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  • GCP QA Auditor - Radiopharmaceuticals & Clinical Trials

    Blackstar 3.4company rating

    Quality assurance manager job in Paramus, NJ

    We are seeking an experienced GCP Quality Assurance Auditor to join our rapidly growing biopharmaceutical company specializing in neurology and psychiatry therapies. This role ensures GXP compliance, drives quality management initiatives, and conducts internal and external audits across clinical trials, safety/pharmacovigilance, and vendor operations (CROs, CMOs, investigator sites). The ideal candidate has extensive GCP experience, a strong pharmaceutical QA background, and expertise in radiopharmaceuticals. This is an on-site position in Northern NJ with flexible hours and minimal domestic travel. Key Responsibilities: Plan and perform global clinical process and vendor audits across all clinical trials Conduct risk-based audits of clinical processes and vendors, including IRT and EDC systems Prepare detailed audit reports and manage related non-conformances Ensure compliance with GCP, FDA, EMA, and ICH regulations Support regulatory inspections and quality improvement initiatives Collaborate with clinical teams, QA, and vendor management Qualifications: Bachelor's degree in a scientific, healthcare, or related discipline 5+ years of pharmaceutical industry experience, including 2+ years in radiopharmaceutical QA Extensive GCP and safety/pharmacovigilance experience Proven experience in internal and external GXP audits Familiarity with QMS, SOPs, clinical systems (IRT, EDC), and regulatory documentation Strong communication and cross-functional collaboration skills Up to 10% domestic travel Why Join Us: Be part of a fast-growing biopharma company making a difference in neurology and psychiatry Hybrid work schedule with flexible hours Opportunity for extension or full-time role
    $68k-110k yearly est. 21d ago
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  • Director, Clinical Quality Assurance

    Eisai 4.8company rating

    Quality assurance manager job in Nutley, NJ

    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
    $109k-151k yearly est. Auto-Apply 60d+ ago
  • Hardware QA Manager

    Standard Bots

    Quality assurance manager job in Glen Cove, NY

    Standard Bot's mission is to significantly lower the barrier to entry to real-world automation, bringing the power of bits to the world of atoms and unlocking productivity for entire new industries and users. We combine advanced engineering, intelligent automation, and world-class manufacturing to create products that redefine what's possible. We are seeking a detail-oriented and experienced Hardware QA Manager to lead our Quality Assurance efforts across all hardware platforms in our fast-paced robotics manufacturing environment. Note: This role will be required to come into our Glen Cove robotics factory 5 days/week We are unable to offer visa sponsorship at this time What you'll do The Hardware QA Manager will be responsible for developing, implementing, and maintaining comprehensive quality assurance systems and protocols for robotic hardware. This individual will lead a team of QA engineers and technicians to ensure all hardware components meet strict reliability, safety, and performance standards before and after release. This role requires close collaboration with cross-functional teams including Engineering, Manufacturing, Supply Chain, and Product Development. Responsibilities Lead the hardware QA team in planning, implementing, and executing test strategies and protocols for robotic hardware systems (mechanical, electrical, and embedded components) Work with the manufacturing and assembly teams to drive improvements in quality and efficiency Define and maintain hardware quality standards and ensure compliance with industry regulations (e.g., ISO, ANSI, IPC, RoHS, etc.) Drive root cause analysis (RCA) and corrective/preventive action (CAPA) for hardware defects or failures Coordinate with Manufacturing and Supply Chain to ensure quality standards are upheld throughout production and vendor operations Develop automated and manual test plans for validation and verification (V&V) of hardware systems at component and system level Participate in design reviews to ensure DFM (Design for Manufacturability) and DFT (Design for Testability) are considered Manage incoming inspection protocols, First Article Inspections (FAIs), and supplier audits Lead internal and external audits and represent the QA function during regulatory inspections or customer visits Build and mentor a high-performing QA team, promoting a culture of quality, accountability, and continuous improvement Skills you'll bring Bachelor's or Master's degree in Electrical Engineering, Mechanical Engineering, Mechatronics, or a related technical field 7+ years of experience in hardware quality assurance, preferably in a robotics, automotive, or high-tech manufacturing environment 3+ years of experience in a management or leadership role within QA Strong understanding of hardware development lifecycles, including prototyping, NPI, production ramp, and sustaining Proficient with quality tools and methodologies such as FMEA, Six Sigma, SPC, 8D, etc Experience with test equipment and diagnostic tools used for electronics, firmware, and electromechanical systems Familiarity with manufacturing processes such as SMT, injection molding, CNC, etc Strong analytical, problem-solving, and communication skills Ability to work in a fast-paced, multidisciplinary team environment Preferred Qualifications Experience with robotics systems, motion control, or autonomous platforms. Bonus for software/firmware experience Experience creating a Quality Management System from scratch (particularly to QA/QC and test generation) Experience working with global suppliers and contract manufacturers Certifications such as ASQ CQE, Six Sigma Black Belt, or ISO 9001 Lead Auditor Compensation and Benefits The salary range for this role is $140,000 to $180,000. We are open to a variety of seniority levels for this role and will build compensation packages that are commensurate with seniority and skill level. Base salary is just one part of the overall compensation at Standard Bots. All Full-Time Employees are eligible for Employee Stock Options. We also offer a package of benefits including paid time off, medical/dental/vision insurance, life insurance, disability insurance, and 401(k) to regular full-time employees.
    $140k-180k yearly Auto-Apply 60d+ ago
  • QA/QC Manager

    Tutor Perini Corporation 4.8company rating

    Quality assurance manager job in Mount Vernon, NY

    is between $160,000 and $220,000 depending on experience Tutor Perini O&G Joint Venture is the company selected to execute construction of the Manhattan Jail Project in New York. Tutor Perini O&G JV is seeking a QA/QC Manager to join the project in Manhattan, NY About Manhattan Jail Project Extraordinary Projects, Exceptional Performance The $3.8B project scope includes design and construction of a new state-of-the-art facility that will have dedicated space for on-site services and programming, indoor and outdoor recreation, food services, staff offices and facilities, amenities, below-grade accessory parking, and a secured entry. The new facility will contain 1,040 beds and provide 125 accessory parking spaces below grade for all staff and service providers. In addition, the facility will provide 20,000 square feet of community and commercial space on the ground floor. Extraordinary Projects need Exceptional Talent Job Description: * Developing and revising Quality Management Plan, based on lesson learned and improve the Quality Management Process * An overall review of incoming inspections, in-process inspections, final inspections, and calibration records, and training * Responsible for internal/external auditing (construction entities, and other subcontractors * Schedule and provide training for Preparation Phase training * The QA for all inspection and test activities and attend and verify tests and inspections required to ensure material compliance with the plans and specifications * Contract Document requirements execution and oversight * Perform quality oversight on all subcontractors by reviewing Subcontractor Quality Management Plan/Quality Control Plan and reviewing agreements with subconsultants * Monitor subconsultant performance and compliance with the Contract * Ensure adequate resources (QC Team) are available for the project * General QC administration * QC staffing and supervision * Coordinate QC testing with QC subconsultant such as Material Testing Lab and Commissioning Agent/System Integrator. * Provide recommendation and communication with DOR for problem solution and verification of corrective actions. Develop and implement corrective measures in cases of noncompliance. * Verify corrective action(s) Maintain QC records in accordance with QMP * Ensure and verify the Subcontractors perform inspection for all construction materials to be used at the site to ensure compliance with material approvals * Responsible for the strict adherence to company safety policies and programs * Perform primary quality assurance/quality control inspections required in conformance with the project contract drawing and specifications * Attend all jobsites and prepare documentation for Quality Meetings Required Skills: * Bachelors Degree in Engineering, Construction Management, Business Management or similar, from an accredited institution * 10 or more years of experience in support heavy civil construction testing, inspection, supervision or management in support of large public works projects * Five (5) or more years as a Supervisor or Manager of construction quality control teams * Experience with contract specifications as they apply to quality control teams * Experience with MS Office * Excellent written and verbal skills Equal Opportunity Employer
    $160k-220k yearly 60d+ ago
  • QA/QC Manager (Coated Textiles)

    Modern Meadow 4.0company rating

    Quality assurance manager job in Nutley, NJ

    Modern Meadow was founded to address the pressing global challenge: the materials that underpin the way we live, work, and play and that support our well-being are fundamentally unsustainable. INNOVERA™ redefines what's possible across the automotive, footwear, furniture and fashion accessories spaces, creating high-performance products with a lower environmental impact. Versatile, functional, immediately scalable and adaptable to any process, INNOVERA™ flows seamlessly with creativity: a material that works in perfect harmony with the legacy of tanneries and brands, without compromising on quality or performance. We are seeking a proactive, hands-on QA/QC Manager who is not only capable of leading quality initiatives but also willing to roll up their sleeves and directly execute QC tasks at hand. This individual should be adaptable, detail-oriented, and ready to grow with our expanding organization-developing leadership capacity while maintaining a strong operational presence. Key Responsibilities: Actively participate in QC activities, including testing, managing QC workload, maintaining QC equipment and troubleshooting, ensuring timely resolution of issues. Quality Management System Oversight Maintain and enhance the digital QMS platform, ensuring alignment with ISO 9001 and Modern Meadow's quality vision. Configure workflows, documentation, and reporting tools to support operational excellence. Audits & Compliance Comply and assist in internal audits and inspections of processes, products, and systems. Ensure timely resolution of non-conformances and CAPAs, and track effectiveness of corrective actions. Continuous Improvement Ability to lead CAPA investigations and root cause analyses using tools such as 5 Whys, Fishbone diagrams, and data analytics. Monitor and report on Quality KPIs, identify trends, and opportunities for improvement. Testing & Lab Management Oversee critical-to-quality testing protocols and ensure QC lab equipment is calibrated, maintained, and compliant. Develop and implement SOPs and work instructions for lab operations. Cross-Functional Collaboration Partner with Production, Engineering, and Supply Chain teams to integrate quality assurance into daily operations. Support supplier quality initiatives and participate in SCAR processes as needed. Qualifications & Experience Bachelor's degree in Engineering, Materials science, Quality Management, or related discipline. Minimum 5 years of progressive experience in QA/QC roles. Strong understanding of ISO 9001 and digital QMS platforms. Experience in the automotive industry a plus with experience in leather or coated textiles preferred. Proficiency in quality tools and methodologies (e.g., Six Sigma, CAPA, FMEA, 8D). Excellent communication skills for interfacing internal teams and external partners. High attention to detail and analytical mindset. We offer: Competitive compensation that includes equity Retirement planning (401k Matching) Flexible paid time off Winter Break (Company observed reset and recharge, final week of the year) Commuter Benefits Comprehensive benefit plans covering medical, dental, vision, life, and disability Identity Theft and Legal services (LifeLock and LegalShield) Family services that include fertility benefits and equal paid parental leave Details of these benefit plans will be provided if a candidate receives an offer of employment. Salary Range: $95,000- $115,000 annually Final compensation will be determined based on experience, skills, and internal equity. Candidates who exceed the minimum qualifications may be considered at the higher end of the salary range Modern Meadow is an equal opportunity employer. In accordance with anti-discrimination law, we prohibit discrimination and harassment of any type and afford equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
    $95k-115k yearly Auto-Apply 60d+ ago
  • Quality Manager

    Avery Dennisonsb

    Quality assurance manager job in Orangeburg, NY

    Avery Dennison (NYSE: AVY) is a global leader in labeling and packaging materials and solutions. Each distinctive product and technological leap forward is brought to light in an energizing environment where teamwork and curiosity thrive. Looking for a collaborative culture where bold ideas turn into action? Then this is the place for you! With over 25,000 employees in more than 50 countries, we're inspired by the art of the possible, and motivated to continuously improve. Avery Dennison RBIS Avery Dennison RBIS, a global leader in apparel and footwear industry solutions, is a $1.6 billion division of Avery Dennison (NYSE: AVY). Avery Dennison RBIS provides intelligent creative and sustainable solutions that elevate brands and accelerate performance throughout the global retail supply chain. We elevate brands through graphic tickets, tags and labels, embellishments and packaging solutions that enhance consumer appeal. We accelerate performance through RFID enabled inventory and loss prevention solutions, price management, global compliance, and brand security solutions. Based in Westborough, Massachusetts Avery Dennison RBIS responsibly serves the global marketplace with operations in 115 locations, 50 countries, across 6 continents. For more information, visit ************************** . Job Description • Have direct report responsibility for Quality Technicians, Quality Assurance Engineers, and QA Lab. • Review customer proposals and provide input as to acceptable QA and reliability requirements. • Review in-house Engineering changes for QA requirements; ensure QA requirements are defined into document changes at Engineering Change Control. • Review material quality issues and lead Material Review Board. • Lead QA surveys and audits of present and proposed suppliers and subcontractors to ensure adequate QA systems are implemented and maintained. • Review quality performance of subcontractors and suppliers and coordinate Corrective Action & Preventive Action (CAPA) Requests and Failure Analysis Requests (FARs) for improvement. • Provide technical support to inspectors on quality procedures, interpretation and implementation. • Devise and implement world class Quality practices (e.g., Pareto Analysis, Histograms, Cause & Effect Diagrams, SPC, etc.) to enact continuous Quality improvement in products and services. • Work with department managers to set up key metrics for process tracking and evaluation. • Coordinate maintenance of quality records. • Generate device qualification and reliability plans and establish and run ongoing reliability monitoring program for raw materials, subassemblies and products. • Establish inspection procedures and processes, and perform some limited inspection of incoming parts, return product and shippable product. • Manages the Corrective and Preventive Action Process. • Conducts the Management Review Meetings. • Compiles and reports out on key quality metrics as directed. • Supports Materials Management Dept for supplier evaluations and ratings. • Manages customer complaint resolution process, while also supporting Sales, Engineering and Marketing with product quality Qualifications WHAT WE WILL BE LOOKING FOR IN YOU • The candidate should have at least 5 years experience in Quality Engineering of Integrated circuits, hybrids/MCMs, or electronic assemblies, including RFID, SMT PWAs. • The candidate must have experience working with IC quality processes and reliability testing and predictions, as well as working with MIL-STD-105 and MIL-STD-883 • The candidate should have a strong theoretical and practical knowledge of RF systems (preferably RFID) - i.e. RF propagation, frequency selection, antenna design, impact of environmental constraints and obstructions to system performance etc. • The candidate must have successfully worked with suppliers and/or subcontractors in implementing corrective actions and improving the quality of delivered items. • A working knowledge of RFID standards EPC Gen 2, JEDEC, ISO 18000 and 15961 is preferred • The candidate should have strong computer skills, experience with the Microsoft Office Suite and QSI is required and Lotus Notes and MiniTab experience is desired. • The candidate should have a strong understanding of Six Sigma and/or Lean Processes. Six Sigma Black Belt a plus. • The candidate should have knowledge in understanding and applying core quality tools such as APQP, SPC, FMEA, MSA. • Up to 15% travel (domestic and foreign). EDUCATION Bachelors Degree in Science or Engineering plus ASQ certification as a Quality or Reliability Engineer. Additional Information All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veteran status or other protected status. EEOE/M/F/Vet/Disabled.
    $74k-109k yearly est. 1d ago
  • SAP QA Manager

    Cygnus Professionals 3.2company rating

    Quality assurance manager job in Hoboken, NJ

    Headquartered in New Jersey (U.S), Cygnus Professionals Inc. is a next generation global information technology Solution and Consulting company powered by strong management and leadership team with over 30 person years of experience. Today, Cygnus has strong footprints in more than 4 countries with more than 25 satisfied customers. We strive to extend our presence across industries and geographies with our industry-focused business excellence. Cygnus Professionals Inc. has been named by the US Pan Asian American Chamber of Commerce Education Foundation (USPAACC) as one of the “Fast 100 Asian American Businesses” - joining the country's fastest-growing Asian American-owned companies, based on percentage revenue growth over the immediate past two years. Job Description Role: SAP QA Manager Location: Hoboken, NJ Duration: 6 Months Contract (will continually extend) Mode of Interview: Face To Face After Phone !! Need Green Card OR US Citizen Candidates Only !! Requirements: • Must have at least 10 years working experience leading QA teams • Must have 5+ years Performance Testing working experience • Must have 5+ years leading managed service teams • Profound knowledge and significant experience with structured risk-based testing • Experience in managing on-site and off-shore geographically distributed teams • Good knowledge of test management and issues tracking systems • Periodic status reports on test progress for the projects adopted for QA testing. • Ability to set high standards and stick by them • Strong skills in critical thinking and analysis • Meeting facilitation • Verbal and written communications • Good organizational skills • BS in Computer science or related field, Masters' degree preferred • Must be willing to travel as required • o Experience with SAP o Develop and implement testing strategy o Define and manage the development of key testing deliverables o Lead analysis and reporting of testing results o Manage the tracking and resolution of risks and issues o Manage coordination of testing resources to support test cycles o Lead test tool setup and administration o Manage key testing deliverables and architecture o Escalate issues as required to SVP & ERP Program Lead o Experience with Rational Quality Manager o Experience with JIRA for defect tracking o International experience o Experience with heavy integration testing Qualifications Desired Experience: • Familiarity with publishing (including Web publishing) industry • Requirements management, test management, and issues tracking tool from at least one manufacturer: - IBM Rational - HP • Experience leading teams in large managed services teams • Experience delivering solution in a fast paced dynamic environment • A background in testing of web-based and mainframes • Good knowledge of standard industry metrics Additional Information ** U.S. Citizens and those who are authorized to work independently in the United States are encouraged to apply. We are unable to sponsor at this time. ** All your information will be kept confidential according to EEO guidelines.
    $98k-132k yearly est. 60d+ ago
  • QA Automation Testing Manager

    Tata Consulting Services 4.3company rating

    Quality assurance manager job in Stamford, CT

    Must Have Technical/Functional Skills We're seeking a QA Automation Testing Manager (SDET) with 10+ years leading multiteam QA programs, to drive engineering-quality practices across complex banking platforms and integrations. You will architect automation frameworks, embed quality into CI/CD, and lead a team of SDETs/QA engineers to deliver reliable, compliant releases at speed. Experience in BFSI systems (core banking, payments, digital channels) and hands-on coding for test automation is essential. Job description * Automation Architecture & Delivery * Design, implement, and scale UI/API/DB automation frameworks (Selenium java/UFT, RestAssured/Postman, Cucumber/BDD, TestNG/JUnit). * Integrate automated suites into CI/CD (Azure DevOps/Jenkins/GitLab) with quality gates, parallelization, test impact analysis, and artifact publishing. * Establish coding standards for test harnesses, mocks, data builders, and service virtualization; enforce code reviews and static analysis for test code. Domain‑Focused Testing (Banking) * Translate banking use cases (core deposits/loans, ACH/wires, card/payments, digital banking) into robust automated scenarios and data validations. * Partner with product owners and vendor teams (e.g., Fiserv, internal platforms) to triage defects, validate patches/hotfixes, and maintain regression beds. Program Leadership & Governance * Lead a squad of SDETs/QA engineers-capacity planning, mentoring, and upskilling on advanced automation topics. * Orchestrate defect triage, root‑cause analysis, and risk‑based test planning; own release readiness (go/no‑go) and rollback validation. * Drive shift‑left practices (contract testing, API first, early data checks) and shift‑right observability (synthetic monitoring, production validation dashboards). * Compliance & Security * Ensure test evidence meets BFSI regulatory/audit needs (SOX); automate traceability from user stories to test results and logs. Required Qualifications * 10-12+ years in software testing/quality engineering, with 5+ years leading SDET/automation teams. * Strong hands‑on coding in Java/C# (or equivalent) for test automation (frameworks, utilities, custom drivers). * Proven delivery of CI/CD‑integrated automation at scale; expert in test design for microservices, REST APIs, and event‑driven systems. * BFSI domain experience-core banking or payments-and vendor/platform collaboration (e.g., Fiserv) for patch/regression cycles. * Solid grasp of SQL and data validation; familiarity with logs/metrics (Splunk/Sumo/Grafana) for test diagnostics. Preferred Skills * Experience with OSAT‑style regression accelerators or similar enterprise frameworks; comfortable with shift‑left/shift‑right test strategies. * Performance testing (JMeter/LoadRunner) * ISTQB (Advanced), Agile/SAFe, or cloud certifications (Azure/AWS). Generic Managerial Skills, If any * Tools & Stack (Illustrative) * Automation: Selenium, Cypress, Playwright, RestAssured, Postman, Cucumber/BDD, Appium (mobile) * CI/CD & SCM: Azure DevOps, Jenkins, GitLab, GitHub Actions; Git * Test Management : Azure Test Plans, ALM/Octane, Zephyr/Xray * Data/DB: SQL Server, Oracle, PostgreSQL; TDM/masking tools * Observability: Splunk/Sumo, Grafana/Prometheus; quality dashboards Education Bachelor's in computer science/engineering or related field (advanced degree a plus). TCS Employee Benefits Summary: * Discretionary Annual Incentive. * Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans. * Family Support: Maternal & Parental Leaves. * Insurance Options: Auto & Home Insurance, Identity Theft Protection. * Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement. * Time Off: Vacation, Time Off, Sick Leave & Holidays. * Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing. Salary Range : $100,000-$120,000 a year
    $100k-120k yearly 21d ago
  • Director of Quality Improvement

    Opengate 3.5company rating

    Quality assurance manager job in Armonk, NY

    The Director of Quality Improvement is responsible for ensuring that Opengate's programs conform to all federal and state regulations and that all agency policies and procedures are adhered to. The Director of Quality Improvement develops and implements Opengate's QI plan, inclusive of scheduled internal audits of each department. Essential Job Functions: Ensures the agency maintains a comprehensive Quality Improvement Plan that is reviewed and updated quarterly, or as needed, to meet regulatory standards and support the agency's mission and goals for providing quality services. Develops and implements quality improvement systems across the agency. Complete internal audits to establish trends or patterns for monitoring and ensuring timely documented completion and implementation of plans of corrective action for internal reviews. Completes routine scheduled observations of program functions, systems and provides follow up. This includes on-site visits of all program areas for evaluation of program and service delivery. Meets with department directors, coordinators and managers to share information and make recommendations. Provides feedback and training recommendations to management and direct support staff. Attend all external surveys/audits, act as agency liaison with external auditors, and ensure timely responses to POCAs. Review statements of deficiency and Exit Conference Forms and completes Plans of Correction Action with input from applicable departments/staff. Collaborate with program administrators to ensure compliance with applicable Federal, State and local regulations and agency policies. Assist the Chief Compliance Officer in developing trends reports. Acts as CAS liaison and oversees the coordination of CAS Assessments for anyone receiving services or supports through Opengate. Assist with the identification of agency training needs resulting from OPWDD, DOH, OFPC, and OMIG regulatory requirements, changes in regulations, deficiencies or internal quality reviews. Participates on the agency Corporate Compliance Committee as requested. Must be able to interact/coordinate with OPWDD, OFPC, OMIG, DOH, and other community partners as necessary. Ensure agency liability notices and updates are distributed and collected upon intake and as needed thereafter. Identifies, responds to and addresses resident, participant or advocate dissatisfaction with services. Follows federal, state and local governmental regulatory guidelines pertaining to a safe, healthy and clean work environment, reporting health and safety concerns to the supervisor. Other duties as assigned by the CCO. Qualifications: A bachelor's degree in health, human services, education or management. Master's degree preferred. Five (5) years of experience working with ID/DD population in an OPWDD setting. Extensive knowledge of state and federal regulations as they pertain to OPWDD service providers. Must have excellent interpersonal skills and the ability to interact well with people receiving supports, employees, and external regulatory agencies and stakeholders. Must have excellent writing, computer, time management, and organization skills. Physical Requirements: Ability to work in a professional office environment for extended periods of time, routinely using standard office equipment. Ability to lift, push and pull up to 50 pounds, as well as bend, kneel and crouch as needed. Salary: $75,000 - $85,000 Compensation will be commensurate with job qualifications and work experience. Opengate is committed to equal employment opportunity. We will not discriminate against employees or applicants for em ployment on any legally-recognized basis including, but not limited to: veteran status, uniform service member status, race, color, religion, sex, national origin, age, physical or mental disability, creed, national origin, ancestry, age, marital status, domestic or civil union partnership status, affectional or sexual orientation, gender identity, genetic information, transgender status, predisposing genetic characteristics, familial status, education, domestic violence victim status, or any other characteristic protected under federal, state, or local law. The Company promotes inclusion and acceptance of all protected classes. In order to promote and maintain a community culture, employees hired to work at Opengate must legally reside and perform their work in the state of New York, New Jersey, Connecticut, or Pennsylvania.
    $75k-85k yearly Auto-Apply 38d ago
  • Manager, Plant Quality

    Voyant Beauty 4.2company rating

    Quality assurance manager job in Ridgefield, NJ

    Voyant Beauty believes our people are more than just employees; they're the driving force behind everything we achieve. Our culture fosters teamwork, respect, and camaraderie, ensuring that every individual's contribution is valued and celebrated. We invest in their growth, providing opportunities for development and advancement within our dynamic team. Voyant Beauty is a company that specializes in the development and manufacturing, of beauty, personal and home care products. We work with various brands, retailers, and businesses to create customer formulations and products tailored to their needs. This can include skincare, haircare, bath and body products, fragrances, and more. Essentially, Voyant Beauty serves as a one-stop-shop for companies looking to bring their beauty and personal care product ideas to life. Safety is a core value at Voyant Beauty. We prioritize the well-being of our team members, ensuring a safe and secure environment where everyone can thrive and excel. If you're seeking to be part of a team where your talents are valued, your safety is paramount, and your efforts contribute to meaningful change, then Voyant Beauty is the place for you. Come join us and be a part of our journey. A Brief OverviewThe Plant Quality Manager provides strategic and operational leadership for all quality functions at a high-volume OTC manufacturing facility. This role ensures GMP compliance, drives a quality culture, and leads quality system improvements to enhance overall site performance. As a critical leader, the Plant Quality Manager will strengthen the Quality organization, foster quality culture transformation, and optimize operational excellence across the facility. The ideal candidate is a hands-on, technically proficient leader with cGMP knowledge (21 CFR 210/211) and the ability to align cross-functional teams to elevate the site's quality systems and compliance.What you will do Lead QA, QC Labs, Document Control, Validation, and Complaint Management operations. Oversee implementation and improvement of site QMS in line with FDA and corporate standards. Serve as quality site lead for FDA and customer inspections. Ensures inspection readiness at all times. Address compliance issues and manage CAPAs effectively. Promote accountability, data integrity, and a right-first-time mindset. Collaborate with Ops, Eng, R&D, etc., on investigations, change management, validations, and continuous improvement. Supervise review of batch records, product release, deviations, and investigations. Work with customers, and other stakeholders to meet compliance expectations. Analyze metrics to drive performance and quality improvement. Coach and develop a High Performing Team. Ensure effective resourcing of quality teams. Represent site quality leadership in executive meetings. Contribute to corporate quality strategy alignment. Participate in strategic planning and facility expansion discussions. Some duties may vary slightly by location. Education Qualifications Bachelor's Degree in Chemistry, Pharmacy, Microbiology, Chemical Engineering, or similar. (Preferred) advanced degree (Preferred) Experience Qualifications 10+ years in FDA-regulated OTC, pharmaceutical, or personal care environments. (Preferred) 10+ years managing FDA inspections and remediation efforts. (Preferred) 10+ years background in aerosol manufacturing and topical formulations is a plus. (Preferred) Skills and Abilities Expertise in cGMPs, 21 CFR 210/211, ICH, USP (High proficiency) Leading FDA/customer audits and inspection readiness (High proficiency) Remediation planning and effectiveness verification (High proficiency) Working with Ops, Eng, and R&D on QMS topics (High proficiency) Team coaching, mentoring, and resourcing (High proficiency) Effective internal/external stakeholder communication (High proficiency) ERP (e.g., SAP), LIMS (e.g., MasterControl), TrackWise (High proficiency) Driving transformation in quality mindset and execution (High proficiency) Licenses and Certifications ASQ Certification (Preferred) Lean Six Sigma or OpEx training (Preferred) To Staffing and Recruiting Agencies:Our company does not accept unsolicited curriculum vitae's or applications from agencies. We are not responsible for any fees related to unsolicited curriculum vitae's or applications and explicitly reserve its right to contact candidates presented in such unsolicited curriculum vitae's or application. Our company provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, color, national origin, sexual orientation, age, disability or veteran status. Voyant Beauty will consider requests for accommodations due to a disability impacting a qualified employee's ability to perform the essential functions of their position consistent with applicable laws. In addition to federal law requirements, Voyant Beauty complies with applicable provincial and local laws governing nondiscrimination in employment in every location in which the company has facilities. 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.
    $81k-101k yearly est. 16d ago
  • Quality Manager

    Crane Aerospace & Electronics

    Quality assurance manager job in West Caldwell, NJ

    **Crane Aerospace and Electronics** has an exciting opportunity for a **Quality Manager** at our **West Caldwell, NJ** location. **About Crane:** Crane Aerospace & Electronics supplies critical systems and components to the aerospace and defense markets. You'll find Crane Aerospace & Electronics in some of the toughest environments: from engines to landing gear; from satellites to medical implants and from missiles to unmanned aerial systems (UAS). Every time you use phone navigation, make a bank transaction or have food delivered to your home, Crane Aerospace & Electronics Microwave product is hard at work. Located in the tight-knit, family-first West Caldwell, NJ., community, our West Caldwell facility supplies industry-leading microwave components and systems for use in space, defense and commercial applications, including GPS III satellites. With more than 60 years of expertise, our Microwave group has proven capabilities in major military, communications, electronic warfare, radar and satellite systems. Start the next chapter of your career with Crane Aerospace & Electronics! **Job Summary:** The Quality Manger is responsible for establishing, implementing and directing quality assurance efforts to ensure components and other materials in finished goods and products conform to quality standards based on the requirements and expectations of the organization and customer. **Essential Functions:** - Management, training and mentoring of all Quality Department employees at site level - Lead problem solving Kaizen events - Manage budget, costs and expenditures within the Quality function and applicable functional support requirement. - Responsible for investigation of and formal response to all customer complaints(SCARS) - Responsible for failure analysis & corrective action reporting system(FRACAS) - Participate in internal and external quality audits - Any other task assigned by your supervisor or management **Minimum Qualifications:** - Experience: 5+ years Quality assurance experience in the defense, space electronics or high end aerospace industry in either a management role or senior quality engineering position; Experience with Lean and Six Sigma methodologies - Knowledge: Expert knowledge of Quality Management Systems as well as Process Improvement and Control Techniques; Demonstrated knowledge of manufacturing best practices, process control (SPC, Six Sigma), logistics processes (inventory management), engineering management (project management) and safety management - Skills/Abililties: Demonstrated strong analytical and problem solving skills; Effective written and verbal communication skills and interpersonal skills; Ability to manage through influence; Abilty to demonstrate a strong sense of urgency - Education/Certification: B.S. degree in electrical or mechanical engineering, or related field **Preferred Qualifications:** - Certified ISO/AS lead assessor credentials **Working Conditions:** - Standard office environment - Work requires substantial visual concentration on detail - Working conditions are normal for a manufacturing environment - Manufacturing operations may require the use of safety equipment to include but not limited to: eye safety glasses, gowning, masks, hearing protectors, heel/wrist straps and any other required PPE - May be exposed to unusual environmental conditions such as loud noises, cold temperatures, confined spaces, dust or fumes - Travel up to 10% may be required Standing: 30% *percentage is approximate and may vary depending on work task Sitting: 70% *percentage is approximate and may vary depending on work task Lifting (in pounds): up to 25 pounds Pushing (in pounds): up to 25 pounds Mental/Visual: use of computer, calculator, filing cabinets Workspace: cubicle/desk Crane Co. reserves the right to change or assign other duties to this position. The statements contained herein reflect general details as necessary to describe the principal functions of this job, the level of knowledge and skill typically required and the scope of accountability and responsibility. These descriptions should not be considered to be all-inclusive listings of work requirements. Crane Co. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, creed, religion, sex, national origin, marital status, age, sexual orientation, gender identity characteristics or expression, physical or mental disability, pregnancy, medical condition, genetic information, or U.S. military or veteran status or any other characteristic protected under federal, state, or applicable local law, in recruiting, hiring, training and promoting **_Salary range: $132,020.70 - $162,894.20._** Several factors contribute to actual salary, including experience in a similar role or performing comparable job responsibilities, skills, training, and other qualifications. Some roles may be eligible for participation in performance-based bonus programs. _This description has been designed to indicate the general nature and level of work being performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job._ _Crane Company. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, gender, sexual orientation, general identity, national origin, disability or veteran status._ At Crane, we believe that attracting and retaining the highest quality people is the best insurance of success. Our goal is to recruit talented people and train them within a culture that calls for performance with trust and respect. Join us. The unique backgrounds and differences of our associates make us stronger, more capable, and more successful. Beyond an associate's base compensation, we reward and reinforce wellbeing with a compelling package of both cash and non-cash benefits, including comprehensive health, wellness incentives, assistance with retirement savings, paid time off, paid holidays, and tuition reimbursement - as well as performance-based bonus programs for certain positions. Crane prioritizes career development for our associates. All associates receive an annual development plan that includes a mixture of on-the-job coaching and formal training experiences to support individual development needs. We firmly believe in associate growth that supports career progression and we will proactively support your ongoing career development.
    $132k-162.9k yearly 42d ago
  • Specialist I, Quality Assurance

    SGS Group 4.8company rating

    Quality assurance manager job in Fairfield, NJ

    SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services. Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential. Specialist I, Quality Assurance is responsible for assisting management with the maintenance of the Quality Systems at SGS. Assignments are generally provided by a Team Leader or Manager. The Quality Assurance Specialist must be sensitive to the demanding regulatory compliance requirements attending to the operation of a pharmaceutical testing laboratory. This job also requires the ability to demonstrate a high commitment to interpersonal relations. * Provides support to technical staff in their efforts to ensure that routine testing submitted by clients is completed within established parameters governing turnaround time, quality specifications, etc. * Performs routine testing in conjunction with client-specific projects * Approves and issues Certificate of Analysis and signs on cGMP related reports * Participates in departmental and/or company-wide projects designed to improve the nature of SGS client services * Demonstrates willingness and ability to train on applicable general SOPs pertaining to the Analytical Laboratory * Participates in general staff training sessions as these are scheduled * Participates in departmental efforts directed toward equipment maintenance and calibration * Adheres to relevant SGS SOPs governing official records and documentation. * Compliance with applicable SOPs related to the handling of customer complaints Qualifications * B.S. in Chemistry, Biology, Microbiology, or equivalent experience required * 0-2 years of experience preferably in Life Sciences supporting cGMP Operations * Thorough knowledge of scientific principles is required Additional Information SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required. This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time. If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call ************ for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.
    $75k-110k yearly est. 43d ago
  • Quality Control Manager

    CBRE Government & Defense Services

    Quality assurance manager job in West Point, NY

    This position shall have overall responsibility for the contractor's quality control management program to include maintaining and overseeing the quality control management program for entire contract. Primary Job Functions Administer quality control management program Responsible for overall quality assurance program Monitor and inspect all delivery orders for compliance Maintain records of inspections and certifications Prepare monthly reports depicting findings of quality inspections Periodically review the quality control program to ensure compliance Examine processes for preventative and corrective maintenance; make suggestions based on findings Perform inspections and re-inspections to ensure problems have been resolved Collect data for the DMLSS system including work orders and equipment history Research safety and quality topics online May prepare incident and accident reports May be tasked with preparing training materials and conducting employee safety meetings May manage the disposal of hazardous waste Fill out RPIE-commissioning forms for new and replacement equipment Prepare service order documentation Perform QC inspections on service orders and other projects May research and issue infection control and interim Life Safety permits May train personnel on material control and equipment and tool management Other duties as assigned Education, Experience and Certification Associate degree in related field 3 years' experience in preparing and enforcing quality management programs (QMS) on contracts of similar size, scope and complexity 2+ years of experience in quality control evaluation and reporting in the fields of construction or facility management work 2+ years of experience working in comparably sized health facilities OHSA Certifications, highly preferred Knowledge, Skills, and Abilities Knowledge of OSHA safety regulations and PPE procedures Ability to conduct accident investigations and safety inspections Strong written and oral communication skills Disclaimer CBRE Government & Defense Services are thrilled at the opportunity for you to apply for one of our roles. The base salary range for this position is $80,000- $110,000. This position may also be eligible for a wide range of competitive benefits that can include but are not limited to medical, well-being, financial planning and short-term benefits. This description is not intended to be an “all inclusive” list of the accountabilities of the job described. Rather, it describes the general nature of the job. In addition, some aspects of this job may change over time, according to business needs, and these changes may not be recorded immediately. The requirements stated represent the minimum levels of knowledge, skills and/or abilities to qualify and satisfactorily perform this job. THIS DOCUMENT SHOULD NOT BE CONSTRUED AS CREATING A CONTRACT OF EMPLOYMENT BETWEEN CBRE GOVERNMENT & DEFENSE SERVICES AND ANY OF ITS EMPLOYEES OR OTHERWISE ALTERING AN EMPLOYEE'S AT WILL EMPLOYMENT RELATIONSHIP WITH CBRE GOVERNMENT & DEFENSE SERVICES.
    $80k-110k yearly 21d ago
  • Quality Manager

    West Star Aviation 4.5company rating

    Quality assurance manager job in Teterboro, NJ

    West Star is the fastest-growing maintenance, repair organization in the industry, and we recognize this is the result of our talented team of trusted employees working together to deliver customer service excellence. We are committed to providing our employees with personal and professional growth opportunities while fostering a culture of respect and well-being with a small company feel. What You Can Expect as a Quality Manager at West Star: This position is responsible to the Quality Control Director for the overall operation of the Quality Department and will have the final authority in the release to service of airframes, engines, propellers, appliances, and the component parts thereof. In addition, the Quality Manager is responsible for directing, planning, and outlining the details of inspection standards, methods, and procedures used by the repair station in compliance with all applicable Federal Aviation Regulations, manufacturers' specifications, and recommendations. You Will Be ESSENTIAL to Many FUNCTIONS, Including: Supervise, mentor, and guide team members of the Quality Department; foster a positive work environment, encourage teamwork, and enhance skills through on-the-job training and performance coaching. Participate in hiring and disciplinary matters while conducting quarterly performance assessments and feedback. Liaise with the local FAA as required to ensure the repair station maintains compliance with FAA regulations. Assure that all inspections are properly performed on all completed work and that the proper inspection records, reports, and forms used by the repair station are completed and executed before releasing the product for service return. Determine that all technical data on articles overhauled or repaired by the repair station are kept current with the latest revisions. Assure that periodic checks are made on all inspection tools and the calibration of precision equipment used by the repair station. Guide the final acceptance of all incoming material, including new parts, supplies, and the airworthiness of articles on which work has been performed outside the repair station. Assure that the proper inspection records, reports, and forms used by the repair station are available to all inspection personnel. Assure that the technician responsible properly executes complete entries on forms and work orders used by the repair station. Assure that procedures used in the procurement and reception of aircraft parts guard against "bogus" and "unapproved" parts from entering the parts system and ensure that any such parts are detected before their use. Ensure that proper entries are made into maintenance logs and work orders. Any other job-related duties as assigned by the supervisor or management. Effectively communicate (i.e., speak, write, read) in English. Any other job-related duties as assigned by the supervisor or management.
    $80k-115k yearly est. 15h ago
  • Quality Control Manager

    Lynkx Staffing LLC

    Quality assurance manager job in Saddle Brook, NJ

    Quality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that quality standards are upheld for all products produced at the facility. The goal is to ensure that the Quality Control group and company is constantly moving towards fulfilling its short-term and long-term objectives and does not diverge from its strategic guidelines. Under the direction of the VP, Global Quality Head, responsibilities of the QC Manager will include but are not limited to: Leading, hiring, developing, training, and evaluating QC personnel Devising sound hiring strategies based on business needs Supervising and overseeing QC personnel in their roles for safe and efficient verification, approval, release/disposition of HCATS and/or client products/materials Delegating responsibilities and supervising the work of laboratory personnel, while providing guidance and motivation to drive maximum performance Ensuring and promoting compliance with applicable cGMP and GTP regulations, while ensuring compliance with company and client methodologies Assuring alignment and efficient continuity in laboratory practices between sites Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records Ensuring completion of all client QC requirements related to GMP cellular products and/or materials Overseeing QC role in material dispositions via deviation reporting system, CoAs, and/or client-based systems, if applicable Prioritizing, scheduling, and managing multiple projects and resources simultaneously Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal and client audit findings Evaluating and investigating customer complaints and deviations; coordinating corrective and preventive actions as they relate to the Quality Control function Delegating maintenance, tracking, and trending aspects of the deviation reporting system Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing Interfacing with vendors, suppliers, and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies, when applicable Interfacing with management at all levels for alignment on significant deviation resolution and corrective action implementation Delegating development, revisions, and implementation of Standard Operating Procedures as related to Quality Control activities Participating in and tracking group budget setting and cost containment drives Communicating and maintaining trust relationships with senior management, business partners, and clients Ensuring company policies and legal guidelines are communicated top-down in the company and that they are followed at all times Completing projects and special tasks as assigned by the Global Quality Head Off-schedule shifts during weekends and holidays based on business requirements a possibility On-call presence preferred while physical personal presence is not possible Candidate will oversee QC Scientist and QC Associate I, II, and III roles. The QC Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes. REQUIREMENTS BA/BS/MS in a science or relevant field required Master's in Business Administration or relevant field will be preferred 7 - 10 years' experience in the pharmaceutical, biologics or related industry Prior cGMP experience required Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must Experience in Flow Cytometry is a must 5 + Years experience leading a team is a must. Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff Sound understanding of current Good Manufacturing Practices (cGMPs) Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of production processes and validation Prior experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, method validations preferred Proven experience in a supervisory or managerial position Demonstrable experience in developing strategic plans based on business needs Strong understanding of Quality Control in pharmaceutical/biotechnology/biologics industries Thorough knowledge of market changes and forces that influence the company Proficient with computer software: Microsoft Office, Visio Strong written, oral, and presentational skills Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review Excellent organizational and leadership skills Excellent communication, interpersonal, and presentation skills Outstanding analytical and problem-solving abilities Strong business acumen Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clients Must be able to handle the standard/moderate noise of the manufacturing facility 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.
    $70k-103k yearly est. 8d ago
  • Supplier Quality Manager

    Cencora, Inc.

    Quality assurance manager job in Kearny, NJ

    Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details The Supplier Quality Manager is responsible for ensuring suppliers meet World Courier quality standards and compliance requirements while driving continuous improvement in supplier performance. This role involves developing and maintaining supplier quality programs, conducting audits, and managing supplier relationships to ensure the delivery of high-quality materials and services. The Supplier Quality Manager collaborates across departments to align supplier performance with organizational goals and regulatory standards. Primary Duties and Responsibilities: Supplier Quality Program Development * Develop and implement supplier quality management policies, procedures, and standards. * Partner with global QA to establish and maintain supplier qualification and approval processes. * Define key performance indicators (KPIs) to monitor supplier quality and performance. Supplier Audits and Assessments * Conduct regular supplier audits to ensure compliance with quality standards, regulatory requirements, and company specifications. * Perform risk assessments for suppliers and identify opportunities for improvement. * Prepare audit reports, corrective actions, and follow-up plans for supplier quality issues. Supplier Relationship Management * Build strong relationships with suppliers to foster collaboration and alignment. * Communicate quality expectations clearly and provide feedback to suppliers on performance. * Work closely with suppliers to implement corrective actions and resolve quality issues. Quality Issue Resolution * Investigate supplier-related quality issues and implement root cause analysis to prevent recurrence. * Collaborate with internal teams to address and resolve supplier-related challenges. * Ensure timely resolution of non-conformance reports (CAPA) and deviations. Compliance and Regulatory Standards * Ensure suppliers comply with industry standards, regulatory requirements, and certifications (e.g., TSA, GDP). * Maintain supplier quality documentation in accordance with company and regulatory standards. * Stay updated on changing regulations and ensure supplier compliance. Continuous Improvement Initiatives * Drive continuous improvement efforts across the supplier base to enhance quality, efficiency, and cost-effectiveness. * Partner with internal supplier management teams to reduce lead time and improve operational efficiency. * Implement best practices for supplier quality management. Required Qualifications: * Bachelor's degree in Engineering, Quality Management, Supply Chain Management, or a related field. * Minimum of 5 years of experience in supplier quality management, quality assurance, or a similar role. * Strong knowledge of quality management systems (e.g., ISO 9001, GDP). * Experience with supplier audits, corrective actions, and root cause analysis. * Proficiency in quality tools and methodologies (e.g., Six Sigma, Lean Manufacturing, FMEA, SPC). * Knowledge of regulatory requirements such as FDA, EMA, or other relevant standards. Skills and Competencies: * Excellent analytical and problem-solving skills. * Strong project management and organizational abilities. * Effective communication and interpersonal skills to collaborate with suppliers and cross-functional teams. * Ability to negotiate and influence supplier performance. * Proficient in quality management software and tools. Preferred Qualifications: * Certifications such as ASQ Certified Quality Engineer (CQE), Six Sigma Green/Black Belt, or similar. * Experience in pharmaceutical, medical device, or highly regulated industries. * Familiarity with ERP systems and supply chain management software. Work Environment: * Office-based with occasional travel to supplier facilities (estimated travel time 40%). * Must be able to travel overseas if required. * Requires working in cross-functional teams and engaging with suppliers globally. * Having a high sense of dedication and collaboration to support quality department's initiatives and moving quality excellence forward. * Detailed, well-organized and able to multi-task and manage multiple projects at the same time, prioritizing required actions accordingly to meet required deadlines. * Strong drive to remain focused, self-motivated and committed to completing or achieving tasks. * Be open minded to industry/organizations change and learn/adopt new skills/knowledge/tools to drive success. * Excellent skills in Microsoft Office (Excel, Word and PowerPoint). * Able to work independently and lead a team when required. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Salary Range* $57,900 - 85,360 * This Salary Range reflects a National Average for this job. The actual range may vary based on your locale. Ranges in Colorado/California/Washington/New York/Hawaii/Vermont/Minnesota/Massachusetts/Illinois State-specific locations may be up to 10% lower than the minimum salary range, and 12% higher than the maximum salary range. Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned . Affiliated Companies: Affiliated Companies: World Courier Inc
    $57.9k-85.4k yearly Auto-Apply 9d ago
  • Clerical Quality Assurance Coordinator (30974)

    Ime Resources

    Quality assurance manager job in Woodbury, NY

    ExamWorks is looking for a Clerical Quality Assurance Coordinator to join our team onsite! The Clerical Quality Assurance Coordinator is responsible for handling various tasks related to client reports including, but not limited to: receiving, coordinating, assigning and returning completed reports to clients. This position works closely with the clinical quality assurance team and ensures work is processed and completed of the highest quality and in compliance with all policy and procedures. Our work hours are from Monday to Friday, 8:30am-5:00pm. This is on onsite role, located at our Woodbury, NY location. We offer a competitive pay of $22-24 per hour depending on experience. Plus overtime opportunities, with competitive benefits (medical, vision, dental), paid time off, and 401k. Our Culture - We believe in a culture of respect and openness. We operate a fast paced, high volume business and value the contributions and partnership of our employees. We have a stable workforce and are looking for employees who have a good work ethic and can operate well in a team environment. While we are heavily focused on work and meeting our clients' expectation and deadlines, we still take time to enjoy the little things, with periodic office lunches and celebrations. What do we do? ExamWorks is a growing and profitable leading provider of innovative healthcare services including independent medical examinations, peer reviews, bill reviews, Medicare compliance, case management, record retrieval, document management and related services. Our clients include property and casualty insurance carriers, law firms, third-party claim administrators and government agencies that use independent services to confirm the veracity of claims by sick or injured individuals under automotive, disability, liability and workers' compensation insurance coverages. ESSENTIAL JOB FUNCTIONS Receive client submissions and input client and examinee data in the system. Verify all cases contain information needed for the clinical review process. Maintain daily contact with the Clinical QA Department regarding workflow and status of pending reports. Track documentation of all processes, communications, report status and due dates. Maintain a daily log of files that require follow up, clarification or concerns in the tracker. Receive completed reports and review for completeness and accuracy, including proper formatting, grammar and sentence structure. Complete and or ensures all invoicing is billed daily and in accordance with company practices and client contract agreements. Handle and respond promptly to incoming communication from physicians or clients requesting report status or information. Work with transcriptionists and/or physicians' offices regarding report details, clarification, addendums, etc. Ensure all medical records and reports are properly documented and saved in the appropriate location. Notify management of any report issues or concerns. Ensure all practices are carried out in accordance with HIPAA compliance practices, state and federal safety standards and legal regulations Promote effective and efficient utilization of clinical resources and supplies. Perform other duties as assigned. Qualifications Education and/or Experience High school diploma or equivalent required. Minimum one year clerical experience; or equivalent combination of education and experience preferred. Experience in a medical office or insurance industry preferred. QUALIFICATIONS Must possess knowledge of general computer, fax, copier, scanner, and telephone. Must be knowledgeable of multiple software programs, including but not limited to Microsoft Word, Outlook, Excel, and the Internet. Must have a full understanding of HIPAA regulations and compliance. Must be a qualified typist with a minimum of 40 W.P.M. Ability to follow instructions and respond to managements' directions accurately. Must demonstrate accuracy, thoroughness, and responsibility for quality of work, and ability to take initiative to identify improvements. Looks for ways to improve and promote quality and monitors own work to ensure quality is met. Must demonstrate exceptional communication skills by conveying necessary information accurately, listening effectively and asking questions where clarification is needed. Must be able to work independently, prioritize work activities and use time efficiently. Must be able to maintain confidentiality. Must be able to demonstrate and promote a positive team -oriented environment. Must be able to stay focused and concentrate under normal or heavy distractions. Must be able to work well under pressure and or stressful conditions. Must possess the ability to manage change, delays, or unexpected events appropriately. Ability to follow all company policies and procedures in effect at time of hire and as they may change or be added from time to time. ExamWorks 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, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected category under applicable federal, state, and local laws.
    $22-24 hourly 17d ago
  • GCP QA Auditor - Radiopharmaceuticals & Clinical Trials

    Blackstar 3.4company rating

    Quality assurance manager job in Paramus, NJ

    We are seeking an experienced GCP Quality Assurance Auditor to join our rapidly growing biopharmaceutical company specializing in neurology and psychiatry therapies. This role ensures GXP compliance, drives quality management initiatives, and conducts internal and external audits across clinical trials, safety/pharmacovigilance, and vendor operations (CROs, CMOs, investigator sites). The ideal candidate has extensive GCP experience, a strong pharmaceutical QA background, and expertise in radiopharmaceuticals. This is an on-site position in Northern NJ with flexible hours and minimal domestic travel. Key Responsibilities: Plan and perform global clinical process and vendor audits across all clinical trials Conduct risk-based audits of clinical processes and vendors, including IRT and EDC systems Prepare detailed audit reports and manage related non-conformances Ensure compliance with GCP, FDA, EMA, and ICH regulations Support regulatory inspections and quality improvement initiatives Collaborate with clinical teams, QA, and vendor management Qualifications: Bachelor's degree in a scientific, healthcare, or related discipline 5+ years of pharmaceutical industry experience, including 2+ years in radiopharmaceutical QA Extensive GCP and safety/pharmacovigilance experience Proven experience in internal and external GXP audits Familiarity with QMS, SOPs, clinical systems (IRT, EDC), and regulatory documentation Strong communication and cross-functional collaboration skills Up to 10% domestic travel Why Join Us: Be part of a fast-growing biopharma company making a difference in neurology and psychiatry Hybrid work schedule with flexible hours Opportunity for extension or full-time role
    $68k-110k yearly est. 21d ago
  • Quality Control Manager

    CBRE Government and Defense Services

    Quality assurance manager job in West Point, NY

    This position shall have overall responsibility for the contractor's quality control management program to include maintaining and overseeing the quality control management program for entire contract. **Primary Job Functions** + Administer quality control management program + Responsible for overall quality assurance program + Monitor and inspect all delivery orders for compliance + Maintain records of inspections and certifications + Prepare monthly reports depicting findings of quality inspections + Periodically review the quality control program to ensure compliance + Examine processes for preventative and corrective maintenance; make suggestions based on findings + Perform inspections and re-inspections to ensure problems have been resolved + Collect data for the DMLSS system including work orders and equipment history + Research safety and quality topics online + May prepare incident and accident reports + May be tasked with preparing training materials and conducting employee safety meetings + May manage the disposal of hazardous waste + Fill out RPIE-commissioning forms for new and replacement equipment + Prepare service order documentation + Perform QC inspections on service orders and other projects + May research and issue infection control and interim Life Safety permits + May train personnel on material control and equipment and tool management + Other duties as assigned **Education, Experience and Certification** + Associate degree in related field + 3 years' experience in preparing and enforcing quality management programs (QMS) on contracts of similar size, scope and complexity + 2+ years of experience in quality control evaluation and reporting in the fields of construction or facility management work + 2+ years of experience working in comparably sized health facilities + OHSA Certifications, highly preferred **Knowledge, Skills, and Abilities** + Knowledge of OSHA safety regulations and PPE procedures + Ability to conduct accident investigations and safety inspections + Strong written and oral communication skills **Disclaimer** CBRE Government & Defense Services are thrilled at the opportunity for you to apply for one of our roles. The base salary range for this position is $80,000- $110,000. This position may also be eligible for a wide range of competitive benefits that can include but are not limited to medical, well-being, financial planning and short-term benefits. This description is not intended to be an "all inclusive" list of the accountabilities of the job described. Rather, it describes the general nature of the job. In addition, some aspects of this job may change over time, according to business needs, and these changes may not be recorded immediately. The requirements stated represent the minimum levels of knowledge, skills and/or abilities to qualify and satisfactorily perform this job. THIS DOCUMENT SHOULD NOT BE CONSTRUED AS CREATING A CONTRACT OF EMPLOYMENT BETWEEN CBRE GOVERNMENT & DEFENSE SERVICES AND ANY OF ITS EMPLOYEES OR OTHERWISE ALTERING AN EMPLOYEE'S AT WILL EMPLOYMENT RELATIONSHIP WITH CBRE GOVERNMENT & DEFENSE SERVICES. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (**************************** notice from the Department of Labor.
    $80k-110k yearly 21d ago
  • Quality Control Manager

    Lynkx Staffing LLC

    Quality assurance manager job in Saddle Brook, NJ

    Quality Assurance Manager The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs.The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes. Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements. Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues. Establish and maintain policy for documentation of all products and perform internal documentation audits. Author and review relevant SOPs, validation and other documents. Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports. Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review. Control Master Batch Records, distribution and label verification. Perform line clearance activities as required. Assign and maintain product lot numbers as applicable. Ensure materials management nonconformance disposition and release activity as applicable. Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions. Provide Quality Assurance related support to various departments. Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies. Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks. Provide support to manufacturing for investigations of deviations, validations, and development of specifications Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements. Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted. Perform employee training on QSR and ISO requirements and company quality systems Perform document control activities as assigned. Mentor/train/develop and manage Quality Assurance team. Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements REQUIREMENTS BS Degree in biological sciences or equivalent. Minimum 5-10 years related experience in the pharmaceutical or biologics industry. Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs). Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc. Sound knowledge of aseptic processing and supporting technologies. Analytical and technical troubleshooting skills are a plus. Proficient with Microsoft Office Suite. Excellent organizational skills and attention to detail. Good verbal and written communication skills. Strong team-oriented interpersonal skills are essential. Travel may be required Strong business acumen Experience with Visio, Microsoft Project and Excel) Ability to think strategically and tactically (detail-oriented) Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment Analytical and problem-solving skills Strong written and oral communication skills Meeting management/facilitation skills/teamwork Ability to multi-task is essential Flexible and able to adapt to company growth and evolving responsibilities 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.
    $70k-103k yearly est. 8d ago

Learn more about quality assurance manager jobs

How much does a quality assurance manager earn in Clarkstown, NY?

The average quality assurance manager in Clarkstown, NY earns between $68,000 and $143,000 annually. This compares to the national average quality assurance manager range of $70,000 to $140,000.

Average quality assurance manager salary in Clarkstown, NY

$98,000

What are the biggest employers of Quality Assurance Managers in Clarkstown, NY?

The biggest employers of Quality Assurance Managers in Clarkstown, NY are:
  1. The Institutes of Applied Human Dynamics
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