Quality assurance scientist jobs near me

About the Role: We are seeking a highly skilled individual to design and optimize advanced biomaterials systems, conduct in-depth analysis, and lead R&D projects from concept to scale-up. Responsibilities: Design advanced biomaterials system including organic and inorganic chemicals with enhanced thermal and mechanical properties. Conduct in-depth reaction mechanism analysis to optimize chemical pathways in organic, polymer, and inorganic systems. Lead wafer level assembly processes, ensuring precision integration of materials at the micro-scale. Collaborate with cross-functional teams on R&D projects, from concept to prototyping and scale-up. Analyze material performance using advanced characterization tools (e.g., TGA, SEM, FTIR, NMR, HPLC, GC-MS) and interpret data for iterative improvements. Prepare technical reports, patents, and publications; present findings to stakeholders and at conferences. Ensure compliance with safety, environmental, and quality standards in all laboratory and production activities. Mentor junior engineers and contribute to continuous improvement of material processes. Prepare and analyze sample batches using standardized protocols and equipment for assigned projects. Qualifications: Education: PhD in Materials Science, Chemistry, Chemical Engineering, or a closely related discipline. Experience: Proven expertise in material chemistry and engineering (biomaterials processing and ceramics processing). Strong background in reaction mechanism analysis, including kinetic modeling and spectroscopic validation. Hands-on experience with material assembly and integration. Preferred Skills: Bilingual: Fluent in English and Chinese is a plus. Strong analytical and problem-solving abilities. Excellent communication and teamwork skills. Attention to detail and a commitment to quality. Application Instructions: Please submit your resume, a cover letter detailing your relevant experience, and any certifications or relevant documents to ***********************

Cipher Surgical is a medical device company established in 2010, known for launching the OpClear platform used in laparoscopic procedures. The OpClear platform ensures continuous intra-abdominal vision for the surgical team, resulting in fewer surgical errors and shorter operating times. Utilizing automated CO2 flow and on-demand saline lens wash, the OpClear platform minimizes the need for scope removal during procedures and quickly clears larger visual obstructions such as blood or particles from energy plumes. This innovative solution enhances the surgical flow and overall efficiency throughout each procedure. Role Description This is a full-time on-site role for a Senior Quality Assurance Specialist, located in Chantilly, VA. The Senior Quality Assurance Specialist will be responsible for overseeing and managing quality assurance processes, ensuring compliance with industry standards and regulations. Day-to-day tasks include conducting quality audits, managing quality management systems, implementing Good Manufacturing Practices (GMP), and developing and maintaining quality control protocols. This role also involves collaborating with cross-functional teams to continually improve product quality and ensure excellence in manufacturing standards. Qualifications Quality Assurance, Quality Control, and Quality Management skills Experience with Good Manufacturing Practice (GMP) and Quality Auditing Strong analytical and problem-solving abilities Excellent communication and interpersonal skills Ability to work collaboratively with cross-functional teams Bachelor's degree in a related field or equivalent experience Experience in the medical device industry is a plus Knowledge of regulatory standards and compliance in the healthcare industry 5+ years of Medical Device experience. ISO 13485 Must be based in Chantilly, VA

B. Braun Medical, Inc. Company: B. Braun US Pharmaceutical Manufacturing LLC Job Posting Location: Irvine, California, United States Functional Area: Quality Working Model: Onsite Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday Shift: 3/4 X 12 Requisition ID: 7753 B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS . Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit Position Summary: Perform routine laboratory analysis of In-Process, finished product, raw material, stability samples and environmental monitoring according to established specifications and procedures using wet chemistry techniques or various laboratory apparatus and instruments (e.g. HPLC, UV/Visible Spectrophotometer, FTIR, TOC, pH meter etc.) in compliance with B. Braun, cGMP, GLPs, SOPs, USP and FDA guidelines. Responsibilities: Essential Duties • Performs routine laboratory analysis of in Process, finished product, raw material, stability samples and environmental monitoring according to established specifications and procedures using wet chemistry techniques or various laboratory apparatus and instruments (e.g. HPLC, UV/Visible Spectrophotometer, FTIR, TOC, pH meter etc.) in compliance with B. Braun, cGMP, GLPs, SOPs, USP and FDA guidelines. • Performs routine qualification, calibration and maintenance of laboratory instruments. • Prepares analytical standards and reagents according to established procedures and specifications. The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time. General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons. Expertise: Knowledge & Skills Assignments are routine and repetitious in nature. Work performed within narrowly defined parameters. Follows established procedures and guidelines. Works under direct supervision and from detailed verbal and/or written instructions. Uses established procedures to accomplish assigned task. May require some limited judgement in resolving problems. Contacts are primarily with direct supervisor, peers and subordinates. Preferred Requirements Bachelor's Degree preferred. Expertise: Qualifications -Education/Experience/Training/Etc Required: Bachelor's degree in Biochemistry, Biology, Microbiology, Chemistry or related scientific field is strongly preferred. 01-02 years related experience required. Regular and predictable on-site attendance Ability to work non-standard schedule as needed While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds. Responsibilities: Other Duties: The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons. Physical Demands: While performing the duties of this job, the employee is expected to: Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. Lifting, Carrying, Pushing, Pulling and Reaching: Occasionally:Push/pull, Sit Frequently:Reaching upward and downward, Stand, Visual Acuity with or without corrective lenses Constantly:N/A Activities: Occasionally:Push/pull, Sitting , Stooping/squatting, Talking - ordinary, loud/quick Frequently:Finger feeling, Handling, Hearing - ordinary, fine distinction, loud (hearing protection required), Reaching upward and downward, Seeing - depth perception, color vision, field of vision/peripheral, Standing, Walking Constantly:N/A Environmental Conditions: Occasionally:Proximity to moving parts, Fumes Frequently:N/A Constantly:N/A Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Noise Intensity:Moderate Occasionally:Production/manufacturing environment Frequently:N/A Constantly:Lab environment $24.21- $29.06 The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate. B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at . Through its “Sharing Expertise ” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here . All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Compensation details: 24.21-29.06 Hourly Wage PIebf2b9f5ad69-30***********0

Job Description T-Rex Solutions is seeking a results-driven Quality Assurance Specialist to support our U.S. Customs and Border Protection (CBP) Network Operations Center (NOC). The program objective is to provide ongoing support for CBP's NOC and Wireless Network Operations Center (WNOC), which are critical components within the Office of Information and Technology. These centers perform real-time monitoring, proactive maintenance, incident detection and response, problem resolution, and network performance reporting across CBP's nationwide enterprise. They ensure network stability, availability, and the rapid escalation and resolution of technical issues. This is a 24x7x365 operation with work performed on-site in Ashburn, VA. Responsibilities: Responsible for the planning, configuration, testing, and implementation of all operational changes to create the release package for the delivery of, or changes to, the designated service. Manage all aspects of the end-to-end release process. Ensure coordination of build and test environments teams and release teams (as applicable). Ensure teams follow the organization's established policies and procedures. Provide configuration management planning. Provide support to the configuration change Operational and approval process. Support the quality assurance process audits. Provide management reports on release progress. Responsible for service roll out planning including method of deployment and plans communication implementation in coordination with the CBP Change Operational Process. Requirements: Bachelor's degree in related technical field such as Management Information Systems, Computer Science, Engineering, IT, Networking and Telecommunications. A minimum eight (8) Plus years of experience in equivalent technical field Relevant certifications such as ITIL v3, CCNA, CCNP, CompTIA, Change Management US citizenship required Ability to obtain and maintain a CBP public trust clearance Desired Skills: Experience directly supporting DHS, CBP or ICE Network Operations Active CBP clearance, or DOD Secret clearance or higher T-Rex Overview Established in 1999, T-Rex Solutions, LLC is a proven mid-tier business providing data-centric mission services to the Federal government as it increasingly tries to secure and leverage the power of data. We design, integrate, secure, and deploy advanced technical solutions for our customers so they can efficiently fulfill their critical objectives. T-Rex offers both IT and professional services to numerous Federal agencies and is a leader in providing high quality and innovative solutions in the areas of Cloud and Infrastructure Services, Cyber Security, and Big Data Engineering. T-Rex is constantly seeking qualified people to join our growing team. We have built a broad client base through our devotion to delivering quality products and customer service, and to do that we need quality individuals. But more than that, we at T-Rex are committed to creating a culture that supports the development of every employee's personal and professional lives. T-Rex has made a commitment to maintain the status of an industry leader in compensation packages and benefits which includes competitive salaries, performance bonuses, training and educational reimbursement, Transamerica 401(k) and Cigna healthcare benefits. T-Rex is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, sex (including pregnancy and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service, or other non-merit based factors. In compliance with pay transparency guidelines, the annual base salary range for this position is $110,000 - $150,000. Please note that the salary information is a general guideline only. T-Rex considers factors such as (but not limited to) scope and responsibilities of the position, candidate's work experience, education/training, key skills, internal peer equity, as well as market and business considerations when extending an offer. T-Rex offers a diverse and collaborative work environment, exciting opportunities for professional growth, and generous benefits, including: PTO available to use immediately upon joining (prorated based on start date), paid parental leave, individual and family health, vision, and dental benefits, annual budget for training, professional development and tuition reimbursement, and a 401(k) plan with company match fully vested after 60 days of employment among other benefits.

The Lead Auditor will play a critical role in ensuring the adequate implementation of the Structural Integrity Associates quality assurance program. The individual in this position will be expected to provide quality engineering support, perform surveillances, and lead and support internal and supplier quality assurance audits. As such, the individual should be able to qualify as a lead auditor under the Structural Integrity Associates quality assurance program within the first six months of hiring on with the company. The position will also involve the performance of contract review and approval, review to support project closeout, and support of the corrective action program. Primary Responsibilities: Plan and conduct comprehensive NQA-1 audits of nuclear processes to verify compliance with regulations, standards, and implementing procedures Perform surveillances to monitor compliance with quality assurance standards Follow-up on audit findings to ensure effective implementation of corrective actions Liaise with organizational stakeholders to manage the corrective action process Contribute to the development and improvement of quality program and procedures Maintain certification as Lead Auditor in accordance with NQA-1 Review project packages against requirements in support of contract review and project closeout Review calibration records to support project activities Update approved suppliers list, performing annual and triennial updates, as applicable, to maintain associated supplier information Knowledge, Skills, and Abilities: Extensive experience with 10 CFR 50, Appendix B and NQA-1 Experience with the implementation of 10 CFR Part 21 is desired Knowledge of commercial grade dedication Familiarity with quality assurance program development, maintenance, and implementation is desired Experience in an operating quality assurance organization is highly desired Skilled in leading NIAC or NUPIC audits is highly desired Experience with customer audits is desired Knowledge in the performance of quality control inspections is desired Problem solving, critical thinking, self-starter, with effective written and verbal communication Minimum Qualifications: Bachelor's degree and five years of nuclear experience, or Associate's degree and seven years of nuclear experience. At least five years of experience in leading nuclear quality assurance audits is desired. Work Environment: The position can be performed remotely, with at least 25% travel to perform audits and support customer audits as needed If remote, the individual must be able to follow the remote work policies Pay Range: The expected salary range for this role in North Carolina is $117,000 - $125,000 annually. Exact pay will be commensurate with experience. Export Control Notice: Certain positions at SIA may require access to information and technology which is subject to Export Administration Regulations 15 CFR 730-774, including those of the US Department of Energy (DOE) in 10 CFR 810 and Nuclear Regulatory Commission (NRC) 10 CFR Part 110. Hiring decisions for such positions must comply with these regulations and may result in SIA limiting its consideration of foreign nationals who are citizens of countries that are not on the DOE's Generally Authorized Destinations List: *************************************************************************************************** About Us: SIA is an engineering consulting firm serving various industries including Nuclear Power, Energy Services, Pipeline Integrity, and Critical Infrastructure. Join a team of internationally recognized experts in a culture based on knowledge, excellence, and respect for one another. Our employees are members of a distinct community of internationally respected professionals committed to quality, engineering innovation and a shared goal of building a safer world. Why Work at SIA? SIA offers a competitive salary and performance-based bonus program. Our retirement benefits include a Traditional 401k, Roth 401k, and an employer match. To help employees maintain a work-life balance, SIA also offers various paid time off including vacation, floating holidays, sick time, and parental leave. Our employees also enjoy a comprehensive benefits program that includes the following: Medical, dental, and vision insurance Life Insurance and AD&D Short-term and long-term disability Health Savings Account with employer contribution Flexible Spending Account for health care and dependent care ID theft protection and credit monitoring Structural Integrity Associates, Inc. is an equal opportunity employer. ***************** SIA does not welcome third-party recruiters, employment agencies, headhunters, etc. Please do not reach out to SIA employees requesting a call, sit down, meeting, or email response.

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: Assures that suppliers and raw materials are suitable for their intended use in clinical and commercial manufacturing. Responsible for compliance with regulations, procedures, and systems that govern the supplier approval, material qualification programs, along with ongoing supplier/material compliance. Supports client audits and regulatory inspections as needed. Support vendor complaint generation and resolution, along with evaluation and internal processing of vendor changes Responsibilities: Contribute and adhere to Supplier Quality Management systems and compliance activities. Participate in Improvement initiatives, within the SQM functional area. Under moderate supervision, complete multiple assigned functions in the SQM Compliance Area: Assist Supplier Quality Management to ensure Suppliers, Materials/Services are suitable for their intended use by conducting routine evaluations (desk/remote/onsite/for-cause audits, annual assessments, etc.). Auditor certification required (ex. ASQ or equivalent) Assist with Quality Agreement assessments and revisions through supplier communications, to ensure documents are current and compliant. Work with internal department personnel (ex. MSAT, QA/QCRM, Manufacturing, AFS, PD, etc.) to onboard new suppliers and materials. Assist with client project material qualification plans through review of the listed materials, alignment with ETQ material profiles, participation in project meetings, review and upload of material qualification data in EtQ, approval of material profiles, and periodic review of material profiles associated with assigned projects. Support and process supplier complaints (SCNs) and Vendor Change Notifications (VCNs). Support SQM related Deviations, CAPAs, and Change Controls as appropriate. Requirements: BS/BA +3 or >5 years relevant experience or combination of education and experience within a QA or cGMP environment in biopharmaceuticals or equivalent, including previous pharmaceutical supplier quality experience. Auditor certification or demonstrated supplier/internal auditing experience. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedures. Ability to effectively present information and respond to questions from staff, colleagues, managers, and clients. Ability to read, analyze, and author complex documentation. Ability to travel domestically and internationally, where needed, for supplier audits. Ability to travel ~10-15% for onsite supplier audits and site-to-site meetings where applicable. Salary Range: $74,000 - $102,300 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit ********************* KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

> Employees Apply Here" onclick="window.location.href = '****************************** InternalUser=true&locale=en_US/';"/> Supplier Quality Assurance Manager - 90398419 - Washington, DC, Wilmington, DE or Philadelphia, PA Company: Amtrak Your success is a train ride away! As we move America's workforce toward the future, Amtrak connects businesses and communities across the country. We employ more than 20,000 diverse, energetic professionals in a variety of career fields throughout the United States. The safety of our passengers, our employees, the public and our operating environment is our priority, and the success of our railroad is due to our employees. Are you ready to join our team? Our values of 'Do the Right Thing, Excel Together and Put Customers First' are at the heart of what matters most to us, and our Core Capabilities, 'Building Trust, Accountability, Effective Communication, Customer Focus, and Proactive Safety & Security' are what every employee needs to know and do to be most impactful at Amtrak. By living the Amtrak values, focusing on our capabilities, and actively embracing and fostering diverse ideas, backgrounds, and perspectives, together we will honor our past and make Amtrak a company of the future. SUMMARY OF DUTIES: The Advanced Supplier Quality Manager provides technical expertise to improve supply base performance from quality, delivery, competitiveness, program launch and management wavelength perspectives. The primary focus of the Quality Manager is developing and executing supplier quality processes that cooperate cross-functionally with Procurement, Engineering, and Programs. The Quality Manager will use structured quality tools to drive continuous improvement internally and externally. ESSENTIAL FUNCTIONS: * Develop, implement and improve business tools and processes based on requirements called out within the Association of American Railroads ("AAR"), The Manual of Standards and Recommended Practices ("MSRP"), The Federal Railroad Administration Code of Federal Regulations and applicable ISO and IATF standards. Coach, mentor and at times lead the use of the tools to improve supply base performance and business efficiency * Develop and maintain strong and positive relationships with internal and external stakeholders to ensure optimal outcomes, especially when circumstances are ambiguous and challenging. * Lead root cause / corrective action to achieve solid problem solving, preventive resolutions for components, large equipment, and fleet. * Support Procurement and Supply Chain strategies, including but not limited to supplier qualification, delivery and quality improvement, program launch support and proactive supply base restructuring. * Drive supplier life-cycle performance management from qualification, onboarding, performance management, capability and capacity development to business transition. * Support Procurement, Capital Delivery and End User department (Mechanical, IMCS and etc) teams in critical procurement programs - such as Airo program, Long Distance Fleet Replacement program, Maintenance of Way special equipment procurement. The support includes participating in Technical Evaluation Committee, supplier qualification, QMS audit, Product Delivery Inspection (PDI) and Commissioning and Warranty. * Provide technical expertise to sourcing and development of suppliers with respect to quality, technology, delivery, competitiveness and logistics. * Coach and develop the supplier quality team to meet both business and professional development goals MINIMUM QUALIFICATIONS: * Bachelor's Degree required OR equivalent combination of training, education and relevant experience may be considered in lieu of a degree. * 7 years of relevant experience required. * Knowledge of shop operations and maintenance procedures * Strong written and verbal communication skills; able to effectively interact and negotiate with others; have strong presentation skills and represent Amtrak in a professional manner * Familiar with quality tools and disciplines, project management tools, operational and capacity management tools * Experience in purchasing and interfacing with suppliers * Position is onsite in Washington DC, Wilmington DE or Philadelphia PA * Able to travel up to 25% * Knowledge of QA standards including ISO 9000. * Knowledgeable in FRA regulations and their application to operations. * Knowledgeable in OSHA 1910 and 1926 standards. * Proficient in MS Office applications and Office365. * Excellent written/oral communication and presentation skills. * Flexibility to work extended hours if required. PREFERRED QUALIFICATIONS: * Engineering Degree Preferred. * Certified Six Sigma Green Belt or Black Belt * ASQ Certified Manager of Quality / Organizational Excellence Relevant manufacturing process knowledge and experience in rolling stock industry * Demonstrated technical writing skills. * ISO Lead Auditor certification. * Experience in railroad related or similar transportation industry. * Experience and knowledge of Safety Management Systems. COMMUNICATION AND INTERPERSONAL SKILLS: Must have excellent oral and written communication skills. The salary/hourly range is $113,200- $146,664. Pay is based on several factors including but not limited to education, work experience, certifications, internal equity, etc. Depending on an employee's assigned worksite or location, Amtrak may consider a geo-pay differential to be applied to the employee's base salary. Amtrak may offer additional incentive and pay programs to recognize and reward our employees, including a short-term incentive bonus based upon factors such as individual and company performance that is commensurate with the level of the position and/or long-term incentive plan compensation. In addition to your salary, Amtrak offers a comprehensive benefit package that includes health, dental, and vision plans; health savings accounts; wellness programs; flexible spending accounts; 401K retirement plan with employer match; life insurance; short and long term disability insurance; paid time off; back-up care; adoption assistance; surrogacy assistance; reimbursement of education expenses; Public Service Loan Forgiveness eligibility; Railroad Retirement sickness and retirement benefits; and rail pass privileges. Learn more about our benefits offerings here. Requisition ID:165261 Work Arrangement:06-Onsite 4/5 Days Click here for more information about work arrangements at Amtrak. Relocation Offered:No Travel Requirements:Up to 25% You power our progress through your performance. We want your work at Amtrak to be more than a job. We want your career at Amtrak to be a fulfilling experience where you find challenging work, rewarding opportunities, respect among colleagues, and attractive compensation. Amtrak maintains a culture that values high performance and recognizes individual employee contributions. Amtrak is committed to a safe workplace free of drugs and alcohol. All Amtrak positions requires a pre-employment background check that includes prior employment verification, a criminal history check and a pre-employment drug screen. Candidates who test positive for marijuana will be disqualified, regardless of any state or local statute, ordinance, regulation, or other law that legalizes or decriminalizes the use or possession of marijuana, whether for medical, recreational, or other use. Amtrak's pre-employment drug testing program is administered in accordance with DOT regulations and applicable law. In accordance with DOT regulations (49 CFR § 40.25), Amtrak is required to obtain prior drug and alcohol testing records for applicants/employees intending to perform safety-sensitive duties for covered Department of Transportation positions. If an applicant/employee refuses to provide written consent for Amtrak to obtain these records, the individual will not be permitted to perform safety-sensitive functions. In accordance with federal law governing security checks of covered individuals for providers of public transportation (Title 6 U.S.C. §1143), Amtrak is required to screen applicants for any permanent or interim disqualifying criminal offenses. Note that any education requirement listed above may be deemed satisfied if you have an equivalent combination of education, training and experience. Amtrak is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race/color, to include traits historically associated with race, including but not limited to, hair texture and hairstyles such as braids, locks and twists, religion, sex (including pregnancy, childbirth and related conditions, such as lactation), national origin/ethnicity, age, disability (intellectual, mental and physical), veteran status, marital status, ancestry, sexual orientation, gender identity and gender expression, genetic information, citizenship or any other personal characteristics protected by law.. > Employees Apply Here" onclick="window.location.href = '****************************** InternalUser=true&locale=en_US/';"/>

Hi Consultant required for the below mentioned requirement QA Manager Duration : Long Term Prefer GC/citizen Skills • 4-5 Banking Industry Experience • MOBILE, MOBILE • Strong IT background - Developer background coupled with QA would be ideal • Experience managing teams - QA leads will be reporting into this person (THiS IS NOT A QA LEAD) • Responsible for reviewing all deliverables of Quality Engineers • Test strategy/risk management • Being able to speak to the product owners • Ensuring the right tools are in place for testing • Reviewing test scripts/automation scipts • Infrastrutuere in place • Technologies: SOAP, Cucumber, Ruby, Gethub (or other source management tool) • WORKED IN TRUE AGILE ENVIRONMENT IS KEY -- Thanks/Regards Ruchie Agarwal Desk: ************ Extn. 299 Cell : ************ Skype : ruchi.droisys Address: 4800 Patrick Henry Dr., Santa Clara, CA 95054 ********************** | *************** | Join Droisys Group “Don't wait for the perfect moment. Take the moment and make it perfect” Additional Information All your information will be kept confidential according to EEO guidelines.

Seeking a highly skilled Quality Assurance (QA) Specialist with a strong background in Information Technology to support mission-critical systems and ensure compliance with DoD and NMCI standards. The QA Specialist will play a pivotal role in verifying the accuracy, completeness, and compliance of deliverables, projects, and processes throughout the software/system lifecycle. This position requires extensive experience with NMCI business processes, as well as advanced proficiency in Microsoft Excel and Microsoft Project. Advanced user of Microsoft Excel (pivot tables, macros, data modeling, dashboarding). Proficient in Microsoft Project, preferably Project Net v6 or higher. Familiarity with NMCI-ACTR systems and processes is highly preferred. Lead QA efforts across IT system development, implementation, and sustainment projects, ensuring compliance with contract requirements, DoD standards, and NMCI policies. Analyze NMCI ACTR documentation to validate alignment with current NMCI provisioning rules, technical baselines, and operational directives. Develop and maintain QA plans, test procedures, checklists, traceability matrices, and risk mitigation strategies. Evaluate deliverables and work products for consistency, accuracy, and completeness; initiate corrective action when deviations are identified. Track project milestones, schedules, and QA checkpoints using Microsoft Project and Excel-based tools. Coordinate and support audits, reviews, and inspections related to quality assurance, including Configuration Control Boards (CCB), Technical Review Boards (TRB), and Acceptance Reviews. Provide expert-level support in data analysis, performance metric reporting, and documentation of trends impacting system or process quality. Serve as liaison with NMCI representatives, internal engineering teams, and customer stakeholders to ensure timely resolution of QA issues. Prepare formal reports and presentations summarizing quality trends, issues, and proposed improvements. In-depth knowledge of NMCI environment, including provisioning, ACTR, and user support workflows. Strong understanding of IT lifecycle management, CMMI, ISO 9001, or Six Sigma principles (certification a plus). Demonstrated ability to conduct process gap analyses and recommend QA process improvements. Experience with automated QA testing tools and defect tracking systems is a plus. Excellent attention to detail, analytical thinking, and written/verbal communication skills. Strong organizational skills with the ability to prioritize and manage multiple assignments under tight deadlines. Required Skills and Experiences: Valid certification of an IAT-2 technical level with one of the following, Security+, or Global Information Assurance Certification's (GIAC) Security Essentials (GSEC), or (ISC)2 Systems Security Certified Practitioner (SSCP) 2+ years' with NMCI Business Processes and Rules Expert in MS Excel and MS Project NET v6 or higher experience preferred NMCI-ACTR experience preferred Must be a U.S. citizen A secret security clearance. Degree Requirements: Preferred: B.S in Information Technology, Information Systems, or Computer Science

Job DescriptionThe Senior Researcher will help shape the future of learning and work by producing original, actionable research on the connections between education and economic opportunity. This full-time role sits within Strada's Institute for the Future of Work and reports to the Institute's Managing Research Director. The Senior Researcher is responsible for leading and executing methodologically rigorous research projects-from data management and statistical analysis to writing and visualizing key findings. This role is ideal for a researcher who thrives at the intersection of empirical inquiry and public impact. The ideal candidate will have deep expertise in quantitative research methods and a strong interest in informing education and workforce policy through rigorous, applied research. This is a hybrid position based in Washington, DC. The Senior Researcher is expected to work in Strada's DC office two days per week, with the flexibility to work remotely from home the remaining three days. About Strada and the Institute for the Future of Work Strada Education Foundation is a national nonprofit organization on a mission to improve lives by forging clearer and more purposeful pathways between education and employment. We work with partners in education and the workforce to identify and scale solutions that help more Americans access postsecondary education and training that leads to good jobs, meaningful careers, and economic mobility. The Strada Institute for the Future of Work produces rigorous, field-leading research focused on strengthening the connection between postsecondary education and economic opportunity. Our work informs policy, practice, and public dialogue-especially in areas where evidence is limited but critical for advancing equity and impact. Key ResponsibilitiesConduct Rigorous Research (40%) Lead the day-to-day execution of complex quantitative research projects aligned with the Institute's priorities. Prepare and manage large, longitudinal datasets for analysis using Stata or R. Make sound methodological decisions regarding sampling, variable construction, and analytic techniques. Perform advanced statistical analyses, data quality checks, and prepare codebooks and documentation. Collaborate with internal teams and external partners to deliver high-quality research. Communicate Research Effectively (40%) Draft and co-author peer-reviewed journal articles, policy briefs, and public reports. Synthesize literature and develop subject matter expertise on key education and workforce topics. Create presentations, data tables, figures, and infographics to communicate findings to technical and non-technical audiences. Deliver presentations at conferences, panels, and internal meetings. Provide feedback on team products to ensure clarity, accuracy, and accessibility. Develop New Research Directions (10%) Identify emerging questions and areas of inquiry aligned with Strada's mission. Cultivate relationships with partners to explore new research collaborations. Support grant development and funding proposals to expand the Institute's research agenda. Lead Teams and Promote Equity (10%) Supervise and mentor junior researchers and contractors; provide clear direction and feedback. Foster a collaborative, inclusive research environment. Contribute to Strada's diversity, equity, and inclusion learning agenda. Support organizational health and DEI goals through respectful, transparent collaboration. Education and Experience PhD (completed or imminent) in public policy, economics, sociology, demography, higher education, or a related discipline. Expertise in quantitative methods, including causal inference and longitudinal data analysis. Strong experience with data cleaning, coding, and management in Stata (preferred) or R. Experience writing for both peer-reviewed journals and broader public or policy audiences. Ability to work independently, manage multiple projects, and meet deadlines. Exceptional writing, verbal communication, and collaboration skills. Preferred Qualifications Experience with education and workforce data at the course, student, institution, or labor market level. Experience with federal education/workforce datasets. Familiarity with qualitative data analysis (e.g., NVivo). Experience writing research reports for policymakers or translating findings for policy audiences. Prior work with state or national higher education/workforce organizations. Experience developing research grant proposals. Our Benefits Include Medical, dental, and vision insurance Generous PTO and paid holidays 401(k) retirement plan with employer contributions Paid parental leave Wellness reimbursement Professional development resources plus annual bonus The pay range listed is based on national compensation benchmark data and may vary depending on skills, experience, job-related knowledge, variations in cost of labor, and in some cases, geographic location. The exact job offer will be determined based on several factors such as the candidate's individual skills, qualifications and experience relative to the requirements of the role. The range displayed with the job posting represents the minimum and maximum target for new hire salaries for the position across the U.S. The company also reviews and considers internal equity (current employee salary) when hiring new employees to the organization. The range is the expected starting base salary for someone hired into this position with room to grow professionally, including increased earning potential beyond the starting pay range. Beyond a new hire's base salary, Strada also offers all full-time employees a comprehensive employee benefit package. Travel Requirements: It is likely the role will naturally entail some travel for conferences and other meetings up to 15%. Mission and Values Alignment: Committed to providing equitable pathways to opportunity through PSET, particularly for individuals who have faced significant barriers. Demonstrated alignment with Strada's guiding values, commitment to building a strong and healthy workplace culture, and working in a collaborative environment. Strategy and Innovation Leadership: Adept at operationalizing strategy and effectively communicating strategic endeavors within the organization and in external contexts, both verbally and in writing. Particular skill in designing annual plans, monitoring progress, and refining plans as needed. Adaptable with tolerance for ambiguity. Able to problem-solve and navigate varied viewpoints. Capacity to refine efforts based on evidence that change is needed. Ability to lead efforts to visualize and monitor change. Capability to see and support innovative ideas and opportunities across the organization, and to embed innovation within operational plans. Capabilities in taking the perspective of others and adapting an agenda and approach - toward a shared aim - accordingly. Strategic Problem Solving: Ability to effectively utilize a hypothesis-driven approach to problem solving, with effective quantitative and communication skills. Ability to take on broad-reaching and sometimes ambiguous questions while working collaboratively and cross-functionally with Strada team members across the organization. Execution and Operations Leadership: Ability to translate innovative, strategic ideas into tangible, actionable steps, as well as to effectively monitor progress and partner with others on identifying improvements during implementation to increase the likelihood of successful execution. DEI Commitment: Commitment and professional experience advancing diversity, equity, and inclusion within and organization, including incorporating stakeholder perspectives in the design, implementation, and evaluation of strategic efforts. Relationship Building and Collaborative Capabilities: Demonstrated ability to cultivate, grow, and manage positive, mutually beneficial relationships at all levels of an organization and with partners outside the organization. Strong communication, interpersonal and relationship management skills-including identifying and working through challenges-underscored by strong judgment and emotional intelligence. Proven collaborator, able to work with colleagues at all levels in the organization. Diversity, equity, and inclusion are central to Strada's organizational vibrancy, employee experience, and mission. Strada is Diversity, Equity, and Inclusion Workplace-certified by Diversity for Social Impact, a strategic professional and organization development company dedicated to promoting diversity and inclusion to drive social impact worldwide. We strongly encourage applicants from people of color/the global majority, immigrant, bilingual, and bicultural individuals; people with disabilities, members of the LGBTQIA2S+ and gender nonconforming communities; and people with other diverse backgrounds and lived experiences. We believe every member on the team enriches our workplace by exposing us to a broad range of ways to understand and engage with the world, identify challenges, and discover, design, and deliver critical insights and solutions. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Cardinal Health Sonexus™ Access and Patient Support helps specialty pharmaceutical manufacturers remove barriers to care so that patients can access, afford and remain on the therapy they need for a better quality of life. Our diverse expertise in pharma, payer and hub services allows us to deliver best-in-class solutions-driving brand and patient markers of success. We're continuously integrating advanced and emerging technologies to streamline patient onboarding, qualification and adherence. Our non-commercial specialty pharmacy is centralized at our custom-designed facility outside of Dallas, Texas, empowering manufacturers to rethink the reach and impact of their products. Together, we can get life-changing therapies to patients who need them-faster. Responsibilities: Leads the team by evaluating calls and assess application usage based on a standard set of criteria, providing constructive feedback and recognition to ensure high performance and continuous improvement. Accurately score interactions to gauge employee's quality performance based on organizational and departmental policies and requirements. Monitor and evaluate team performance ensuring adherence to company quality standards, and compliance with industry regulations. Tracks and reports any trends from the customer experience that can be improved or celebrated. Analyze and provide weekly & monthly trend analysis to leadership. Provide support to leadership by participating in and hosting internal/external client calibration sessions. Engage in and lead projects to promote quality enhancements and/or broaden services for the team. Shows an understanding of the requirements and is capable of conducting gap assessments based on those requirements. Uphold quality standards that adhere to company, regulatory, and HIPAA policies and procedures. Collaborates across various functions, interprets requirements, and educates and influences others regarding those requirements. Identifies training needs or potential disciplinary actions which will be reported to leadership. Demonstrates ability to build strong customer relationships and deliver customer-centric solutions. Optimize work processes by identifying effective and efficient methods to complete tasks, with an emphasis on continuous improvement. Develops strategic alliances and cooperates with stakeholders to achieve mutual goals. Demonstrates resourcefulness by adeptly securing and efficiently deploying resources. Analyzes complex and high-quality, sometimes contradictory, information to solve problems effectively. Holds oneself and others accountable for meeting commitments and objectives. Exhibits situational adaptability by adjusting approach and demeanor in real time to meet the changing demands of various situations. Creates and implements diverse communication strategies that clearly address the specific requirements of various target audiences. Demonstrates knowledge of quality systems and methodologies. Demonstrates an understanding of the relevant regulations, standards, and operating procedures. Demonstrates ability to perform investigations / root cause analysis and develop corrective actions. Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements. Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving. Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements. Qualifications: Bilingual in Spanish Call monitoring/audit experience preferred. Case audit experience preferred. HS Diploma, GED or technical certification in related field or equivalent experience, preferred. Adverse Event reporting experience strongly preferred. Strong customer service/quality background experience. Excellent verbal and written communication skills Strong prioritization and leadership skills. High regard for superior quality of service. Ability to prioritize and manage multiple responsibilities. Experience handling tasks where attention to detail is critical to success. 3+ years' experience in related field, preferred. What is expected of you and others at this level: Effectively applies knowledge of job and company policies and procedures to complete a variety of assignments. In-depth knowledge in technical or specialty area Applies advanced skills to resolve complex problems independently. May modify process to resolve situations. Works independently within established procedures; may receive general guidance on new assignments. May provide general guidance or technical assistance to less experienced team members. TRAINING AND WORK SCHEDULES: Your new hire training will take place 8:00am-5:00pm CST, mandatory on camera attendance is required. This position is full-time (40 hours/week). Employees are required to have flexibility to work any of our shift schedules during our normal business hours of Monday-Friday, 7:00am- 7:00pm CST. REMOTE DETAILS: You will work remotely, full-time. It will require a dedicated, quiet, private, distraction free environment with access to high-speed internet. We will provide you with the computer, technology and equipment needed to successfully perform your job. You will be responsible for providing high-speed internet. Internet requirements include the following: Maintain a secure, high-speed, broadband internet connection (DSL, Cable, or Fiber) at the remote location. Dial-up, satellite, WIFI, Cellular connections are NOT acceptable. Download speed of 15Mbps (megabyte per second) Upload speed of 5Mbps (megabyte per second) Ping Rate Maximum of 30ms (milliseconds) Hardwired to the router Surge protector with Network Line Protection for CAH issued equipment Anticipated hourly range: $17.75 per hour - $25.60 per hour Bonus eligible: No Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being. Medical, dental and vision coverage Paid time off plan Health savings account (HSA) 401k savings plan Access to wages before pay day with my FlexPay Flexible spending accounts (FSAs) Short- and long-term disability coverage Work-Life resources Paid parental leave Healthy lifestyle programs Application window anticipated to close: 01/06/2026 *if interested in opportunity, please submit application as soon as possible. The hourly range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity. Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law. To read and review this privacy notice click here

Who we are REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities. As a member of our Bioanalytical Sciences team, you will be responsible for performing nonclinical and clinical sample testing (PK, Immunogenicity, PCR, etc.) following developed, qualified, and/or validated bioanalytical methods in support of REGENXBIO projects and programs. You will also be responsible for developing and validating bioanalytical methods for gene therapy products. You will also be responsible for performing QC review of documentation produced in the Bioanalytical laboratory, including assay runs, summary tables, reports, protocols and collaborate with various departments to ensure compliance with regulatory expectations.What you'll be doing Conduct assay operations and maintains accurate testing records. Review technical documents. Perform QC peer reviews and manages project-related activities. Troubleshoot analytical method issues and maintains lab inventories. Support Sample receipt/Accession, buffer preparation and lab maintenance Performs additional tasks or assist with special projects as assigned or needed. We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications: Bachelor's degree in a relevant scientific field with 2+ years of industry experience, or Master's with 1+ year. Hands-on experience with immunoassays (ELISA, MSD), cell-based assays, qPCR, and/or LC-MS. Analytical, problem-solving, and organizational skills with excellent attention to detail. Collaborative team player with strong written and verbal communication skills. Proficient in data analysis software (e.g., SoftMax) and Microsoft Office applications. By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients. In addition, professional development is important to us. By joining our team, you'll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally. We are proud to offer a comprehensive rewards package which includes a market-competitive base salary, an annual performance-based bonus program, stock grants at all levels, and benefits such as health, dental, and vision insurance, retirement plan with 401(k) match, summer hours, and more! The estimated compensation range for this role is $66,000-$89,000 annually. The actual salary offered to the final candidate depends on a number of factors such as relevant work experience, skills, education, and years of experience.

Job Description Bioanalytical Quality Assurance Specialist Salary: $70,000 to $80,000 per year Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services. We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more, visit ****************** Responsibilities: Comply with the Company's Health and Safety, and Radiation Safety Program. Quality systems - to audit assigned aspects of the Company's regulated activities, with the exception of the Finance Department, and report to Test Site Management any non-compliance to the Company SOPs, protocols, policies, or relevant regulations. Identify critical non-compliances and report them immediately to the Study Lead, Director of Quality Assurance, and Test Site Management. Provide advice and support to assigned functions with regards to quality issues. Schedule and execute audits of plans, data, and reports for accuracy and compliance for regulated studies. Audit laboratory activities performed by operations for compliance. Schedule and execute facility audits of equipment, systems, and processes in compliance with QAU SOPs. Provide, track, and close written audit reports for all auditing activities. Contribute to the Quality Assurance Metrics Report to Management. Provide support for Regulatory and client inspections. Quality Assurance Unit - to adhere to the operations of the QAU and to make recommendations for further implementation or improvement of any of its systems. To prepare standard operating procedures for use by the Company as required. To assist the Company, meet its business objectives by demonstrating to Sponsors the quality processes and continuous improvement activities within the Company. What We're Looking For: Bachelors of Science in Chemistry + 2 years experience working in the regulated pharmaceutical. Experience working in a CRO Quality Department performing auditing. Knowledge of Bioanalysis. Knowledge and ability to apply GLP and Part 11 Code of Federal Regulations, GCP/ICH Guidelines, and other applicable regulations or guidelines. Attention to detail to ensure data and reports are accurate and the study conduct meets protocol. Why Pharmaron? Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China. Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centred" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators. Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package: Insurance including Medical, Dental & Vision with significant employer contributions Employer-funded Health Reimbursement Account Healthcare & Dependent Care Flexible Spending Accounts 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance 401k plan with generous employer match Access to an Employee Assistance Program How to Apply: Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences. #LI-JB1

** The QA associate for documentation ensures compliance with cGMP and internal policies, procedures, and specifications. This position is responsible for performing inspections, batch record review, and quality system functions in accordance with cGMP and related company SOP's, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines. JOB DUTIES & RESPONSIBILITIES Manage and maintain company document control and archival systems (hardcopy and electronic) in compliance with internal procedures and policies as well as regulatory requirements. Manage the routing, review, approval, distribution and archival of new and revised controlled documents. Track controlled documents through the issuance of Document Control numbers, logbooks, change requests, and document status reports. Archive and maintain hardcopy and electronic copies of batch records files, audit files, vendor files, product, label files and change history files. Control and issuance of labeling components. Manage all document control logbooks and spreadsheets. Perform the release of finished product batches packaged. Provide new hire training on GMP's, Safety, and Pharmacovigilance and maintain the training program documentation. Ensure standard operating procedures are periodically reviewed for relevance and accuracy in compliance with company policies and procedures. Collaborate with team members to ensure timely deliverables for documentation. Ensuring all documents are up to date with respect to version control and issuance Perform and support maintenance and closure activities of documents such as reports, protocols exceptions/deviations, CAPAs, change controls and complaints. cGMP Compliance in Document Control. Any other activity as assigned by the Supervisor Requirements Knowledge & Skills cGMP compliance within the pharmaceutical manufacturing industry. Writing and maintaining cGMP documentation. Analyze data/information and resolve complex issues. Verbal and written communication skills. Work and communicate with cross-functional teams. Multiple priorities and re-prioritize tasks. Experience & Education At least two (2) years' experience in a quality assurance role in a cGMP-regulated environment. A college Degree preferably in Sciences (i.e. Pharmacy, Biology, Chemistry etc.) Physical Requirements/Working Environment While performing the duties of this job, the employee is regularly required to, stand, sit, talk, hear, and use hands and fingers to operate a computer and telephone keyboard. Specific vision abilities required by this job include close vision requirements due to computer work. Ability to sit at a computer terminal for an extended period of time. Light to moderate lifting up to 10-15 lbs. is required. Ability to work in a confined area.

R&D Chemist - Stability Coordinator - Winchester, VATri-Pac, Inc., a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking an experienced R&D Chemist-Stability Coordinator to join our fast-growing team immediately. This position is in Winchester, VA. Job Description The R&D Chemist -Stability Coordinator and stability coordinator is responsible for coordinating and supporting the site stability program, formulation, and stability sampling activities in compliance with the FDA ICH guidelines, company quality guidelines, SOP's and other regulatory requirements. This position will be required to work well with the cross-functional teams and will be the key point of contact for all stability programs for OTC, Medical device, and Cosmetic products. Responsibilities This will include initiating stability studies, coordinating stability pulls, making sure the testing schedule of stability samples is met, analyzing stability data, and evaluating trends, and writing stability reports. To author stability protocols, interim reports, and reports for stability studies This includes routine campaign stability studies and non-routine project stability studies. Report the trending of stability data through data management and trend analysis using appropriate software. To escalate any trends to the R&D Manager and support any investigations, based on the test data collected. To support the business in requests relating to stability data (including temperature excursion assessments, regulatory requests, and investigational work) To own and support stability related Deviations, CAPAs and Change Controls, and progress department improvements. Manage stability studies following internal procedures, ensuring studies are set up per the protocol. The Stability Coordinator will interact with other groups in R&D and other departments (such as QC and production) as required. Will collaborate with relevant QC laboratories to ensure stability samples are tested within their specified time frame for actives, and micro. Coordinate the shipment of stability samples to outside labs when required. Maintain stability tracker for routine annual stability and lab stabilities. Good knowledge about lab equipment/test - Viscosity; pH; specific gravity; API's etc. Knowledge of cGMP regulations; GLP. Support R&D lab with formulation development for OTC; Cosmetic and Medical device in different forms - Aerosol; liquid and BOV. Improve current product formulations. Lead formulation development activities with a focus on stability as the primary responsibility. Proficient in Microsoft office 365. Education And/or Experience Associate or bachelor's (B.A or B.S) in a scientific discipline; and 2 or more years related experience and/or training; or equivalent combination of education and experience. Must demonstrate knowledge of common analytical tools and techniques. Must have previous experience with conducting stability studies and knowledge of statistics. Must have previous experience in a GMP environment. Benefits Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term), and Continuous Training. Work where you are HAPPY! Tri-Pac, Inc. also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth. ************** Thank you for your interest and consideration of a career with Tri-Pac, Inc. Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer To Staffing & Recruitment Agencies: Our Company does not accept unsolicited CV's or applications from agencies. We are not responsible for any fees related to unsolicited CV's or applications and explicitly reserve its right to contact candidates presented in such unsolicited CV or application.

Requirements A day in the life of a Quality Assurance Manager will include: Quality Assurance - Developing, implementing and maintaining the credit union's quality assurance program (specifically to drive consistency within Member Engagement and all member-facing teams). Performing audits and targeted testing for compliance requirements. Analyzing data to identify trends and discrepancies. Review new accounts for verification, accuracy and risk mitigation. Collaboration - Working with credit union partners that evaluate interactions and provide 3rd party survey results to evaluate tools and agent performance. Partnering with internal departments to ensure consistent quality standards. Assisting with internal & external audits. Training & Development - Conducting training sessions to improve compliance awareness. Mentoring and coaching specialists to enhance service quality. Maintaining updated training materials related to quality assurance. Member Service - Ensuring member interactions are handled with empathy and efficiency. Monitors for sentiment, resolution rates and service levels. Supports initiatives that enhance member experience Leadership - Ensuring adherence to internal policies and regulatory standards. Provides recommendations for operational improvements. Supervises staff within the Member Engagement department. Experience: One year to three years of similar or related experience. Education: (1) A two-year college degree, or (2) completion of a specialized certification or licensing, or (3) completion of specialized training courses conducted by vendors, or (4) job-specific skills acquired through an apprenticeship program. Top benefits or perks: Joining Lafayette Federal comes with perks to support you in your personal and professional journey. We provide employees with a generous benefits package including: Employer paid (99.9%) health insurance premium for single and family coverage (HMO Plan) Fully funded deductible (HMO Plan) 401k employer matching contribution Income protection with life insurance, short and long-term disability Paid time off, holiday leave & birthday leave Educational assistance Commuter benefits program and more! The job posting highlights the most critical responsibilities and requirements of the job. It is not all-inclusive. There may be additional duties, responsibilities, and qualifications for this job. Pay: $76,000 - $80,000 annually depending on experience and qualifications. *Lafayette Federal Credit Union is an Equal Opportunity and E-Verify Employer *EOE/AA/DISABILITY/VETERAN

You chart the course; we help you lift off. At YHB, we aren't limited by small-firm constraints or stuck in the big-firm mentality. Our culture is based on relationships between our teams and our clients. We aim to hire great people who want to take ownership of their careers while we help to provide the tools for success. Assurance Associates are responsible for assisting in the completion of all engagements that they have been assigned. They should complete all assigned tasks in a timely, efficient manner and actively search for additional responsibilities when time permits; to become fluent with the Assurance process and methodology. Roles and Responsibilities Technical Expertise and Work Quality Possess an intermediate level of understanding related to Assurance and accounting principles. Follow YHB guidance regarding secure use of hardware, software, and client information. Maintain proficiency and identify efficiency with relevant firm technical resources and computer applications. Demonstrate effective use of these resources and use file and workpaper organization techniques. Demonstrate a commonsense approach to problem solving, clearly identifying issues and/or problems as they arise and bringing them to the attention of the Assurance Supervisor and/or Manager. Develop a clear understanding of the engagement objective to perform necessary procedures. Listen carefully to instructions, take notes, ask questions, and seek clarification of instructions and assignments. Prepare workpapers that are neat, organized, and cross-referenced, in accordance with YHB procedures. Apply professional skepticism to the audit. Complete specific tasks, reports, and deliverables within assigned timeframes and budget. Document procedures performed, and conclusions reached. Prepare complete workpapers in conformity with standards including adequate supporting documentation, tick mark, and workpaper cross references. Ensure assigned sections have been completed, including after leaving the client site. Assist the Assurance Supervisor with wrap-up through the completion of the engagement. Gain proficiency in developing analytics and a willingness to understand the analytics produced. Begin to develop an understanding of control processes and identifying internal control weaknesses. Clear any review comments received from the engagement Supervisor and/or Manager. Increase technical knowledge based on primary niche industry. Client Management and Service Communicate with others in a tactful and business-like manner. Provide regular and frequent communication with in-charge staff regarding the status of assignments in progress. Accurately complete tasks within the timeframes established by clients as communicated through in-charge staff. Demonstrate efforts to gain an understanding of the client (rather than just copying workpapers) through inquiry, observation, and study as well as interaction with in-charge staff and others at YHB. Be responsive to the need to meet client expectations, deadlines, and be flexible as much as possible in assisting the team to meet these expectations and deadlines. Display confidence in expressing ideas and proposed solutions. Initiate communication with Supervisors and circle leaders to determine job responsibilities (ie. equipment responsibilities, dress code, and basic understanding of client) prior to arrival. Maintain the complete confidentiality of all client and firm information. A commitment to respond to clients within 24 hours. Represent YHB to clients in a professional manner, adhering to YHB standards. Maintain daily time entry for accurate reporting firm wide. Business Development Learn and demonstrate knowledge in the YHB's service capabilities. Recognize the need to expand our practice and that all team members can participate in the process. Establish a network of client and business contacts and seek ways to increase YHB visibility among peers or by becoming involved in a professional or community organization. Be aware of potential opportunities with existing clients or non-clients and bring these to the attention of others within the firm. Personal Participation and Professional Development Follow YHB's time reporting requirements including timely entry of weekly time for payroll and billing purposes. Prepare for and complete the CPA exam. Demonstrate active involvement in self-improvement activities, including the awareness and development of their functional and industry specialization. Take responsibility for attaining chargeable hour requirements. Initiate and respond to suggestions to improve work quality. Actively participate in self-development activities such as reading technical information, interacting with firm leaders, and maintaining minimum standards for firm professional licensing/continuing education requirements. Solicit overall performance feedback on assigned areas from Supervisors and Managers. When not assigned to an engagement, actively seek chargeable work from Supervisors and Managers. During periods of non-billable time, seek out value-added projects such as writing newsletters, marketing activities, or research projects. Set challenging goals and be receptive to goals set by their circle leaders. Be cognizant of interactions within the community, realizing that in many cases you may be the only source of exposure for YHB. Demonstrate an increasing ability to work through challenging tasks, however, still seeking guidance and input from in-charge staff to maintain efficiency. Honestly assess your own performance upon completion of engagement or assignments. Gain understanding of department goals and responsibilities. Understanding the role of Supervisor and working to expand roles and responsibilities to that level. Overnight travel to out-of-town YHB offices, client locations and continuing professional education may be required. Leading and Developing Others Participate in staff recruiting activities, including campus visits, internship, externship, etc. when it does not interfere with client work. Use peers as a resource for personal development and information sharing. Provide feedback during annual upward evaluations. Understand the importance of cooperation and teamwork. Demonstrate this understanding by maintaining positive working relationships with firm leaders, clients, and other team members, which requires an attitude of helpfulness, a focus on team success, and the consideration of ideas from others. Required Education and Experience Bachelor's degree in accounting or a relevant field required or equivalent combination of education and work experience. Accounting course work and credit hour requirements (150) to achieve the CPA certification preferred. A dedication to teamwork and leadership Effective verbal and written communication skills Ability to handle multiple tasks simultaneously. Possesses a high level of integrity and ability to respect confidentiality. Enthusiastic and self-motivated Demonstrated time and work management skills necessary to manage a complex workload Benefits & Perks We believe that real effort should be rewarded. That is why YHB is investing in our people and fostering a supportive, rewarding work environment. As part of our team, you will enjoy: Competitive Compensation & Rewards: Market-competitive salary with performance-based bonuses. Retirement savings plan with a 401(k) & profit-sharing plan. Comprehensive Health & Wellness: Health, dental, and vision insurance. Wellness programs and employee assistance programs (EAP). Paid parental leave and family support. Professional Development: Learning and development opportunities. Tuition reimbursement. CPA exam support, certification reimbursements, and mentorship programs. Internal promotions and career pathing opportunities. Work-Life Balance: Generous paid time off (PTO) and holidays. Flexible work arrangements (hybrid/remote options available). Engaging Work Culture: Collaborative and inclusive work environment. Employee resource groups and diversity initiatives. Social events, team-building activities, and volunteer opportunities. YHB is strongly committed to providing equal employment opportunity for all employees and all applicants for employment. For us, this is the only acceptable way to do business!

Provides clerical and administrative support related to documentation processes and systems. Creates logbooks and other control issued documents. Assists in maintaining the document archival room. Responsible for filing and maintenance of controlled documents and records. Ensures files are accurate and easily retrievable. Scans, verifies and archives documentation and records. Performs general word processing tasks and support ensuring accuracy. Ensure the correct and timely input of database entries. Data input accuracy is critical. Participates in training on issues affecting own area of work. Notifies manager of compliance questions and issues. Provides additional support and assistance on tasks and projects as directed by management. Skills Critical to this Job: Attention to detail Ability to multitask Organizational skills Typing and computer skills Verbal and written communication Educational Requirements: High school diploma or equivalent required. Bachelors degree in a related field is preferred.

The MEP QC works closely with the project team, supporting and assisting the QC Manager, Project Manager and Project Superintendent in the management and administration of all facets of the project's mechanical, electrical, plumbing/piping, and fire protection operations. Job Duties: * Assess sub-contractors' capabilities to meet the quality requirements of the project as required. * Responsibility for the performance of all MEP inspection and testing activities. * On Design-Build projects, assist with design reviews and contract document/code conformance. * Complete responsibility for the entire MEP & FP submittal process. * Assure that the contract obligations' for testing and record keeping are adhered to. * Control calibrated measuring and test equipment used on the project. * Keep calibration records and ensure that all testing equipment has current calibration records. Ensure proper turnover of complete quality control package(s). Responsible for ensuring that turnover documentation is maintained, organized and turned over on schedule. * Maintain project quality records for the construction phase of the project and quality audit plans, performance and management thereof. * Perform evaluations of sub-contractors' facilities to determine their capabilities in meeting the quality requirements. * Conduct periodic Quality Program training for site supervisory personnel. * All other duties as normally required by our QC Department, and as required by day-to-day business. * Work with in precise limits and standards of accuracy * Work within the BLHI company policy, BLHI Safety Manual and OSHA Safety rules. Perform other duties as assigned by the supervisor as needed. Requirements: * Five (5) years of formal training and experience on industrial, commercial, or federal projects. * Must have a comprehensive understanding of mechanical, electrical, plumbing and controls systems as it pertains to installation, coordination, operation, and start-up and commissioning. * Ability to effectively interact with project team members, clients, subcontractors, and craft employees. * Must be capable of obtaining or possess inspection licenses and/or certifications as required