign-offs. Program and Project Leadership: * Take ownership of individual projects, driving them from conception to completion and ensuring they meet or exceed client and pet needs. * Oversee various medical programs, including but not limited to the MADE New Graduates Program, AI Scribing, Surgical Hub and Spoke, Clinic Flow, and Development DVM. * Ensure each program/project has measurable KPIs and regularly review efficiency and effectiveness. * Lead with metrics-driven analysis, leveraging data to inform decision-making. Clinical standards & SOPs * Maintain the system's clinical protocols/SOP library (change control, versioning, and adoption audits); partner with SMEs (dentistry, anesthesia/analgesia, ECC) to keep content current and practical. * Create concise checklists, job aids, and owner communication templates for high-impact workflows (diagnostic follow-up, surgery booking, pre/post-op instructions). Medical communication * With administrative support, curate and edit a monthly Medical Newsletter and a short weekly update for clinic teams; ensure consistent messaging and rapid dissemination of critical changes. * Serve as an accessible medical quality voice to internal and external stakeholders. Technology & partnerships * Lead medical evaluation of care-enablement technology (e.g., AI scribe, training/education tools); oversee pilots, collect user feedback, and communicate outcomes. * Manage key vendor relationships and track usage, experience, and ROI; maintain a lightweight partner log and pilot pipeline. * Foster a culture of creativity and innovation within the Medical Operations team, constantly seeking new ways to solve challenges in the pet healthcare industry Cross-functional leadership * Work closely with other Medical Programs and project leaders, Support Center Functions (Finance, People Team, Legal) to drive project success. * Act as a bridge between medical expertise and strategic initiatives, ensuring that the medical voice is incorporated into decision-making processes. Business Acumen: * Develop a deep understanding of the pet healthcare industry, market trends, and competitive landscape. * Monitor the financial health of the business and collaborate with Field leaders to implement early interventions when necessary. * Provide guidance on financial aspects related to medical programs and projects. Travel & Availability * Routine travel to clinics and events; occasional evening/weekend commitments tied to CE or community activities. * 1 day in-clinic, 4 days support of Medical Operations (remote or in person) * Up to 50% (CEs, Conferences, in-clinic presence as needed) You Have: * Veterinary Medical Degree (DVM/VMD or equivalent foreign degree) * State licensure that is in good standing OR eligibility for such licensure - to include all states for clinics under supervision * DEA licensure and CDS licensure if needed for all states for clinics under supervision * 7+ years of clinical veterinary experience * 3+ years of Medical Director / Leadership Experience; multi-unit leadership experience is considered ideal but not required * Comfort in general practice and urgent care veterinary settings. Willing and able to complete clinical shifts. Pay Range: $170,000-$250,000 annually. Currently working elsewhere? We get it - the vet world is small. We're committed to a confidential and positive experience. Just looking to chat? Let's grab a coffee or hop on the phone. Email our Team at **********************. At Bond Vet, we're proud to be vet founded and vet led. We are on a mission to enhance the human-animal bond through innovative urgent and primary care combined with seasoned expertise, friendliness, and compassion. Our clinics combine modern design, seamless technology, and a collaborative culture. We believe veterinary professionals deserve a career they love, not just a job. Our unique offerings include work-life flexibility, competitive pay and the chance to shape your own path. With industry-leading NPS scores, our approach resonates. Join us for a rewarding career where we work happy, feel empowered and are obsessed with pets. bondvet.com By submitting an application, you agree to receive SMS messages from Bond Vet regarding your application and interview process, including, but not limited to, your interviews, scheduling, offers, reference checks, background checks, and general communication throughout the process. Opt out anytime by messaging STOP. Text HELP for help. Message frequency varies and message and data rates may apply. Find more information in our privacy policy. Employment with Bond Vet is contingent upon the Company's completion of a satisfactory investigation of your background.

Job Description About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit's team is inspired to touch and help change lives through Summit's clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: The Manager, Clinical QA will collaborate closely with Regulatory Affairs, QA, R&D and other cross functional teams within the Company to provide GCP/GLP/GPV and compliance-related advice to internal clinical study teams. This will be accomplished through ensuring tactical support is provided to assignments and wherever necessary, taking the lead in ensuring project related procedural documents, comply to relevant GxP's and regulatory requirements and guidelines. Role and Responsibilities: Partnering and collaborating with key stakeholders (R&D teams) to ensure that appropriate Quality support is provided to Summit Clinical and pre-clinical programs Ensuring end-to-end quality management through proactive compliance based on Clinical Development Plan (CDP) Liaising with the Global Audits and Compliance function to provide lessons learned from audits and inspections to program teams and support implementation of corrective actions Supporting CRO-relevant meetings, when necessary, to provide quality overview/ training to relevant stakeholders Providing support during the development and execution of Corrective and Preventive Actions (CAPAs). Coordinating and reviewing CAPAs to ensure adequate CAPAs are defined, implemented, and closed. Support formal investigations of issues as they arise, ensuring timely escalation to line management if critical incidents are not resolved in due course Identifying areas of continuous process improvement and engaging QA and key stakeholders as necessary QA support in interactions with internal and external contacts and Health Authorities (HA), as appropriate. In collaboration with the Global QA team, ensure inspection management by assisting in preparing program teams for FDA, EU, and key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspections. Support in providing interpretation of regulations and company process standards, guidelines, policies, and procedures to personnel for assigned programs or for continuous improvement projects Supporting or leading development and driving the implementation of study/program-specific quality plans to ensure proactive management of quality Supporting rectifying any necessary vendor-relevant issues identified for the assigned program Ensuring that protocols for assigned programs can be operationalized and address potential risks with key stakeholders Perform internal audits as applicable All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Bachelor's Degree in Life Sciences, Pharmacy, or Nursing required Master's Degree or other advanced degree preferred Minimum of 5+ or more years Quality Assurance experience and or Clinical Operations involvement in regulated activities or equivalent experience required Broad understanding of global expectations of Health Authorities in the management of clinical trials preferred Thorough understanding of international GCP/GLP regulations including FDA/EU GCP, ICH, pharmacovigilance, new drug regulations, other key HA guidance's, and current industry practice preferred Ability to travel up to 20% Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable Strong computer and database skills Attention to detail, accuracy and confidentiality Clear and concise oral and written communication skills Excellent organizational skills Critical thinking, problem solving, ability to work independently Must be able to effectively multi-task and manage time-sensitive and highly confidential documents Communicate effectively and articulate complex ideas in an easily understandable way Prioritize conflicting demands Work in a fast-paced, demanding and collaborative environment The pay range for this role is $139,000-$163,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's Talent Acquisition team at ********************* to obtain prior written authorization before referring any candidates to Summit.

Spectrum Vascular is an innovative medical device company focused on vascular access and medication management. Our mission is to improve the lives of patients worldwide by providing caregivers with high quality, innovative products with exceptional customer service. We are a company that was formed through the acquisition of a portfolio of trusted products that have been widely used by customers for decades. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics. This role represents a unique opportunity to join a dynamic and growing team with established products and an entrepreneurial mindset. Role Description: The Quality Manager position will be filled by a professional who possesses knowledge and skills necessary to provide direction and guidance in current Good Manufacturing Practice (cGMP) regulations as well as ISO13485 Quality Management Systems in a medical device company, including coordination with Regulatory Affairs on complaint management, as well as the application of risk management principles. Role Responsibilities: Quality Systems: The Quality Manager has responsibility for working directly with the Contract Manufacturer (CMO) on the implementation, maintenance and improvement of procedures and processes to ensure compliance with current regulations, standards, guidance and state of the art/ industry best practices for medical devices that adhere to cGMP. Quality oversight of various Quality functions as assigned (e.g. Manufacturing Process controls and changes, Verification and Validation) Works to assure the quality, accuracy, and integrity of data in manufacturing, to assure that effective and appropriate Quality Management Systems are in place and followed Ensures manufacturing are completed according to established SOPs, including usage and control of raw materials, components and labels. Maintains and helps improve current quality systems, processes, tools, policies, SOPs and validations to ensure compliance with regulatory requirements. Deviations, Change Control, CAPAS, and Complaints Quality System Subject Matter Expert including leadership and execution to completion of Change Controls, deviations, CAPAs and complaints Works directly with Engineering, Regulatory Affairs, Supply Chain, Manufacturing, and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner Coordination and review of change controls, deviations, CAPAs, and effectiveness checks Leads and/or supports CAPA investigations, implementation, CAPA effectiveness and closure Executes data analysis, trending Audits and Annual Product Reviews, including Management Review Conducts internal audits of company systems to assure compliance with regulatory requirements. Manages the Product Quality Review processes; coordinating cross functionally to ensure regulatory requirements are met and that actions arising are managed to conclusion. Participates in preparation for and hosting of external audits and FDA inspections in collaboration with the Sr. VP Regulatory Affairs. Assures periodic Management Review meetings are held to meet regulatory requirements. Provides comprehensive support for FDA audits and offers global guidance for drug product-related matters. Interacts with representatives from the Food and Drug Administration (FDA) and other regulatory agencies during audits including helping to resolve issues or questions. Helps oversee post-audit activities Assists in coordination of supplier and internal audits and regulatory authority audits Document Control Provides oversight and coordination of all controlled documents including administrative, technical and production documents. Authors and/or supports gap assessments of Quality System and Documents Ensures that the Document Control System is maintained including SOPs, methods, production records, change controls, deviations, validation documents, operation manuals, training documents and any other relevant controlled documents in compliance with cGMPs, and international policies and procedures. Ensures management of documents, including regulating access to controlled documents and obsolescence of documents accordingly. Training Develops training programs as applicable to ensure organization understands and maintains compliance with the regulations, standards and guidance Develop and/or delivers training programs, and administration as required, e.g., GMP, data integrity, good documentation practices, and inspection readiness Helps create, improve and conduct training as needed. Trains and mentors other staff to perform quality duties Role Qualifications: Bachelor's degree in a technical field (e.g., Biology, Chemistry, Engineering) required 5+ years proven experience in quality management, preferably in a manufacturing or production environment Strong analytical skills with the ability to analyze data and identify trends Excellent project management skills with the ability to prioritize tasks and meet deadlines Knowledge of quality control methodologies and tools (e.g., Six Sigma, Lean) Familiarity with regulatory requirements and standards (e.g., ISO, AAMI, FDA, cGMP) Strong communication skills, both verbal and written Attention to detail and a commitment to delivering high-quality results Spectrum Vascular is an Equal Opportunity Employer and committed to creating a diverse and inclusive company culture. Spectrum Vascular does not discriminate against candidates and employees because of their disability, sex, race, gender identity, sexual orientation, religion, national origin, age, veteran status, or any other protected status under the law.

We're looking for a dedicated and detail-oriented Food Safety & Quality professional to join our team! In this role, you'll play a key part in maintaining our high standards for: Product safety Quality Regulatory compliance You'll lead internal audits and inspections, support incident investigations, maintain accurate compliance documentation, and help drive a strong food safety culture throughout the organization. This position is ideal for someone who is passionate about continuous improvement, thrives in a fast-paced environment, and takes pride in ensuring products meet the highest safety and quality standards. If you're proactive, organized, and committed to excellence in food safety, we'd love to hear from you! Monday to Friday from 8:00am to 4:30pm

Our client is a mid-sized personal care company that values efficiency, teamwork, and attention to detail. Their quality team plays a key role in ensuring all products are up to the proper standards before being commercialized. They are seeking a QA Manager - Personal Care to join their team. Salary/Hourly Rate: $90k - $120k Annually Position Overview: The QA Manager - Personal Care will oversee quality systems, supplier quality, and process standardization to ensure full compliance with regulatory and internal standards. This role focuses on building strong quality frameworks, managing audits, leading continuous improvement efforts, and supervising a small QA team. Responsibilities of the QA Manager - Personal Care: * Lead external manufacturing and supplier quality audits, including scheduling, documentation, and corrective action follow-up. * Provide coaching and performance evaluations to QA team members. * Maintain and develop quality documentation, including SOPs, manuals, and standardized procedures. * Analyze audit trends and quality data to drive process improvements. * Administer change control processes and run mock recall/traceability exercises. * Oversee execution and optimization of QMS software and digital quality tools for CAPAs, audits, SOPs, etc. * Oversee consumer complaint data tracking and ensure timely resolution. * Manage supplier qualification, quality agreements, and ongoing performance monitoring. * Develop and deliver quality and cGMP training programs. * Monitor, report, and improve quality KPIs and overall compliance status. Required Experience/Skills for the QA Manager - Personal Care: * 5+ years of experience in a quality role within cosmetics or a related industry. * Strong Quality Assurance background. * Strong Excel and Microsoft Office proficiency. * Experience leading audits and managing supplier quality. * Experience implementing or managing QMS programs and writing SOPs. * Excellent communication and strong attention to detail. * Supervisory experience supporting or leading technical staff. * Ability to operate independently and work cross-functionally. * Willingness to travel up to 30%. Preferred Experience/Skills for the QA Manager - Personal Care: * Familiarity with quality standards such as ISO 22716 and MoCRA. * Prior leadership experience aligned with a QA Manager - Personal Care. Education Requirements: * Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering, or a related discipline is required. Benefits: * Medical, dental, and vision insurance. * 401(K) match. * PTO. * Paid holidays. * Maternity/paternity leave.

Job DescriptionBenefits/Perks Highly enriched & healthy work environment Excellent growth opportunities Competitive Pay Career Advancement We are seeking an experienced Quality Assurance Specialist to join our team. In this role, you will be responsible for overseeing the quality of goods and services our company provides. You will perform routine inspections, implement quality assurance policies and procedures, and identify any workflow issues. The ideal candidate is an excellent verbal and written communicator with strong attention to detail. Position Summary The Quality Assurance Specialist Clinical Trial Supply plays a critical role in ensuring the quality, safety, integrity, and compliance of clinical trial materials throughout their lifecyclefrom receipt and storage to packaging, labeling, distribution, and returns. This role supports GxP operations, oversees Quality System activities, and collaborates cross-functionally with Operations, Warehouse, Packaging, Project Management, and external suppliers/CROs to maintain compliance with FDA, EU-GMP, GDP, ICH-GCP, DSCSA, and internal JRS standards. The QA Specialist ensures that all products and processes meet regulatory and customer expectations while supporting JRSs mission to deliver reliable, resilient, and high-quality clinical supply solutions worldwide. Key Responsibilities 1. Quality Systems & Compliance Ensure compliance with GMP, GDP, GCP, ICH, FDA, EMA, MHRA, TGA, CDSCO and JRS internal SOPs. Review, approve, and maintain controlled documents including SOPs, Work Instructions, Forms, Batch Records, Labeling Specs, and Packaging Records. Support implementation and continuous improvement of Quality Management Systems (QMS) including Deviation Management, CAPA, Change Control, Training, and Document Control. Participate in internal audits, customer audits, vendor qualifications, and regulatory inspections. 2. Clinical Supply Chain Quality Oversight Perform QA review and approval of: Incoming clinical supplies (comparator drugs, IMPs, ancillary supplies) Packaging and labeling activities Storage and temperature monitoring records Distribution documentation including shipping records, AWBs, and temperature logger data Verify completion and accuracy of Line Clearance, Batch Packaging Records (BPR), and Label Control Logs. Review and approve EPCIS/DSCSA traceability files, CoA/CoC, pedigrees, and other regulatory documentation. 3. Investigations & Deviation Management Lead or support investigations for: Temperature excursions Packaging or labeling discrepancies Shipment issues Supplier or customer complaints Perform root cause analysis (RCA), risk evaluation, and implement effective CAPAs. 4. Vendor & Customer Quality Support Support supplier qualification by reviewing: GMP/GDP licenses ISO certifications Quality Agreements (QTA) Questionnaires and risk assessments Collaborate with customers to ensure project-specific quality requirements are met. 5. Documentation & Regulatory Support Ensure accurate completion of QA documentation related to: Clinical supply release Temperature-controlled shipping Storage of controlled and non-controlled materials Destruction, return, and reconciliation Maintain updated Quality and Technical Agreements (QTA) with clients and suppliers. 6. Training & Continuous Improvement Deliver and maintain training programs for QA and Operations teams on: GDP/GMP compliance SOP revisions Packaging and labeling quality requirements Temperature control best practices Participate in continuous improvement initiatives to enhance operational efficiency and compliance. Required Qualifications Bachelors degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or related field. 25 years of experience in Quality Assurance within Clinical Trial Supply, Pharmaceutical, Biotech, CRO, CDMO, or GMP/GDP warehouse environment. Strong understanding of GMP, GDP, GCP, DSCSA/EPCIS, ICH guidelines, and clinical supply chain processes. Experience with deviations, CAPA, change control, labeling review, packaging operations, and QA release. Preferred Qualifications Experience working with temperature-controlled logistics (28C, -20C, CRT). Knowledge of comparator sourcing workflows and global distribution practices. Familiarity with Quality Agreements, Supplier Qualification, and Vendor Audits. Experience with Power BI, SharePoint QMS, and ERP/WMS systems. Certification in GMP/GDP/GCP (optional but advantageous). Core Competencies Strong attention to detail and documentation accuracy. Excellent communication and problem-solving skills. Ability to work cross-functionally and manage multiple priorities. Proactive, organized, and committed to quality and compliance. Ability to make decisions based on risk, data analysis, and regulatory expectations. Why Join Jupiter Research Services? Work in a rapidly growing organization focused on resilient clinical supply chain solutions. Gain exposure to global clinical trials, high-impact projects, and innovative supply models. Contribute to a compliance-driven organization with strong customer and patient-centric values. Opportunities for growth in Quality, Operations, Regulatory, and Project Management.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions · Independently conduct audits · Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits · Facilitate Sponsor health authority inspections of global clinical facilities and study sites · Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs · Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. · May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements · Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. · 5+ years of experience in GCP auditing. · Substantial experience in inspection management. · Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. · Demonstrated ability to operate and influence decision-making processes · Effective communication skills · Successful track record of supervising employees and managing cross-cultural differences · Technical and administrative capabilities to independently carry out routine, complex and for-cause audits · Knowledge of data integrity controls and systems quality for clinical area · Strong analytical skills and report writing skills · Experience with GxP systems including computer system validation and associated regulations, recommended. · Ability to Travel (approximately 20%) · Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

**Quality Assurance Manager** **Princeton, NJ** Step into a pivotal role where you'll champion quality assurance and shape a First-Time-Right culture at our Princeton Perfumery & Beauty site. As the voice of quality, you'll lead a committed local team and collaborate closely with internal partners and external clients to ensure excellence across every stage of delivery. This is your chance to make a meaningful impact in a fast-paced, dynamic industry while expanding your expertise and influence. If you're ready to drive end-to-end quality and elevate standards, we want to hear from you. **Your key responsibilities** + Non conformances management expert: Lead Customer (product / service) and / Internal site Non conformances and follow up on any related actions/projects in coordination with appropriate site partners. Tasks include customer communication, investigation and CAPA (correction and preventive action) definition, validation, and verification. + Continuous improvement enhancer: Analyze Quality data and be a solution partner to improve Quality and reinforce end-to-end Quality/ Product protection - Culture and Performance. Lead Projects linked with Quality / Product Protection and support Operations Projects Develop and deliver Quality/Product protection trainings with the support of our Operations training department. + Quality Management System expert: Maintain the Local Quality System supporting end to end robustness of our processes and successful ISO 9001 and be part of the site Audit program: Internal, Clients and Suppliers audits. + Training of applicable Quality Assurance projects + Build relationships with internal and external customers to understand their requirements and answer their requests in a timely fashion. + Support the Quality organization by providing sensory expertise to grow the team's skillset and provide support in sensory related non-conformances. **We bring** + Unique career paths across health, nutrition and beauty - explore what drives you and get the support to make it happen + A chance to impact millions of consumers every day - sustainability embedded in all we do + A science led company, cutting edge research and creativity everywhere - from biotech breakthroughs to sustainability game-changers, you'll work on what's next + Growth that keeps up with you - you join an industry leader that will develop your expertise and leadership + A culture that lifts you up - with collaborative teams, shared wins, and people who cheer each other on. + A community where your voice matters - it is essential to serve our customers well. **You bring** + Bachelor's degree in Chemistry/Quality or related scientific field. + - 5+ years of experience in a quality or regulatory related role + Extensive background in perfumery ingredients and formulations highly preferred + Sensory experience in Perfumery industry highly preferred + 5+ years leadership skills preferred. The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant's job-related skills, experience, relevant education, or training, and primary work location. Salary $130,000 - $140,000. In addition to base salary, we also offer a comprehensive total rewards package, inclusive of annual incentive pay, a retirement savings plan, health care coverage, paid time off, recognition programs and a broad range of other benefits. All benefits and incentives are subject to eligibility requirements. **About dsm-firmenich** At dsm-firmenich, we don't just meet expectations - we go beyond them. Join our global team powered by science, creativity, and a shared purpose: to bring progress to life. From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere. And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future. Because real progress only happens when we go beyond, together. **Inclusion, belonging and equal opportunity statement** At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong. We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve. We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you. And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work. **Agency statement** We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role.

This position is primarily responsible for coordinating and directing quality assurance programs and reviewing, preparation/maintenance of SOPs, calibration and other controlled document to ensure accuracy, completeness, and adherence to establishment standards by performing the following duties. EDUCATIONAL QUALIFICATION: Four-year college degree or master's degree; and two to three years related experience and/or training; or equivalent combination of education and experience. ESSENTIAL DUTIES AND RESPONSIBILITIES: Ensures compliance with cGMP, Company SOPs and FDA requirements during all phases of operations. Sampling and disposition of Packaging Materials and Packaging Components as per standard operating procedures To support raw material sampling as needed. Issuance of Batch Manufacturing records and Batch Packaging Records as per requirements. Disposition of raw materials and finished products as per standard operating procedures. Prepares and maintains vendor qualification reports and its requalification reports. Prepares, maintains and issues raw material specifications. Prepares and maintains analytical specification for raw material testing and retest. Organizes and ensures accurate and reliable filing systems for all paper-based GMP Documents. Review of executed batch manufacturing and packaging records. Prepare shipment for samples as per requirements for customers. Completes quality assurance operational requirements by scheduling or co-ordination Prepares and maintains all Quality Systems, including CAPA, Complaint Handling, Deviations, Nonconforming Product, and Internal Auditing to comply with regulatory requirements. Prepare and maintain master manufacturing record, COA, SDS, finished product /packaged product specification. Preparation of Annual Product Quality Review. To ensure appropriate storage, issuance, periodic visual inspection and destruction of retain samples. To provide all required information in time as requested by the customer. To ensure appropriate storage, issuance and destruction of retain samples. Other duties as assigned by management.

FRAUD ALERT: Please note that DSV will never request a chat interview or solicit funds from applicants or employees through its interviewing and hiring process. We do not require any form of payment and will not ask for personal financial information, such as credit card or bank account number. Our recruiters have an @dsv.com or @us.dsv.com email address. If you question the legitimacy of any DSV job posting, please reach out to *************. DSV - Global transport and logistics In 1976, ten independent hauliers joined forces and founded DSV in Denmark. Since then, DSV has evolved to become the world's 3rd largest supplier of global solutions within transport and logistics. Today, we add value to our customers' entire supply chain by transporting, storing, packaging, re-packaging, processing and clearing all types of goods. We work every day from our many offices in more than 80 countries to ensure a steady supply of goods to production lines, outlets, stores and consumers all over the world. Our reach is global yet our presence is local and close to our customers. Read more at *********** Location: USA - Plainfield, 2363 East Perry Road Division: Air & Sea Job Posting Title: Quality Assurance Specialist, Warehousing & Logistics Time Type: Full Time As a Quality Assurance Specialist at DSV, you will be responsible for ensuring that all processes, procedures, and services meet the company's quality standards and regulatory requirements. Your role involves implementing quality management systems, conducting audits, and providing recommendations to improve operational efficiency and customer satisfaction. Duties and Responsibilities: Train & implement ISO9001, ISO45001, ISO14001 requirements for DSV locations within area of responsibility (AR). Perform internal QHSE audits according to the regional audit plan. Perform external Supplier audits as needed. Perform periodic quality, health, safety & environmental (QHSE) gap analysis in AR & engage local QHSE agents in the AR as needed if performance is not being met. Conduct incident/accident investigations as needed and ensure effectiveness of corrective actions. Provide guidance to the AR on the requirements of identifying and implementing local HSE laws and monitor that compliance has been achieved. Coordinate environmental activities with local QHSE agents, including collection of Eco-Consumption data, implementing local sustainability campaigns, review and communication of key environmental documents to ensure ISO 14001 compliance. Continuous identification & evaluation of Customer/Industry requirements. Support customer audits for the AR. Cross functional root cause/corrective action problem solving skills Authority to stop work when deemed unsafe within AR Ability to communicate openly, effectively and confidently Robust time management & decision-making skills Capable of building relationships across different functions Ability to travel domestically 20-30% within AR WORK EXPERIENCE/SKILLS/TRAINING Proficient in Microsoft Office Suite (PowerPoint, Excel, Word) 3-5 years of related work experience Quality Auditing Experience Required Associates or Bachelor's Degree (preferred) Certified Quality Auditor (preferred) OSHA 30-Hour certified (preferred) Skills Mathematical Skills Ability to perform basic mathematical calculations, such as calculating costs and rates Other Skills Excellent organizational and time management skills Strong communication and interpersonal skills Attention to detail and accuracy Ability to work well under pressure and in a fast-paced environment Function / Market & Industry Knowledge / Business Acumen / Processes Knowledge of ocean freight logistics and customs regulations Understanding of trade laws and regulations Language skills Fluency in English is required Knowledge of additional languages is a plus Computer Literacy Proficiency in Microsoft Office Suite Experience with logistics software and systems is preferred At Will Employment DSV Air & Sea Inc. employees are hired for an undefined period of time as “at will” employees. This means that an employee may be terminated for any reason, or no reason at all, at any time, provided the discharge does not violate any law*. Additionally, each employee has the right to terminate his/her employment at any time. *Except if employed in Montana, where termination requires just cause. For this position, the expected base pay is: $62,500 - $84,500/ Annual. Actual base compensation will be determined based on various factors including job-related knowledge, skills, experience, and other objective business considerations. DSV does not accept unsolicited agency resumes. Please do not forward unsolicited resumes to our website, employees, or Human Resources. DSV will not be responsible for any agency fees associated with unsolicited resumes. Unsolicited resumes received will be considered property of DSV and will be processed accordingly without fees. DSV is an equal employment opportunity employer. Candidates are considered for employment without regard to race, creed, color, national origin, age, sex, religion, ancestry, disability, veteran status, marital status, gender identity, sexual orientation, national origin, or any other characteristic protected by applicable federal, state or local law. If you require special assistance or accommodation while seeking employment with DSV, please contact Human Resources at *************. If you are interested in learning the status of your application, please note you will be contacted directly by the appropriate human resources contact person if you are selected for further consideration. DSV reserves the right to defer or close a vacancy at any time. DSV - Global transport and logistics Working at DSV means playing in a different league. As a global leader in transport and logistics, we have been on an extraordinary journey of growth. Let's grow together as we continue to innovate, digitalise and build on our achievements. With close to 160,000 colleagues in over 90 countries, we work every day to offer solid services and meet our customers' needs and help them achieve their goals. We know that the best way to achieve this is by bringing in new talent, fresh perspectives and ambitious individuals like you. At DSV, performance is in our DNA. We don't just work - we aim to shape the future of logistics. This ambition fuels a dynamic environment built on collaboration with world-class team players, accountability and action. We value inclusivity, embrace different cultures and respect the dignity and rights of every individual. If you want to make an impact, be trusted by customers and grow your career in a forward-thinking company - this is the place to be. Start here. Go anywhere Visit dsv.com and follow us on LinkedIn and Facebook.

Job Description THE COMPANY Octane Learning is a professional learning and training development agency, working exclusively for pharmaceutical, biotech, medical device, and healthcare companies. We advise on learning strategies and create the right experiences, including online study, virtual, in-person and hybrid workshops, reference resources, sales/corporate training events, and more. We are rapidly expanding, and have an opportunity for a QA Specialist/Copyeditor to join our team in Princeton, New Jersey. THE LOCATION This position requires work to be performed from our Princeton, NJ offices. THE WORK You will work on a variety of projects with several different styles of training, primarily interactive media such as eLearning, instructor-led courses/workshops, videos, and print resources. For these materials, within the constraints of our/clients' guidelines, you will: Copyedit assets created by subject matter experts or instructional designers during various project life cycles. Implement straightforward client or SME edits. Upload and appropriately tag and link reference materials to manuscripts in client review platform. Proof deliverables ensuring they are consistent with the client-approved manuscript. QA software to make sure it operates as per client-approved specifications. Work with team leads and proofread/copyedit corporate marketing assets. Maintain and update Octane's corporate mailing lists on an as needed basis. Manage marketing email communications on an as needed basis. You will work closely with internal team members to ensure successful project completion and delivery. THE CANDIDATE Bachelor's degree in English, journalism, communications, marketing, or a related field. You are proficient in PowerPoint, Excel, and Word, with excellent editorial skills. You are well-organized, with strong attention to detail. You have good presentation, communication, and interpersonal skills. You are technologically savvy, and willing to learn how to work within various platforms, including CRM platforms and Veeva. You should have the capacity to: Work in a fast-paced environment, pivoting to the highest priority or client need Faithfully execute written and verbal instructions and seek clarification, when needed Work within established timelines and our clients' regulated environments Speak your mind if you feel a project or process can be improved Learn new things and cultivate your capabilities as the workload may dictate THE FIT We are more interested in finding the right talent and attitude than the exact match to a list of skills and qualifications. We're looking for someone that is excited and motivated to learn new things in creating learning/training resources in scientific, compliance, and regulatory areas. BENEFITS Retirement Plan Matching Medical Insurance Dental Insurance Vision Insurance Disability Insurance Paid Time Off Powered by JazzHR wb6VHKJuSd

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: Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a QA Specialist II! This position will be located in Raritan, NJ! At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at *************** and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies. Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, 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 oversight for daily activities related to the production of 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: Partner with Operations teams to support production activities in a cGMP manufacturing facility. Perform review and approval of completed batch records and production documentation in support of batch release activities including preparation of product release documentation. Provide quality oversight for incoming shipments of raw materials, working cell banks and consumables and outgoing shipments of viral vector drug substance. Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner. 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. Supports site inspections and inspection readiness activities. Ensure the site is audit ready. Support data integrity efforts. 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 Monday - Friday, 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 an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource. #CAR-T Required Skills: Preferred Skills: The anticipated base pay range for this position is : $69,500-$102,350 USD$ Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. 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 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 Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************

Piper Companies is seeking a Quality Assurance Specialist to support GMP manufacturing operations for a leading biotechnology company developing next-generation allogeneic cell therapies for oncology. This is an onsite position in Branchburg, NJ and a long term contract assignment with potential for conversion. Responsibilities: * Support GMP manufacturing and clinical operations through documentation control and quality oversight. * Review executed batch records and resolve discrepancies with manufacturing teams. * Manage issuance, routing, and archiving of quality records and controlled documents. * Perform QA review and release of incoming raw materials. * Revise SOPs, protocols, and reports as needed to maintain compliance. Qualifications: * 2-4 years of QA experience in a GMP-regulated biopharma or cell/gene therapy environment. * Strong understanding of cGMP requirements and documentation practices. * Excellent attention to detail and ability to communicate effectively across teams. * Team-oriented, proactive, and able to work in a fast-paced environment. * BS or MS in a biological, technical, or engineering discipline. Compensation: * Pay Rate: $40-$45/hour, depending on experience * Benefits Available: Medical, Dental, Vision, Sick Leave as required by law, and This job opens for applications on 12/15/2025. Applications for this job will be accepted for at least 30 days from the posting date. #LI-KP1#LI-ONSITE