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Who you are: You are a detail-oriented and proactive team player who thrives in a fast-paced, collaborative environment. You are eager to learn, organized, and ready to support cross-functional projects from initiation to completion. You bring strong communication skills, a growth mindset, and a passion for delivering results. What you will do: • Support project planning, scheduling, and documentation across multiple workstreams., • Tracking project milestones, deliverables, and dependencies., • Coordinate & lead meetings, prepare agendas, and capture action items., • Collaborate with internal teams and external vendors to ensure timely execution., • Help monitor risks and escalate issues to senior project leads., • Maintain project dashboards and status reports for leadership visibility., • Contribute to process improvement initiatives and team retrospectives. You Will Need to Have: • 3–5 years of hands-on project management experience in Retail Operations., • Strong background leading projects involving retail POS or retail technology platforms (Aptos experience strongly preferred – Aptos Store or Aptos One with understanding of related Sales Audit/CRM/POS ecosystems)., • Experience coordinating cross-functional teams across regions/time zones; global project experience is a strong plus., • Familiarity with project management tools (e.g., Smartsheet, Jira, Asana, MS Project, Microsoft Suite)., • Strong organizational and time management skills., • Excellent written and verbal communication., • Ability to manage multiple priorities and meet deadlines., • Strong problem-solving and critical-thinking skills., • Bachelor’s degree in business, project management, or related field preferred., • Experience in Retail Industry, • Willing to go occasionally to NYC office to directly support Retail Business partners We’d Would Love to See: • Solid understanding of software development lifecycle, QA, UAT, and deployment processes—especially in retail tech environments., • Ability to manage multiple workstreams, track milestones, identify risks, and drive issue resolution proactively., • Strong communication skills and confidence working with internal teams, external vendors, and global partners., • Comfortable managing evolving requirements and shifting priorities in a fast-paced environment; highly adaptable and flexible., • Exposure to retail systems (POS), eCommerce, or IT project environments., • Experience managing Business and IT Stakeholders, • Anticipate and address potential roadblocks, escalating when necessary, • Basic functional understanding of Agile and Waterfall methodologies., • Project management certifications (PMP, CSM) are a plus but not required. Capri Perks: • Generous Paid Time Off & Holiday Calendar, • Summer Fridays, • Internal Mobility Across Brands, • Cross-brand Discount, • Exclusive Employee Sales, • Fav 5 Cards (MK Discount for friends and family), • 401k Match, • Paid Parental Leave, • Thrive Wellness Program, • Commuter Benefits, • Gym Discounts CAPRI HOLDINGS is a global fashion luxury group consisting of iconic, founder-led brands Jimmy Choo and Michael Kors. Our commitment to glamorous style and craftsmanship is at the heart of each brand, as we design innovative products across the full spectrum of fashion luxury categories. The unique DNA and heritage of each brand, combined with the diversity and passion of our people, and our dedication to clients and communities, define our success. The Company is an equal employment opportunity employer. The Company’s policy is not to unlawfully discriminate against any applicant or employee on the basis of race, color, sex, sexual orientation, gender identity, religion, national origin, age, military status, disability, genetic information or any other consideration made unlawful by applicable federal, state, or local laws. The Company also prohibits harassment of applicants and employees based on any of these protected categories. At Capri Holdings Limited, we are committed to providing a fair and accessible recruitment process. If you require a reasonable accommodation for the interview or application process, please contact our Talent Acquisition team at . In compliance with certain Pay Transparency laws, employers are required to disclose a salary range. The salary for this position will vary based on role requirements, skill set and years of experience.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The primary purpose of this position is to lead, develop, establish, and maintain quality engineering policies, processes, procedures and controls ensuring that design, development, performance and quality of products conform to internal specifications and established standards. Coordinates with stakeholders in R&D and Manufacturing to assure design quality and accuracy in both new and sustaining product development. Responsible to manage and maintain product Risk Files. Leads Health Hazard Evaluations (HHEs) to help assess product performance risk to enable appropriate Field Action decisions. Maintains oversight and upkeep of Field Action Plans. Job Responsibilities and Essential Duties • Define, maintain, and revise processes, and QMS procedures to ensure company and products comply with applicable regulations and laws. Specifically for Design Controls, Risk Management, HHE, Field Actions and Test Method Validations., • Provide guidance throughout product development lifecycle focusing on areas of Design Controls and Risk Management, ensuring compliance to 21 CFR 820 and ISO 13485., • Review Design Input, Output and verification artefacts to ensure Customer Requirements are translated to feasible technical solutions with an acceptable risk., • Provide quality oversight during new product development (NPD) and design changes, ensuring risk-based decision-making., • Support design verification and validation (V&V) activities, including test method validation, failure investigations, and nonconformance resolution. Oversee validation of software used in medical devices (embedded, standalone, SaMD). Review and approve software validation, • plans, protocols, and reports to ensure regulatory compliance and product safety. Work with cross-functional teams to assess the impact of software changes, patches, and updates on device safety and performance., • Support and Lead (when appropriate) product quality investigations, driving root cause analysis and corrective actions., • Provide support to project teams in the use of data analysis tools such as DFSS and DOE. Lead effort in data driven decision making activities., • Establish, implement, and maintain a comprehensive Risk Management process in accordance with ISO 14971 and global regulatory requirements., • Own and manage product risk files, ensuring continuous updates throughout the product lifecycle., • Partner with R&D and Regulatory teams to ensure risk-benefit analysis aligns with regulatory submissions and post-market feedback., • Drive Failure Modes and Effects Analysis (FMEA) sessions to proactively identify and mitigate design, process, and use-related risks., • Lead the Health Hazard Evaluation (HHE) process, ensuring thorough risk assessment for field issues, complaints, and potential recalls., • Drive decision-making for field actions, including recalls, corrections, and removals, in compliance with global regulatory expectations., • Work cross-functionally with Regulatory, Medical Affairs, and Legal teams to develop risk mitigation strategies and regulatory submissions for field actions., • Support internal and external audits, including FDA, Notified Body, and MDSAP audits, ensuring a state of continuous inspection readiness., • Monitor the effectiveness of document control & records control processes are developed and maintained., • Establish quality metrics and KPIs (for processed under assigned responsibility) to track product/process performance and effectiveness of quality initiatives (when applicable)., • Identify and lead continuous improvement projects and CAPAs and HHE's. Ensure adequate follow-up through the implementation of corrective and preventive actions as appropriate., • Ensure that the conformity of the devices is appropriately checked, in accordance with the Quality Management System under which the devices are manufactured, before a device is released to comply with Article 15 of European Union Medical Device Regulation (EU MDR) (Regulation (EU) 2017/745 of the European Parliament and of the council of 05 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC)., • Collaborate with post-market surveillance teams to assess field performance and identify opportunities for product improvements., • Support post-market surveillance activities to ensure compliance with Article 10(10) of European Union Medical Device Regulation (EU MDR) (Regulation (EU) 2017/745 of the European Parliament and of the council of 05 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC). Ensure any new risks identified in this effort are reflected in the Risk Management File in a timely manner. ___Minimum Requirements • Bachelor's Degree in Science or Engineering or equivalent combination of education and experience., • A Master's of Science in Engineering, Science or related field is preferred., • A minimum of 7 years' experience in design controls, related experience in QA in a Medical Device manufacturing environment. Sterile disposable experience a plus., • Knowledge of process, equipment and software validation., • Previous background and experience in Quality Assurance and Manufacturing., • Strong knowledge and experience in 21 CFR part 820, ISO 13485 and other related regulatory requirements., • Successful interactions and experience with regulatory agencies., • Good knowledge of statistics and practical application of the QSR and ISO 13485. Required Knowledge, Skills and Abilities • Solid Project Management and Leadership experience is required., • Experience in FDA regulated industry or ISO certified organization., • Demonstrated proficiency in Statistical analysis, ability to analyze and solve complex problems, proficient with analytical software applications and the ability to communicate effectively across departments, with R&D and Manufacturing., • Experience in design controls, sustaining engineering, and post-market surveillance., • Experience in risk management, including FMEA and maintaining product risk files., • Strong problem-solving skills with experience in root cause analysis and CAPA., • Experience with regulatory audits and inspections (FDA, Notified Body, MDSAP, etc.), • Strong knowledge of ISO 13485, FDA 21 CFR Part 820, 21 CFR 806, ISO 14971, IEC 62304, MDR 2017/745, and other global regulatory requirements., • Experience with sterile and electro-mechanical medical devices, including applicable standards (ISO 11135, ISO11607-1, IEC 60601)., • Experience in conducting and participating in FDA/Customer/corporate audits., • Excellent leadership, communication, and cross-functional collaboration skills., • Proficiency in using tools like MINITAB, SAP or equivalent software applications. Salary Range: $140-165k plus 15% bonus (depending on overall company performance) #LI-LG1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Principal Quality Auditor plays a vital role in leading and participating in internal and external audits within the medical device industry. This position ensures compliance with medical device regulations including, but not limited to ISO 13485, ISO 14971, 21 CFR Part 820. The auditor brings expert knowledge from prior roles leading audits and driving compliance improvements, risk management, and regulatory adherence. The position requires strong leadership in audit planning, execution, reporting, and follow-up, as well as mentoring audit teams and liaising with regulatory agencies. Job Responsibilities and Essential Duties • Lead and execute comprehensive audits of quality systems and processes to ensure compliance with ISO 13485, ISO 14971, 21 CFR Part 820, EU MDR, etc., • Participate in and lead FDA and Notified Body audits, including audit planning, execution, reporting, and corrective action follow-up., • Evaluate Quality Management Systems (QMS) for effectiveness, regulatory compliance, and risk management integration., • Assess and verify compliance with risk management standards (ISO 14971) and reporting requirements (21 CFR Part 803 Medical Device Reporting)., • Conduct audits on various QMS elements such as design controls, complaint handling, CAPA systems, supplier controls, and production processes., • Review and approve audit reports, findings, and CAPA plans to ensure timely and effective resolution of nonconformities., • Provide training and mentorship to internal audit teams to build auditor competency and ensure consistency., • Collaborate with cross-functional teams (Regulatory Affairs, QA, R&D, Manufacturing) to drive audit readiness and regulatory compliance., • Serve as a subject matter expert representing the company during regulatory inspections and notified body assessments., • Maintain up-to-date knowledge of regulatory changes and communicate their impact on quality systems and audit processes., • Facilitate internal audits and risk assessments to support continuous improvement and regulatory compliance readiness., • Bachelor's degree in Engineering, Science, or equivalent; advanced degree preferred., • Minimum of 7 years of quality auditing experience in the medical device industry, including direct audit leadership at FDA or Notified Bodies preferred., • Deep expertise in ISO 13485, ISO 14971, and 21 CFR Part 820 regulations., • Certified Quality Auditor (CQA) or equivalent ISO 13485 Lead Auditor Certification preferred., • Proven experience in planning, conducting, and leading regulatory audits and inspections., • Strong knowledge of risk management principles and medical device regulatory reporting requirements., • Excellent ability to analyze complex quality systems and processes and identify compliance gaps., • Strong communication skills to effectively present audit results and influence corrective action implementation., • Proficiency with quality management software tools and Microsoft Office. Salary range: $155k - $165k #LI-LG1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

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Job DescriptionSr. Manager Quality Assurance Validation Computerization Systems The incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • Bachelor’s Degree in a Scientific or Engineering discipline, • 8 + years of computerized system experience with IT compliance/validation/qualification activities., • 8 + years of experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • 10% travel required., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionThe incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • Bachelor’s Degree in a Scientific or Engineering discipline, • 8 + years of computerized system experience with IT compliance/validation/qualification activities., • 8 + years of experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • 10% travel required., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionQuality Assurance Manager The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs.The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. • The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes., • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality AgreementsREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Travel may be required, • Strong business acumen, • Experience with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential, • Flexible and able to adapt to company growth and evolving responsibilitiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionJob Title: Lab Technician Job Description This role performs routine and non-routine analytical testing on food samples to ensure product safety, quality, and compliance with established standards. The lab technician conducts chemical and microbiological analyses, maintains accurate documentation in line with GMP, SOP, and HACCP requirements, and supports quality assurance activities within a food industry environment. The position contributes to continuous improvement of testing methods and laboratory workflows while strictly adhering to safety, quality, and regulatory guidelines. Responsibilities • Perform routine and non-routine analytical tests on samples using standard laboratory equipment to measure pH, moisture, temperature, weight, and microbiological safety., • Carry out microbiological analyses on food ingredients and products to support product safety and compliance with quality standards., • Maintain accurate, complete, and timely records of all test results and laboratory activities in accordance with GMP, SOPs, and HACCP requirements., • Follow established laboratory procedures, quality assurance protocols, and quality control methods to ensure reliable and reproducible test results., • Support cross-functional investigations by providing analytical data, documentation, and technical insight as needed., • Contribute to continuous improvement initiatives by identifying opportunities to enhance testing methods, documentation practices, and laboratory workflows., • Ensure laboratory equipment is used correctly, handled safely, calibrated as required, and maintained in good working condition., • Adhere to all safety, quality, and regulatory guidelines while working in the laboratory., • Collaborate with quality assurance and other teams to support testing of food ingredients for QA purposes., • Document and communicate test findings clearly to relevant stakeholders in a timely manner.Essential Skills, • Demonstrated ability to perform routine and non-routine analytical tests using standard laboratory equipment to measure pH, moisture, temperature, weight, and microbiological safety., • Experience in quality assurance or quality control within the food industry, or a food science degree (open to recent graduates)., • Hands-on experience with HACCP and the ability to work in accordance with HACCP requirements., • Skills in testing food ingredients for quality assurance purposes., • Foundational knowledge of chemistry and microbiology as applied in a laboratory setting., • Strong documentation skills with the ability to maintain accurate, complete, and timely records in line with GMP and SOPs., • Ability to follow established laboratory procedures and quality assurance protocols., • Attention to detail and strong analytical mindset for interpreting test results., • Ability to work effectively in a laboratory environment and handle chemical and microbiological materials safely.Additional Skills & Qualifications, • Food science degree or related scientific discipline, particularly suited to recent graduates seeking a laboratory-based role., • Prior quality assurance experience in the food industry., • SQF experience or familiarity with SQF standards, preferred., • Experience with microbiological testing methods for food products and ingredients., • Bilingual communication skills, which can support collaboration and documentation., • General chemistry laboratory experience, including safe handling of chemicals and use of standard lab equipment., • Experience working under formal quality systems such as GMP, SOPs, and HACCP., • Strong organizational skills and the ability to manage multiple tests and documentation requirements concurrently.Work Environment This position operates in a laboratory environment within the food industry, working primarily with chemical and microbiological testing of food ingredients and products. The role is scheduled on a second shift, Monday through Friday from 2:30 p.m. to 11:00 p.m. The lab uses standard analytical equipment for measuring pH, moisture, temperature, weight, and microbiological safety, and follows structured quality systems such as GMP, SOPs, HACCP, and potentially SQF. Team members adhere to strict safety, quality, and regulatory guidelines while handling samples, reagents, and equipment. The work environment emphasizes precision, cleanliness, and compliance with established laboratory and quality assurance procedures. Job Type & Location This is a Contract position based out of Elmwood Park, NJ. Pay and Benefits The pay range for this position is $17.00 - $20.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program • Hiring diverse talent, • Maintaining an inclusive environment through persistent self-reflection, • Building a culture of care, engagement, and recognition with clear outcomes Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Job Description Bluu Inc., founded in 2007, is a end-to-end POS hardware service provider for merchants nationwide. Bluu Inc. is a leader in developing innovative POS software. Currently, Bluu Inc. hardware is installed in more than 10,000 locations, and has been the product of choice by many international franchise retailers. Location: Hackensack, NJ Employment Type: Full-time About the Role: We are seeking a detail-oriented and motivated QA Coordinatorto join our team. The ideal candidate will be responsible for creating, documenting, and executing system test plans and test scripts, as well as validating data and analyzing test results. This role involves identifying, reporting, and tracking software issues, and communicating findings and progress updates with our software development team in Korea. Key Responsibilities: * Develop, document, and execute comprehensive system test plans and test scripts. * Perform data validation and analyze test results to ensure software quality. * Record, report, track, and retest bugs found during testing. * Collaborate and communicate effectively with software developers in Korea to resolve issues. * Support continuous improvement of testing processes and documentation. Qualifications: * Bachelor’s degree in Computer Science or a related field. * Bilingual proficiency in Korean and English (both written and verbal). * 1–2 years of experience in system testing of Windows-based Point of Sales (POS) software. * Hands-on experience with PC POS peripherals such as printers, barcode scanners, customer displays (CDP), and dot matrix printers. * Strong analytical, problem-solving, and communication skills. * High attention to detail and ability to work in a fast-paced environment. Benefits: Group Health Insurance (Medical, Dental, Vision) Employer paid Life Insurance Paid Sick and Vacation 401K with 3% matching Gym Reimbursement Company Lunch Please visit our website for more information

Job DescriptionIs This You? • Do you spot a defect in seconds and love proving it with crisp documentation?, • Do you enjoy collaborating with suppliers to keep materials compliant?, • Inspect inbound goods against defined specifications and acceptance standards., • Record and report nonconformances, defects, and discrepancies immediately., • Partner with suppliers to resolve issues and ensure ongoing compliance., • Conduct periodic audits of receiving processes to maintain quality rigor., • Assist in creating, refining, and implementing QA protocols., • Keep thorough inspection records and quality assessment documentation., • Share insights and best practices during team discussions to improve outcomes.You Have, • High school diploma or equivalent (extra QA education is a plus)., • Background in quality or receiving (preferred)., • Strong attention to detail and sharp observation., • Ability to work independently and contribute in a team setting., • Knowledge of QC methodologies and tools., • Effective written and verbal communication.

Job DescriptionQuality Assurance Manager (Compliance)Allendale, NJ The Manager, Quality Assurance manages the PPU support unit services of the QA Department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs. The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. • The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes., • Start-up Compliance arm of the Quality Assurance Department., • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality AgreementsREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Travel may be required, • Strong business acumen, • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionQuality Assurance ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs. The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes. • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements, • Travel may be requiredREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Strong business acumen, • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential, • Flexible and able to adapt to company growth and evolving responsibilitiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionCompany Description For More Open Positions Visit us at: Our Mission WOONGJIN, Inc. is a rapidly growing team who provides a range of unique, exceptional, and enhanced services to our clients. We have a strong moral code that includes the service of goodness without expectations of reward. We are motivated by the sense of responsibility and servant leadership. Benefits • Medical Insurance, • Vision Insurance, • Dental Insurance, • 401(k), • Paid Sick hoursJob Description We have established internal Development and Operations teams who are eager to adopt this technology, but we need an experienced OutSystems Platform Architect to lead the way. As the "conductor" of this transition, you will not just be building apps; you will lay the foundational architecture, establish enterprise-wide governance, and serve as the primary mentor for our internal teams. If you are passionate about standardizing low-code environments, preventing technical debt, and upskilling traditional developers, this is the perfect role for you. Key Responsibilities • Platform Architecture & Governance: Design and implement a scalable, enterprise-grade architecture using the OutSystems 4-Layer Canvas methodology. Establish coding standards, naming conventions, and UI/UX guidelines to prevent "spaghetti architecture.", • Migration Strategy & Integration: Lead the strategy for migrating complex legacy business logic to OutSystems. Design secure and efficient integrations with external databases, third-party APIs (REST/SOAP), and build custom C#/.NET extensions using Integration Studio when out-of-the-box features are insufficient., • CI/CD & DevOps Collaboration: Work closely with our internal Operations team to configure and manage deployment pipelines (Dev, QA, Prod) via OutSystems LifeTime. Establish robust release management and version control policies., • Team Mentorship & Code Review: Act as the subject matter expert and mentor for our internal Development and Ops teams who are new to OutSystems. Conduct regular code reviews, monitor the Architecture Dashboard, and ensure the team adheres to best practices. Qualifications • Experience: 10+ years of experience in software engineering, with at least 5+ years of hands-on experience designing and delivering enterprise solutions specifically on the OutSystems platform., • Certifications: Active OutSystems Architecture Specialist certification (or proven equivalent architectural experience)., • Technical Skills: * Strong proficiency in relational database design and SQL query optimization (SQL Server, Oracle, etc.)., • Hands-on experience with C# and .NET for building custom OutSystems extensions., • Solid understanding of modern web technologies (HTML, CSS, JavaScript)., • Work Arrangement: Must be located in New Jersey or the Greater NYC area with the ability to reliably commute to our [Ramsey, NJ] office [5 days a week / 3 days a week]., • OutSystems Professional or Expert Developer certifications., • Experience setting up or leading a Low-Code Center of Excellence (CoE)., • Strong understanding of enterprise IT infrastructure and security protocols (SSO, Active Directory, OAuth). Additional Information All your information will be kept confidential according to EEO guidelines. * NO C2C *

Job DescriptionSalary: At Phillip Jeffries, we believe beautiful design begins with passion, integrity, and connection. What started in 1976 as a small family business with just ten grasscloths in a New Jersey garage has grown into a global luxury brand offering more than 1,000 wallcoverings to designers and architects around the world. Through decades of growth, our values remain the foundation of everything we do. We are committed to craftsmanship, creativity, and delivering exceptional experiences at every touchpoint. The Development Coordinator plays a key role in bringing software enhancements to life by supporting work from early planning through deployment. In this highly collaborative position, youll partner closely with developers, QA, and business stakeholders to keep initiatives moving forward, ensure tasks are clearly defined, and maintain visibility into progress and priorities. Your coordination and attention to detail help create smoother handoffs, well-prepared releases, and high-quality outcomes that directly support the business. This role operates on a hybrid schedule, combining on-site collaboration with remote work. What You Will Be Doing Development Coordination • Partner with the Development Manager and technical teams to prepare approved development tasks, documenting scope, requirements, and acceptance criteria., • Coordinate and track development work across multiple teams, keeping task status current and aligned with the release schedule., • Monitor progress and proactively share updates, risks, and potential blockers with the Development Manager and stakeholders., • Collaborate with developers and QA to gather and document development effort estimates., • Review completed development work to ensure its complete, well-documented, and ready to move smoothly into Quality Assurance (QA) testing. Deployments • Help prepare deployments by organizing documentation, tickets, release notes, and supporting materials., • Work closely with developers and QA to confirm all release items have successfully completed required testing phases., • Support deployment readiness by verifying checklist completion and ensuring all criteria are met ahead of scheduled release windows., • Communicate release scope, progress, and potential risks to the Development Manager and key stakeholders., • Capture post-deployment observations, issues, and follow-up actions to support continuous improvement., • Assist with deployment preparation activities and help coordinate logistics with designated deployment resources. Support and Advisory • Serve as a go-to coordination partner for developers by helping address enhancement-related questions and facilitating follow-up when needed., • Spot potential risks or concerns early in the development process and escalate complex or high-impact issues appropriately., • Reinforce established development standards, workflows, and best practices across assigned work., • Help keep communication flowing between developers, QA, and stakeholders to ensure alignment and timely resolution of questions., • Share knowledge related to tools, processes, and documentation practices to support team efficiency and consistency. Continuous Improvement • Support ongoing adherence to development and IT project management processes., • Provide feedback and insights on coordination, communication, and workflow opportunities to the Development Manager., • Assist with rolling out approved process improvements, including updates to tools, templates, and documentation standards., • Track and report key metrics related to task progress, estimation accuracy, and QA readiness., • Stay current on industry tools, practices, and trends and bring forward ideas that could benefit the team., • Participate in training, workshops, or seminars to continue building technical and operational skills. What You Bring to the Table • Bachelor's degree in Computer Science or a related field, or equivalent experience, • Minimum of 2-4 years of experience in software development, QA or technical coordination, • Working knowledge of programming concepts (Power Platform, PHP, Ruby on Rails, and Angular), • Experience in project management methodologies and tools, such as Agile or Scrum, • Exposure to version control and DevOps practices, • Information Technology Infrastructure Library (ITIL) Certification would be ideal, • Strong organizational and communication skills, with a collaborative approach to coordinating work across teams., • Ability to work a hybrid schedule with atleast 3 days onsite our Fairfield, NJ location The Phillip Jeffries Experience At Phillip Jeffries, we believe exceptional work deserves exceptional care. Our commitment to creating a more beautiful world extends to how we support our team, offering thoughtfully designed benefits and meaningful perks that reflect our appreciation for your talent and time. Your Compensation Journey • Competitive salary wage ranging from$100,000 to $115,000,based on your experience and technical expertise, • Annual bonus opportunity to reward your performance, • Cost of Living increases that honor your growth and commitment, • Comprehensive medical coverage with employee premiums as low as $40 per month, • Coverage options for spouse, domestic partner, civil union partner, and family, • Health Reimbursement Account (HRA) to offset medical expenses, • Prescription, dental, and vision coverage to support whole-person wellness, • Flexible Spending Accounts (FSAs) for healthcare and dependent care, • Employee Assistance Program that supports your mental, financial, and physical well-being, • 16 paid personal days each year to relax, recharge, or travel, • Paid holidays including New Years Day, Martin Luther King Jr. Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, the day after Thanksgiving, Christmas Eve, Christmas Day, and New Years Eve, • Additional paid time off during our annual company closure between Christmas and New Years, • Earn extra paid time off by completing your annual wellness physical, • Exclusive employee discount on Phillip Jeffries wallcoverings to elevate your home, • Access to Working Advantage with discounts on travel, entertainment, and everyday purchases Phillip Jeffries is an Equal Opportunity Employer committed to diversity, inclusion, and equality in the workplace. All qualified applicants will receive consideration for employment without regard to sex, race, color, age, national origin, religion, physical and mental disability, genetic information, marital status, sexual orientation, gender identity/assignment, citizenship, pregnancy or maternity, protected veteran status, or any other status prohibited by applicable national, federal, state or local law.

Sr QA Automation Engineer/Test Lead / Software >.

Join Our Team as a Website Tester at Little Wheel Little Wheel is a gambling technology company focused on researching and building products that put players first.We are currently hiring Website Testers across Michigan, New Jersey, Pennsylvania, and West Virginia.This is a great opportunity to earn

Participate/ Lead validation and verification activities for manufacturing processes, equipment, and software systems to ensure they meet quality and regulatory requirements. Proficiency in Microsoft Office Products such as Word, Excel, or equivalent software applications.

Join Our Team as a Website Tester at Little Wheel.Little Wheel is a gambling technology company focused on researching and building products that put players first.We are currently hiring Website Testers across Michigan, New Jersey, Pennsylvania, and West Virginia.This is a great opportunity to earn

This role is responsible for designing, developing, and maintaining automated test suites to ensure the reliability, performance, and scalability of our software products. Solid understanding of software testing methodologies and the.

Join Our Team as a Website Tester at Little Wheel Little Wheel is a gambling technology company focused on researching and building products that put players first.We are currently hiring Website Testers across Michigan, New Jersey, Pennsylvania, and West Virginia.This is a great opportunity to earn

Role: QA Automation Engineer - OTT. QA Automation testing experience.

Join Our Team as a Website Tester at Little Wheel.Little Wheel is a gambling technology company focused on researching and building products that put players first.We are currently hiring Website Testers across Michigan, New Jersey, Pennsylvania, and West Virginia.This is a great opportunity to earn

Certifications: CMM Certification on Zeiss Calypso Other technologies/inspection instrumentation Structured Light Systems: Experience using structured light machines and performing analysis preferably using the Zeiss Inspection Software. Zeiss Calypso software, CMM programming, measurement uncertain

Join Our Team as a Website Tester at Little Wheel.Little Wheel is a gambling technology company focused on researching and building products that put players first.We are currently hiring Website Testers across Michigan, New Jersey, Pennsylvania, and West Virginia.This is a great opportunity to earn

A tech company specializing in IT services is seeking a Senior Software Engineer based in New Jersey.

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Software Engineer page is loaded## Software Engineerlocations: Secaucus, New Jerseytime type: Full timeposted on: Posted Yesterdayjob requisition id: R0011051Software Engineer - We offer competitive benefits!The Location: Secaucus, New Jersey. We offer medical, dental, vision and mat

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Solid understanding of software architecture, design patterns, and microservice principles. Bachelor's degree in Computer Science, Software Engineering, or a related field preferred – but proven experience and demonstrable skills are valued equally.

AI/ML or software development with AI/LLM projects.

Software Engineering/Development: 3D Graphics Software Engineer. Understanding of scientific visualization, simulation software, or game engine architecture. C++ with experience in real-time 3D rendering using the OpenGL with a good understanding of the software lifecycle, the ability to work in a f

If you're passionate about solving complex problems at the intersection of software, hardware, and AI, there's never been a more exciting time to join our team.

IRIS Americas is seeking a skilled Senior Software Engineer (. Experience in mentoring, guiding, and supporting junior software engineers. Mentor and support junior software engineers, fostering a culture of knowledge sharing and growth.

As a Senior Software Engineer on the Models team, you will build core features that directly improve how ML engineers interact with and understand their experiment data.

Sr QA Automation Engineer/Test Lead / Software >.

Build and maintain a unified React, TypeScript, and Next.Design and implement RESTful APIs that expose device operations, telemetry, and configuration to the web console.Integrate with distributed backend microservices to surface real-time hardware telemetry, job scheduling, and system status in the

About the Opportunity_**A leading AI research organization is seeking expert software engineers with deep, hands-on experience in one or more specialized programming languages — Scala, COBOL, ABAP, Verilog, Fortran, or Slang — to contribute to a high-impact technical evaluation initiative.

Experience with software architecture, distributed systems, and enterprise application design.