Quality assurance manager jobs in Burlington, VT - 38 jobs

Description & Requirements Maximus is currently hiring for a Quality Assurance and Training Manager to support our Kansas Eligibility Operations team. This is a remote opportunity. The Quality Assurance and Training Manager will will oversee quality assurance programs, manage remote training teams, and ensure compliance with contractual and regulatory standards. In this role, the Quality Assurance and Training Manager will design and implement training strategies, monitor performance, and leverage standardized quality tools to enhance service delivery and to meet client's needs. *This role is contingent upon contract award* Why joining Maximus? - • Competitive Compensation - Quarterly bonuses based on performance included! - • Comprehensive Insurance Coverage - Choose from various plans, including Medical, Dental, Vision, Prescription, and partially funded HSA. Additionally, enjoy Life insurance benefits and discounts on Auto, Home, Renter's, and Pet insurance. - • Future Planning - Prepare for retirement with our 401K Retirement Savings plan and Company Matching. - • Unlimited Time Off Package - Enjoy UTO, Holidays, and sick leave, - • Holistic Wellness Support - Access resources for physical, emotional, and financial wellness through our Employee Assistance Program (EAP). - • Recognition Platform - Acknowledge and appreciate outstanding employee contributions. - • Tuition Reimbursement - Invest in your ongoing education and development. - • Employee Perks and Discounts - Additional benefits and discounts exclusively for employees. - • Maximus Wellness Program and Resources - Access a range of wellness programs and resources tailored to your needs. - • Professional Development Opportunities- Participate in training programs, workshops, and conferences. Essential Duties and Responsibilities: - Design, develop and implement training curriculum and supporting materials. - Develop training schedules based on the evaluation of the need for new staff. - Develop and deliver training through input and communication with the client and leadership. - Ensure that Client Service Reps are provided with updated knowledge required for the project, which includes management of changes to scope and direction. - Communicate operating policies and procedures and ensure compliance with contractual agreement. - Arrange staff training on a regular and ongoing basis regarding telephone protocols and project information obtained through quality assurance monitoring. - Manage quality operations including planning, implementing, monitoring, and reporting functions. - Manage internal and external customer expectations related to quality management, and effectively communicate corporate quality standards across the project. - Support and improve the Quality Program and provide the leadership and direction to enhance accepted standards of quality practices, continuous improvement, and ethical considerations. - Aggregate and analyze quality data and identify opportunities for improvement in product and service quality, and the design and implementation of key business and quality processes. - Maintain responsibility for developing, implementing, and writing procedures, work instructions and flow-charts for quality management activities and monitoring compliance with contractual agreements. Minimum Requirements - Bachelor's degree in relevant field of study and 5+ years of relevant professional experience required, or equivalent combination of education and experience. - Must be willing and able to travel up to 25% of the time as business need dictates. - Lean Six Sigma experience with a minimum of Yellow Belt Certification required. - Experience managing direct reports remotely required, as well as multiple training sessions virtually. - Experience with designing, implementing and reporting customer satisfaction surveys required. - Experience with standardized quality tools required. - Experience with call and voice monitoring platforms required. - Experience with a large-scale telephony system required. - Experience with Client Relationship Management (CRM) platforms required. - Experience with contract compliance and quality platforms required. - Experience with statistical processes required. - Premium contact center billing experience required. - Financial experience with Oracle preferred. - Medicaid program knowledge and experience highly preferred. Home Office Requirements: - Internet speed of 25mbps or higher required (you can test this by going to ******************* - Connectivity to the internet via either Wi-Fi or Category 5 or 6 ethernet patch cable to the home router. - Must currently and permanently reside in the Continental US. EEO Statement Maximus is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information and other legally protected characteristics. Pay Transparency Maximus compensation is based on various factors including but not limited to job location, a candidate's education, training, experience, expected quality and quantity of work, required travel (if any), external market and internal value analysis including seniority and merit systems, as well as internal pay alignment. Annual salary is just one component of Maximus's total compensation package. Other rewards may include short- and long-term incentives as well as program-specific awards. Additionally, Maximus provides a variety of benefits to employees, including health insurance coverage, life and disability insurance, a retirement savings plan, paid holidays and paid time off. Compensation ranges may differ based on contract value but will be commensurate with job duties and relevant work experience. An applicant's salary history will not be used in determining compensation. Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances. Accommodations Maximus provides reasonable accommodations to individuals requiring assistance during any phase of the employment process due to a disability, medical condition, or physical or mental impairment. If you require assistance at any stage of the employment process-including accessing job postings, completing assessments, or participating in interviews,-please contact People Operations at **************************. Minimum Salary $ 100,000.00 Maximum Salary $ 112,400.00

The Senior Manager of Global Quality Management (GQM) supports the execution of clinical quality activities to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and internal standards across global clinical trials. This role provides hands-on quality oversight, supports audit and inspection readiness, and collaborates with internal teams and external partners to maintain high-quality standards throughout the clinical development lifecycle. **Key Responsibilities** **Clinical Study Support** + Serve as a GCP quality resource to clinical teams during study planning, conduct, and close-out. + Support the review of study documents (e.g., protocols, monitoring plans, vendor agreements) for quality and compliance. + Assist in identifying and resolving quality issues, protocol deviations, and potential noncompliance. + Collaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs to embed quality practices throughout the study lifecycle. **Inspection Readiness** + Support inspection readiness activities including mock audits, documentation reviews, and training coordination. + Maintain inspection readiness tools, trackers, and communication plans. + Participate in regulatory inspections and assist in preparing response documentation. **Audit Program Execution** + Contribute to the development of the annual audit plan using risk-based approaches. + Coordinate and support investigator site, vendor, and internal process audits. + Track audit findings and ensure timely implementation of corrective and preventive actions (CAPAs). + Monitor audit trends and escalate recurring issues to senior leadership. **Quality Systems & Compliance** + Support the implementation and continuous improvement of clinical quality systems, SOPs, and policies. + Assist with deviation management, root cause analysis, and CAPA tracking related to clinical activities. + Stay current with evolving global GCP regulations and industry best practices. **Collaboration & Team Support** + Partner with internal stakeholders and CROs to ensure consistent quality oversight. + May mentor junior staff or contractors. + Contribute to cross-functional initiatives that promote a culture of quality and compliance. **Qualifications** Required + Bachelor's degree in life sciences or related field; advanced degree a plus. + 6-8 years of experience in clinical quality assurance or clinical research within the pharmaceutical or biotech industry. + Solid understanding of GCP, ICH guidelines, and global regulatory requirements. + Experience supporting inspection readiness and participating in audits or inspections. + Strong communication, organizational, and problem-solving skills. + Ability to travel domestically and internationally as needed. + Proficiency in MS Office (Word, Excel, PowerPoint). **Preferred:** + Experience with TrackWise or similar quality management systems. + Prior collaboration with CROs and external vendors. + Exposure to FDA or other health authority inspections. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Datavant is a data platform company and the world's leader in health data exchange. Our vision is that every healthcare decision is powered by the right data, at the right time, in the right format. Our platform is powered by the largest, most diverse health data network in the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world's leading life sciences companies, government agencies, and those who deliver and pay for care. By joining Datavant today, you're stepping onto a high-performing, values-driven team. Together, we're rising to the challenge of tackling some of healthcare's most complex problems with technology-forward solutions. Datavanters bring a diversity of professional, educational and life experiences to realize our bold vision for healthcare. Datavant is seeking a strategic and hands-on **Director of Quality** to lead product and supplier quality assurance efforts within our **Life Sciences business unit** , which includes the **Datavant Connect** and **Aetion Evidence Platform** . These platforms deliver regulatory-grade real-world data (RWD) solutions through tokenization, data linkage, and privacy-preserving analytics. As Director of Quality, you will own the implementation and evolution of GxP-aligned quality practices that support regulated data services and software. This includes oversight of software validation, privacy compliance, supplier qualification, and audit readiness. You will also lead a team of quality specialists and partner cross-functionally with Product, Engineering, Security, Privacy, and Customer Assurance to ensure that we meet or exceed regulatory expectations and customer trust standards. This role is essential to operationalizing Datavant's **Quality Management System (QMS)** across internal and external stakeholders and enabling continued growth in regulated RWD and evidence generation environments. **What You Will Do** + Lead the development and continuous improvement of Datavant's QMS across Life Sciences products and supplier relationships, ensuring GxP and privacy compliance. + Manage and mentor a team of quality specialists responsible for core functions such as CAPA, internal audits, validation, and supplier monitoring. + Serve as the primary quality liaison to product development teams (Connect and Aetion), providing guidance on SDLC quality controls, validation strategies (GAMP 5, Part 11), and regulatory risk mitigation. + Oversee supplier qualification and re-evaluation processes, including risk-based assessments, audit coordination, and performance monitoring. + Establish and maintain quality metrics (e.g., CAPA closure, audit readiness scores, supplier performance) and drive continuous improvement initiatives. + Support readiness for and participation in customer audits and external assessments (e.g., pharma clients, CROs, regulatory partners). + Partner with Security and Privacy teams to align product and supplier practices with frameworks like HIPAA, GDPR, and FedRAMP. + Lead or support periodic management reviews of the QMS and contribute to strategic quality planning and resource allocation. + Ensure clear documentation and traceability across all quality activities, systems, and changes in compliance with FDA 21 CFR Part 11 and ICH E6(R3). + Represent Datavant's quality program in external communications, including client onboarding, RFIs, and quality-related escalations. **What You Need to Succeed** + 8+ years of experience in quality, compliance, or regulatory roles within life sciences, digital health, or regulated software organizations. + Strong working knowledge of relevant regulations and frameworks, including **FDA 21 CFR Part 11, GAMP 5, ISO 9001, ICH E6(R3), HIPAA** , and **GDPR** . + Proven leadership in scaling and operationalizing a **QMS in a SaaS, RWD, or GxP context** . + Experience managing and mentoring cross-functional teams. + Demonstrated success overseeing **validation, supplier oversight, internal audits, and CAPA management** . + Deep understanding of **data governance, privacy, and security** best practices. + Experience interacting with external auditors, customer compliance teams, or regulatory agencies. + Strong communication skills-capable of explaining complex quality topics to product, legal, technical, and customer-facing stakeholders. **What Helps You Stand Out** + Prior experience supporting real-world data (RWD) platforms or evidence generation technologies used in regulatory submissions. + Background working in or with tokenization, health data linkage, or privacy-enhancing technologies. + Experience interfacing directly with pharmaceutical, biotech, or CRO quality teams. + Training or certification in Six Sigma, ISO Auditing, or software validation methodologies. + Familiarity with supplier portals, quality dashboards, or eQMS platforms (e.g., Veeva, MasterControl). + Experience contributing to industry working groups on quality, data integrity, or health data compliance. \#LI-BC1 We are committed to building a diverse team of Datavanters who are all responsible for stewarding a high-performance culture in which all Datavanters belong and thrive. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. At Datavant our total rewards strategy powers a high-growth, high-performance, health technology company that rewards our employees for transforming health care through creating industry-defining data logistics products and services. The range posted is for a given job title, which can include multiple levels. Individual rates for the same job title may differ based on their level, responsibilities, skills, and experience for a specific job. This role is eligible for additional variable compensation. The estimated base salary range (not including variable pay) for this role is: $165,000-$230,000 USD To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion. This job is not eligible for employment sponsorship. Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here (************************************************** . Know Your Rights (*********************************************************************** , explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way. Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, (************************************************************** Id=**********48790029&layout Id=**********48795462) by selecting the 'Interview Accommodation Request' category. You will need your requisition ID when submitting your request, you can find instructions for locating it here (******************************************************************************************************* . Requests for reasonable accommodations will be reviewed on a case-by-case basis. For more information about how we collect and use your data, please review our Privacy Policy (**************************************** .

_\*\*\*This position will be Remote, but with a preference for candidates in Ohio, Missouri, Texas or Louisiana\*\*\*_ This is your chance to be part of an in\-house Brands team of industry experts in the domains of hospitality, brand management, innovation, food and beverage, wellness, owner relations, and more, for all of Hilton's unique brands\! As Manager, QA Auditor, you will support the team that leads our brands with the steadfast goal of strengthening and growing the Hilton portfolio\. On the Brands team reporting to Area Manager Quality Assurance, you will perform numerous QA audits and have responsibility for 100 hotels in your territory\. Your main duty is to protect the integrity of the brands inspected in terms of cleanliness, condition, guest safety, and brand standards\. **HOW WE WILL SUPPORT YOU** Hilton is proud to support the mental and physical wellbeing of all Team Members so they can Thrive personally and professionally in a diverse and inclusive environment, thanks to programs and benefits such as: + Go Hilton travel program: 110 nights of discounted travel with room rates as low as $40/night + Hilton Shares: Our employee stock purchase program \(ESPP\) \- you can purchase Hilton shares at a 15 percent discount + Paid parental leave for eligible Team Members, including partners and adoptive parents + Mental health resources including free counseling through our Employee Assistance Program + Paid Time Off \(PTO\) + Learn more about the rest of our benefits \(****************************************** At Hilton, we believe every Team Member is a leader\. We are committed to offering leadership development opportunities and programs through every step of a Team Member's career journey and at every level, both in our hotels and across corporate\. \*\*Available benefits may vary depending upon terms and conditions of employment and are subject to the terms and conditions of the plans\. **HOW YOU WILL MAKE AN IMPACT** Your role is important and below are some of the fundamental job duties that make your work unique\. **What your day\-to\-day will be like:** + Perform routine Quality Assurance evaluations\. + Address inquiries and communications made internally, both verbally and in written communications\. + Monitor expenses incurred from travel completed/scheduled, both based upon monthly and yearly goals\. + Participate in Consistency exercises\. + Participate in activities outside of QA to gain a better knowledge of other departments\. **How you will collaborate with others:** + Communicate with Quality Auditors, Area Managers in QA, Directors, Vice President of QA, Brand teams, Design and Construction, and Human Resources to answer inquiries about brand standard compliance, QA, brand protocol, procedures, and Improvement Plans\. **What projects you will take ownership of:** + Coordinate upcoming activities such as travel plans and hotel scheduling, ensuring downtime work is completed and submitted by established deadlines\. **WHY YOU'LL BE A GREAT FIT** **You have these minimum qualifications:** + Five \(5\) years of management experience \- Hotel Operations + Three \(3\) years of experience as a General Manager, Executive Committee Member, or Director + Valid Driver's license + Travel 90% of the time **It would be useful if you have:** + BA/BS Bachelor's Degree + Fluency in a foreign language + Food Safety certification + Project management skills + Working knowledge of product replacement cycles, renovations and physical upgrades + Problem resolution and consulting skills to mitigate potential conflicts/issues with general managers, owners, and/or internal customers while upholding the integrity of the brand + Current resident in the states of Ohio, Missouri, Texas, or Louisiana **WHAT IT IS LIKE WORKING FOR HILTON** Hilton, the \#1 World's Best Workplace, is a leading global hospitality company with a diverse portfolio of world\-class brands \(**************************************** \. Dedicated to filling the earth with the light and warmth of hospitality, we have welcomed more than 3 billion guests in our more\-than 100\-year history\. Hilton is proud to have an award\-winning workplace culture and we are consistently named among one of the World's Best Workplaces\. Check out the Hilton Careers blog \(************************************** and Instagram \(******************************************** to learn more about what it's like to be on Team Hilton\! We provide reasonable accommodations to qualified persons with disabilities to perform the essential functions of the position and provide other benefits and privileges of employment in accordance with applicable law\. Please contact us \(https://cdn\.phenompeople\.com/CareerConnectResources/prod/HILTGLOBAL/documents/Applicant\_Accommodation\_and\_Accessibility\_Assistance\-English\-20************253430519\.pdf\) if you require an accommodation during the application process\. Hilton offers its eligible team members a comprehensive benefits package including medical and prescription drug coverage, dental coverage, vision coverage, life insurance, short\-and long\-term disability insurance, access to our employee stock purchase plan \(ESPP\) where you can purchase Hilton shares at a 15 percent discount, a 401\(k\) savings plan, 20 days of paid time off accruing over your first year of employment and increasing up to 25 days after completing one year of full employment, up to 12 weeks of paid leave for birth parents and 4 weeks for non\-birth parents, 10 paid holidays and 2 floating holidays throughout the year, up to 5 bereavement days, flexible spending accounts, a health savings account, an employee assistance program, access to a care coordination program \("Wellthy"\), a legal services program, an educational assistance program, adoption assistance, a backup childcare program, pre\-tax commuter benefit and our travel discount\. The annual salary range for this role is $75,000 \- $100,000 and is determined based on applicable and specialized experience and location\. Subject to plan terms and conditions, you will be eligible to participate in the Hilton Annual Incentive \(Bonus\) Plan, consistent with other team members at the same level and/or position within the Company\.\#LI\-REMOTE **Job:** _Brands_ **Title:** _Manager Quality Assurance_ **Location:** _null_ **Requisition ID:** _COR015IF_ **EOE/AA/Disabled/Veterans**

Manages all quality department activities, including but not limited to all QA personnel, inspection records, specifications, standards, root cause analysis and inspection procedure documents. Manages interface with customers in resolution of quality issues in a timely manner and participates in all client audits. Develops new inspection procedures and assures implementation and consistency. RESPONSIBILITIES: Responsible for development, maintenance and implementation of Quality Management system Evaluate and develop internal specifications from customer specs and requirements Assure consistency and control of manufacturing processes Identify and interpret poor quality trends and develop methods geared toward continuous improvement and Food Safety Lead efforts in root cause analysis, corrective action of customer and quality complaints Oversee incoming inspection on all received raw material resins, colorant, poly bags, liners, and all outside service assembly jobs Ensure compliance to GMP and other pharmaceutical and food industry regulations in manufacturing area Perform audits on production equipment to ensure part quality criteria is met Manage all evaluations for sales, technical, manufacturing, process engineering, and customer complaints to include new colorant, additives and material evaluations, cycle improvements, prototype sample parts and new production tools Manage, host, and coordinate all customer audits REQUIREMENTS Four-year college degree 5+ years of management experience in quality assurance functions within manufacturing environment Plastics/ closures industry preferred Certified CQE/CQA desirable Knowledge of SPC; ISO desirable Quality system regulation, cGMP or ISO9000 knowledge Abides by MRP Solutions' values and beliefs: Integrity - We have the courage to act with the highest level of integrity, even when no one is watching. We do what is right 100% of the time. Value Creation - The sole reason a company exists is to create real long-term value for society. This starts with ensuring human safety, as value cannot be created without first protecting human life. We seek opportunities for mutual benefit with all our stakeholders, including customers, employees, shareholders, suppliers, and the communities in which we operate. In everything we do, our overarching goal is to deliver superior results. Accountability - We are accountable to each other and to our stakeholders. We say what we do and do what we say. We embrace a culture of ownership, empowering and equipping employees with the ability to own their outcomes. Entrepreneurial - Everyone thinks and acts like owners, employing good economic and critical thinking skills while adopting the risk profile of our shareholders. We are inquisitive, constantly seeking out opportunities to improve, actively searching for and innovating across every aspect of our business. We relentlessly strive to understand and profitably anticipate what our customers need and value, because if our customers do not grow, we do not grow. Respectful and Friendly - Everyone deserves to be treated with respect and dignity. Because everyone's perspective has value, we embrace diversity of thought, background and experiences. We are friendly and lead with a smile. What we do is important, but how we do it is what makes it impactful. Change - We actively seek out and embrace change wherever profitable. Because society is constantly identifying and employing new and better ways of accomplishing tasks, we must constantly innovate, reinvent and, ultimately, destroy the old ways of doing business. We actively engage in rigorous debate and embrace challenges to ensure we stay relevant and deliver superior results. Physical Requirements: While performing the duties, the employee will be working in an office environment as well as on the manufacturing plant floor. The employee is required to sit and/or stand for computer or floor responsibilities, reach with hands and arms and handle objects and other tools, stoop, squat, twist, push and pull, maintain balance, bend at the waist, kneel, walk varying distances, and climb stairs. Employees may be required to lift up to 20 pounds. About Us: MRP Solutions is a leading provider of high-quality, injection molded closures, jars and recyclable packaging components used every day by millions of consumers around the globe. But we offer more than just plastic caps and lids - we deliver fast, flexible and reliable packaging solutions. MRP Solutions combines extensive packaging expertise with a consultative approach to reliably uncover customer needs. By understanding your business goals, we can tailor smarter, safer, and more flexible packaging solutions that reduce costs and increase speed to market, helping your businesses capitalize on opportunity. MRP Solutions combines extensive packaging expertise with a consultative approach to reliably uncover customer needs. By understanding your business goals, we can tailor smarter, safer, and more flexible packaging solutions that reduce costs and increase speed to market, helping your businesses capitalize on opportunity. Our vision: We deliver industry-leading packaging solutions tailored to each customer's unique requirements, providing best-in-class product protection while ensuring consumer confidence. We are passionate about partnering with distributors and manufacturers who understand that plastic caps and lids are a small but important part of how people experience their brands. Together, we deliver packaging with purpose. By constantly innovating, MRP enables our customers to grow, making us a preferred partner. MRP Solutions is an equal opportunity and affirmative action employer. We do not discriminate in recruiting, hiring or promotion based on race, color, religion, sex (including sexual orientation, gender identity or expression, transgender status), national origin, age, disability, medical condition, marital or protected veteran status or any other basis or characteristic prohibited by applicable federal, state, or local law. Consistent with the obligations of state and federal law, MRP Solutions will make reasonable accommodation for qualified individuals with disabilities. Any employee who needs reasonable accommodation should contact Human Resources.

Adecco Permanent Recruitment is partnering with a leading manufacturer of engineered industrial products to help them hire a Quality Control Manager for their Williston, VT facility. This is a key leadership role within a precision manufacturing environment, responsible for overseeing plant-level quality systems, supervising QC personnel, and ensuring products meet industry, customer, and regulatory standards. The position offers the opportunity to drive quality improvements across production operations, support compliance initiatives, and play a critical role in the reliability and performance of highly engineered components used in demanding applications. **Key Responsibilities** + Ensure plant compliance with internal quality procedures, certification requirements, and applicable industry codes (ISO, ASME, ASTM) + Oversee incoming, in-process, and final inspection activities to confirm materials and finished goods meet quality standards + Lead internal and external audit preparation, participation, and corrective action deployment + Manage non-conformance investigations, Return Goods Authorizations (RGAs), and disposition processes + Develop, maintain, and analyze quality metrics and KPIs, including rework, scrap, and Cost of Non-Quality (CONQ) + Supervise and provide guidance to QC inspectors, including performance reviews, training, and technical support + Lead rapid-response (ANDON) efforts to resolve quality issues impacting production flow + Conduct or oversee root-cause analysis and corrective and preventive action implementation + Collaborate cross-functionally with production leadership, engineering, and customer representatives to support on-time delivery and customer satisfaction + Participate in customer witness activities such as testing, NDT, coating inspections, and final product checks **Qualifications and Must-Haves** + Background in manufacturing quality control within industries such as machining, metals, aerospace, industrial equipment, automotive, or similar environments + Experience with quality systems, audits, NCRs, and corrective action processes + Working knowledge of ISO9001 or ASME/ASTM standards (full expertise not required) + Proven ability to lead or supervise QC or inspection personnel + Strong analytical, problem-solving, and communication skills + Ability to interpret technical specifications and support production troubleshooting + U.S. citizenship required for regulatory compliance **Preferred but Not Required** + Experience with pressure-containing products, valves, or complex engineered components + Continuous improvement training such as Green Belt or similar + Experience supporting customer inspectors or regulatory audits **Pay Details:** $90,000.00 to $120,000.00 per year Equal Opportunity Employer/Veterans/Disabled Military connected talent encouraged to apply To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to ********************************************** The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: + The California Fair Chance Act + Los Angeles City Fair Chance Ordinance + Los Angeles County Fair Chance Ordinance for Employers + San Francisco Fair Chance Ordinance **Massachusetts Candidates Only:** It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

**Job** **Title:** SAP Test Lead **Type:** Independent Contract - Corp to Corp/1099 **Contract Length:** 6 months - Potentially Renewable The SAP Test Lead role offers a unique opportunity to drive critical testing initiatives within SAP implementation and enhancement projects. As an independent contractor, the Test Lead will be responsible for ensuring the quality, reliability, and performance of SAP applications by defining and executing robust testing strategies. This role requires a combination of technical expertise in SAP, strong leadership capabilities, and experience in various testing methodologies and frameworks. The SAP Test Lead will collaborate with cross-functional teams, including business stakeholders, developers, and project managers, to deliver high-quality SAP solutions while mitigating risks and ensuring seamless integration with business processes. This position is well-suited for seasoned professionals who thrive in dynamic project-based environments and can deliver exceptional results with minimal supervision. **Responsibilities** **Key Responsibilities:** + Test Planning & Strategy: Define the overall test scope, objectives, and approach for project/engagement. Develop detailed test plans, schedules, and deliverables for all testing phases (e.g., SIT, UAT, performance, regression). + Environment & Data Management: Ensure the readiness of test environments and manage test data for various testing phases. + Team Leadership & Management: Lead, mentor, and motivate the testing team, assigning tasks, monitoring progress, and providing regular feedback and guidance. + Test Case Development & Execution: Oversee the design and development of comprehensive test scenarios and test cases that cover all functional and non-functional requirements. Ensure test execution follows the established plan. + Defect Management: Track, document, and manage defects using a bug tracking system. Liaise with developers and other stakeholders to ensure timely resolution and retesting of issues. + Reporting & Communication: Prepare and present regular status reports, quality metrics, and test results to project managers, senior management, and clients. Facilitate communication between testing, development, and business teams. + Risk Management: Identify potential project risks, develop mitigation strategies, and prioritize testing activities based on risk and business impact. **Qualifications** **Required Skills & Qualifications:** + **Experience** : + Experience in at least one full lifecycle SAP implementation project (e.g., S/4HANA, ECC). + Experience working in Agile, Waterfall, and hybrid methodologies. + **Technical Knowledge** : + Understanding of core SAP modules and end-to-end business processes. Understanding of SAP EAM module will be a plus. + Proficiency with test management and defect tracking tools (e.g., Microsoft Azure, JIRA, HP ALM, SAP Solution Manager). + Hands-on experience with performance testing frameworks/tools. + **Soft Skills** : + Excellent leadership, communication, and stakeholder management skills. + Strong analytical, problem-solving, and decision-making abilities. + Strong organizational and project management skills. **Other Duties:** _Please note this job description is not designed to cover or contain a comprehensive list 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._ _Cayuse is an Equal Opportunity Employer. All employment decisions are based on merit, qualifications, skills, and abilities. All qualified applicants will receive consideration for employment in accordance with any applicable federal, state, or local l_ _aw._ **Pay Range** USD $55.00 - USD $65.00 /Hr. Submit a Referral (************************************************************************************************************************** **Can't find the right opportunity?** Join our Talent Community (********************************************************** or Language Services Talent Community (******************************************************** and be among the first to discover exciting new possibilities! **Location** _US-_ **ID** _2025-3043_ **Category** _Information Technology_ **Position Type** _Independent Contractor_ **Remote** _Yes_ **Clearance Required** _None_

Meta is seeking an experienced Building Management System (BMS) Quality Manager to join our Data Center Engineering & Construction (DEC) Quality team. Our team's mission is to optimize the delivery of our Building Management Systems to ensure it is completed on time, is safe, robust, reliable, and conforms to our design and quality requirements. Role will be supporting internal cross-functional teams, lead installation and commissioning efforts, oversee quality, and quickly adapt in an evolving space.Our data centers are the foundation upon which our rapidly growing infrastructure efficiently operates, and our innovative services are delivered. Building and operating data centers the "right" way is synonymous with ensuring high uptime, capacity availability and capital conservation. The data center engineering team thinks from chip to chiller (or electrical substation), determining configurations and ensuring maximum efficiency of our compute infrastructure. **Required Skills:** BMS Quality Manager (BQM) - Data Center Design, Engineering and Construction Responsibilities: 1. Manage, onboard, and lead the General Contractor BMS Lead(s), the Control Systems Integrator (CSI) and Electrical and Installation (E&I) controls contractor s throughout all phases of the project, while developing efficiency improvements and incorporating lessons learned to ensure a safe, robust, reliable and functional controls system that adheres to Meta's design and quality requirements 2. Establish a clear vision and foster cross-functional collaboration, coordination, and support among on-site project teams, including the Meta BMS team, general contractors, Control System Integrators, and installation contractors 3. Drive consistency and standardization across all buildings and Control System Integrators and installation contractors 4. Review, understand and ensure project level adherence to the issued revision of the BMS PLC Playbook 5. Perform BMS inspections (wiring, installation, and commissioning) and validate the status/progress of the projects including supporting the project teams, both internal and external, starting from the early stages of Mechanical, Electrical and Plumbing (MEP) construction by working with project level Construction Managers (both internal and external) to check the health of the project (including schedule), working with the project teams and supporting Regional Quality Managers (RQMs). Align internally on program/project related communications to ensure a clear, consistent message to trade partners 6. Assess team performance, build relationships and to support the project benchmark and mock-up process of the BMS installations to assure consistency across the project while coordinating these efforts across multiple cross-functional partners, in a timely manner, to minimize re-work 7. Work with Construction Managers, Regional Quality Managers and General Contractors to ensure creation, accuracy and maintenance of logical schedule(s) for construction, commissioning, and packaged equipment BMS activities while leveraging this data to identify early finish dates for detailed design delivery 8. Coordinate and manage both packaged equipment factory installed controls audits and BMS commissioning audits to ensure specification/requirement adherence and track identified deficiencies through completion 9. Coordinate and lead large multi-stakeholder meetings on a regular basis and communicate discussions to all key stakeholders 10. Support custom tooling and their integration into the construction processes as well as supporting other cross-functional program/project initiatives that directly impact the delivery of the BMS while simultaneously working to identify and mitigate risk associated with these efforts 11. Travel domestically as needed (anticipated 40-50% travel) **Minimum Qualifications:** Minimum Qualifications: 12. Bachelor's degree (Engineering, Construction Management, or equivalent degree) or relevant work experience 13. 10+ years of experience with a combination of Instrumentation and Controls programming/installation, general contractor MEP coordination/project management, commissioning (both mechanical and electrical) of data centers, or other large scale mission critical buildings 14. Experience with Industrial Automation and Building Management Control Systems (i.e. PLC/DDC) 15. 3+ years of experience with programming/designing of HVAC control systems & Electrical Power Monitoring **Preferred Qualifications:** Preferred Qualifications: 16. Experience with PLC, SCADA and OPC UA systems 17. Experience with Schneider Electric Unity Pro, AVEVA, and Ignition platforms 18. Experience with Schneider Modicon and Rockwell Allen-Bradley PLC Platforms 19. Experience with Autodesk ACC Build and Procore Platforms 20. Certified in the following: cGMP, CAP (Certified Automation Professional), and/or PMP (Project Management Professional) **Public Compensation:** $150,000/year to $209,000/year + bonus + equity + benefits **Industry:** Internet **Equal Opportunity:** Meta is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. Meta participates in the E-Verify program in certain locations, as required by law. Please note that Meta may leverage artificial intelligence and machine learning technologies in connection with applications for employment. Meta is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know at accommodations-ext@fb.com.

Quality Systems Specialist We are seeking a detail-oriented and experienced Quality Systems Specialist to lead the development, implementation, and maintenance of an AS9100-compliant Quality Management System (QMS). This role will play a critical part in ensuring our organization's processes meet the stringent requirements of the aerospace and defense industry. The ideal candidate will have a strong understanding of quality standards (AS9100, ISO 9001), process mapping, document control, and internal auditing. Essential Duties and responsibilities: Develop, implement, and maintain the QMS in accordance with statutory and regulatory requirements Take ownership of quality policies, procedures, and documentation to ensure they are current, accurate, and effectively implemented Conduct gap assessments against AS9100D standards and develop corrective action plans Lead cross-functional problem-solving sessions to address significant QMS issues using structured methodologies like root cause analysis, and prepare for external regulatory audits by ensuring readiness and collaboration with key stakeholders Conduct regular audits and assessments to verify compliance with QMS requirements Provide training to employees on quality system procedures and AS9100 requirements Monitor key performance indicators (KPIs) to ensure continuous improvement and compliance Prepare for and support third-party AS9100 certification audits and surveillance audits. Minimum Qualifications: (your Knowledge, Experience, and Abilities): Bachelor's degree in Engineering, Quality Management, Industrial Engineering, or related field 3-5 years of experience in quality systems or compliance roles in an aerospace or defense mfg environment Experience developing and implementing QMS from the ground up or significantly revising existing systems Strong understanding of document control, process auditing, and root cause analysis (e.g., 8D, 5 Whys, Fishbone) Excellent communication, organizational, and project management skills Above and Beyond Qualifications that will distinguish you: (preferred qualifications): Passionate about electrifying aviation AS9100 Lead Auditor certification, Lean Six Sigma Certification, ASQ Certified Quality Engineer Working knowledge of FAA regulatory standards, specifically 14 CFR Part 21

Mylan Technologies, Inc. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of geography or circumstance; Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and Partnership - Leveraging our collective expertise to connect people to products and services. Every day, we rise to the challenge to make a difference and here's how the Lead Specialist QA Investigations role will make an impact: Key responsibilities for this role include: Lead critical / complex investigations of incidents, issues, and trends. Leads / facilitates cross functional structured problem solving in support of investigations. Propose associated CAPA actions and prepare associated investigation reports. Lead / participate in the triage of deviations, assuring appropriate initial evaluation of extent/scope and containment actions occur to minimize risk and potential product/quality impact. Provides mentorship and supports training/development of QA Specialist Investigators. Compile and analyze investigation information required for Annual Product Reviews, Management Review, Site Metrics, and other business needs, and prepare associated reports and/or presentation slides. Present to local and vertical leadership as required. Prepare and/or approve associated reports. Performs review/close out and effectiveness checks of completed CAPA, in accordance with the approved CAPA. Leads periodic and special cause trending assessments to determine corrective actions to address trends. Prepare periodic reports as assigned. Leads continuous improvement project teams, as well as owns and executes department CAPA as assigned. Develops strategies and tactics for accomplishing objectives, manages tasks execution through completion. Authors new or revised site procedures as assigned. Prepares and provides training related to investigations, site procedures and cGMP as assigned Approves laboratory investigations, incidents, and investigations as authorized. The minimum qualifications for this role are: Minimum of a Bachelor's degree (or equivalent) and 4-7 years of experience. However, a combination of experience and/or education will be taken into consideration. Must possess a working knowledge of cGMP, Quality Systems, and root cause analysis techniques. Must understand the cGMP standards for the investigation of non-conformances and the contents of investigation reports. Ability to add, subtract, multiply and divide. Statistical Analysis, Advanced Mathematical calculations. Must possess strong communication skills (written and verbal). Must have experience in technical writing. Exact compensation may vary based on skills, experience, and location. The salary range for this position is: $66,000 - $127,000. At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

Mylan Technologies, Inc. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: * Access - Providing high quality trusted medicines regardless of geography or circumstance; * Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and * Partnership - Leveraging our collective expertise to connect people to products and services. Every day, we rise to the challenge to make a difference and here's how the Lead Specialist QA Investigations role will make an impact: Key responsibilities for this role include: * Lead critical / complex investigations of incidents, issues, and trends. Leads / facilitates cross functional structured problem solving in support of investigations. Propose associated CAPA actions and prepare associated investigation reports. * Lead / participate in the triage of deviations, assuring appropriate initial evaluation of extent/scope and containment actions occur to minimize risk and potential product/quality impact. * Provides mentorship and supports training/development of QA Specialist Investigators. * Compile and analyze investigation information required for Annual Product Reviews, Management Review, Site Metrics, and other business needs, and prepare associated reports and/or presentation slides. Present to local and vertical leadership as required. Prepare and/or approve associated reports. * Performs review/close out and effectiveness checks of completed CAPA, in accordance with the approved CAPA. * Leads periodic and special cause trending assessments to determine corrective actions to address trends. Prepare periodic reports as assigned. * Leads continuous improvement project teams, as well as owns and executes department CAPA as assigned. Develops strategies and tactics for accomplishing objectives, manages tasks execution through completion. * Authors new or revised site procedures as assigned. Prepares and provides training related to investigations, site procedures and cGMP as assigned * Approves laboratory investigations, incidents, and investigations as authorized. The minimum qualifications for this role are: * Minimum of a Bachelor's degree (or equivalent) and 4-7 years of experience. However, a combination of experience and/or education will be taken into consideration. * Must possess a working knowledge of cGMP, Quality Systems, and root cause analysis techniques. Must understand the cGMP standards for the investigation of non-conformances and the contents of investigation reports. * Ability to add, subtract, multiply and divide. Statistical Analysis, Advanced Mathematical calculations. * Must possess strong communication skills (written and verbal). Must have experience in technical writing. Exact compensation may vary based on skills, experience, and location. The salary range for this position is: $66,000 - $127,000. At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Specialist QA II Manufacturing Oversight in Boca Raton, FL! Job Title: Specialist QA II Manufacturing Oversight : Position Summary The QA Specialist II - Manufacturing Oversight will perform manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include, but are not limited to, real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor. Essential Functions (ES) and Responsibilities * Possess and understanding of processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}). * Perform Quality Assurance review and approval of Deviation Reports. * Possess an understanding cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600. * Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies. * Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers) and their associated activities, as required. * Review and release of Plasma pools to manufacturing. * Review all manufacturing support documentation (logbooks, log sheets, charts, etc.) * Review and release of raw materials in LIMS/SAP. * Perform audits of Nitrogen receipt process. * Perform notification and disposition of associated Lookback units. * Assist with quarantining and release of critical systems, equipment, and controlled environments.\ * Write, review, and revise QA SOPs. * Review SOPs and documents from other departments and provide feedback as necessary. * Work with other departments to assess if Deviations, CAPAs, and Change Controls are required. * Assist with training of new employees. * Coordinate and perform any additional activities or projects assigned by QA Management. * Experience with LIMS and SAP preferred. Job Responsibilities or Job Requirements Competencies Exceptional organizational and communication skills required Must have excellent writing and oral skills Experience Requirements EDUCATION REQUIREMENTS: * Bachelor's Degree preferred but can be offset by experience. EXPERIENCE REQUIREMENTS: * 3-5 years' experience in pharmaceutical or biotechnology industry or other related industry. Preferred Experience Compliance Requirements (ES) As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including: * 401K plan with employer match and immediate vesting * Medical, Vision, Life and Dental Insurance * Pet Insurance * Company paid STD and LTD * Company Paid Holidays * 3 Weeks' Paid Time Off (within the first year) * Tuition Assistance (after the first year) * Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail station * ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. * To learn more about E-Verify, including your rights and responsibilities, please visit ********************* * ADMA Biologics is an Equal Opportunity Employer. Apply now

Gifford is seeking a results-driven individual to join our team in Quality as a Quality Improvement and Infection Prevention Consultant. The Quality Improvement and Infection Prevention Consultant plays a key role in partnering with leadership to identify, develop, implement, and monitor clinical and operational system improvement initiatives aimed at delivering high-quality care, promoting patient safety, and fostering employee engagement. This position is responsible for the identification, investigation, reporting, prevention, and control of infections, while providing staff education on process improvement methodologies and techniques to ensure the safety of patients and staff and minimize the risk of infection transmission. Acting as a change agent, the QI # IP Consultant utilizes quality management skills to enhance system performance and achieve measurable outcomes. The role involves assisting leadership in identifying high-risk or problem-prone areas, recommending departmental and system-wide objectives, and developing action plans. The consultant collaborates with teams, interprets accreditation and regulatory standards, develops operational indicators, and coordinates improvement strategies to maintain compliance. Additional responsibilities include policy maintenance, providing guidance on patient safety and adverse event reporting, developing and maintaining the organizational Infection Prevention and Control Plan according to CDC and APIC guidelines, conducting surveillance of healthcare-associated infections, reporting to health agencies, consulting with providers and staff on infection prevention and management, collaborating with Employee Health regarding infection risk, and pursuing continuing education to stay current with regulations, best practices, and emerging products. Strong interpersonal and communication skills are essential to successfully perform in this role. Requirements: Bachelor#s degree in Nursing or related Science required; Master#s degree preferred Current Vermont RN license or Medical Laboratory Scientist (MLS) certification required 3#5 years of clinical experience in an acute care setting Previous infection prevention/control experience preferred; Certified Infection Control (CIC) preferred, with CIC expected within three years of hire Experience with performance improvement methods and tools, group facilitation, and project management; CPHQ certification desired (or equivalent) Proficiency in Microsoft Office (Word, Outlook, Excel, PowerPoint) Gifford Health Care offers competitive compensation and a comprehensive benefits package. Our Total Rewards package includes, but is not limited to: Competitive wages Onsite parking 403b retirement plan Health plans including dental and vision insurance Tax-saving flexible spending accounts Health Savings Plan with employer contribution Long and short-term disability insurance Tuition Reimbursement Employee Assistance Program Life Insurance Regular performance reviews Learning opportunities EOE Gifford is seeking a results-driven individual to join our team in Quality as a Quality Improvement and Infection Prevention Consultant. The Quality Improvement and Infection Prevention Consultant plays a key role in partnering with leadership to identify, develop, implement, and monitor clinical and operational system improvement initiatives aimed at delivering high-quality care, promoting patient safety, and fostering employee engagement. This position is responsible for the identification, investigation, reporting, prevention, and control of infections, while providing staff education on process improvement methodologies and techniques to ensure the safety of patients and staff and minimize the risk of infection transmission. Acting as a change agent, the QI & IP Consultant utilizes quality management skills to enhance system performance and achieve measurable outcomes. The role involves assisting leadership in identifying high-risk or problem-prone areas, recommending departmental and system-wide objectives, and developing action plans. The consultant collaborates with teams, interprets accreditation and regulatory standards, develops operational indicators, and coordinates improvement strategies to maintain compliance. Additional responsibilities include policy maintenance, providing guidance on patient safety and adverse event reporting, developing and maintaining the organizational Infection Prevention and Control Plan according to CDC and APIC guidelines, conducting surveillance of healthcare-associated infections, reporting to health agencies, consulting with providers and staff on infection prevention and management, collaborating with Employee Health regarding infection risk, and pursuing continuing education to stay current with regulations, best practices, and emerging products. Strong interpersonal and communication skills are essential to successfully perform in this role. Requirements: * Bachelor's degree in Nursing or related Science required; Master's degree preferred * Current Vermont RN license or Medical Laboratory Scientist (MLS) certification required * 3-5 years of clinical experience in an acute care setting * Previous infection prevention/control experience preferred; Certified Infection Control (CIC) preferred, with CIC expected within three years of hire * Experience with performance improvement methods and tools, group facilitation, and project management; CPHQ certification desired (or equivalent) * Proficiency in Microsoft Office (Word, Outlook, Excel, PowerPoint) Gifford Health Care offers competitive compensation and a comprehensive benefits package. Our Total Rewards package includes, but is not limited to: * Competitive wages * Onsite parking * 403b retirement plan * Health plans including dental and vision insurance * Tax-saving flexible spending accounts * Health Savings Plan with employer contribution * Long and short-term disability insurance * Tuition Reimbursement * Employee Assistance Program * Life Insurance * Regular performance reviews * Learning opportunities EOE

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.Bionique Testing Laboratories LLC (Bionique) has been a leading global provider of mycoplasma testing services for the biopharmaceutical industry for over 35 years. Bionique offers the full breadth of services from lot and Final Drug Product release testing per regulatory guidelines to a GMP compliant Real-Time PCR assay to support clients' needs from concept to clinical trials and commercialization for biopharmaceutical and cell therapy products. Bionique's experience and expertise extends to development and validation of rapid microbiological methods to support abbreviated release timelines. Additional services such as regulatory and compliance consultancy add to Bionique's unique position in this niche analytical testing space. Located in Saranac Lake, NY, Bionique is an FDA registered and GMP compliant contract testing facility. Bionique aims to offer unsurpassed quality mycoplasma testing services to meet the specific scientific and regulatory needs of each client and partner. Company: Bionique Testing Laboratories LLC Job Description: Summary: We are seeking a highly motivated and detail-oriented Quality Specialist to join our cGMP-compliant testing facility. This role is critical in ensuring the integrity of our sterility and endotoxin testing services, supporting regulatory compliance, and facilitating the adoption of new testing methodologies. The ideal candidate will have a strong background in microbiological quality control, regulatory affairs, and continuous improvement within a pharmaceutical or biopharmaceutical environment. Key Accountabilities and Responsibilities: Documentation Review and Approval: Review and approve Quality Control (QC) documentation, including test data, logbooks, equipment qualification records, and test reports for our routine and new testing services that include mycoplasma, sterility, and endotoxin testing. Batch Record Review and Product Release: Perform timely review of batch production records and associated quality event documents to support the release of finished sterile products. Auditing and Compliance: Responsible for ensuring protocols & reports, validation qualification studies, process changes, and new services and products validation meet industry standards and regulatory requirements Participate in and/or support internal, external, and regulatory audits (e.g., FDA, EP, JP) as a subject matter expert for microbiology and sterility assurance ensuring testing activities comply with CGMP, USP, EP, and other applicable regulatory standards. Deviation and CAPA Management: Collaborate with investigation teams to manage quality events, deviations, Out-of-Specification (OOS) results, and complaints related to sterility assurance. Lead or support root cause analysis investigations, risk assessments, and the development/approval of Corrective and Preventive Actions (CAPAs). SOP Development and Revision: Develop, maintain, revise, and approve Standard Operating Procedures (SOPs), appendices, technical documents, and other controlled documents impacting sterility assurance, laboratory practices, and the overall Quality Management System. Environmental Monitoring (EM) Oversight: Analyze data from environmental and utility monitoring programs to identify trends, establish alert/action levels, and ensure the contamination control strategy (CCS) is effectively implemented and compliant with guidance documents. Validation Support: Review and approve validation protocols and reports for sterilization processes, test methods, and equipment. Interdepartmental Support: Provide Quality support for sterility and endotoxin testing, including method validation, routine testing, and troubleshooting. Collaborate with laboratory teams to ensure accurate and timely execution of testing procedures. Assist in the evaluation and implementation of new testing services and technologies. Training and Mentorship: provide training and guidance to staff on Quality standards, aseptic techniques, and regulatory requirements Maintain professional and technical knowledge of regulatory requirements and industry best practices related to endotoxin, sterility, and other new microbiological testing. Continuous Process Improvement: Identify and implement process improvements to enhance quality and efficiency. Report Generation: generates reports and presents/analyzes metrics related to assigned projects as needed Supports commissioning and equipment validation/qualification Supports Quality and operational metrics review such as track and trending analysis Reviews testing records as needed May represent Bionique's Quality Department at various internal and external meetings Communicates effectively with internal personnel as well as external customers Investigate and troubleshoot problems, determining solutions or recommendations for changes and/or improvements. Perform additional duties as assigned Additional Accountabilities and Responsibilities Works independently and proactively Proactively communicates progress and furthers understanding amongst colleagues and supervisors Highly organized and delivers on commitments without reminders Driven to continuously improve individual work and departmental processes Handles recurring issues with comfort and escalates new ones appropriately Ability to independently assess impact and retesting requirements in the event of a deviation Possesses working knowledge of regulatory environment and industry standards Accurately performs quality reviews of items as requested May serve as a delegated backup for senior staff when requested Strong critical thinking and problem-solving skills required Requirements: Bachelor's degree from an accredited college/university in microbiology, biology, biotechnology, chemistry, or related scientific field; experience or combination of experience with degree may be substituted for Bachelor's degree requirement 3 years' experience in a cGMP-regulated environment, preferably in a microbiological testing or quality role Regulatory knowledge for sterility and endotoxin testing required (e.g. LAL assays, membrane filtration) Experience supporting method development or validation for new testing services is strongly preferred Familiarity with aseptic processing and cleanroom environments is preferred Strong understanding and knowledge of USP , USP , USP , USP , and other regulatory guidelines (FDA, EMA, ICH) Ability to handle multiple tasks and projects under deadline pressure Able to adapt quickly to change Ability to work cross-functionally in a fast-paced, regulated setting Highly analytical with strong attention to detail Excellent documentation, organizational, verbal and written communication skills A results-oriented team player Proficient with Microsoft Office Suite and Quality systems (e.g. LIMS, QMS) Physical Requirements: Prolonged periods of sitting on a chair, working at a desk, and working on a computer and/or telephone must be able to lift up to 50 pounds Pay Rate: The base compensation range for this role is between $60,000/yr - $70,000/yr. The actual compensation is commensurate with experience. #LI-MG1 As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.

If you're looking for a special place to build or grow your career, you've found it. Whether you're an experienced professional, a recent college graduate or somewhere in between, IDEX is a place where you can apply your existing skills and learn new ones in an environment where you can make an impact. With interesting opportunities in engineering, marketing, sales, supply chain, operations, HR, finance, and more across more than 40 diverse businesses around the globe, chances are, we have something special for you. About the Company: STC Material Solutions (STC) is an innovative Vermont-based manufacturer of high precision, high performance ceramic components for use in medical, aerospace and defense applications, as well as in many semiconductor and industrial manufacturing processes. Our components are even in Mars Rover! The company is now part of IDEX Corporation, a US-based Fortune 500 company focused on technological innovation and niche manufacturing. This business combination allows us to offer you the best of two worlds. At STC you'll enjoy the collaborative and friendly culture that seems to be the hallmark of the very best Vermont-based businesses. At the same time, you will be challenged to learn and grow on our team as you help us on our journey to build world-class analytical and reporting practices that suit the IDEX environment. IDEX is committed to professional development at every level. If you are top performer interested in developing your career beyond Vermont and within an American corporation with locations around the US and the world, you will have opportunities for advancement here and elsewhere in the organization. Job Summary: The Senior Quality Engineer will be responsible for activities that drive Quality Improvement and compliance to all defined requirements, including STC's AS9100 based Quality Management System. The Senior Quality Engineer will work to support STC's Quality principles: Right the First Time in everything we do and produce Agree what can be delivered in what timeframe and develop a plan on how delivery can be met Work co-operatively with all departments and suppliers to exceed customer expectations Always develop and execute a quality plan Understand customers' business objectives as well as their technical requirements Ensure sufficient staff training and help to manage the impact of change Essential Functions: General: Develop and implement quality engineering tools including SPC, AQL, and CPk to improve process reliability throughout STC facilities. Promote continuous improvement activities to increase productivity, eliminate scrap, and reduce rework operations. Lead the use of quality and statistical process control programs, including tools such as Process Mapping, FMEA, Gage R&R, Hypothesis Testing, Regression Analysis, Capability Analysis, Control Plans, SPC, and Lean practices. Work hands-on with inspection personnel, shop floor personnel, Materials Engineering, and Manufacturing Engineering to sustain and improve product and shop floor processes. Provide additional information and/or support to Manufacturing Engineering to facilitate the completion of MRB activities for non-conforming materials, products and services submitted, when applicable. Evaluate and disposition materials, products and services, found non-conforming at Inspection within authorized limits, to arrive at the most economical disposition, while meeting all quality requirements. Lead and mentor STC personnel in performing good quality manufacturing practices. Assist with continuous improvement of the Quality Management System (QMS) including, but not limited to: QMS documented information; quality audits, internal; quality audits, external. Work hands-on with office and professional staff to sustain and improve quality of contractual and office processes. Ability to perform contract review to identify quality requirements. Develop and maintain customer and external provider Advanced Product Quality Planning (APQP) documents, i.e.PPAP's,. Establish and maintain effective professional relationships with customers, external providers, source inspectors, and outside auditors. Lead closure of action items for areas of concern. Other related duties as assigned or required. STC Facilities Measuring Equipment and Non-Destructive Product Process Ownership Ensures measurement and non-destructive processes, equipment, tooling, fixtures, tools, et al used in inspection and production have adequate documentation including, but not limited to, inspection/test plans, functional specifications, and system documentation. Assures planning and scheduling of internal and external calibrations are in place and successfully executed to ensure compliance with documented procedures and regulatory requirements. Return Material Authorization (RMA); Corrective Actions & Preventive Actions (CAPA) Process Ownership Develop, measure, and continuously improve the RMA & CAPA processes. Responsible for activities including, but not limited to: Customer RMA - authorize issue of RMA number; maintain documentation; review of non-conforming material and/or containment activities (i.e. WIP, finished goods, and/or returned products), as applicable; disposition of RMA's within authorized limits. CAPA - initiate, lead, and track progress of customer, external provider, and internal CAPA's, as applicable; as required, mentor or assist individuals or teams to facilitate completion of CAPA activities. Works with cross-functional peers to facilitate documentation and findings are reported to stakeholders, as applicable. Knowledge & Experience: BS in Engineering or equivalent job experience, with 5 years minimum experience in a manufacturing environment; preferred Ability to read & interpret engineering drawings, including GDT, standards and specifications. Ability to work independently. Ability to solve problems and assume a leadership role with cross-functional peers. Exceptional interpersonal skills and ability to build strong relationships. Strong leadership, project management, and time management skills. Excellent written, verbal, and non-verbal communication skills. Solid business acumen, management reporting, and decision making. Detail oriented, organized, a highly motivated leader of people, and champion of improvements. Demonstrated proficiency in all aspects of Microsoft Office Expected travel is 10% yearly. Strongly Preferred AS9100 and/or ISO9001 Lead Auditor Certification demonstrating ability to support AS9100 and other regulatory compliance activities. Ability to complete customer PPAP requirements. Program CMM utilizing knowledge of 3D vector math, geometry, trigonometry, etc. Demonstrated experience in continuous improvement, Lean preferred. Total Rewards: The compensation range for this position is $86,000 - $129,000, depending on experience. This position may be eligible for performance-based bonus plan. Benefits Package: Our comprehensive U.S. benefit offerings include: Health benefits, 401(k) retirement savings program with company match, PTO, and more. More information on our benefits and rewards can be found on our career page: ********************************************************* Work Environment & Physical Demands: Work environments and physical demands vary by role and may include: Use of personal protective equipment (PPE) or safety gear, provided by STC. A combination of seated and standing work; walking for moderate to extended periods. Fine motor skills, hand-eye coordination, and visual focus for detailed tasks, including tool use, computer work, or microscope inspection. Exposure to repetitive motions; adaptive devices or reasonable accommodation may be provided as needed. Deadlines, shifting priorities, and peak workloads that may create a fast-paced environment. Manufacturing & Production Areas: Work performed on the shop floor, in climate-controlled spaces, or clean rooms. Some areas may be noisy, dusty, or warm. Mandatory use of job-specific PPE and machine guards. Occasional bending, squatting, reaching, and lifting up to 50 lbs.; some roles require pushing loaded carts. Maintenance & C1D2 Workspaces: Includes all manufacturing/production requirements, plus additional PPE such as ESD shoes, coveralls, gloves, and full-face respirators. Office & Sales Roles: Climate-controlled office setting with occasional visits to production areas. Occasional bending, squatting, reaching, and lifting up to 25 lbs. May require travel by air or car to attend conferences or visit customer sites. Remote/home office environments may vary. Superior Technical Ceramics Corporation is an equal opportunity employer and offers employment opportunity to all qualified persons without regard to race, creed, color, religious belief, sex, sexual orientation, gender identity, age, national origin, ancestry, place of birth, physical or mental disability, or veteran status. Are you ready to join a different kind of company where our people, our culture, and our commitments are centered around providing trusted solutions that improve lives around the world? Total Rewards The compensation range for this position is $86,000.00 - $129,000.00, depending on experience. This position may be eligible for performance based bonus plan. Benefits Package Our comprehensive U.S. benefit offerings include: Health benefits, 401(k) retirement savings program with company match, PTO, and more. More information on our benefits and rewards can be found on our career page: ********************************************************** IDEX is an Equal Opportunity Employer. IDEX gives consideration for employment to qualified applicants without regard to race, color, religion, creed, genetic information, sex, sexual orientation, gender identity or expression, marital status, age, national origin, disability, protected veteran status, or any other consideration or protected category made unlawful by federal, state or local laws. Attention Applicants: If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, please let us know. Likewise, if you are limited in the ability to access or use this online application process and need an alternative method for applying, we will determine an alternate way for you to apply. Please contact our Talent Acquisition Team at ********************** for assistance with an accommodation. These contact tools may be used only by individuals with a disability for accommodation requests. Do not inquire as to the status of an application.

Description & Requirements Maximus is looking to hire a Training and QA Lead. This position is remote but will occasionally require travel to the work site in Alexandria, Virginia. The role will require the candidate to possess an active Public Trust security clearance or the ability to successfully pass a Public Trust clearance process. Essential Duties and Responsibilities: - Support the design, development, and distribution of training programs and materials. - Develop and support the design, development, and distribution of training programs and materials. - Establish and communicate the training methodologies to participants. - Schedule training sessions and individual training programs, ensuring facilities set-up, audio-visual set up, and participant notification. - Support the change management process, including ensuring accuracy and timeliness of document review, approval, and storage. Job-Specific Essential Duties and Responsibilities: - Design, develop, and implement training curriculum - Develop qualitative and quantitative assessment tools to measure learner requirements and competencies - Review, evaluate, and modify existing and proposed curriculums and recommend changes to policies and procedures as applicable. - Maintain continuous monitoring of call and chat quality - Conduct regular calibrations with the team to ensure quality standards are understood - Conduct feedback sessions with Analysts based on monitoring results - Conduct regular calibrations with the team to ensure quality standards are understood - Support leadership with assigned duties and acts as the department's subject matter expert Job-Specific Minimum Requirements: - Due to contract requirements candidates must be U.S. citizens without dual citizenship with another country - Additionally, candidates must have an active Public Trust clearance or be able to successfully pass a Public Trust clearance process - Bachelor's degree in related field of study strongly preferred - 5 years in Learning and Development and quality role - Ability to create new curriculum and update existing curriculum - Must be able to provide feedback to a team and individual - Must know the ADDIE (or other applicable) learning and development lifecycle - Must be able to travel to work site in Alexandria, VA as required Minimum Requirements - High School diploma or equivalent with 2-3 years of experience. - Bachelor's degree preferred. - May have additional training or education in area of specialization. Preferred Skills and Qualifications: - Experience with DTMO TAC processes, policies and systems - Working knowledge of DTMO terminology - Experience with eLearning tools and Learning Management Systems (LMS) - Excellent written and oral communications and presentation skills. - Ability to work independently #techjobs #HotJobs1209LI #HotJobs1209FB #HotJobs1209X #HotJobs1209TH #TrendingJobs EEO Statement Maximus is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information and other legally protected characteristics. Pay Transparency For positions on this contract, Maximus will pay the prevailing wage rate for the location in which the employee is working, as determined by the Department of Labor. That wage rate will vary depending on locality. An applicant's salary history will not be used in determining compensation. Accommodations Maximus provides reasonable accommodations to individuals requiring assistance during any phase of the employment process due to a disability, medical condition, or physical or mental impairment. If you require assistance at any stage of the employment process-including accessing job postings, completing assessments, or participating in interviews,-please contact People Operations at **************************. Minimum Salary $ 25.00 Maximum Salary $ 48.86

Manages all quality department activities, including but not limited to all QA personnel, inspection records, specifications, standards, root cause analysis and inspection procedure documents. Manages interface with customers in resolution of quality issues in a timely manner and participates in all client audits. Develops new inspection procedures and assures implementation and consistency. RESPONSIBILITIES: Responsible for development, maintenance and implementation of Quality Management system Evaluate and develop internal specifications from customer specs and requirements Assure consistency and control of manufacturing processes Identify and interpret poor quality trends and develop methods geared toward continuous improvement and Food Safety Lead efforts in root cause analysis, corrective action of customer and quality complaints Oversee incoming inspection on all received raw material resins, colorant, poly bags, liners, and all outside service assembly jobs Ensure compliance to GMP and other pharmaceutical and food industry regulations in manufacturing area Perform audits on production equipment to ensure part quality criteria is met Manage all evaluations for sales, technical, manufacturing, process engineering, and customer complaints to include new colorant, additives and material evaluations, cycle improvements, prototype sample parts and new production tools Manage, host, and coordinate all customer audits REQUIREMENTS Four-year college degree 5+ years of management experience in quality assurance functions within manufacturing environment Plastics/ closures industry preferred Certified CQE/CQA desirable Knowledge of SPC; ISO desirable Quality system regulation, cGMP or ISO9000 knowledge Abides by MRP Solutions' values and beliefs: Integrity - We have the courage to act with the highest level of integrity, even when no one is watching. We do what is right 100% of the time. Value Creation - The sole reason a company exists is to create real long-term value for society. This starts with ensuring human safety, as value cannot be created without first protecting human life. We seek opportunities for mutual benefit with all our stakeholders, including customers, employees, shareholders, suppliers, and the communities in which we operate. In everything we do, our overarching goal is to deliver superior results. Accountability - We are accountable to each other and to our stakeholders. We say what we do and do what we say. We embrace a culture of ownership, empowering and equipping employees with the ability to own their outcomes. Entrepreneurial - Everyone thinks and acts like owners, employing good economic and critical thinking skills while adopting the risk profile of our shareholders. We are inquisitive, constantly seeking out opportunities to improve, actively searching for and innovating across every aspect of our business. We relentlessly strive to understand and profitably anticipate what our customers need and value, because if our customers do not grow, we do not grow. Respectful and Friendly - Everyone deserves to be treated with respect and dignity. Because everyone's perspective has value, we embrace diversity of thought, background and experiences. We are friendly and lead with a smile. What we do is important, but how we do it is what makes it impactful. Change - We actively seek out and embrace change wherever profitable. Because society is constantly identifying and employing new and better ways of accomplishing tasks, we must constantly innovate, reinvent and, ultimately, destroy the old ways of doing business. We actively engage in rigorous debate and embrace challenges to ensure we stay relevant and deliver superior results. Physical Requirements: While performing the duties, the employee will be working in an office environment as well as on the manufacturing plant floor. The employee is required to sit and/or stand for computer or floor responsibilities, reach with hands and arms and handle objects and other tools, stoop, squat, twist, push and pull, maintain balance, bend at the waist, kneel, walk varying distances, and climb stairs. Employees may be required to lift up to 20 pounds. About Us: MRP Solutions is a leading provider of high-quality, injection molded closures, jars and recyclable packaging components used every day by millions of consumers around the globe. But we offer more than just plastic caps and lids - we deliver fast, flexible and reliable packaging solutions. MRP Solutions combines extensive packaging expertise with a consultative approach to reliably uncover customer needs. By understanding your business goals, we can tailor smarter, safer, and more flexible packaging solutions that reduce costs and increase speed to market, helping your businesses capitalize on opportunity. MRP Solutions combines extensive packaging expertise with a consultative approach to reliably uncover customer needs. By understanding your business goals, we can tailor smarter, safer, and more flexible packaging solutions that reduce costs and increase speed to market, helping your businesses capitalize on opportunity. Our vision: We deliver industry-leading packaging solutions tailored to each customer's unique requirements, providing best-in-class product protection while ensuring consumer confidence. We are passionate about partnering with distributors and manufacturers who understand that plastic caps and lids are a small but important part of how people experience their brands. Together, we deliver packaging with purpose. By constantly innovating, MRP enables our customers to grow, making us a preferred partner. MRP Solutions is an equal opportunity and affirmative action employer. We do not discriminate in recruiting, hiring or promotion based on race, color, religion, sex (including sexual orientation, gender identity or expression, transgender status), national origin, age, disability, medical condition, marital or protected veteran status or any other basis or characteristic prohibited by applicable federal, state, or local law. Consistent with the obligations of state and federal law, MRP Solutions will make reasonable accommodation for qualified individuals with disabilities. Any employee who needs reasonable accommodation should contact Human Resources.

The Manager, Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, Supply Chain, Product Development, and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled substances. The role may also support day to day quality oversight of clinical and commercial products to ensure they are manufactured, tested, packaged, stored and distributed in compliance with Current Good Manufacturing Practices (CGMP) regulations, Otsuka Quality Standards and US/global (if applicable) regulatory requirements. **Key Responsibilities** + Product Oversight: Provide GMP oversight and guidance during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers.Act as a liaison with regulatory agencies and internal compliance teams regarding controlled substance matters. + Quality & Compliance:Serve as the quality and compliance lead for controlled substances, ensuring adherence to DEA regulations and other global controlled substance requirements (e.g., Health Canada, EMA, ANVISA). Develop, implement, and maintain global SOPs and standards for the compliant handling, storage, transportation, and distribution of controlled substances. Ensure warehousing and distribution operations meet all applicable regulatory and internal quality requirements, including security, inventory reconciliation, and chain-of-custody controls. + Audit & Inspection Readiness: Support DEA inspections, audits, and regulatory submissions, ensuring readiness and robust documentation. Participates in regulatory inspections and audits as required. + Process Optimization: Oversee and enhance quality systems related to product quality complaints, CAPA, deviations, and change control for controlled substances. + Data Analysis & Reporting: Monitor and analyze compliance metrics and trends to identify risks and drive continuous improvement initiatives. + Cross-functional Collaboration: Collaborate with R&D, Supply Chain, Product Development, and Manufacturing to ensure quality and compliance are integrated throughout the lifecycle of controlled substance products. + Training & Documentation: Provide training and guidance to global teams on controlled substance regulations, GMP expectations, and best practices. Authors and maintains SOPs, Work practices and Job Aids, related to assigned quality activities. **Qualifications** Required + Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field. + Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device), with 3-5 years in pharmaceutical quality, with specific experience in controlled substances and commercial quality operations. + Demonstrated expertise in DEA regulations and compliance, including registration, quota management, recordkeeping, and reporting. + Working knowledge and understanding of FDA/ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and Part 11 (and Part 820, if applicable), ICH Q7 + Strong understanding of GMP requirements and global regulatory expectations for controlled substances. + Experience managing quality systems (e.g., deviations, CAPA, change control, complaints) in a regulated environment. + Proven experience in warehousing and distribution controls, including security, inventory management, and transportation compliance for controlled substances. + Excellent communication, collaboration, and project management skills. + Must be detail oriented and able to write and/or review Technical Documents + Ability to work effectively in a global, cross-functional, and matrixed environment Preferred Experience + Experience with electronic Quality Management Systems (eQMS) such as Veeva, TrackWise, or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs. **Disclaimer** This is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $104,640.00 - Maximum $156,400.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Product Quality Engineer will be responsible for developing, implementing, and maintaining quality processes throughout the product lifecycle-from design and development to production and field operations. This role ensures that our electric aviation products meet rigorous safety, regulatory, and customer requirements. The ideal candidate has experience in aerospace or high-reliability industries, strong problem-solving skills, and a passion for advancing clean aviation technology. How you will contribute to revolutionizing electric aviation: Develop, implement, and maintain quality assurance processes for product development and manufacturing. Collaborate with Engineering, Manufacturing Engineering, Manufacturing, Airworthiness, Program Operations, and Supply Chain teams to identify and mitigate quality risks. Perform root cause analysis, failure investigations, and corrective/preventive actions (CAPA) for product issues. Ensure compliance with aviation regulatory standards (e.g., FAA, EASA) and industry best practices. Establish and monitor key quality metrics to drive continuous improvement. Review design changes, engineering specifications, and test plans for quality implications. Participate in product testing, validation, and verification to confirm conformance to requirements. Lead cross-functional problem-solving efforts to address complex product or process issues. Provide training and guidance on quality standards, tools, and methodologies. Minimum Qualifications: (your Knowledge, Experience, and Abilities): Bachelor's degree in Aerospace, Mechanical, Electrical Engineering or related field. 3+ years of experience in aerospace, aviation, or high-reliability manufacturing environments, preferably in the aviation or defense industries. Proven experience in program-level quality engineering, risk management, and CAPA processes. Strong knowledge of quality tools and methodologies (e.g., FMEA, 8D, root cause analysis, SPC). Proficient with statistical tools, root cause analysis methods, and quality management software. Excellent communication and cross-functional collaboration skills. Strong problem-solving skills and attention to detail. Ability to work in a fast-paced, innovative, and evolving environment. Above and Beyond Qualifications: (preferred qualifications): Experience with composite materials, electric propulsion systems, battery technology, or aviation sub-systems. Familiarity with aviation standards and regulatory requirements (e.g., AS9100, FAA/EASA guidelines). Six Sigma or Lean certification. APQP and PPAP expertise Familiarity with design for manufacturability (DFM) and design for reliability (DFR) principles.