Quality assurance manager jobs in Ossining, NY - 146 jobs

Now Hiring: GCP Quality Assurance Auditor Contract Length: 11 weeks Pay Rate: $50-$60/hr (W2) Schedule: Hybrid. Onsite Tuesday, Wednesday, and Thursday, each week. The hours can be flexible, between 7:30am and 5pm (8 hour shift). About the Role We are seeking a highly motivated GCP Quality Assurance Auditor to join our growing biopharmaceutical team focused on Neurology and Psychiatry therapies. Reporting to the Director of GCP/PVG Quality Assurance, you will play a key role in ensuring GXP compliance, implementing compliance initiatives, and supporting quality management systems across clinical operations, non-clinical, and manufacturing. This position involves conducting both internal and external GXP audits, managing relationships with CROs, CMOs, investigator sites, and vendors, and supporting the organization in maintaining the highest quality standards. This is an onsite position in Northern New Jersey. Key Responsibilities Plan and conduct scheduled global clinical process and vendor audits across all clinical trials. Conduct risk-based audits of specific clinical processes. Perform clinical vendor audits alongside SMEs (e.g., IRT, EDC) to evaluate vendor services. Prepare audit reports and distribute to relevant stakeholders. Manage vendor non-conformances and follow up on corrective actions. Review and apply clinical regulations and guidelines (FDA regulations, GCP, etc.). Collaborate with clinical sourcing, supplier quality, and clinical teams to manage vendor performance. Support regulatory inspections and participate in quality improvement projects. Qualifications Must have 2+ years of experience in radiopharmaceuticals and quality assurance. Bachelor's degree in a scientific, healthcare, or related discipline. Extensive knowledge of GCP and safety standards. Experience conducting internal and external process and system audits. Strong understanding of development policies, procedures, and SOPs/QMS. Ability to work with global clinical teams to define audit objectives. Willingness to travel up to 10%. EQUAL EMPLOYMENT OPPORTUNITY STATEMENT: Suna Solutions 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. 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. Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws. REQUESTING AN ACCOMODATION Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired. If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at ****************, send us an email or speak with your recruiter. PAY TRANSPARENCY POLICY STATEMENT Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington.

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!

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

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.

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

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

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

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.

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

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 Overview The 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.

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

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.

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

*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.

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 3 rd 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 3 rd party Sanitation program for the facility. Quality / Customer Service Lead 3 rd 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.

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.

The QCM maintains overall responsibility for the contractor's quality control management program and ensures full oversight of quality standards across the contract. Primary Job Functions - Administer the Quality Control Management Program - Manage the overall Quality Assurance program - Monitor and inspect all delivery orders for compliance - Maintain all inspection and certification records - Prepare monthly reports summarizing QC findings - Periodically review the QC program for compliance - Evaluate preventative and corrective maintenance processes and provide recommendations - Conduct inspections and re-inspections to verify problem resolution - Collect DMLSS data including work orders & equipment history - Research safety and quality topics - May prepare incident/accident reports - May prepare employee safety training materials and conduct safety meetings - May manage hazardous waste disposal - Complete RPIE-commissioning forms for new/replacement equipment - Prepare service order documentation - Perform QC inspections on service orders & projects - May research and issue infection control & interim Life Safety permits - May train personnel on material control, equipment, and tool management - Other duties as assigned We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to ********************.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: **************************************************** Skills and Requirements - Associate degree in related field - 3 years' experience preparing and enforcing QMS programs on comparable contracts - 2+ years QC evaluation/reporting in construction or facility management - 2+ years experience in comparably sized hospital/ health facilities (must be explicitly shown) - OSHA certifications highly preferred - Knowledge of OSHA safety regulations and PPE procedures - Ability to conduct accident investigations and inspections - Strong written and verbal communication skills

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

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.