Quality assurance manager jobs in East Orange, NJ

Under the direction of the Vice President and Chief Quality Officer, the Director of Quality Improvement is responsible for developing and implementing the organization's Performance Improvement plan and priorities consistent with regulatory standards and evidence based best practices. As a member of the leadership team, serves as a role model and leader to colleagues and staff throughout the organization. Thoughtfully develops and implements initiatives to achieve improvements consistent with hospital strategic priorities. Promotes a culture that is positive, that values individual strengths, and is committed to optimal patient care, and compliance with regulatory standards. This position is responsible for direct supervision of the Quality Analyst and Quality Improvement Specialist and serves as the Stroke Coordinator. Key responsibilities include: • Strategic focus on improving quality. Responsible for goal setting and achievement using SJMC established Performance Improvement methodology and analytic tools. Defines measurable and actionable metrics and ongoing monitors to sustain performance. • Identifies and drives analytic needs for improvement projects/initiatives. Supports leaders in development of problem charter and selection of the best tools for data analysis. Mastery of basic statistical concepts, tools and techniques and working knowledge of improvement tools and techniques. Teaches/mentors others on basic topics and able to assist others with advanced topics. • Serves as Stroke Coordinator and supports the Stroke Program including defining and developing structure, process and outcome measures, policies, accreditation and facilitating and actively developing initiatives to meet and exceed evidence-based care metrics for stroke patients. • Lead and/or facilitate complex multidisciplinary improvement teams as needed to achieve quality and performance improvement goals. • Responsible for oversight of data collection, measurement, and data analysis for organizational, federal and state quality metrics. • Coordinate mortality, patient complaint, and outcome reviews. • Serve as a regulatory resource regarding state and federal regulations and standards, including but not limited to CMS, TJC, and NYS. • Create and present data needed for evaluation and appropriate action by committees, leadership, and quality improvement teams. • Represents the organization within and external to the community when required. • Assist in improving patient experience through analysis of data and implementation of initiatives to improve performance. Requirements: • Bachelor's Degree or commensurate experience required. • Registered Nurse in New York State required • Master's Degree in Healthcare specialty preferred • Current certification as CPHQ strongly preferred. Certification required within 3 years of hire date. • Previous managerial experience preferred. • Competence in Microsoft office products including PowerPoint and Microsoft Excel. • Familiarity with health care clinical operations and processes in an acute care hospital setting. • Familiarity with regulatory requirements as related to hospital setting. Other Requirements: • The employee must regularly lift, carry or push/pull less than 10 pounds, frequently lift, carry or push/pull less than 10 pounds, and occasionally lift, carry or push/pull up to 10 pounds. • While performing the duties of this Job, the employee is regularly required to perform activities that require fine motor skills. The employee is frequently required to do repetitive motion, hear, reach, sit, and speak. The employee is occasionally required to walk. • Specific vision abilities required by this job include color vision, far vision, and near vision. • The noise level in the work environment is usually quiet. Salary: $170K-$180K Saint Joseph's Medical Center is an equal opportunity employer.

Work Shifts 9:00 A.M - 5:00 P.M Duties & Responsibilities Under the direction of the Budget Director (Corporate), compiles, administers and obtains approvals of the Capital Facilities Budget; evaluates project proposals, monitors and reports regularly on project status; maintains Corporation records of funds, contracts and cash outlays. Develops, recommends and implements criteria and procedures to improve the effectiveness of the Corporation's facilities improvement programs. Examples of Typical Tasks Directs annual budget cycles which include receipt and program and fiscal analysis of capital requests and Article 28 applications from health care facilities. Evaluates requests and makes recommendations to Director of Planning for funding and work orders. Obtains approvals of Capital Budget, Programs and Contracts from the City, Board of Estimate, Financial Control Board, HSA and State Health Department. Generates project cost data and establishes criteria procedures necessary to maintain a sound investment strategy and to sustain effective participation by the hospitals, community boards and regulatory and financing agencies in our facilities improvement programs. Monitors and reports regularly on Capital project status to the Corporation and the City of New York using a computerized Management Information System. Maintains records of capital funds, expenditures and cash outlays. Certifies capital funding for expenditures and estimates costs for fixed asset accounting and reimbursement reporting. Interfaces with City Comptroller and land and construction agency records to establish costs of construction, debt management and related services furnished by the City for Corporation purposes and maintains separate records of these cost auditable to City source records. Assists in audits of financial records as required by the Corporation, the City Comptroller, City Construction Board, State Emergency Financial Control Board and reimbursement agencies. Prepares forecasts of fund and cash requirements and requisitions cash from the City Capital Project Fund. Administers an employee time recording and billing system to record time and cost of staff design and construction services for each capital project and vouchers and receives cash from the city Capital Project Fund for staff services provided under interfund agreements. Administers contract change control requirements. Evaluates purchase and contract regulations, procedures and standard contracts and certifies purchase and receipt of all major equipment and permanently identifies the piece and record data in the major equipment inventory control system. Develops procedures with criteria for Prequalification of Contractors as provided in Section 8 of the Corporation Act. Solicits, evaluates and communicates prequalification status to all contractors maintaining lists and individual contractor financial and experience records. Serves as a member of the Architectural and Engineering Selection Board. Supervises and directs the staff assigned to assist in the performance of these major duties and evaluates employee performance. Minimum Qualifications 1. A Masters Degree in Business Administration, Science, Health Care Administration, Engineering or related discipline from an accredited college or university or a license as a Professional Engineer or registration as an Architect; and, 2. Eight years managerial experience in Capital Program or budget work in the construction field including four years experience in budget administration and management of health care facilities; or, 3. A satisfactory equivalent combination of education, training and experience. Department Preferences Preference will be given to qualified candidates with the following knowledge, abilities, education, experience and/or skills: EDUCATION: A Master's degree from an accredited college or university in Hospital Administration, Health Care Planning, Business Administration, Public Administration or an approved related program. LICENSE: A New York State license as a professional engineer or registered architect or a license as a professional engineer or registered architect from a state that has reciprocity with New York State may be substituted for the four years of education and experience. EXPERIENCE: At least 10 years of related experience in design and/or construction management with experience in healthcare clinics; or as a journeyperson in one or more of the skilled building construction trades. Full-time satisfactory experience in planning, design and program development pertaining to meeting health needs, health care planning, design and program implementation, with at least three years of responsible level administrative experience coordinating the planning, design, and construction and commissioning. KNOWLEDGE IN: Thorough knowledge of the principles, practices and methods of Healthcare and Space Management. Long Term Capital Planning Design Management, Construction Management, Budget Management and Time Management Negotiations Regulatory (DOB, FDNY, DOH) Close outs SKILLS: Excellent verbal / written skills. Excellent technical, conceptual, and financial skills. Motivate team efforts to accomplish goals. COMPUTER PROGRAMS/SOFTWARE OPERATED: Microsoft Word and Excel (required) Microsoft Access, MS Project Auto CADD/Revit. Procore/E-builder or similar

The QA Specialist will play a key role in ensuring the quality, safety, and compliance of raw materials and related processes in support of biotechnology manufacturing operations. This position is responsible for reviewing raw material documentation, coordinating and reviewing raw material sampling and release, verifying QC data, and supporting the review of stability reports to ensure adherence to internal procedures, regulatory guidelines, and cGMP standards. Key Responsibilities: Review and approve raw material documentation (e.g., Certificates of Analysis, specifications, vendor documents) for accuracy and compliance. Perform raw material release activities in accordance with established SOPs and GMP requirements. Coordinate and/or review raw material sampling to ensure proper identification, handling, and chain of custody. Review QC laboratory documentation and analytical data for accuracy, completeness, and compliance with applicable procedures and specifications. Review and track stability reports, ensuring timely completion, accuracy, and adherence to protocols. Support investigations, deviations, CAPAs, and change controls related to raw materials and QC data. Collaborate cross-functionally with Quality Control, Supply Chain, and Manufacturing to ensure smooth flow of materials and documentation. Participate in internal and external audits, as needed. Identify and support opportunities for continuous improvement in quality systems and documentation processes. Qualifications: Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field) required. 2-5 years of experience in Quality Assurance within the biotechnology, biopharmaceutical, or pharmaceutical industry. Strong knowledge of GMP regulations (21 CFR Part 210/211) and quality system principles. Experience reviewing QC data, raw material documentation, and stability reports. Detail-oriented with strong organizational and documentation skills. Excellent communication and teamwork abilities. Proficiency with Microsoft Office and familiarity with quality management systems (QMS) or LIMS preferred.

About the Company The eGIS team is seeking two skilled contractors to support data quality assurance and testing efforts for the Gas division of our project. This role involves working with Schneider's ArcFM and ESRI GIS platforms to validate and enhance the integrity of migrated mapping data. About the Role This role involves working with Schneider's ArcFM and ESRI GIS platforms to validate and enhance the integrity of migrated mapping data. Responsibilities Perform spatial and attribute data validation for legacy Gas mapping data migrated to ESRI systems. Conduct spatial queries and analysis to ensure connectivity and accuracy of Gas infrastructure components. Review and correct land base symmetry and structure connectivity. Update and standardize map symbology as needed. Execute system testing to verify functionality of new mapping tools. Maintain organized tracking of data review progress using Excel and other tools. Prioritize tasks and manage timelines to meet project milestones. Support additional eGIS initiatives as required. Qualifications Bachelor's degree in a relevant field. Minimum of 2 years of hands-on experience with ESRI ArcMap. Proficiency in MXD creation, spatial queries, and spatial analysis. Strong understanding of GIS concepts and ESRI platform tools. Self-motivated, detail-oriented, and capable of working independently. Excellent analytical and organizational skills. Proficiency in Microsoft Office applications. Required Skills Experience with Schneider's ArcFM platform. Experience with ESRI GIS platforms. Familiarity with utility mapping systems and Gas infrastructure. Ability to interpret various types of Gas maps and technical documents. Experience supporting GIS-related software implementation projects, including configuration, testing, and deployment of geospatial tools or platforms. Familiarity with IT project management principles, particularly in environments involving data quality assurance and system integration. Exposure to project tracking tools (e.g., Jira, Trello, MS Project) and collaborative platforms used in technical project environments. Ability to work effectively with cross-functional teams including GIS analysts, developers, and project managers. Understanding of change management and user support strategies during technology rollouts or upgrades. Preferred Skills Familiarity with utility mapping systems and Gas infrastructure. Ability to interpret various types of Gas maps and technical documents.

Job Title: Project Quality Engineer Shift: 1st Shift (Monday - Friday) Pay Rate: Up to $75000-$95,000 annually (commensurate with experience) Type: Direct Hire Reports To: QA Manager Dept.: Quality Assurance Job Description The Project Quality Engineer supports the Quality Assurance Manager in overseeing the Quality Assurance program for assigned rail car manufacturing projects. This role ensures compliance with contract requirements, technical specifications, and industry standards across production, acceptance, warranty, and modification phases. Responsibilities include creating Master Test and Inspection Plans, First Article Inspection schedules, Project Quality Plans, and audit procedures. The Project Quality Engineer coordinates closely with customers, vendors, and internal Kawasaki divisions to align project requirements, resolve quality issues, and support continuous improvement initiatives. This position also monitors documentation, leads corrective action activities, conducts contract reviews, and provides weekly and monthly quality reports. The engineer will serve as a primary Quality liaison between internal teams, subcontractors, and customer Resident Inspectors, ensuring timely communication, follow-up, and delivery of all quality-related commitments. Candidate Fit Summary This candidate is an excellent fit for organizations in the rail, aerospace, transportation, and heavy manufacturing sectors where strict compliance, technical quality standards, and contractual requirements are essential. They bring strong experience supporting complex production programs, managing supplier and customer interfaces, and developing detailed quality documentation. Skilled in FAI, FMEA, audits, and ISO 9001 processes, they excel in environments requiring strict quality controls, cross-functional coordination, and schedule accountability. Their ability to lead inspections, manage customer quality requirements, and drive corrective actions makes them a strong match for production-focused, project-driven engineering organizations. Essential Functions Implement and maintain QA programs for assigned contracts. Develop Master Test and Inspection Plans, Project Quality Plans, FAI schedules, and audit procedures. Attend project meetings and provide detailed quality status updates and reports. Analyze quality issues, identify root causes, and drive corrective actions. Coordinate with customers, suppliers, and internal teams across production and warranty phases. Manage project quality schedules and interface with Resident Inspectors. Ensure compliance with customer specifications, contract terms, and Kawasaki quality standards. Review and approve subcontractor/supplier documentation (PSI, FAI, audits, drawings, field reports). Monitor and report deviations, implement process improvements, and update procedures. Support Configuration Management planning, execution, and product delivery. Assist with subcontractor activity quality review and documentation. Travel domestically/internationally up to 30% to support project quality functions. Job Specifications Bachelor's Degree in Engineering (Master's preferred). Minimum five (5) years' experience in rail, aerospace, transportation, or heavy manufacturing. Knowledge of FAI, FMEA, ISO 9001, and source inspection processes. Strong communication, analytical, reporting, and computer skills. Ability to plan, coordinate, and manage workloads across multiple concurrent projects. Capable of working in both office and field/manufacturing environments. Work Environment Office and manufacturing floor settings. Frequent interaction with engineering, production, and customer teams. PPE required in production areas; must adhere to all safety protocols. Candidate Fit This candidate is a strong fit for Project Quality Engineering roles in complex manufacturing environments like rail, aerospace, automotive, and heavy industrial production. They have demonstrated capability in quality planning, regulatory compliance, supplier oversight, and customer interface management. With experience leading FAIs, audits, and corrective actions while supporting production schedules, they excel in driving continuous improvement, ensuring contract compliance, and maintaining high standards of safety, product quality, and documentation integrity. Their structured approach, technical acumen, and ability to manage project-based workloads make them a key contributor to high-complexity engineering programs. Company Overview Founded in 2010, Top Prospect Group was created with a focus on matching high-quality candidates with top-tier clients while fostering an environment where success is shared by all. In 2023, the company was acquired by HW Staffing Solutions, expanding its service offerings to include technology, engineering, and professional services. Qualified candidates are encouraged to apply immediately! Please include a clean copy of your resume, salary expectations, and availability with your application.

Hanwha Vision America (HVA) is an affiliate of the Hanwha Group, a Fortune Global 500 company. HVA is an industry-leading provider of advanced network video surveillance products, including IP cameras, storage devices, and video management systems, founded on world-class technologies. We offer end-to-end security solutions and have achieved global success across a wide range of industry verticals, including retail, transportation, education, banking, healthcare, hospitality, and airports. Hanwha Vision America (HVA) is seeking a Repair/ Quality Engineer to support HTCC's engineering and repair operations by performing intake screening, basic diagnostics, quality checks, and documentation. The role ensures that incoming units are properly evaluated, repair processes run efficiently, and completed products meet quality standards before shipment. This position combines repair-support responsibilities with quality assurance activities to improve workflow efficiency, accuracy, and overall service performance. Major Functions / Accountabilities Perform initial screening and basic functional checks on incoming units Identify obvious issues or simple conditions that can be resolved before repair Support repair workflow by preparing units, organizing information, and performing basic diagnostics Conduct quality checks on completed repair units to ensure they meet internal standards Document inspection results and update system records accurately Assist with failure analysis for repeated issues and provide feedback to engineering Inspect packaging quality and verify final shipment readiness Collaborate with repair staff, engineering, logistics, and warehouse teams as needed Maintain checklists, guidelines, and standard procedures for inspection work Support process improvements related to efficiency, quality, and documentation compliance Knowledge, Skills & Requirements Preferred background: Electronics, Electrical Engineering, Computer Engineering, or related field Basic understanding of electronic components (e.g., resistors, capacitors, diodes) Ability to use multimeters and basic diagnostic tools Strong attention to detail and problem-solving skills Ability to follow technical checklists and standardized procedures Proficiency with Microsoft Office and basic system data entry Bilingual (Korean/English) preferred but not required

Mandatory Technical / Functional Skills • Software Quality Assurance consultant with at least 10 years' experience in playing QA Director Technical/Functional Skills • Experience in formulating QA strategy and leading QA execution for large programs • Ability to play advisory role to customer on how to manage testing in an end to end scenario (right from planning and requirement phase to User acceptance testing) • Excellent understanding of QA metrics, entry/exit criteria • Experience in Insurance or Financial services industry sector will be good to have Roles & Responsibilities • Formulate Software Quality Assurance strategy (QA and UAT) • Establish quality standards • Establish quality documentation by writing and updating quality assurance procedures • Participate in Requirement analysis, Test strategy sessions of the program to understand and gather the necessary details to ensure its alignment to quality strategy, standards and procedures • Review all the program testing deliverables across Software Testing Life Cycle (STLC) • Ensure testing deliverables completeness on test scope coverage • Ensure program testing schedule is realistic •Ensure traceability on program requirement to test cases & result • Perform root cause analysis and create pattern to identify frequently occurring defects • Arrange review finding walk-through sessions, publish detail review findings • Provide corrective actions/recommendations/best practices in reducing defect trend • Track closure of review findings and implementation of actions/recommendations • Ensure program testing risks and assumptions are clearly articulated • Create and publish program quality dashboard Thanks & Regards, Additional Information If you are comfortable with the position and location then please revert me back at the earliest with your updated resume and following details or I would really appreciate if you can call me back on my number. Full Name: Email: Skype id: Contact Nos.: Current Location: Open to relocate: Start Availability: Work Permit: Flexible time for INTERVIEW: Current Company: Current Rate: Expected Rate: Total IT Experience [Years]: Total US Experience [Years]: Key Skill Set: Best time to call: 2 Slots for phone interview: In case you are not interested, I will be very grateful if you can pass this position to your colleagues or friends who might be interested. All your information will be kept confidential according to EEO guidelines.

& Sons Schweid & Sons is a family-owned and operated premium ground beef company with a proud heritage spanning four generations. We supply top-quality beef to Retail, Foodservice, and National Account customers across the U.S. and are committed to quality, customer service, and innovation in protein manufacturing. Summary: This is a leadership role within the organization that is responsible for a broad range of processes, products, and team members over 2 shifts of production as well as the relationship with FSIS and 3rd party sanitation. Essential Job Functions: Food Safety / Regulatory * Managing implementation of the HACCP Plan, its associated documents and including reassessments * Maintaining records in accordance to the policy / HACCP program * Conduct plant GMP inspections and monitor GMP's for compliance * Responsible for maintaining the company's compliance with FSIS regulations. * Ensure compliance with established policies and procedures such as HACCP, GMP's, SSOP, CAPA, and hold and release of products. * Oversee training program for GMP's, HACCP and Food Defense/Food Fraud. * Respond to non-compliance reports issued by FSIS. * Manage the 3rd party Sanitation program for the facility. Quality / Customer Service * Lead 3rd party audits (SQF / Customer Specific) and Customer tours including CAPA's. * Strive for continuous improvements of products, process, procedures, and reliability. * Maintain data of customer requirements, quality specifications and reporting requirements. * Manage quality training program. * Ensure specification compliance for raw materials and finished products. * Managing implementation of quality programs. * Assist with product development and special projects associated with product development. * Respond to customer complaints with CAPA's / letters as needed. * Establish the raw material and finished product shelf life. Other * Contributing to a Safety Culture Manage FSQA Department (Techs, Sanitations, Supervisors) including exempt and non-exempt labor * Manage the department to meet budget. * Other tasks and projects may be assigned. * 10 - 20% travel required Minimum Requirements: * Red Meat Experience a Must * Bachelor of Science in Food Technology, Food Process Engineering, or related field; MS preferred. * 5 plus years' experience working in the Food Industry in a leadership role. * HACCP Knowledge and Experience * SQF / BRC Knowledge and Experience * Ability to think independently and take responsibility for decisions. What We Offer * The expected compensation for this role is $100,000 - $130,000 per year, depending on experience and qualifications. Final compensation will be discussed during the interview process. * Time Off: PTO, Safe & Sick Time, and Paid Holidays. * Health Benefits: Medical, vision, dental, HRA and voluntary disability benefits. * Financial Benefits: 401(k) + employer match and life insurance. * Location: This is an on-site role located in Carlstadt, NJ. * Environment: Our facility is refrigerated. In this role you will be exposed to < 40 degrees for multiple hours of the day.

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 :195,000-256,000 Under 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

Under the direction of the Vice President, the Director of Ambulatory Care Quality plans, implements, and directs quality improvement and patient experience initiatives across all SBH Ambulatory Care sites. The Director is responsible for developing and managing action plans to improve performance on quality metrics, maintain regulatory compliance, and enhance the patient experience. The position leads the governance and facilitation of the Ambulatory Quality Committee and the Ambulatory Patient Experience Workgroup. The role oversees performance improvement projects, chart audits, documentation reviews, and new workflow implementations to enhance outcomes and patient-centered care. The director also assists the VP with departmental compliance programs and reviews. Responsibilities: Provides leadership to the Ambulatory Care Quality & Population Health department, supporting the VP with department strategy, operations and management. Prepares and facilitates the Ambulatory Quality Committee, including agenda development, data reporting, and tracking of follow-up items and performance improvement plans. Prepares and facilitates the Ambulatory Patient Experience Workgroup, including agenda development, data reporting, and tracking of follow-up items and performance improvement plans. Designs and implements quality assurance and performance improvement (QAPI) initiatives to improve patient care, advance population health, and drive value-based care outcomes. Supports Ambulatory Care Directors and leaders to implement QAPI initiatives in their own areas, and to develop QAPI reports and Performance Improvement posters. Develops training content and performance feedback tools to coach ambulatory providers and staff on quality improvement best practices. Leads internal audit processes, regulatory survey readiness (e.g., Joint Commission, NCQA, NYS DOH), and documentation compliance reviews. Assists the VP with departmental compliance programs and reviews including chart and billing audits, and investigations. Performs other related duties at the discretion of the Vice President. Attends scheduled department and division meetings and participates as appropriate.

Job Description Community Federal Savings Bank (CFSB), located in New York City is seeking a highly skilled and detail-oriented Head of Financial Crimes Compliance Quality Assurance to join our Program Management & Assurance function within the Compliance department. CFSB offers a full range of banking services including ACH settlement services, pre-paid card issuance, and retail banking. In addition to serving our general customer base, we also service various types of money service businesses and FinTech companies. This individual will be primarily responsible for overseeing a robust quality assurance program to ensure compliance controls are operating as designed. They will drive strategic Financial Crimes Compliance QA initiatives, enhance transparency, and provide data-driven insights to inform decision-making and regulatory readiness. Key Responsibilities: Enhance and maintain the Financial Crimes Compliance Quality Assurance (QA) framework to assess whether key compliance control activities-conducted internally or by external consultants-adhere to internal standards, regulatory expectations, and Bank policy. Implement and continuously refine standardized QA test scripts, workpapers, and documentation templates to drive consistency, transparency, and auditability across QA reviews. Lead and develop a high-performing team of Financial Crimes Compliance QA Managers and staff, providing coaching, mentorship, and oversight to ensure effective execution and professional growth. Partner with Internal Control functions to align Financial Crimes Compliance QA insights with broader risk trends, inform planning cycles, and enhance control evaluations across business units. Stay current on regulatory developments, enforcement actions, and industry best practices; translate regulatory changes into QA control enhancements and update procedures accordingly. Provide structured, actionable feedback and guidance to control owners and business partners based on QA findings, supporting the adoption of practical, risk-aligned solutions and best practices. Lead the design and delivery of training content and workshops to improve the quality, consistency, and defensibility of investigations, control execution, and documentation. Establish Financial Crimes Compliance QA metrics and dashboards to support continuous improvement, trend analysis, and executive-level reporting to governance committees, senior leadership, and regulators. Ensure Financial Crimes Compliance QA processes integrate technology and data analytics where feasible to improve efficiency, risk detection, and traceability. Act as a strategic partner across Compliance, Legal, Audit, Operations, and Technology to promote a culture of accountability, transparency, and continuous improvement. Support internal and external regulatory examinations by providing Financial Crimes Compliance QA reporting, documentation, and commentary as needed. Qualifications: Deep subject matter expertise in regulatory compliance, quality assurance methodologies, and risk management within the financial services industry. Proven ability to design and lead Financial Crimes Compliance QA programs in complex, matrixed environments involving third-party partnerships, fintech platforms, and high-risk product offerings. Demonstrated experience presenting Financial Crimes Compliance QA findings, thematic trends, and risk insights to executive leadership, Board-level committees, and regulatory agencies. Strong working knowledge of BSA/AML/OFAC requirements. Strategic mindset with the ability to drive long-term program maturity while executing detailed operational reviews and initiatives. Proficient in leveraging technology platforms to support Financial Crimes Compliance QA activities, including GRC systems, workflow tools, and automated testing solutions. Exceptional written and verbal communication skills, with the ability to translate complex compliance matters into actionable, business-aligned recommendations. Collaborative leader with a track record of building high-performing teams and influencing cross-functional partners across Compliance, Legal, Risk, Operations, and Technology. Bachelor's degree required; advanced degree (e.g., JD, MBA) or relevant professional certifications (e.g., CAMS, CRCM, CISA, CFE) strongly preferred. Minimum of 10 years of experience in Compliance, Audit, Risk, or Internal Controls, with at least 5 years in a senior leadership or QA oversight role. Prior experience overseeing Financial Crimes Compliance QA or testing programs focused on consumer protection, AML, sanctions, or third-party oversight is highly desirable. Exposure to dynamic and hybrid business models, such as banking-as-a-service (BaaS), money service businesses (MSBs), fintech partnerships, or international payments, is strongly preferred. Salary: $180,000 - $210,000 K / year "Base salary range does not include performance-based bonus and/or other benefits, where applicable. Actual base salary offer will vary based on skills and experience." About Community Federal Savings Bank (CFSB) Community Federal Savings Bank (CFSB) is a federally chartered bank founded in 2001 and headquartered in New York City. CFSB has focused on providing superior service and added value to clients though a solid understanding of relationship banking. We offer a full range of services, including loans, bill payments, card services, internet banking, and merchant processing. We are an equal opportunity employer and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, military and/or veteran status, or any other Federal or State legally-protected classes.

Job Description Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. Immuneering's R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge MA. Immuneering has grown to more than 50+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering's team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development. General Summary of Duties: The Director, Quality Assurance is a strategic leadership role responsible for overseeing key aspects of Quality within the organization including the development, implementation, and management of GxP (cGMP, GCP, and GLP) quality systems. To accomplish this, the candidate should have a strong knowledge of relevant regulations and be able to work cross-functionally to ensure compliance of Immuneering's ongoing development programs with local, state, federal, and international requirements. This position will be supportive in developing a culture of quality, ensuring compliance with global regulatory requirements, driving continuous improvement in quality systems, and supporting the successful development, manufacturing, and commercialization of pharmaceutical products. A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player. Specific Duties, may include but not be limited to the following: · Assist with developing, implementing, and maintaining GxP compliant quality systems and processes to ensure compliance with FDA, EMA, ICH, and global competent authority regulations and industry guidance · Co- lead quality audits, risk assessments, and investigations, ensuring timely resolution of quality issues. · Work with the company's external suppliers and contract organizations to ensure consistent quality and compliance. · Prepare for and manage inspections by regulatory agencies and commercial partners, serving as a liaison between the Company and auditors, including reporting and follow-up to any finding · Work on qualification and validation plans, assure proper batch releases and disposition. · Oversee resolution of any product concerns, including investigation, tracking and corrective action plans (CAPA) · Provide quality input on contracts and serve as a point person for negotiations of quality agreements. · Champion a culture of quality and continuous improvement across manufacturing and development operations. Desired Skills and Qualifications · Bachelor's degree in biological sciences or related field, with a minimum of 7 or more years experience in Quality Assurance or related fields within the pharmaceutical or biotechnology industry · Extensive knowledge of GxP (GMP, GLP, and GCP) regulations and guidelines, including FDA, EMA, and ICH requirements · Demonstrated hands on experience working on complex projects. · In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC. · Strong partnering and communication skills required, as well as project management skills. · Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble. · Ability to work effectively in a collaborative, fast-paced environment. Pay scale: $175-210 annually, final offer to be commensurate with education and depth of experience, with potential for equity participation, bonus and comprehensive benefits. Location: Remote or Hybrid, if you live near an Immuneering office, regular Meet Ups are available. Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

The Director of Quality Assurance & Training ensures appropriate and effective monitoring of existing procedures of program operations and delivery of services. The position also maintains an ongoing staff training program to ensure that staff are up to date on policies, procedures, and enhanced service practices. What You'll Do Create SOPs and Desk Guides for new and existing programs, reviewing and updating materials for programs and conducting training with staff to ensure understanding and compliance with both funder and Fedcap requirements. Develop and maintain an annual report that provides a thorough description of Fedcap's Quality Assurance activities with an established Quality Improvement Plan (QIP) model. Develop and implement quality assurance tools to measure and assess the impact of systems, policies and protocols on operational efficiencies and program effectiveness. Conduct site visits to observe staff interaction with participants including intakes, service plan creation, and workshops. Review case files for completeness, accuracy, and compliance. Monitor Customer Service standards including conducting participant focus groups and analyzing surveys to gather feedback and increase awareness of participants' perspective of program services. Prepare monthly and quarterly reports for Senior Leadership and regulatory bodies. Identify gaps in program and staff performance and designing and conducting staff training to cure deficiencies and reiterate company standards. Develop and conduct training programs to provide to WeCARE operations staff on various policies, procedures, and best practices. Research and continuously update training modules on various topics relevant to providing the best possible services to WeCARE participants. Assist with external audits conducted by funders and third-party auditors. Conduct safety and risk assessment to ensure compliance with ADA and regulatory standards at service locations. Work collaboratively with program departments, external agencies and stakeholders to support compliance efforts and monitor remediation (Corrective Action) activities. You're a great fit for this role if you have: A bachelor's degree in public health, public administration, human services, or a related field, with master's degree preferred. At least 2 years' experience in quality assurance, preferably in social services, public health, or workforce development. Experience with workforce development is a plus. Compensation $120,000-$130,000 The Fedcap Group provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. We are an EEO employer committed to diversity, M/F/D/V.

Job Description QUALITY MANAGER to 130k MANUFACTURING ISO 9001 Handson Leader Aerospace industry must have enough work/life experience 5-7 years management experience 5-7 years machining experience Career progression in the quality field ISO 9001 - 14001 - 45001 ITAR Environment & Safety experience INDUSTRIAL MANUFACTURING DOD MANUFACTURING ITAR A PLUS Westchester County NY . Long established, financially stable manufacturer. APPLICANT REQUIREMENTS: MUST HAVE... 5-7 years of management experience, ideally in a manufacturing or job shop setting 5-7 years of machining experience with a solid understanding of dimensional tools (e.g. calipers, micrometers, Sunnen gauges, optical comparator, CMM machines) Demonstrated career progression in the quality field ISO 9001:2015 and AS9100 experience required; certifications in ISO 14001, ISO 45001, or similar a plus Experience with ITAR compliance Exposure to or direct involvement in environmental and safety standards (EHS) Excellent blueprint reading and interpretation skills Familiarity with Pre-Production Approval Process (PPAP) and Failure Mode Effects Analysis (FMEA) Root Cause Analysis and Product Control Plans/Inspection Methods Strong grasp of statistical process improvement techniques, including Six Sigma (Green or Black Belt preferred) Excellent math, computer, and communication skills High energy, highly organized, and detail-oriented Bachelor's degree preferred; however, equivalent work/life experience will be strongly considered DUTIES and RESPONSIBILITIES: Serve as the Quality System Management Representative, maintaining and auditing the company-wide ISO 9001 Quality Management System Manage the daily operations of the Quality Department in an ISO 9001 / AS9100 environment Oversee physical inspections of incoming materials, in-process production, and final product before shipment Maintain and control quality documentation including the Quality Manual, SOPs, and Work Instructions Lead and participate in internal audits, address nonconformances, and develop corrective action plans Collaborate with cross-functional teams to monitor and enhance product quality Prepare reports and support quarterly executive management reviews on quality metrics and audit outcomes Drive continuous improvement initiatives and enforce company quality standards Support environmental and workplace safety practices in coordination with EHS requirements A comprehensive benefits package which includes Medical, vision, dental, life insurance Sick days, holidays, vacation 401(k) Plan

Job DescriptionJob Title: Quality Manager - Food Manufacturing About the Role: We are seeking a dedicated and experienced Quality Manager to join our team in the food manufacturing sector. The ideal candidate will be responsible for ensuring that our products meet the highest standards of quality and safety. You will lead quality assurance initiatives and drive continuous improvement across all production processes. Key Responsibilities: Develop, implement, and maintain quality assurance protocols and procedures specific to food manufacturing. Oversee the quality control processes to ensure compliance with industry standards and food safety regulations. Collaborate with cross-functional teams to identify and resolve quality issues. Conduct regular audits and inspections to ensure adherence to quality standards and regulatory requirements. Analyze data and reports to identify areas for improvement and implement corrective actions. Lead and mentor the quality assurance team to achieve departmental goals. Liaise with suppliers and vendors to ensure quality standards are met throughout the supply chain. Qualifications: Bachelor's degree in Food Science, Quality Management, Engineering, or a related field. Proven experience as a Quality Manager or similar role in the food manufacturing industry. Strong knowledge of quality assurance methodologies and food safety standards (e.g., HACCP, ISO 22000). Excellent analytical and problem-solving skills. Strong leadership and communication abilities. Experience with quality management software and tools. Attention to detail and a commitment to excellence. Preferred Skills: Certification in quality management or food safety (e.g., Six Sigma, CQE). Familiarity with regulatory requirements relevant to the food industry.

We are working with a globally produced brand that brings premium specialty food to US consumers. Their diverse portfolio fits any table, in or out of the home. Their generations of craft, expertise, and passion enrich every meal. This company is seeking a Senior Quality Control Manager to supervise the QC and Sanitation departments. Reporting in to the QC Director, this individual will ensure HACCP, PCQI, SQF, and GMP standards are met. Location: Edison, NJ Job Responsibilities: Directly supervise a team of QC Technicians and Sanitation Team to ensure they understand and successfully perform job duties associated with the FSQA role. Train QC technicians to complete all required documentation relating to quality checks, sanitation, product holds and release, and any other function to maintain and improve quality and integrity of the products. Verify that all CCP's and quality checks are correctly carried out and completed. Completion of the all-around day finished product inspection to ensure the fitness of next-day shipping. Ensure all testing equipment is in good operating condition and calibrated according to the written procedure. Carry out environmental swabbing, ensure Swabs and finished product samples are sent to the lab. Helps QC Director to implement SQF requirements, company's GMP, Quality, and Food Safety policies and procedures. Able to communicate and provide guidelines (Hazzard Analysis and Risk-Based Preventive Controls) for any product and procedures to the Quality Team as well as Production Supervisor/Line Leads in the absence of the QC Director. Ability to perform Customer Complaints investigations and conduct Rot Cause Analysis. Help Director for updating and maintaining SQF compliance documentation for the 1 st and 2 nd shift. Work with Production Manager and QC Director for completing monthly food safety inspections, corrective actions, and risk assessments. Conduct internal GMP and Facility audits and monitor Sanitation activity to achieve objectives while fostering s a safe working environment. Keep inventory of all PPE and Sanitation supplies and communicate to QC Director for re-order as necessary. Required Skills/Qualifications: Bachelor's degree in Food Science or associate with a minimum of three years of Food Manufacturing Quality Assurance experience in place of degree required. Knowledge of the industry's best practices of GMP HACCP Certified PCQI Certified A bilingual (Spanish) communication skill is highly preferred to manage and train staff to maintain the high-quality standards in the facility. Previous dairy industry experience is a big plus. Ability to stand/walk for a minimum of 6 hours during shift. Ability to work occasional weekends and flexible schedules as business needs demand. Ability to work with or around a cold environment and confined spaces like spiral, freezer, etc. Must be able to wear/utilize personal protective equipment when and where needed.

Job SummaryDirect, lead and supervise the development of a total quality environment with an emphasis on unexcelled customer satisfaction and continual quality improvement. Accomplish quality-related objectives using quality meetings, planning, training, statistics, and internal/external audits. Ensure that processes and products are in compliance with the current Quality Management System requirements and applicable regulatory obligations. Serve as the designated authority for regulatory programs (e.g., ODA), maintaining compliance with external agency expectations while aligning with company quality standards.Job Description Key Accountabilities: •Direct and coordinate all aspects of Quality Management, including ISO/AS/TS compliance, quality improvement initiatives (CQIB), and customer satisfaction strategies to support company goals and objectives. •Report on the suitability and effectiveness of the Quality Assurance System while fostering a strong quality culture across all branches through leadership collaboration and communication. •Partner with department managers to establish goals, assess competencies, and guide quality outputs in alignment with corporate Quality Objectives. •Maintain frequent communication with site Quality Assurance Representatives to ensure consistency, effectiveness, and alignment across regions. •Lead and oversee quality assurance functions, including planning, statistical process controls, corrective/preventive action systems (CPAR), customer/vendor claims, trend analysis, and documentation of customer quality requirements. •Direct internal and external audits, provide technical assistance, root cause/corrective action process, manage quality non-conformance and drive employee training and development in quality, regulatory compliance, LEAN, and safety. •Support overall ODA program activities as required, including maintaining Unit Member records, coordinating application reviews and evaluation panels, tracking required FAA training, and assisting with annual evaluations and related correspondence. •Assist in developing, revising, and maintaining ODA quality manuals and procedures in collaboration with ODA representatives and stakeholders, ensuring alignment with FAA policies and identifying process or training impacts from regulatory updates. •Contribute to planning and execution of ODA and FAA audits, including preparing audit materials and reports, coordinating timely closure of corrective actions, and ensuring accurate tracking and reporting of ODA/FAA-required metrics and quarterly submissions. •Provide leadership and direct supervision to quality department teams across multiple functions, ensuring alignment with organizational goals. •Report directly to the Plant Manager and indirectly to Corporate Regulatory/Trade Compliance leadership to drive corporate quality, standardization, and safety initiatives. •Participate, support, and comply with all health, safety, quality, ISO and 6S Initiatives, compliance and Lean initiatives, requirements, and/or trainings. •Ability to access and work in SAP or other Warehouse Management System •Provide leadership and direct supervision to quality department teams across multiple functions, ensuring alignment with organizational goals. •Report directly to the Plant Manager and indirectly to Corporate Regulatory/Trade Compliance leadership to drive corporate quality, standardization, and safety initiatives. •Participate, support, and comply with all health, safety, quality, ISO and 6S Initiatives, compliance and Lean initiatives, requirements, and/or trainings. •Ability to access and work in SAP or other Warehouse Management System The above is intended to describe the general content of and requirement for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements. Meet all other TKMNA employee attributes and competencies Qualifications: Minimum Requirements: This position requires access to export-controlled technical data or technology. Employment is contingent upon obtaining any required export authorization from the appropriate government agency or agencies. When export authorization is necessary, the length of time to obtain the authorization by the government is outside of the Company's control. •Bachelor's degree/ 3+ years management experience/ leadership/team building/training in Quality Assurance/Control. •ODA Certification/industry credential & knowledge of ODA programs, FAA regulations, or aerospace regulatory compliance. •3+ years relevant experience working as a supplier ODA Focal or Unit Member in an aerospace or any equivalent industry. •Experience in TQM, ISO/QS 9000 ISO Assessor Certification, SPC. •Demonstrated proficiency in Microsoft Word, Excel, and PowerPoint, with strong verbal, written, and interpersonal communication skills. •Demonstrates dedication to delivering high-quality customer service while being positive, detail-oriented, organized, team-oriented, and a proactive problem-solver capable of multitasking and prioritizing in a fast-paced, deadline-driven environment. Preferred Requirements: •ASQ certification •ISO Lead Assessor Certification •5 years plus Quality Assurance/Control •3+ years of experience as an FAA ODA Unit Member or Supplier ODA Focal, with working knowledge of FAA rules, regulations, ODA programs, and aerospace regulatory compliance (or equivalent industry experience). •Training in strategic planning and motivation Benefits Overview We offer competitive company benefits to eligible positions, such as : Medical, Dental, Vision Insurance Life Insurance and Disability Voluntary Wellness Programs 401(k) and RRSP programs with Company Match Paid Vacation and Holidays Tuition Reimbursement And more! Benefits may vary based on job, country, union role, and/or company segment. Please work with your recruiter or tk representative for applicable benefits information. Disclaimer This is to notify the general public that some individuals/entities are using the thyssenkrupp (“TK”) name, trademark, domain name, and logo without authorization. They are posing as employees, representatives, or agents of TK and its associated/group companies. These individuals/entities are fraudulently offering jobs online through texts, websites, telephone calls, emails, or by issuing fake offer letters. They are also soliciting jobseekers to deposit money in certain bank accounts or providing jobseekers with fraudulent checks to obtain banking information. TK does not ask, solicit, or accept any monies in any form from candidates, job applicants, or potential jobseekers, who have applied to or wish to apply to TK, whether online or otherwise as a pre-employment requirement. TK bears no responsibility for money being deposited/withdrawn therefrom in response to such fake offers. TK does not: 1. Send job offers from free email services like Gmail, Rediffmail, Yahoo mail, etc.; 2. Request payment of any kind from prospective jobseekers or candidates for employment; 3. 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Our client is a fast-growing personal care and cosmetics manufacturer known for innovation, high standards of product excellence, and a passionate consumer base. They are looking to add a Quality Control (QC) Manager to their team. Salary/Hourly Rate: $90k - $115k Annually Position Overview: The Quality Control (QC) Manager will lead product-focused quality control operations to ensure that all finished goods meet established specifications, regulatory requirements, and internal quality standards. This role is integral in overseeing product release, managing QC laboratory functions, supporting investigations, and driving continuous improvement initiatives. The Quality Control (QC) Manager will supervise a team of 2-3 specialists and serve as a key partner to the Quality Director in strengthening quality systems, documentation, and operational readiness. Expected travel: 30% to contract manufacturers nationwide Responsibilities of the Quality Control (QC) Manager: * Oversee the complete product release process, including incoming inspection, analytical testing, disposition, and management of nonconformances. * Review and approve deviations, investigations, and CAPA documentation to ensure thorough root-cause analysis and effective corrective actions. * Collaborate cross-functionally to support new formulation launches and ensure quality requirements, inspection criteria, and testing protocols are clearly defined and implemented. * Manage the QC laboratory, including equipment oversight, instrument calibration, cleanliness, and adherence to safety practices. * Supervise the retention program and maintain product master standards. * Evaluate consumer complaint samples and support trend analysis. * Administer and enhance the Quality Management System (QMS) for documents, SOPs, CAPAs, audit records, and inspections. * Develop and deliver training on cGMP, quality systems, and technical processes. * Provide leadership, coaching, and performance feedback to QC Specialists. * Monitor, analyze, and report on quality KPIs to drive improvements across QC operations. Required Experience/Skills for the Quality Control (QC) Manager: * 5+ years of QC or quality-related experience in personal care, cosmetics, or fragrance manufacturing (required). * Prior supervisory experience. Ability to lead and develop laboratory personnel. * Strong background in nonconformance management, analytical testing, and release processes. * Experience operating in cGMP/ISO 22716 environments. Education Requirements: * Bachelor's degree in a scientific or engineering discipline (or equivalent experience) is required. Benefits: * Comprehensive medical, dental, and vision (including HSA with employer contribution). * PTO. * Paid holidays. * 401(K) and many more!

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.