Quality Assurance Manager Jobs in Marlboro, NJ

About Jericho Project Jericho Project is a nationally acclaimed nonprofit ending homelessness by enabling individuals and families experiencing homelessness to attain quality housing, employment, and mental and physical health services. The 42-year-old nonprofit serves over 2,500 individuals, including 700 veterans, annually. Jericho has been a key partner in New York City's initiative to end veterans' homelessness, and is leading bold, innovative strategies to do the same for families and young adults. Our programs touch four cornerstones of a person's life: housing, employment, wellness, and family stability. We create a culture of “moving on” through a foundation of housing and supportive services provided by expert program specialists and case managers. We have over 700 units of permanent supportive housing including 7 residences in the Bronx and Harlem, as well as scatter-site apartments throughout NYC. Jericho further provides case management, employment and health care access services to over 100 units of supportive housing in Brooklyn and “light touch” case management services in several housing developments throughout New York City. About the Position Jericho Project is seeking a driven and enthusiastic Director of Government Contracts and Quality Assurance. The incumbent will be responsible for managing procurement, renewal and compliance reporting of a range of government grants and contracts. The selected individual will be critical in ensuring that programs have full knowledge of all contract requirements, that Jericho Project is compliant with all government grant-related reporting and regulations and that, based on execution of contracts and information provided to finance, billed revenue is maximized. In addition, they will serve as the system administrator for various on-line reporting systems utilized by Jericho Project and coordinate Data Quality issues in the agency as well as lead the maintenance of Jericho's CARF accreditation. The FLSA status of this position is Exempt. Responsibilities: Contracts Management Ø Responsible for submitting all documents required for contract renewals on single or multiyear contracts, in conjunction with program, operations, and finance staff (DOHMH, DHS, HRA, HUD, VA, etc.). Ø Coordinate preparation of government grants and proposals in response to RFPs in conjunction with Executive Assistant, program staff, and/or Development Department. Ø Respond to senior staff requests for information in a timely manner. Ø Keep abreast of government/funding agency policy changes. Ø Manage the HUD NOFO process and other submissions for the NYC CoC (HIC PIT, HOPE Count). Ø Provide budget insights and analysis to inform senior management and the Finance department. Ø Monitor government contracts and grants for maximum spending and efficient use of resources. Performance Measurement, Data Quality & Compliance Reporting: Ø Serve as System Administrator, overseeing day-to-day activities and operations of a complex, highly customized Electronic Health Record used primarily for electronic case record management (AWARDS) including troubleshooting support and training. Ø Serve as System Administrator for internal Appfolio property management system. Ø Co-manage user roles, security, profiles, workflow rules, and other configuration options in the Electronic Health Record and Property Management system and serve as the backup to the IT Administrator. Ø Troubleshoot and resolve user issues for external reporting platforms and data collection systems in collaboration with external system managers (Foothold Technology, OMH applications, DOHMH applications, CAPS and other HRA applications, HUD& VA applications). Ø Collect program information to complete government progress reports and other funder required reports as assigned and required (DOHMH LOS, HUD APRs/SAGE, OMH MHPD and Bi-Annual Patient Characteristics Survey). Ø Manage monthly data uploads for HMIS (VA Repository, HUD - NYC CoC). Ø Collaborate on the development and implementation of routine processes for monitoring data quality, accuracy and completeness across all platforms. Ø Provide clinical and operational key performance indicator data to senior management, program directors, and property managers. Ø Maintain and reconcile data quality for unit subsidy and social services criteria assignments for PSH portfolio across data systems. Ø Assist Property Managers (Managers of Building Operations) and Finance department in maintaining high quality information of supportive housing portfolio reporting and other administrative requirements for their grants/contracts including tenant rent collection, rental assistance payments, HQS inspections, and LIHTC Compliance. Ø Work with program staff to identify management info needs and if applicable, create custom reports and dashboards to share data across departments, teams, and the organization. Continuous Quality Improvement (Risk Management & Quality Controls): Ø Keep abreast of changing CARF requirements, lead relationships with CARF consultants and maintain CARF accreditation. Ø Interpret and communicate CARF changes to program and senior staff. Ø Work with agency staff to operationalize CARF standards and monitor their effective implementation. Ø Monitor adherence to CARF standards and maintain related Survey Monkey data collection systems. Ø Manage and participate in projects to improve use of the Electronic Health Record and property management systems, including working with staff and external consultants to implement enhancements to the system. Ø Manage and highlight concerns about data management and oversee the integrity of data collection. Ø Assist senior staff in design and implementation of procedures to bring operations into compliance with funders and regulations, monitor for ongoing improvement. Ø Collaborate on development and implementation of quantitative systems to measure risk management performance improvement in areas such as Stakeholder Satisfaction, Provision of Evidence Based Practices, and Critical Incidents. Ø Monitor completeness of Incident Management documentation and work with senior managers to highlight trends. Ø Monitor completeness of the client grievance process and resolutions. Ø Work with program staff, senior managers and MBOs to identify staff training needs around issues of compliance and data quality; in partnership with the Chief Program Officer and Chief Operating Officer, develop and implement such trainings. Ø Receive, analyze, and evaluate and implement requests for changes from users to determine organization-wide impacts including creating data collection tools, adding new fields; editing page layouts; creating list views, reports and dashboards, workflow and validation rules for AWARDS and Appfolio. Ø Conduct audits for quality and completeness of records within programs and property management. Ø Develops corrective action plans and processes to ensure contract compliance and continuous quality improvement. Ø Supervise Contracts & Quality Assurance Manager(s). Ø Serve as HIPAA Privacy Officer. Ø Performs other related duties as assigned. Requirements: Ø Master's degree required (preferably in Human Services, or related field). Ø At least 3 to 5 years of experience with grants and contracts in government, healthcare, human services, or other non-profit settings. Ø Managerial experience required. Ø Knowledge of online systems preferred including: Grants.gov, NY State Financial System, NYC Passport, Grants Gateway, AWARDS, Electronic Health Record, TMS, E-SNAPS and SAGE. Ø Ability to communicate with and effectively train staff on grants and use of systems. Ø Passion for Jericho's mission, values, and approach. Ø Proficient in the use of business computing software including intermediate to advanced experience with MS Office Suite, Google Workspace, Dashboard Software (Tableau, Power BI). Ø Excellent interpersonal and communication skills. Ø Ability to work independently and collaboratively, set priorities and exercise sound judgment. Ø Excellent attention to detail, strong project management skills, and ability to manage multiple complex tasks while maintaining composure under demanding deadlines. Ø Flexibility in approach and willingness to adapt when necessary. Compensation: The salary range for this position is $90,000.00 to $100,000.00 annualized . Salary negotiable. Jericho Project offers a comprehensive benefits package. Employees are eligible for a merit increase annually. Merit increases are based on the employee's performance during the prior year.

A leading company in the food production space is seeking a Spanish-speaking Director of Quality Assurance to lead quality and food safety programs across its dynamic, multi-site manufacturing operations. This role is ideal for a strategic thinker with a passion for continuous improvement, regulatory compliance, and team development. Key Responsibilities Direct and develop the QA and regulatory teams across four bakeries and multiple warehouses. Foster a culture of quality, safety, and continuous improvement throughout the organizations Maintain and enhance food safety systems to meet BRC, FDA, USDA, Kosher, Gluten-Free, and Organic standards. Serve as the primary lead for all internal and external audits; train QA staff to manage audits independently. Collaborate with cross-functional teams including EHS, Manufacturing, Planning, Logistics, and Customer Service. Promote and implement efficiency and safety programs across all facilities. Oversee COA processes to ensure timely and accurate documentation for customers. Lead vendor compliance programs for raw materials, packaging, and logistics partners. Investigate and resolve quality and food safety issues using tools like HACCP, cGMP, FIFO, and root cause analysis (5 Whys, Pareto). Lead recall and traceability programs, including mock recall exercises. Qualifications Bachelor's degree in Food Science, Biology, Chemistry, Engineering, or a related technical field. 8+ years in Quality Assurance, including leadership roles in food manufacturing (bakery experience preferred). Strong leadership and team development capabilities. Excellent communication and collaboration skills across all levels. Proficient in Microsoft Office and QA-related systems. Strong analytical and problem-solving abilities. LEAN, Six Sigma, or similar certifications are a plus. Bilingual in English and Spanish is required. Routine travel to NY and NJ facilities is expected.

Required skills: Specific Quality Assurance experience with Guidewire Policy center solutions in the Property & Casualty Policy lifecycle is essential. Strong experience in Rating & Forms for US GL lines. Job details: Conduct a thorough review and analysis of system specifications to extract test requirements and craft detailed Test Cases/Scripts. Develop, document, and sustain a repository of functional test cases and supplementary test artifacts including test data, data validation procedures, and automated scripts. Engage in collaborative efforts with QA engineers to devise comprehensive Test Plans. Execute manual and automated test cases with precision, and systematically report the outcomes. Identify, document, and communicate bugs and errors to the development teams in a timely manner. Maintain logs to chronicle the various testing phases-functional, end-to-end, and regression-and track defects. Partner with cross-functional teams to promote and uphold quality throughout the software development lifecycle. TECHNICAL QUALIFICATIONS A minimum of 6 years of experience as a Quality Assurance tester. Proficiency in QA Methodology and hands-on testing experience within the Insurance industry. Demonstrated experience with testing UI, Web services, batch-based integrations, and Web portals. Familiarity with Microsoft TFS and Test Manager (MTM) is preferred. Proficiency in VB Script, XML, SQL, or related programming languages. Working knowledge with Automation Tools such as HP QTP, Selenium, etc. to running Test scripts & Defect Management Specific Quality Assurance experience with Guidewire solutions in the P&C Policy lifecycle is essential. Strong experience in Rating & Forms for US GL lines.

The Director of Quality Assurance will oversee the quality systems and standards for the organization, ensuring that all products meet regulatory requirements and internal specifications. This leadership role is critical to maintaining our commitment to excellence and compliance throughout the product lifecycle. This position aims to monitor and improve a quality management system, maintaining compliance with established standards and agency guidelines. SUMMARY OF RESPONSIBILITIES: Act as a Management Representative, as needed. Implement the necessary changes in the quality system for improvements and maintain compliance with established standards. Maintain quality assurance programs, policies, processes, procedures, and controls, ensuring that the performance and quality of the products conform to established standards and agency guidelines. Provide leadership for quality systems improvements and business process improvement initiatives. Responsible for providing adequate support for creating and preparing documentation that is required by the regulatory department for global registration submissions and approvals to introduce new products in the US, EU, Canada, Australia, and other jurisdictions for Class I, II devices, NHPs, and drugs. KEY RESPONSIBILITIES: Act as a Management Representative, as necessary. Report to VP of QA/RA and Mfg. Be responsible for the performance of the quality management system and address any need for improvement. Ensure the promotion of awareness of regulatory and customer requirements throughout the organization. Oversee generation and review of documents used in good manufacturing practices and monitor audits of production and quality control areas. Provide expertise and guidance in interpreting governmental Quality regulations, agency guidelines, and internal policies to ensure compliance and effectiveness. Manage document control and oversee related quality systems such as training and other electronic quality systems to ensure effectiveness. Participate with peers in formulating overall direction, processes, systems, and talent development for the QA organizations. Provide adequate support for document preparation for global regulatory submissions, including but not limited to the FDA 510(k), technical documentation for medical devices and dossiers for drugs, Canadian medical device, NHP and drug license applications, internal "Letters to File", etc. Assess device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes. Review and sign off on product and manufacturing changes for compliance with applicable regulations. Review, assess, and approve product documents, including but not limited to the design and manufacturing changes and labeling. Review and approve test protocols to support regulatory submissions. Oversee Risk Management and provide input in design verification, design validation and shelf-life studies. Provide technical guidance and training / mentoring to other QA employees and cross-functional teams. Develop and implement departmental goals, policies, and procedures. Monitor industry trends and regulatory changes to ensure that company practices remain compliant and competitive. Other duties as assigned. KNOWLEDGE / EDUCATION Bachelor's degree in science minimum. (Master's degree in science preferred). Knowledge of the FDA drug regulations, guidance, and import / exports requirements. Strong understanding of the quality system regulations. Thorough knowledge of product development process, design control and Quality System. Strong technical knowledge of OTC Drug products. Strong technical understanding of relevant procedures, practices, and medical terminology. JOB EXPERIENCE At least 10 years of experience in the medical industry as a Director or Senior Manager of Quality Assurance. At least 10 years of experience managing/leading a team. Demonstrated success in Quality Management. Demonstrated management skills and experience. Experience developing a team and individuals Knowledge of or experience in Risk management. Knowledge of QS regulations preferred. Statistical analysis and problem-solving abilities are strongly preferred. Demonstrate extensive experience with the FDA, ISO 13485, and Notified Body inspections SKILLS / COMPETENCIES Proficient in timely review of technical and clinical data. Proficient in FDA and international regulations (e.g., EU and Canada) Technical knowledge of medical devices (class I and II) and drugs. Ability to write clear, concise, and well-thought-out technical documents. Good presentation skills. Strong communication skills Ability to perform well in stressful or time-sensitive situations Able to manage complex problems/projects by exercising independent decision-making and analytical thinking skills, with minimal supervision Computer skills: MS Word, PowerPoint, MS Project, Adobe Acrobat, Excel, graphics presentation etc. Strong leadership, organizational, interpersonal, and influencing skills Strong written and oral communication skills Detail-oriented and self-motivated. Ability to work well with team members and clients Ability to exercise judgment in selecting innovative, practical methods to achieve problem resolution. Excellent negotiation skills. Ability to work under minimal supervision and independently. Must be able to deliver high-quality work in a tight-timeline-driven environment. Strong leadership, interpersonal and influencing skills. Ability to be flexible and adjust to changing circumstances. This is a full-time, on-site role based in our Santa Rosa Headquarters. Must be available to work 5 days per week, one Saturday per month and as needed per business requirements. BENEFITS Competitive salary bonus potential Relocation support as needed Health benefits including medical, dental and vision coverage for employee and family 401(k) with 4% match 2 weeks paid vacation 6 paid holidays

PMV Pharmaceuticals is looking for an individual to join the company as Sr. Manager, Quality Assurance (GCP) Contractor. This role will be focused on ensuring GCP compliance, providing day to day support to Quality Assurance and project team activities. This candidate will conduct and/or participate in all GCP QA audit programs which includes both internal & external GCP audits. This individual will support the quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. This is a full-time hybrid position based out of Princeton, NJ. Responsibilities Leads and supports GCP QA audit activities including internal and external audits of CROs, vendors, system, facility, and investigator sites. Provide GCP compliance expertise / leadership and work effectively with PMV staff to manage the quality program for assigned programs. Collaborate on day to day activities with clinical operations including document review such as protocols, SOPs, and other such documents. Takes a lead role in regulatory inspectional activities as audit lead or triage management. Support/lead the development of audit plans for clinical programs and quality agreements with vendors/partners. Support risk based management actiivties including deviation and CAPA management and the generation of clinical quality metrics. Support the creation and management of GxP and departmental SOPs throughout the PMV organization. Provide QA support for validation efforts for electronic databases that will be utilized for regulatory or quality assurance purposes. A minimum of 20% Travel / Field work is required to domestic and international locations in a lead / support role with consultants, partners, subject matter experts, inspections, etc. Perform other duties, as required. Qualifications In depth knowledge of GCP regulations and guidances Knowledge of GLP and PV, including their application in quality systems, quality assurance, quality control, audits and health authority inspections Minimum of 5 years of work experience in the pharmaceutical/biotech industry with direct experience supporting and performing GCP QA onsite and remote audits, globally. Hands-on experience in regulatory inspections, investigator site audits, vendor audits/qualifications, internal audits and document audits is preferred. Experience in the use of electronic quality management systems such as Veeva. Oncology experience preferred Knowledge of risk management approaches in a clinical environment Ability to work both independently with minimal direction and within project teams, etc. supporting multiple projects simultaneously. Bachelor's degree in Life/Health Sciences or equivalent work experience Strong verbal / written communication and presentation skills. Ability to work well in a deadline-driven environment. Excellent computer skills; use of Microsoft Office (Excel, Word, Microsoft Project, PowerPoint).

We are a leading general contractor specializing in high-quality construction projects. Our commitment to excellence and adherence to industry standards ensure that we deliver exceptional results. As a Quality Control Manager, you will be responsible for overseeing the quality of construction throughout the project with special attention to aesthetics and finishes. This role is vital in maintaining our excellence and ensuring compliance with all relevant standards. Responsibilities Develop and implement quality control procedures to ensure project compliance with specifications. Conduct regular inspections of construction sites to monitor quality standards. Analyze inspection data and prepare reports on quality performance. Collaborate with project managers to address quality issues and implement corrective actions. Review specifications to ensure all requirements are met during construction. Qualifications Proven experience in quality control within the construction industry. Strong knowledge of construction inspection processes and quality assurance standards. Excellent analytical skills with the ability to interpret data effectively. Familiarity with construction management principles is a plus. Strong communication skills for effective collaboration with team members and clients. Detail-oriented with a commitment to maintaining high-quality standards. If you are dedicated to ensuring top-notch quality in construction projects and want to make a significant impact at Strekte, we invite you to apply today! Job Type: Full-time Benefits: Paid time off

Mauricio Ducassi is looking for a Director of Quality Assurance for an Aspetic-based CDMO client. The Director of Quality Assurance is a key member of the executive leadership team responsible for overseeing and ensuring the highest standards of quality across all manufacturing and operational functions. This role requires deep expertise in aseptic manufacturing and a demonstrated track record within the Contract Development and Manufacturing Organization (CDMO) space. The ideal candidate will lead quality assurance strategies that support sterile injectable product development, clinical supply, and commercial manufacturing services while ensuring full compliance with FDA, EMA, and global regulatory expectations. Key Responsibilities: Serve as the primary authority on Quality Assurance across sterile, aseptic, and parenteral manufacturing processes. Direct and oversee all aspects of the Quality Management System (QMS), including document control, batch release, investigations, deviations, CAPA, change control, and product complaints. Ensure site-wide compliance with current Good Manufacturing Practices (cGMP), aseptic processing guidelines, and other applicable regulatory requirements. Lead, mentor, and develop a high-performing QA team, including QA Operations, QA Compliance, and QA Validation personnel. Collaborate cross-functionally with Manufacturing, Quality Control, Regulatory Affairs, and Product Development teams to support internal and client-driven projects. Drive a culture of continuous improvement, right-first-time execution, and risk-based decision-making. Act as the quality lead during client audits, regulatory inspections (e.g., FDA, EMA), and third-party vendor assessments. Review and approve critical quality documents including batch records, validation protocols/reports, and specifications. Establish and monitor key quality performance indicators (KPIs) and report to senior leadership. Serve as the client-facing QA authority for project kickoff meetings, quality agreements, and ongoing technical discussions. Provide strategic input for new equipment qualification, facility expansions, and technology transfers. Qualifications: Bachelor's degree in Chemistry, Pharmacy, Microbiology, Engineering, or related scientific discipline is required; advanced degree (MS or PhD) preferred. Minimum of 10 years of progressive Quality Assurance experience in the pharmaceutical industry, with at least 5 years in a senior leadership role. Proven experience working in a CDMO environment supporting sterile drug products (vials, syringes, lyophilized formulations, etc.). Extensive knowledge of aseptic processing, sterile fill/finish operations, and microbiological controls. Demonstrated success navigating regulatory inspections (e.g., FDA, EMA, MHRA) and client audits. Strong leadership, communication, and organizational skills with the ability to lead cross-functional teams. Deep understanding of cGMPs, ICH guidelines, and global regulatory frameworks. Experience implementing and scaling Quality Systems in a fast-paced, growth-oriented environment. Location: North Brunswick, NJ

Food Safety Quality Assurance Manager - $100k - $115k Rutherford, NJ US Citizens and Green card holders only No C2C My client, a family-owned fourth generation Food Manufacturing company are looking for a Food Safety Quality Assurance Manager. You will be overseeing a wide range of processes, products, and team members across two production shifts, while managing relationships with regulatory bodies and third-party sanitation services. Responsibilities Food Safety / Regulatory Manage the implementation of the HACCP Plan, including associated documents and reassessments. Maintain records in accordance with policy and HACCP program requirements. Conduct facility GMP inspections and ensure compliance with GMP standards. Ensure adherence to regulatory requirements and established policies, including HACCP, GMPs, SSOP, CAPA, and product hold/release procedures. Oversee training programs for GMPs, HACCP, and Food Defense/Food Fraud. Address non-compliance reports issued by regulatory authorities. Manage the third-party sanitation program for the facility. Quality / Customer Service Lead third-party audits (e.g., SQF or customer-specific) and customer tours, including corrective action plans (CAPAs). Drive continuous improvement in products, processes, procedures, and reliability. Maintain data on customer requirements, quality specifications, and reporting obligations. Manage the quality training program. Ensure specification compliance for raw materials and finished products. Oversee the implementation of quality programs. Support product development and special projects related to product development. Respond to customer complaints with CAPAs and correspondence as needed. Establish shelf life for raw materials and finished products. Other Foster a culture of safety within the organization. Manage the Food Safety and Quality Assurance (FSQA) Department, including technicians, sanitation staff, and supervisors (both exempt and non-exempt labor). Ensure the department meets budgetary goals. Perform additional tasks and projects as assigned. 10-20% travel required. Minimum Requirements: Experience in red meat processing is essential. Bachelor's degree in Food Technology, Food Process Engineering, or a related field; Master's degree preferred. 5+ years of experience in a leadership role within the food industry. Strong knowledge and experience with HACCP. Familiarity with SQF and/or BRC standards. Ability to think independently and take ownership of decisions.

A rapidly growing bioanalytical CRO to support their search for a Director of Quality Assurance. This is a leadership role where you'll drive the development and continuous improvement of GLP and GcLP quality systems supporting both nonclinical and clinical testing. You'll be the face of Quality during client and regulatory inspections, help shape regulatory strategy across sites, and build a culture of excellence by mentoring and growing the QA team. This is a great fit for someone with experience in GLP/GcLP - Bioanalysis and 10+ years of QA leadership experience in a CRO or biotech setting. Qualifications: In person job in GLP bioanalytical lab in Pleasanton, CA. The position reports directly to the CSO & CEO and is a key leadership role responsible for building and leading the QA function on site. Must have hands-on GLP QA experience in a CRO or bio/pharma setting Experience in GLP/GcLP, Bioanalysis. 10+ years of relevant QA or regulatory background Experience leading regulatory and client inspections Will oversee quality systems, SOPs, and compliance If you believe you'd be a good fit for the opportunity and have extensive experience with GLP in a bioanalytical lab or CRO setting, please apply.

Are you ready to join an organization that provides a dynamic, customer-focused environment? Join us at Jubilant Radiopharma, where we combine global clinical expertise with a leading pharmacy network to support our customers and advance the practice of nuclear medicine. As an industry-leading pharmaceutical company, we specialize in developing, manufacturing, and distributing high-quality diagnostic and therapeutic agents. Our mission is to improve lives through nuclear medicine on a global scale. Position Summary The Director of Quality is responsible for the development, implementation, and continuous improvement of the Quality Management System (QMS) across all pharmaceutical operations. This role ensures compliance with cGMP, FDA, Board of Pharmacy, and ISO/ICH standards. The Director will lead quality teams across PET manufacturing, radiopharmacies, and CDMO operations, and serve as the primary authority on quality decisions, risk assessments, and regulatory compliance. Key Responsibilities Strategic Leadership & Compliance Oversight Lead the Quality Unit with full authority to approve or reject all materials, products, and procedures impacting drug quality. Serve as the primary advisor to executive leadership on all matters related to cGMP, regulatory compliance, and quality risk management. Develop and implement a comprehensive QMS aligned with 21 CFR Parts 211 & 212, FDA, Board of Pharmacy, ISO, and ICH standards. Ensure compliance across internal operations and third-party contractors, including CDMO and PET manufacturing partners. Audit & Inspection Readiness Establish and manage a robust internal audit program to ensure continuous compliance with FDA and Board of Pharmacy regulations. Lead preparation and response efforts for regulatory inspections and customer audits. Oversee the pharmacy audit team and ensure corrective actions are implemented and sustained across the JDR network. Quality Operations & Documentation Oversee review and approval of batch records, laboratory data, SOPs, deviations, CAPAs, and change controls. Ensure all quality-related documentation is accurate, complete, and compliant with data integrity standards. Maintain and report quality metrics to senior leadership, regulatory agencies, and customers. Incident Management & Patient Safety Lead investigations into quality incidents, adverse drug events, and patient safety concerns. Coordinate timely and effective responses to regulatory bodies and customers. Ensure root cause analysis and preventive actions are implemented and monitored. Cross-Functional Collaboration Partner with Operations, R&D, Regulatory Affairs, and Supply Chain to embed quality into all stages of product development and manufacturing. Collaborate with Regional Operations Directors and Pharmacy Managers to address recurring compliance issues and implement sustainable improvements. Talent Development & Team Leadership Recruit, train, and mentor quality professionals across multiple sites. Conduct performance evaluations, provide coaching, and support career development. Manage staffing plans, succession planning, and organizational development for the Quality function. Regulatory Intelligence & Policy Development Monitor evolving regulatory requirements and industry trends, particularly in nuclear pharmacy and radiopharmaceuticals. Update internal policies and procedures to reflect new regulations and ensure organization-wide implementation. Represent the company in industry associations, boards, and regulatory forums. Licensing & Compliance Governance Oversee the process for obtaining and renewing Board of Pharmacy licenses for all facilities. Serve as Chair and Subject Matter Expert for the Corporate Compliance Committee. Provide regular updates on compliance status, risks, and mitigation strategies. Required Qualifications Bachelor's degree in Pharmaceutical Sciences, Life Sciences, or related field. Minimum 10 years of progressive experience in pharmaceutical quality assurance, with a strong preference for radiopharmaceutical or nuclear pharmacy experience. Deep knowledge of cGMP, FDA regulations, BOP standards, and compounding pharmacy compliance. Proven leadership in managing QA/QC programs, regulatory audits, and compliance investigations. Strong technical writing, communication, and team leadership skills. Willingness to travel to multiple facility locations as needed. At Jubilant Radiopharma, we champion an inclusive workplace that treasures diverse perspectives, experiences, and backgrounds. We are committed to building a diverse yet inclusive workplace that is representative of the marketplace and the communities in which the Company operates. Jubilant Radiopharma is proud to be an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status about public assistance, genetic status or any other status protected by federal, state or local law. If qualified individuals with a disability need assistance in applying for this position, call Human Resources at ************ informing us regarding the nature of your request and providing your contact information. We look forward to speaking with you about this exciting new career opportunity, apply today!

Final compensation will be based on a combination of: · Relevant work experience · Education · Project size · Project location · Required working hours · Candidate subject matter expertise and/or specialty · Ability to be approved by agencies/owners as required · *Final salary determination is negotiable* Come bridge the gap between you and your career goals! Recently ranked as a best U.S. construction workplace by Fortune Magazine, MLJ Contracting is driven by passion and built on trust. When you work at MLJ, you work for a company that values your well-being, your talent, and your career aspirations. If you are looking for a fulfilling career, come join our family and turn big ideas into even bigger realities. As a premier general contractor in the heavy construction market, MLJ Contracting successfully performs major public works projects for client agencies across the New York city area. Proud of our quality workmanship and engaging projects, we always maintain the highest standards of safety and professionalism. Want to build a career that stands the test of time? Join MLJ and lay the foundation for a better future. The Quality Manager is responsible for all quality-related functions on projects to which they are assigned. II. EDUCATION/CERTIFICATIONS BS in engineering or related field or equivalent years' experience in the industry. Certified Quality Engineer(CQE) as recognized by the American Society for Quality (ASQ). Certified ISO-9000 Lead Auditor, as recognized by the ANSI-ASQ National Accreditation Board (ANAB). The QM shall be a member of ASQ, or other recognized national quality-focused organization. III. KEY RESPONSIBILITIES Review submittals (catalog cuts, shop drawings, as-built drawings etc.) to ensure that they meet contract requirements. Prepare reports to document compliance with quality requirements or issue non-conformance reports as necessary. Identify and report quality problems or trends in the assigned area or program. Recommend corrective action to quality problems. Aid or lead project-wide system audits and surveillance, including supplier or subcontractor audits or surveillance to approved checklists and procedures. Support quality assurance for a project to ensure it is designed, procured, and installed to meet customer and division quality requirements. Write quality plans, procedures, audit checklists, and plans. Implement training sessions to reduce turnover. Conduct inspections of work as required- material tests, form work, reinforcement, structural steel, etc. Participate in the preparation and execution of equipment inspections/testing May participate in development/modifications of equipment inspections/testing Schedule special inspections as required. The Quality Manager is responsible for developing and implementing the Quality Plan and for the management and oversight of all quality issues. Perform other duties as required. IV. QUALIFICATIONS OF THE POSITION: A minimum of 10 years' total experience with the past five (5) years being Quality related. Prior Experience in Quality related functions on MTA Heavy Civil Projects.

We are seeking an experienced and detail-oriented Quality Program Manager to lead and oversee quality assurance and control efforts for complex construction and infrastructure projects. This role requires strong leadership, expertise in Quality Management Systems (QMS), and the ability to ensure compliance with regulatory and customer requirements-particularly for Capital Investment Grant (CIG)-funded Federal Transit Administration (FTA) projects. Key Responsibilities Develop and Implement QMS: Design, deploy, and continuously improve Quality Management Systems in alignment with ISO 9001 and other applicable standards. Oversee QA/QC Activities: Manage quality assurance and control to ensure compliance with technical specifications and contract requirements. Quality Planning: Define project quality objectives, inspection/test plans, and protocols to meet stakeholder expectations. Audits and Inspections: Lead internal, external, supplier, and site audits to ensure adherence to all standards and procedures. Monitor Quality Metrics: Track and analyze KPIs to identify trends, root causes, and recommend corrective/preventive actions (CAPA). Regulatory Compliance: Ensure adherence to all applicable regulations and requirements, including those for CIG-funded FTA projects. Continuous Improvement: Apply Lean, Six Sigma, or Kaizen principles to increase efficiency and improve outcomes. Customer Satisfaction: Address and resolve customer complaints and non-conformances in a timely and effective manner. Team Leadership: Train and mentor quality personnel and project teams to promote a culture of quality and accountability. Cross-Functional Collaboration: Partner with project managers, engineers, procurement teams, and subcontractors to embed quality throughout all project phases. Minimum Requirements 10+ years of experience in construction and project management for infrastructure projects (public or private sector). Demonstrated experience supporting or leading a major project of similar size and complexity. Deep understanding of QA/QC requirements for CIG-funded FTA projects. Strong foundation in quality assurance best practices, risk management, and contract compliance. Preferred Qualifications Certifications: Certified Quality Manager (CQM) or equivalent (e.g., ASQ Certified Manager of Quality/Organizational Excellence). ISO 9001 Lead Auditor certification is a plus. Skills & Competencies: Proficient in quality planning, auditing, inspections, and compliance monitoring. Skilled in statistical analysis and quality reporting tools. Strong organizational, leadership, and communication skills. Experience using quality software and construction management platforms. Proven ability to lead and influence cross-functional teams. Work Environment May require occasional travel to job sites and field offices. Must be able to work in both office and active construction site settings. About Seneca Resources: Seneca Resources is client driven provider of strategic Information Technology consulting services and Workforce Solutions to government and industry. Seneca Resources is a leading IT services provider with offices in Virginia, Alabama, Atlanta, Philadelphia & Dallas that service clients throughout the United States. The key to our success lies within our strong corporate culture which drives our business. We challenge our staff through engaging work, and we reward our staff through competitive compensation, extensive professional training, and excellent opportunities for career advancement. In turn, we look for only the best and brightest to join our team. We are an Equal Opportunity Employer and value the benefits of diversity in our workplace.

Our Food/CPG client is currently seeking a Quality Control Specialist for their facility near Union City, New Jersey. ***Only candidates with FOOD/CPG experience and auditing knowledge will be considered*** This job will have the following responsibilities: Maintain, organize and schedule samples for testing, conduct appropriate evaluations and summarize results. Perform various physical and chemical tests of finished products while recording accurate data in a timely manner. Ensure that testing equipment is accurately calibrated and functioning properly. Monitor weights, codes, labeling, and perform sensory evaluations and record data. Other duties include auditing distribution centers and manufacturing sites to ensure compliance to regulatory regulations, GFSI auditing schemes, HACCP and best food industry practices. Qualifications & Requirements: Five years experience within the food quality assurance industry. Experience with food safety programs such as HACCP, food safety plans, allergen control programs and BRCGs standards. SQF or BRC Auditing experience Experience in food environment with GFSI experience a plus Bilingual, English / Spanish is a plus

Empowered By Innovation Birlasoft, a global leader at the forefront of Cloud, AI, and Digital technologies, seamlessly blends domain expertise with enterprise solutions. The company's consultative and design-thinking approach empowers societies worldwide, enhancing the efficiency and productivity of businesses. As part of the multibillion-dollar diversified CKA Birla Group, Birlasoft with its 12,000+ professionals, is committed to continuing the Group's 170-year heritage of building sustainable communities. Job Details: A minimum of 7+ years of experience as a Quality Assurance tester. Experience in GUIDEWIRE POLICY CENTER testing. Proficiency in QA Methodology and hands-on testing experience within the Insurance industry. Demonstrated experience with testing UI, Web services, batch-based integrations, and Web portals. Familiarity with Microsoft TFS and Test Manager (MTM) is preferred. Proficiency in VB Script, XML, SQL, or related programming languages. Working knowledge with Automation Tools such as HP QTP, Selenium, etc. to running Test scripts & Defect Management Specific Quality Assurance experience with Guidewire solutions in the P&C Policy lifecycle is essential. Strong experience in Rating & Forms for US GL lines.

Golden Platter Foods, a leader in the frozen food sector, is expanding its operations. We are seeking a fully onsite Quality Control Supervisor to oversee our QC department and to assist in maintaining the processes and procedures required for this USDA/FDA operation. Job Overview: The Quality Control Supervisor will aid in monitoring the food safety program in accordance with company policies and federal and state requirements. The incumbent will provide guidance and support to ensure that food quality standards, food safety guidelines, and customer service expectations are met. Key Responsibilities: Ensure conformance to all applicable product and food standards (e.g., FDA, SQF, HACCP, GFSI). Be one of the company's subject matter experts on food safety and quality assurance. Be one of the drivers behind a perfect quality culture. Assist in ensuring that all current certification requirements are met as well as the addition and/or compliance of any new required certification. Assist in the development and update of food safety manuals. Regularly provide food safety training and development for all new and existing employees. Perform quality control analysis, including tests and inspections of products and processes, as well as monthly internal audits of the QA program. Provide direction and influence for the development, implementation, and continuous improvement of all quality systems and processes. Maintain testing specifications and protocols in accordance with SOP and regulatory requirements. Investigate, determine, and coordinate corrective actions on non-conformances. Ensure monitoring and production equipment is compliant with all certifications, customer requirements, and internal requirements. Assist in the performing of investigative analysis, assign root cause, and determination of corrective actions. Support the implementation of all new products and continuous quality improvement projects. Notify and prepare all departments, vendors, and/or suppliers of inspection dates, if required. Manage PPE requirements and maintain and organize vendors related to such services. Assist in the development and maintenance of all incoming material quality and compliance. Perform all other duties as required. Qualifications: Minimum of 4 years progressive experience in a food manufacturing plant. Bachelor's degree in chemistry, Microbiology, Food Science, Chemical Engineering, or related program preferred but open to a combination of experience and education. Proficiency in Good Manufacturing Practices (GMP) is required. In-depth knowledge of food safety and food defense principles Demonstrated experience in developing Standard Operating Procedures (SOP's) Strong capability to comprehend laboratory-related technical details and regulatory compliance standards. Ability to maintain confidentiality in all aspects of the job. Preferred Qualifications but not necessary: PCQI (Preventive Controls Qualified Individual) certification desirable HACCP (Hazard Analysis and Critical Control Points certification is beneficial Schedule Expectation: This position may require occasional weekend or holiday work to support special projects. Candidates must be flexible and willing to work extended hours or travel withing New Jersey as necessary. What We Offer: Competitive salary and benefits package. Opportunities for professional development in a growing company. A collaborative and dynamic work environment where your contributions are valued and recognized.

Key Responsibilities Quality Systems & Compliance Maintain and continuously improve Quality Systems in alignment with FDA 21 CFR Part 820, ISO 13485, and MDSAP requirements. Oversee quality planning, document control, internal audits, inspection procedures, change management, and CAPA processes. Risk Management & Process Validation Lead the development of PFMEAs, Control Plans, and other risk analysis tools for new and existing products. Plan and execute validation activities (IQ/OQ/PQ) for processes, equipment, and test methods in compliance with regulatory standards. Design Transfer & Production Support Review and approve Engineering Change Orders (ECOs), Manufacturing Variances (MVs), and process documentation. Support new product introduction (NPI) initiatives and major process changes with robust quality planning. Quality Monitoring & Continuous Improvement Analyze production and field return data to identify trends, root causes, and improvement opportunities. Participate in or lead Product Line Quality Committees (PLQCs) to drive process enhancements and product reliability. Generate reports on non-conformances, CAPAs, and other quality metrics; present findings to cross-functional teams. Problem Solving & CAPA Management Lead or support investigations and root cause analyses; drive effective corrective and preventive actions. Utilize statistical tools (SPC, Minitab, etc.) to support data-driven decision making. Qualifications Deep understanding of FDA 21 CFR Part 820, ISO 13485, and MDSAP requirements. Demonstrated experience in validation (IQ/OQ/PQ), PFMEAs, risk analysis, and quality planning. Proficient in data analysis, SPC, and report generation using tools such as Minitab or similar. Skilled in inspection techniques, sampling plans, and quality control procedures. Strong interpersonal, communication, and cross-functional collaboration skills. Proficiency in Microsoft Office Suite (Word, Excel, Access); experience with Power BI, MasterControl, or other quality systems is a plus. Six Sigma Green Belt and internal auditing experience are highly desirable. Education & Experience Bachelor's degree in Engineering, Life Sciences, or a related technical field. Minimum of 6+ years of experience in Quality Engineering within a regulated medical device or IVD industry, or 2+ years at a senior level.

The Quality Systems Engineer II drive TMC's Corporate CAPA Program to ensure it is compliant with applicable global Quality System regulations (i.e., 21 CFR Part 820, ISO 13485:2016, MDR etc.), effective, and efficient in dealing with quality issues. Job Details/Responsibilities Support the management and effectiveness of the Quality Management System, primarily the CAPA system by: Establishing and maintaining CAPA process metrics Providing guidance to CAPA Teams Participating on CAPA Teams as needed Reviewing content of CAPA root cause investigations, corrective actions, effectiveness criteria, and supporting data for adequacy, logicality, completeness, and compliance to regulatory and procedural requirements Being responsible for approving corrective and preventive action plans, implementation of required activities and objective evidence, and effectiveness verification Teaching and mentoring CAPA owners on root cause analysis and technical writing Organizing the Stewardship reviews of CAPA documentation Managing the CAPA portfolio of projects to ensure these issues are being managed in a timely and compliant manner. Facilitating activities related to the CAPA Board Work with Organizational Stakeholders to ensure CAPA and other quality system requirements are well understood appropriately incorporated into CAPA documentation and Management Review Generate Quality System Standard Operating Procedures as required. Contribute to the development of Quality System training materials and deliver training where applicable. Contribute to the development of Quality System performance measures. Support FDA & third-party audits as required. Follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large. Other duties as assigned. Knowledge, Skills and Abilities (KSA) Knowledge in 21 CRF Part 820, ISO 13485:2016, Medical Device Directive / Regulation. Strong computer knowledge (MS Office), technical writing skills and proofreading ability. Ability to develop, communicate, and support the interpretation and implementation of comprehensive quality systems/regulatory requirements. Advanced skill in developing and maintaining spreadsheets, pivot tables, metrics, statistical applications, charts/graphs, and user-friendly reports. Demonstrated ability to lead a group of participants from problem statement, root cause identification, and verification of effectiveness. Demonstrated ability to interact with all levels of managements, co-workers, and regulators. Strong decision-making and prioritization skills. Strong written, verbal, and interpersonal communication skills. Strong organizational and presentation skills. Qualifications/ Background Experiences Position requires a 4-year degree in engineering or a scientific discipline or equivalent work experience. Minimum 2 years' experience in a Quality Engineering, Compliance, or other related Quality System role(s) in a medical device or pharmaceutical company Experience performing root cause analysis/investigations. Experience supporting a regulated manufacturing operation. Experience with electronic quality system tools. Six Sigma Black/Green Belt Certification a plus ISO 13485 Lead Auditor Certification a plus

🚀 Aerospace Quality Engineer 📍 Rahway, NJ | 💰 Up to $90,000 | 🕐 Full-Time | 💼 On-Site A leading aerospace and defense manufacturer is seeking a Quality Engineer with deep expertise in aerospace quality systems, auditing, and regulatory compliance. This is a hands-on role critical to ensuring compliance with international standards and continuous improvement across production and supplier operations. 🔧 Key Responsibilities: Develop, revise, and manage quality system documentation (policies, procedures, forms, work instructions) in alignment with AS9100 and FAA standards Monitor, analyze, and report quality and performance metrics Lead root cause and corrective action (RCCA) investigations for non-conformances in materials and products Serve as the main interface for internal and external audits-coordinate audit schedules, lead tours, and manage findings Conduct internal audits to ensure system compliance and effectiveness Interface with suppliers for quality audits, non-conformances, and corrective actions Compile and present background information to support process improvement, investigations, and audits 🎯 Qualifications: Bachelor's degree or equivalent industry experience 7-10 years of experience in a Quality function Minimum 2 years of aerospace-specific quality experience Strong knowledge of FAA regulatory requirements Expert understanding of AS9100 and related aerospace standards (AS, ARP, NAS) Ability to read and interpret technical documentation (drawings, specs, contractual requirements) Prior experience in supplier quality, internal auditing, and RCCA ⭐ Preferred Skills: Military or defense aerospace experience Lead Auditor or Internal Auditor certification (AS9100 or ISO 9001) Familiarity with Six Sigma methodologies 📈 What You'll Gain: High-impact role in a regulated, mission-critical industry Exposure to international quality standards and cross-functional teams Competitive compensation and opportunities for professional development Interested candidates with strong aerospace compliance and auditing backgrounds are encouraged to apply. This role offers the opportunity to take ownership of critical quality systems in a fast-paced and highly regulated environment.

**General Description:** Supports QA investigation activities, ensuring the successful day to day management of: Deviations, root cause analysis, CAPA's, effectiveness checks, internal and external customer complaints, and related support activities. Works to support QA Key Performance Indicators (KPIs) such as SOP mandated cycle times, on time closure dates, and QA objectives, whilst adhering to regulatory compliance and achieving business success. Work to support both internal GMP audits and Health Authority audits. Supports QA Manufacturing related tasks as assigned by QA Management.to ensure the efficient and effective day to day running of the QA Manufacturing Team. **Essential Functions of the job:** + Ensures the development of Manufacturing QA and Compliance SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being 'fit for purpose' operationally and commercially. + Supports QA manufacturing shop floor activities with resources as needed. + Support all QA shop floor and batch systems to ensure compliance with FDA/EU regulations, covering cGMP for commercial medicinal products and clinical material for human use. + Significant participation in regulatory and customer inspections/audits. + Significant knowledge in GMPs: CFR 210, 211, and 600; knowledgeable in EU Advanced Therapy Medicinal Products (ATMPs). + Ensures all activities are performed in accordance with GMPs, SOPs and Health and Safety policies. + Maintaining an awareness of new and proposed legislation that impacts the business and communicating any changes to the Senior Management Team. + Ensuring that the QA batch release function and Deviation and CAPA processes meet or improve key performance indicators (KPIs). + Supervises direct reports, to ensure compliance with business procedures and GMP's + Ensuring appropriate investigation of discrepancies, errors, complaints, failures, or adverse events requiring documented review and action. + Undertaking any other duties for any department within the business, which may be requested by the QA Department Head, for which training and/or an explanation has been provided and the scope of work is understood. **Core Competencies, Knowledge, and Skill Requirements** + Scientific degree (ideally biotechnology, biology, pharmacy, pharmaceutical sciences, chemistry or related scientific field). + Minimum of 5+ years of experience in biological quality assurance, preferably with advanced knowledge of large molecule manufacturing in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility required. + Minimum of 2-5 years of experience in people management, knowledge of cGMP and Data Integrity Guidance utilized in a manufacturing operations environment. + Demonstrable track record and skills/experience gained within a similar position(s), at a similar level. + Working knowledge of cGMPs: 21CFR parts 2010 & 211, knowledge of 21CFR600 - Biologics desirable. + Wide knowledge of products and processes used in the manufacture of unlicensed medicines (clinical materials, mfd. under and IND or IMP). Knowledge of commercial BLA products. + Strong personal leadership skills and experience, ability to lead small teams. + Good communicator (written and verbal) and strategic thinker, highly customer focused. + Strong analytical and problem-solving ability. + Strong project management skills. + Hands-on approach, with a 'can do' attitude. + Ability to prioritize, demonstrating good time management skills. + Excellent attention to detail, with the ability to work accurately in a busy and demanding environment. + Self-motivated, with the ability to work proactively using own initiative. + Committed to learning and development. + Highly Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook) **Significant Contacts** + Interacts with BeOne employees in all departments; CMOs. **Supervisory Responsibilities:** + Supervises direct reports within the Manufacturing QA and Compliance Team, assists with batch review and release as necessary. QA, Mfg. shop floor QA oversight. Works to ensure that QA Compliance requirements are adequate and meet global standards. **Computer Skills:** + Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint). + Ability to work on a computer for extended periods of time **Other Qualifications:** **Education Required:** Bachelor of Science Degree (or above) in a related scientific discipline Must be able to work in the US without corporate sponsorship. **Travel:** + Ability to travel approximately10%; Requires a valid passport. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.