Quality assurance manager jobs in Greenwich, CT - 181 jobs

Quality Control Supervisor Our client, a leading biopharmaceutical company, is seeking an experienced Quality Control Supervisor to join their team. This role is responsible for overseeing QC operations in a GMP-regulated environment, ensuring compliance with regulatory standards and internal procedures. Key Responsibilities: Supervise and mentor QC analysts; provide technical guidance and support. Ensure compliance with cGMP, USP, and 21 CFR Parts 210 & 211. Review and approve analytical data, investigations, and CAPAs. Troubleshoot analytical instruments (HPLC, GC, PSD) and support method validation and transfers. Manage testing schedules for raw materials, finished products, stability, and validation samples. Qualifications: BS in a scientific discipline with 5+ years of experience or MS with 3+ years. Hands-on experience with HPLC and Empower software. Strong knowledge of cGMP, USP, and ICH guidelines. Supervisory experience required. This is an excellent opportunity to join a growing organization and make an impact, please apply in directly for more information!

BUSINESS: CIRCOR Aerospace, Inc DIRECT REPORTING: Quality Manager About CIRCOR Aerospace & Defense CIRCOR Aerospace & Defense is focused on the design, development, and manufacture of specialty fluid and motion control products for demanding aerospace and defense applications. CIRCOR products are flying on most commercial and military aircraft, including single and twin aisle air transport, business and regional jets, military transports and fighters, and commercial and military rotorcraft. Other markets include unmanned aircraft, shipboard applications, and military ground vehicles. Business units are in Hauppauge, New York; Corona, California; Warren, Massachusetts; Paris, France; Uxbridge, UK; and Tangier, Morocco. Parent company CIRCOR International is headquartered in Burlington, Massachusetts and CIRCOR Aerospace & Defense is headquartered in Corona, California. Principal Activities · Acting as first line QA contact for customer calls regarding product problems; then liaising internally with appropriate persons to give the customer a prompt response. · Raising and closing In Service Defect Reports (ISDRs). · Where appropriate raising of Corrective Action Requests (CARs) and leading root cause corrective action (RCCA). · Participate in product improvement programs to correct in-field defects and manufacturing abnormalities. · Working with production and other departments to resolve queries. · Carry out detailed "root-cause analysis" and formulate corrective actions. Manage the process of driving changes and improvements as a result of this. · Liaising with purchasing and with suppliers to resolve any supplier certification issues. · Direct contact with customers and suppliers on QA related matters. · Provide technical guidance on quality standards, specifications, and processes. · Drive improvements in key defect drivers, processes, and systems to enhance assembly performance and meet site quality objectives. CANDIDATE REQUIREMENTS Knowledge Skills & Abilities · A strong interest in Quality Assurance in the widest sense is prerequisite with an aptitude for problem solving and continuous improvement. · The job holder should have an outgoing personality and be comfortable dealing with customers and internal personnel at all levels. · Excellent problem-solving skills aimed at identifying and correcting the root causes of problems. · Demonstrated working knowledge of problem-solving tools: 5-Whys, failure mode and effects analysis, 8-D, Pareto analysis, fault tree analysis, Bayesian inference and Ishikawa diagrams. · Thorough knowledge of Word, Excel, Power Point, Visio, Project, and other applicable tools. · Knowledge of Mil Spec Standards. Education & Experience · Bachelor's degree in Mechanical, or Manufacturing Engineering, or a technical field required with relevant work experience. · Experience with AS9100 and/or ISO9001 quality management systems. · Experience in Lean Six Sigma or continuous improvement practices. · Experience with leading root cause corrective action (RCCA) and applying quality methodologies and tools. PAY RANGE: $100K-110K. Pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience CIRCOR is an EEO Employer of Females/Minorities/Veterans/Individuals with Disabilities Our Benefits: Comprehensive healthcare plans PTO and family leave 401(K) Work Life Balance Career Development Other Benefits & Perks Why CIRCOR: Work in a collaborative and innovative environment with a focus on professional growth. Contribute to a diverse and inclusive workforce that values individuality and creativity. Competitive compensation package and comprehensive benefits.

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

The Director of Quality is responsible for developing, implementing, and maintaining a comprehensive quality improvement (QI) and performance management program for the Federally Qualified Health Center (FQHC). This role ensures compliance with HRSA requirements, NCQA Patient-Centered Medical Home (PCMH) standards, UDS reporting, and other regulatory or accreditation bodies, while fostering a culture of continuous improvement in clinical, operational, and patient experience outcomes. RESPONSIBILITIES: * Directly supervises the Quality Coordinators. * Develops Quality Assurance policies to ensure successful implementation of improvement standards. * Serves as the primary liaison between JPA and Managed Care Organizations (MCOs), representing the organization in all quality-related engagements and ensuring active participation in MCO quality meetings. Assesses patient medical records to ensure compliance with established quality standards. * Coordinates and ensures timely completion of the quarterly provider peer review cycle. * Conduct on-site visits to monitor and assess the implementation of QA/QI activities, including pre-visit planning and daily huddles. * Aggregates statistical quality assurance data, develops comprehensive narrative reports, and partners with clinical informatics specialists to support data-driven improvements. * Collaborates with the CMO to revise the Quality Assurance and Utilization Review plan in accordance with HRSA guidelines. * Coordinates recurring QI/QA meetings with the Quality Coordinators and Department Leads, manages meeting coordination, records minutes, tracks participation, and ensures timely follow-up on all assigned tasks and activities. * Monitor and track performance on HEDIS and other quality measures across payer contracts. * Identify and prioritize care gaps in collaboration with clinical and operational teams. * Develop and implement strategies to close care gaps, including outreach campaigns, provider engagement, and patient education. * Collaborate with clinical teams, payors, and population health staff to align quality improvement efforts with value-based care goals. Maintain up-to-date knowledge of CMS, NCQA, and payer-specific quality measure requirements. * Assist in the reporting and analysis of quality metrics to identify trends, disparities, and opportunities for improvement. * Coordinate with IT and analytics teams to ensure accurate and timely data capture and reporting. * Support the preparation of documentation and evidence for HEDIS audits and external reviews. * Contribute to quality improvement initiatives, such as PDSA cycles, root cause analyses, and performance dashboards. * May be required to perform other duties as assigned or when necessary. QUALIFICATIONS: Education: * Bachelor's degree in healthcare administration, public health, Nursing, or related field required. * Master's degree in public health, Healthcare Administration, or related field preferred. * A licensed Registered Nurse (RN) or Nurse Practitioner (NP) with a strong background in healthcare quality improvement will also be considered in lieu of a master's degree. Experience: * Minimum 5 years of progressively responsible experience in healthcare quality or performance improvement, preferably in a community health center or FQHC setting. * Strong working knowledge of HRSA, UDS, NCQA PCMH, and related regulatory requirements. Skills: * Demonstrated ability to lead quality initiatives and manage cross-functional teams. * Proficiency in data analysis and quality improvement tools (e.g., Excel, EHR reporting, QI methodologies). Excellent verbal and written communication skills. * Experience with risk management, clinical compliance, and patient safety programs is a plus. Working Conditions: * Primarily office-based with some travel between clinical sites. * May require occasional evenings or weekends for meetings or training. Why Join Us: Be part of a mission-driven organization focused on improving patient outcomes and advancing health equity. Collaborate with cross-functional teams to shape the future of value-based care. Opportunities for growth and professional development in a dynamic healthcare environment.

360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT solutions. 360 IT Professionals work along with its clients to deliver high-performance results, based exclusively on the one of a kind requirement. Our services are vast and we produce software and web products. We specialize in Mobile development, i.e. iPhone and Android apps. We use Objective C and Swift programming languages to create native applications for iPhone, whereas we use Android Code to develop native applications for Android devices. To create applications that work on cross-platforms, we use a number of frameworks such as Titanium, PhoneGap and JQuery mobile. Furthermore, we build web products and offer services such as web designing, layouts, responsive designing, graphic designing, web application development using frameworks based on model view controller architecture and content management system. Our services also extend to the domain of Cloud Computing, where we provide Salesforce CRM to effectively manage one's business and ease out all the operations by giving an easy platform. Apart from this, we also provide IT Staffing services that can help your organization to a great extent as you can hire highly skilled personnel's through us. We make sure that we deliver performance driven products that are optimally developed as per your organization's needs. Take a shot at us for your IT requirements and experience a radical change. Job Description Responsibilities: · Provide necessary definition, development and deployment of software quality assurance strategy and roadmap. · Develop and maintain current and comprehensive test plans for Navigators applications. · Act as Subject Matter Expert on the technical aspects, and tools related to testing end to end processes. · Lead and develop the execution of manual and automation test cases and scripts. · Lead and perform various types of testing including functional, regression, performance, user acceptance, etc. · Identify, document and track quality issues through to completion. · Responsible for maintaining up-to-date test plans. · Supervise quality assurance team who may be both internal and external resources and who may be geographically dispersed to ensure the delivery of the QA department goals and objectives · Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment in production environments. · Responsible embedding for QA as part of the SDLC · Meet target deployment schedules. · Measure and evaluate product and QA team performance; recommend improvements. · Identify risks and manage contingencies. · Gather and communicate testing results. · Work with Internal Audit to test and evaluate the design and operating effectiveness of internal controls. Requirements: · Bachelor's Degree or equivalent experience · 7+ years of software testing experience · 4+ years of team leadership · Thorough understanding of formalized QA process and concepts · Proven track record of delivering projects on time and within budget · Experience with Software Development Life Cycle (SDLC) · Strong analytical and problem solving abilities · Additional Information Thanks & Regards Vikas Kumar vikas.kumar(@)360itpro.com

Superior Motion Controls designs, produces and delivers precision components and assemblies for defense and aerospace systems. We are seeking a highly experienced and hands-on Process and Quality Manager to oversee all aspects of our Quality Program including design and development, precision machining, assembly and test of electromechanical assemblies. This role is responsible for supervising and scheduling internal inspection personnel and interfacing with engineering and production management to ensure all work products (WIP and final components) meet requirements. The Process and Quality Manager will serve as the principal adviser to executive management on elements of the company's Quality Management System and directly lead the company's efforts to maintain all required certifications with respect to external standards (ISO9001:2015, AS9100, etc.). Key Responsibilities ▪ Oversee all aspects of the company's Quality Program and the Inspection Department. ▪ Supervise and schedule the activities of all company quality inspectors ▪ Recruit and train Quality Inspectors to ensure adequate staffing to meet demand ▪ Achieve and maintain proficiency as a Quality Inspector ▪ Ensure all inspection tools and systems are calibrated on schedule as required and maintain appropriate documentation. ▪ Lead the Company through all required external quality audits (Standards based such as ISO 9001, AS9100 as well as any customer required) Requirements Qualifications ▪ Minimum 10 years experience in quality control, with at least 5 years in a leadership or management capacity; preferably in a precision machining/manufacturing environment ▪ Ability to read and interpret complex engineering drawings and GD&T ▪ Strong skills in coaching and developing inspectors with a range of experience levels ▪ Familiarity with lean manufacturing principles, ERP systems, and performance metrics ▪ Effective communicator with strong collaboration skills across departments

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

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

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

Quality Control Manager, Training & ComplianceAllendale, NJ The Quality Control (QC) Manager, Training and Compliance will manage the training and compliance programs across the analytical and microbiological laboratories. This role will ensure that there is a robust training program for the analytical and microbiological laboratories. In addition, this role will manage compliance activities within the laboratory such as deviations, CAPAs, document review, etc. The QC Manager will also be responsible for the management of external laboratories to include development of Quality Agreements, review of test results and resolution of any issues. Develop and maintain training program within Quality Control which includes, onboarding and continuous training Manage deviations, CAPAs, change controls and document review to ensure compliance Ensure OOS investigations are completed adequately. Manage external laboratories to include development of Quality Agreements, monitoring of samples and test results, reviewing deviations/OOS investigations, resolving issues and developing a scorecard to monitor the quality performance of the external laboratories Identify resources needed for training and compliance and build team accordingly Ensure compliance with applicable cGMP regulations while ensuring compliance with company and client requirements. Monitor effectiveness of CAPAs, change control activities, and audit observation closure. Directly supervises 1-4 employees within the Quality Control department(s).Directly supervised the following roles - Technical Trainers, Compliance Investigators Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. REQUIREMENTS BA/BS/MS in a science or relevant field required Prior cGMP experience required Prior QC laboratory experience in a cGMP environment a must 3-5 years' experience in the pharmaceutical, biologics ore related industry Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of five (5) years in a management position Sound understanding of cGMPs Experience in laboratory training and compliance External laboratory management experience Strong knowledge of testing methodologies, philosophies, method validation and method transfers. Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner Experience with laboratory training programs Knowledge of GMP requirements Excellent organizational and leadership skills Outstanding analytical problem-solving abilities While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. 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.

*This role is geared toward an entry level candidate (i.e. recent college graduate who possesses 1-3 years of professional work experience) About Harvest Hill: Harvest Hill Beverage Company is one of the nation's largest independent branded beverage producers, delivering consistent annual revenue growth, with sales of over $1 billion. The company was formed in June 2014 with the acquisition of Juicy Juice and further expanded with 3 subsequent acquisitions which were consolidated into one company in May 2017. Our portfolio of iconic brands includes Juicy Juice , SunnyD , Veryfine , Fruit2O , Little HUG , Daily's Cocktails , and Nutrament . We manufacture, market, and distribute across multi-channels including Grocery, Mass Merchandisers, Warehouse Clubs, Convenience, Foodservice, and Liquor Distributors. Harvest Hill is headquartered in Stamford, CT with a nationwide network of manufacturing and distribution facilities, employing over 1,000 employees in the United States. For more information visit harvesthill.com. Position Summary: The QA Coordinator posts files to appropriate internal/external sites and ensures corresponding databases are maintained and up to date. Creates, maintains and ensures all internal HHBC finished product quality documentation is current, accurate and project timelines for the QA team are maintained. The QA Coordinator creates updates & sustains Customer Portal and program documentation; carries out follow-up activities with customers and generates finished product standards as necessary. Directly assist in customer, consumer and field complaint support activities. Primary Position Responsibilities: • Maintain and update internal/external databases (TraceGains/Repositrak/Others) with customer documentation through active engagement in customer portal processes. Generate monthly reports defining completeness, gaps and goals. • Preserve the Harvest Hill customer list identifying products and manufacturing locations with a routine engagement of the gap assessment and resolution activities. • Efficiently coordinate the tracking of consumer, customer and field complaints with weekly reports. • Issue ongoing consumer investigation requests and maintain logs with timeline completion rates. Follow-up with sites on investigations. Support QA Mgr in trends and Complaint rates by categories. • Assists QA Mgr in developing concise feedback on status of field CAPA's and associated timelines. • Supports retrieval of technical details in the development of external and internal technical specifications for finished goods. Meanwhile adhering to HH, FDA, State and Local Regulations and Co-Manufacturing Alliance agreements. • Update and sustain Customer Portal with appropriate program documentation. Ensure through management engagement that customers receive the correct and accurate information. (no more no less). Foster meetings and communication with sales, customer service and QA to ensure accuracy. • Illustrate QA meetings as assigned, document activities and initiate follow-up. • Manage the receipt of new products, trial samples, consumer complaints that are delivered to the CT office. Track and photo packages received, identify location to store and act on disposal as required. Reach out to Sr Director or QA Mgr for direction. • Generate quarterly project timelines for the QA department corporate team. • Analyze & support QA Mgr in recommended next steps as it relates to handling and transportation deficiencies of finished goods. • AX acumen for the HHBC QA team. Within the first 180 days, train on AX, develop tutorials and train all members of our CT staff. • Review all co manufacturer requests for destruction of surplus, expired or defunct finished goods. • As a back-up to cross-functional QA team, learn documentation OOSR, ATS, shelf-life update process. • Support Co-Man and DC Trace exercises which occur a few times a year. • Support product manual upkeep with direct supervision by Head of FSQA. • Additional duties that may be assigned. Position Qualifications: • Candidate should possess a BS/BA degree in science, project management or related field and a minimum preferred of two years of professional career experience. • Proven experience of working with databases, include inputting and extracting data. • Excellent attention to detail with organizational and planning skills. • Ability to self-manage, prioritize and work under pressure to tight deadlines. • Ability to communicate effectively with colleagues, participants and external stakeholders. • Ability to work effectively as part of a team. • Undertake any training and professional development as and when required. • Proficient in Microsoft Office, particularly Access, Word and Excel. Systems experience may include: Microsoft Access, TRACEGAINS, Sharepoint and Red Zone.

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

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

The Quality Control & Operations Manager (QCOM) is responsible for managing and performing the daily QC responsibilities of specific assigned projects to ensure the projects are constructed in accordance with the established University standards. The role includes direct oversight and review of the entire documentation and physical inspection phase of the workflow process and working with other in-house personnel (e.g., Project Managers, Capital Projects Director, etc.) and external personnel to produce and document quality projects. The incumbent reports directly to the Executive Director of Capital Projects. In addition to the above, the position will require to be the facilities liaison between off-campus entities & University Construction & Facilities Department director(s). Principal Duties & Responsibilities The QCOM must be on the project site at all times during physical work activities. The QCOM will be an individual within an on-site work organization who will be responsible for overall project QC management and have the authority to act in all QC matters. The QCOM will aid in the continued development, implementation, and administration of the university-specific QC Plan for projects in the construction phase. Ensure all project personnel, including CMs/ GCs/ subcontractors, understand and comply with the University QC requirements. Certify that all submittals are in compliance with contract requirements. Develop the Preparatory QA/QC Meeting agendas, facilitate the Preparatory Meetings, and participate in the Initial, Follow-up, and Final Inspections. Conducts preparatory, initial, and follow-up meetings to establish an understanding of the standards of Construction desired for each definable feature of work. Verifies and documents that all materials received for the project are in conformance with approved submittals and contract specifications. Verifies all onsite materials are handled and stored properly for use on the project Review plans and specifications to ensure requirements are met for each scope of work within assigned Projects. Complete necessary inspection reports and documentation.Records daily quality control observations on all construction activities in daily inspection logs and takes photos of the progress. Inspect and evaluate the adequacy of work performed by contractors; Identify non-conformities, analyze root causes, and inform stakeholders of required corrective measures. Coordinate University QC activities with GC/ CMs. Maintain daily project reports/ logs for assigned Projects. Manage and monitor required University owned material & systems testing and verify proper testing process of CM owned scope. Conduct pre-final/final inspections; establish punch list; and ensure all deficiencies are corrected. Conduct and/or attend QC meetings. Verify that the assembling and submittals required by the Contractor(s) for project closeout documents include O&M manuals, as-builts, warranties, and other relevant project-specific information/ data per University standards. Prepare documentation for each definable feature of work in their area of responsibility; Distribute written inspection/test results to appropriate project personnel/stakeholders. Ability to organize tasks and work efficiently Assist the Executive Director of Capital Projects with project management related tasks in the construction phase as assigned; Schedule monitoring Financial monitoring Closeout phase administration Development & administering of scope required for Existing Facility Assessments Other duties as assigned. Knowledge, Skills, Abilities & Other Attributes Bachelor's Degree from an accredited college or university program in one of the following disciplines: Engineering, Architecture, Construction Management, Engineering Technology, Building Construction, or Building Science; related field or equivalent combination of education and experience may be substituted for this requirement. Must have 5+ years of relevant construction experience as a quality control manager or have worked in the construction field for a CM/GC firm for medium ($10 million or more) construction projects. Must have a good understanding of applicable construction laws for local, state, and federal regulatory requirements. Ability to communicate with clients in written and oral formats, solve problems, and have attention to detail with proper paperwork. Ability to prioritize and organize own work to meet agreed-upon deadlines. Works with others to achieve team goals. Thorough knowledge and understanding of construction means and methods. Unusual Working Conditions Able to navigate through active construction sites and adhere to all site safety requirements necessary to accomplish inspections as required for the role. May require evening and weekend hours.

Location: Hackensack, NJ Employment Type: Full-time About the Role: We are seeking a detail-oriented and motivated QA Coordinator to join our team. The ideal candidate will be responsible for creating, documenting, and executing system test plans and test scripts, as well as validating data and analyzing test results. This role involves identifying, reporting, and tracking software issues, and communicating findings and progress updates with our software development team in Korea. Key Responsibilities: Develop, document, and execute comprehensive system test plans and test scripts. Perform data validation and analyze test results to ensure software quality. Record, report, track, and retest bugs found during testing. Collaborate and communicate effectively with software developers in Korea to resolve issues. Support continuous improvement of testing processes and documentation. Qualifications: Bachelor's degree in Computer Science or a related field. Bilingual proficiency in Korean and English (both written and verbal). 1-2 years of experience in system testing of Windows-based Point of Sales (POS) software. Hands-on experience with PC POS peripherals such as printers, barcode scanners, customer displays (CDP), and dot matrix printers. Strong analytical, problem-solving, and communication skills. High attention to detail and ability to work in a fast-paced environment. Benefits: Group Health Insurance (Medical, Dental, Vision) Employer paid Life Insurance Paid Sick and Vacation 401K with 3% matching Gym Reimbursement Company Lunch Please visit our website ************* for more information

The Director of Quality is responsible for developing, implementing, and maintaining a comprehensive quality improvement (QI) and performance management program for the Federally Qualified Health Center (FQHC). This role ensures compliance with HRSA requirements, NCQA Patient-Centered Medical Home (PCMH) standards, UDS reporting, and other regulatory or accreditation bodies, while fostering a culture of continuous improvement in clinical, operational, and patient experience outcomes. RESPONSIBILITIES: Directly supervises the Quality Coordinators. Develops Quality Assurance policies to ensure successful implementation of improvement standards. Serves as the primary liaison between JPA and Managed Care Organizations (MCOs), representing the organization in all quality-related engagements and ensuring active participation in MCO quality meetings. Assesses patient medical records to ensure compliance with established quality standards. Coordinates and ensures timely completion of the quarterly provider peer review cycle. Conduct on-site visits to monitor and assess the implementation of QA/QI activities, including pre-visit planning and daily huddles. Aggregates statistical quality assurance data, develops comprehensive narrative reports, and partners with clinical informatics specialists to support data-driven improvements. Collaborates with the CMO to revise the Quality Assurance and Utilization Review plan in accordance with HRSA guidelines. Coordinates recurring QI/QA meetings with the Quality Coordinators and Department Leads, manages meeting coordination, records minutes, tracks participation, and ensures timely follow-up on all assigned tasks and activities. Monitor and track performance on HEDIS and other quality measures across payer contracts. Identify and prioritize care gaps in collaboration with clinical and operational teams. Develop and implement strategies to close care gaps, including outreach campaigns, provider engagement, and patient education. Collaborate with clinical teams, payors, and population health staff to align quality improvement efforts with value-based care goals. Maintain up-to-date knowledge of CMS, NCQA, and payer-specific quality measure requirements. Assist in the reporting and analysis of quality metrics to identify trends, disparities, and opportunities for improvement. Coordinate with IT and analytics teams to ensure accurate and timely data capture and reporting. Support the preparation of documentation and evidence for HEDIS audits and external reviews. Contribute to quality improvement initiatives, such as PDSA cycles, root cause analyses, and performance dashboards. May be required to perform other duties as assigned or when necessary. QUALIFICATIONS: Education: Bachelor's degree in healthcare administration, public health, Nursing, or related field required. Master's degree in public health, Healthcare Administration, or related field preferred. A licensed Registered Nurse (RN) or Nurse Practitioner (NP) with a strong background in healthcare quality improvement will also be considered in lieu of a master's degree. Experience: Minimum 5 years of progressively responsible experience in healthcare quality or performance improvement, preferably in a community health center or FQHC setting. Strong working knowledge of HRSA, UDS, NCQA PCMH, and related regulatory requirements. Skills: Demonstrated ability to lead quality initiatives and manage cross-functional teams. Proficiency in data analysis and quality improvement tools (e.g., Excel, EHR reporting, QI methodologies). Excellent verbal and written communication skills. Experience with risk management, clinical compliance, and patient safety programs is a plus. Working Conditions: Primarily office-based with some travel between clinical sites. May require occasional evenings or weekends for meetings or training. Why Join Us: Be part of a mission-driven organization focused on improving patient outcomes and advancing health equity. Collaborate with cross-functional teams to shape the future of value-based care. Opportunities for growth and professional development in a dynamic healthcare environment.

Job Description Superior Motion Controls designs, produces and delivers precision components and assemblies for defense and aerospace systems. We are seeking a highly experienced and hands-on Process and Quality Manager to oversee all aspects of our Quality Program including design and development, precision machining, assembly and test of electromechanical assemblies. This role is responsible for supervising and scheduling internal inspection personnel and interfacing with engineering and production management to ensure all work products (WIP and final components) meet requirements. The Process and Quality Manager will serve as the principal adviser to executive management on elements of the company's Quality Management System and directly lead the company's efforts to maintain all required certifications with respect to external standards (ISO9001:2015, AS9100, etc.). Key Responsibilities ▪ Oversee all aspects of the company's Quality Program and the Inspection Department. ▪ Supervise and schedule the activities of all company quality inspectors ▪ Recruit and train Quality Inspectors to ensure adequate staffing to meet demand ▪ Achieve and maintain proficiency as a Quality Inspector ▪ Ensure all inspection tools and systems are calibrated on schedule as required and maintain appropriate documentation. ▪ Lead the Company through all required external quality audits (Standards based such as ISO 9001, AS9100 as well as any customer required) Requirements Qualifications ▪ Minimum 10 years experience in quality control, with at least 5 years in a leadership or management capacity; preferably in a precision machining/manufacturing environment ▪ Ability to read and interpret complex engineering drawings and GD&T ▪ Strong skills in coaching and developing inspectors with a range of experience levels ▪ Familiarity with lean manufacturing principles, ERP systems, and performance metrics ▪ Effective communicator with strong collaboration skills across departments

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

Quality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that quality standards are upheld for all products produced at the facility. The goal is to ensure that the Quality Control group and company is constantly moving towards fulfilling its short-term and long-term objectives and does not diverge from its strategic guidelines. Under the direction of the VP, Global Quality Head, responsibilities of the QC Manager will include but are not limited to: Leading, hiring, developing, training, and evaluating QC personnel Devising sound hiring strategies based on business needs Supervising and overseeing QC personnel in their roles for safe and efficient verification, approval, release/disposition of HCATS and/or client products/materials Delegating responsibilities and supervising the work of laboratory personnel, while providing guidance and motivation to drive maximum performance Ensuring and promoting compliance with applicable cGMP and GTP regulations, while ensuring compliance with company and client methodologies Assuring alignment and efficient continuity in laboratory practices between sites Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records Ensuring completion of all client QC requirements related to GMP cellular products and/or materials Overseeing QC role in material dispositions via deviation reporting system, CoAs, and/or client-based systems, if applicable Prioritizing, scheduling, and managing multiple projects and resources simultaneously Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal and client audit findings Evaluating and investigating customer complaints and deviations; coordinating corrective and preventive actions as they relate to the Quality Control function Delegating maintenance, tracking, and trending aspects of the deviation reporting system Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing Interfacing with vendors, suppliers, and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies, when applicable Interfacing with management at all levels for alignment on significant deviation resolution and corrective action implementation Delegating development, revisions, and implementation of Standard Operating Procedures as related to Quality Control activities Participating in and tracking group budget setting and cost containment drives Communicating and maintaining trust relationships with senior management, business partners, and clients Ensuring company policies and legal guidelines are communicated top-down in the company and that they are followed at all times Completing projects and special tasks as assigned by the Global Quality Head Off-schedule shifts during weekends and holidays based on business requirements a possibility On-call presence preferred while physical personal presence is not possible Candidate will oversee QC Scientist and QC Associate I, II, and III roles. The QC Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes. REQUIREMENTS BA/BS/MS in a science or relevant field required Master's in Business Administration or relevant field will be preferred 7 - 10 years' experience in the pharmaceutical, biologics or related industry Prior cGMP experience required Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must Experience in Flow Cytometry is a must 5 + Years experience leading a team is a must. Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff Sound understanding of current Good Manufacturing Practices (cGMPs) Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of production processes and validation Prior experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, method validations preferred Proven experience in a supervisory or managerial position Demonstrable experience in developing strategic plans based on business needs Strong understanding of Quality Control in pharmaceutical/biotechnology/biologics industries Thorough knowledge of market changes and forces that influence the company Proficient with computer software: Microsoft Office, Visio Strong written, oral, and presentational skills Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review Excellent organizational and leadership skills Excellent communication, interpersonal, and presentation skills Outstanding analytical and problem-solving abilities Strong business acumen Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clients Must be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.