Quality assurance specialist jobs in Levittown, PA

Preferred Experience: Experience with testing and testing tools. Drupal 10/11 Experience with writing automated tests Experience with Playwright Troubleshooting and debugging skills Manual testing Drupal Site Building Experience with version control and package management tools. Experience with PHP, HTMLS, CSS3, SASS, Twig GitHub Repo/Projects Code review and deployment Demonstrated understanding of accessibility standards and best practices for inclusive ---web development. Ability to write secure code and tests following Drupal coding standards and security guidelines. Example of Duties: Develop, apply, and implement tests and automated testing. Troubleshoot issues and provide insights on how to solve. Keeping tests up to date with latest code changes and deployments. Collaborate with other team members and teams on projects to plan, develop, test, deploy, support, and enhance Drupal websites. Work independently and efficiently as required. Communicate and meet with management and stake holders to get a better understanding of business requirements. Implement best practices and standards for website accessibility according to the latest published guidelines. Participate in code quality checks and deployment processes. Work directly with cloud platform vendors and infrastructure support teams to create and manage cloud-hosted website environments and code repositories. Perform code updates to ensure websites remain stable and secure. Stay up to date with the latest in Drupal developments and trends. Provide guidance and mentorship to team members regarding best practices and efficient use of Drupal. Ensure all websites meet Judiciary standards for information security. Required Skills Experience in Drupal site building, features, and theming - 4 Years Working experience with Drupal 10/11 ecosystem (Git, Composer, TWIG) and Playwright - 4 Years Understanding of Drupal architecture and ability to develop site testing strategy - 4 Years Experience with Drupal UI development, UX, theme development, and community theme customization - 4 Years Ability to code/debug in PHP, HTML, CSS, JavaScript/jQuery - 4 Years Experience working in iterative development (Jira, GitHub Projects, Agile, SCRUM) - 4 Years Keeping tests updated with latest code changes - 6 Years Experience with advanced PHP frameworks/workflows (Symfony, Composer) - 6 Years Bachelor's Degree - Required Desired Skills Acquia Drupal Developer Certification - 4 Years Familiarity with Acquia tools (Cloud IDE, Acquia Pipelines, BLT, DDEV, Acquia Cloud) - 5 Years

JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

HCLTech is looking for a highly talented and self-motivated GxP Test Lead to join it in advancing the technological world through innovation and creativity. Job Title: GxP Test Lead Position Type: Full-time Location: King of Prussia, PA (Onsite) Role/Responsibilities AWS Cloud Migration. Database Migration. Qualifications & Experience Minimum Requirements Hands on experience with AWS Cloud migration testing. Hands-on experience in Data base and migration testing strategies. Must have life sciences and GxP application testing experience. Experience in handling large programs with multiple applications. Must be able to develop comprehensive migration planning. Experience in working in a multi-vendor environment. Experienced in agile methodology and tools. Must have Pharma, Life Science domain exp. Must have good communication skills. Education: Bachelor's degree in computer science, Sciences or a related education (e.g. life science, medicine) , master's preferable. Pay and Benefits Pay Range Minimum: $ 65000 per year Pay Range Maximum: $ 133100 per year HCLTech is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to ****************** for investigation. Compensation and Benefits A candidate's pay within the range will depend on their work location, skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year. How You'll Grow At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.

e&e is seeking a Lead Data QA for a hybrid contract opportunity in Philadelphia, PA! The Lead Data QA is responsible for defining and driving the overall Data Quality Assurance strategy for enterprise-scale data platforms. This role ensures that all data systems meet rigorous standards for accuracy, performance, integration, security, and compliance. The Lead Data QA will provide leadership and mentorship to a team of data QA analysts and testers, establish quality frameworks for ETL/ELT pipelines, and integrate automation within Azure Data Factory (ADF), Databricks, and Snowflake environments. The ideal candidate possesses a deep understanding of data engineering, automation frameworks, and regulatory data compliance (HIPAA, CMS) within modern cloud architectures. Responsibilities: Leadership & Strategy Define and own the enterprise Data QA strategy encompassing functional, non-functional, integration, and performance testing. Lead and mentor a distributed team of Data QA professionals across multiple programs and data initiatives. Establish and maintain data quality SLAs, KPIs, and dashboards for critical datasets. Collaborate with data governance, engineering, and architecture teams to embed QA best practices across the data lifecycle. Data Testing & Validation Design and implement automated test plans, scripts, and frameworks for ELT/ETL pipelines. Validate complex payer datasets including claims, membership, provider, and clinical data. Conduct FHIR-based API testing for CMS interoperability and compliance standards. Verify HEDIS measure calculations, healthcare quality metrics, and performance data accuracy. Log and track defects using appropriate QA tools; provide detailed feedback to engineering and architecture teams. Automation Strategy & Framework Develop and implement a data QA automation framework for Databricks (Delta Live Tables, Delta constraints) and ADF pipelines. Utilize Great Expectations for reusable validation suites integrated into CI/CD workflows. Embed automated schema validation, reconciliation logic, and drift detection into data pipeline operations. CI/CD Integration Develop QA gates and automated quality checks within Azure DevOps pipelines for Databricks Jobs/DLT, SQL metadata, and ADF deployments. Collaborate with DevOps and Engineering teams to embed QA automation into continuous integration and deployment processes. Technical Delivery Partner with ADF, Databricks, and Snowflake teams to ensure end-to-end data quality. Build and maintain automation frameworks leveraging Python, PySpark, and SQL. Participate in code reviews, data model validation, and regression testing across environments. Work with business and data governance teams to identify, investigate, and remediate data quality issues. Performance & Compliance Design and execute automated load and stress tests for large-scale pipelines and dataflows. Ensure all data QA processes align with HIPAA, CMS, and payer industry compliance standards. Support audits through proper documentation of QA processes, test results, and lineage verification. Requirements: Education: Bachelor's or Master's degree in Computer Science, Data Engineering, Information Systems, or a related field. Experience & Skills: 10+ years of experience in Data QA/Testing, with at least 5 years in a leadership capacity. Strong proficiency with Azure Databricks (Delta Lake, Delta Live Tables, Unity Catalog). Hands-on experience with Azure Data Factory pipelines, monitoring, and CI/CD deployment. Advanced skills in Python, PySpark, and SQL for test automation. Experience with Great Expectations, Azure DevOps, and data quality automation frameworks. Familiarity with data governance, PII compliance, and enterprise data quality frameworks. Proven success integrating QA practices into DevOps pipelines within cloud data environments. Excellent communication, leadership, and cross-functional collaboration abilities. Experience in Agile/Scrum environments is a plus. Preferred Qualifications: Experience with HL7/FHIR data models beyond payer use cases. Knowledge of Lakehouse and medallion architecture Familiarity with BI validation using Power BI or Tableau. Understanding of data governance platforms (e.g., Collibra). Prior experience designing data QA automation frameworks for pipelines and regression testing. Certifications such as Microsoft Certified: Azure Data Engineer Associate or Databricks Certified Data Engineer.

Duration: 6 Months Contract We are seeking a Data Exchange Quality Readiness Lead to drive enterprise-level quality governance, data integrity, and release readiness across complex data exchange platforms. This role is responsible for aligning programs, validating end-to-end data flows, ensuring high-quality releases, and enabling operational readiness through governance, testing leadership, and data lineage insights. The ideal candidate brings deep expertise in quality strategy, data systems, cross-functional collaboration, and analytical problem solving. Key Responsibilities Program Alignment & Quality Governance Establish quality governance practices aligned with strategic initiatives and ART delivery models. Partner with ART teams to connect Epics, Product Increments, and scope items. Ensure traceability between acceptance criteria and test plans to guarantee full coverage. Document and enforce Definition of Done across teams. Provide oversight for strategic initiatives including GDE, Workday Wellness, EE Navigator, and OBF integrations (CMC, Event Hub, ADP APIs). Testing Strategy & Execution Define testing strategy across DevQA, Production Simulation, and Production environments. Establish best practices for end-to-end system validation. Ensure release readiness by enforcing quality gates and exit criteria. Champion a quality-first and defect-prevention culture. Data Quality & Lineage Perform hands-on data analysis of inbound source files (Workday, EE Navigator, ADP). Trace processing through Group Data Exchange (GDE) and Group Data Hub (GDH). Validate outbound data flows through routers, APIs, and file processors. Maintain complete data lineage documentation for transparency and auditing. Known Issues & Release Transparency Maintain and publish Known Issues Logs for each release. Track accepted defects and known data differences across GDE, ENE, LADE, and Fineos. Ensure stakeholders have clear visibility into risks before production releases. Training & Enablement Develop operational training materials and business-ready documentation. Enable ITSM, business operations, and configurators with guides and release notes. Drive knowledge transfer to accelerate adoption and reduce production issues. GenAI-Driven Quality Insights Design AI-enabled solutions for automated data profiling and anomaly detection. Leverage GenAI tools (e.g., ChatGPT) for reporting automation and quality insights. Convert outputs into easy-to-understand business communications. Reporting & Intelligence Build release dashboards and quality health reports. Provide predictive insights using GenAI and trend analysis. Deliver executive-ready summaries with recommendations. Collaboration & Stakeholder Engagement Work closely with: Product Managers RTE / STE Quality Engineering & Systems Teams Data Exchange Teams ITSM and Business Operations Required Qualifications Bachelor's degree in Computer Science, Information Systems, Business, or related field. 7+ years of experience in: Quality Engineering Data Systems Release Readiness Governance or QA Leadership Strong understanding of: Data pipelines and ETL flows API integrations Enterprise data platforms Experience with Agile / SAFe / ART frameworks. Proficient in test strategy development and execution. Strong analytical, documentation, and communication skills. Ability to convert technical findings into business-level insights. Comfortable working with senior leadership and cross-functional teams.

The primary responsibilities include data collection and presentation for regulatory compliance, assistance with site visit preparation for United Network of Organ Sharing (UNOS), Centers for Medicaid and Medicare Services (CMS), and the Joint commission (TJC), and creating action plans through to completion with the Transplant clinical and operational teams. This position works with the Transplant Director of Quality and partners with TUH's Performance Excellence Department and the Department of Regulatory Affairs. Directly responsible for action plans and performance improvement projects to maintain regulatory compliance. Provides training on regulatory requirements and defines Transplant measures of success. Provides input on the performance of transplant team members regarding timeliness and accuracy of data reporting and documentation within regulatory compliance. Education Master's Degree Health care discipline, informatics or related field of study Required Other Graduate certificate in Healthcare Quality and Safety or equivalent Preferred Experience 3 years experience in Transplant and/or Healthcare Quality or Regulatory Required General Experience General knowledge of CMS, TJC and UNOS regulations Required Schedule: Monday - Friday Day Shifts, no on-call, no weekends Our Hospital/Organization Descriptions Your Tomorrow is Here! Temple University Hospital is a nationally respected teaching hospital on Temple University's bustling Health Sciences Center campus. The hospital provides a comprehensive array of healthcare services both basic and complex to patients from around the corner, across the country and around the world. As the chief clinical training site for the Lewis Katz School of Medicine at Temple University, the hospital provides a dynamic environment for high-quality care, teaching, and cutting edge research. Health System Descriptions Your Tomorrow is Here! Temple Health is a dynamic network of outstanding hospitals, specialty centers, and physician practices that is advancing the fight against disease, pushing the boundaries of medical science, and educating future healthcare professionals. Temple Health consists of Temple University Hospital (TUH), Fox Chase Cancer Center, TUH-Jeanes Campus, TUH-Episcopal Campus, TUH-Northeastern Campus, Temple Physicians, Inc., and Temple Transport Team. Temple Health is proudly affiliated with the Lewis Katz School of Medicine at Temple University. To support this mission, Temple Health is continuously recruiting top talent to join its diverse, 10,000 strong workforce that fosters a healthy, safe and productive environment for its patients, visitors, students and colleagues alike. At Temple Health, your tomorrow is here! Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Schedule: 6pm to 6am (Overnight) (Will cover onsite interview and relocation cost) Key Responsibilities As the Quality Supervisor, you will oversee and manage a team of Quality Technicians to ensure our products meet the highest standards of quality, food safety, and regulatory compliance. Responsibilities include: 1. Interim Management of Quality Technicians Lead and manage the Quality Technician team to ensure product conformity with customer, company, and regulatory standards Oversee work schedules, timecard approvals, job assignments, training, and time-off requests 2. Internal Audits & Corrective Actions Participate in internal audits to identify areas of non-conformance Lead implementation of corrective actions and ensure timely resolution Track, document, and maintain records for compliance 3. Food Safety & Quality Issue Management Take prompt action to resolve food safety and quality issues Coordinate and support food safety and quality training for plant personnel Oversee the collection and submission of product samples for quality testing Ensure accurate documentation of test results and sample status 5. Quality Improvement Activities Lead initiatives to improve product quality and reliability Collaborate with production shift leaders to ensure quality and consistency Conduct root-cause analysis for product holds or customer complaints and implement corrective actions to prevent recurrence 6. Compliance Reporting Maintain detailed and organized quality control records Prepare and submit reports related to food safety, quality issues, corrective actions, and ongoing improvement initiatives Requirements Proven experience in Quality Control or Quality Assurance, ideally within food manufacturing or another regulated environment Better Process Control Aseptic Certification (preferred, not required) Strong problem-solving abilities, particularly in food safety and quality-control-related issues Experience conducting audits and implementing corrective actions Familiarity with compliance reporting and quality improvement processes

12-month contract Hybrid in Princeton, NJ - onsite on Wednesday Responsibilities: Shadow and support quality oversight activities for 10+ ongoing clinical studies (from planning to reporting stages), ensuring best practices are identified and followed. Partner and communicate with Clinical Managers (CMs) and Functional Area (FA) stakeholders to provide cross-functional team support and attend project/study-level meetings. With guidance from senior GCP auditors, consult on and escalate major/critical quality issues, serious breaches, data integrity concerns, and protocol deviations to senior management. Conduct periodic resolution checks and follow-ups on quality issues for assigned studies. Contribute to risk assessments and development of the annual GQM Audit Plan by recommending the number and type of site/vendor audits based on study risk. Gather and provide study-related documentation and insights to the audit team and GCP Level 2 auditors in preparation for audits. Participate in the risk evaluation of preferred and active vendors to support the annual GQM Vendor Audit Plan. Support CAPA (Corrective and Preventive Action) reviews stemming from quality issues, audits, inspections, and eTMF (electronic Trial Master File) assessments. Engage in weekly, monthly, and quarterly GQM GCP team meetings, as well as QA:QA and Quality Council meetings alongside senior audit team members. Assist in the review and harmonization of controlled documents including protocols, informed consent forms (ICFs), clinical study reports (CSRs), amendments, SOPs, and templates. Participate in ongoing GCP training, including ICH E6 R3 guidelines, 21 CFR modules, and team-led educational sessions. Provide support across portfolio-wide inspection readiness activities (sponsor, site, CRO), including delivery of Do & Don't training, interview preparation, debriefs, and findings analysis. Review and assess the Pharmacovigilance System Master File (PSMF) and conduct PV-related quality activities as assigned. Qualifications: Bachelor's degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related field. 1-2 years of experience in clinical research, clinical quality assurance, or GxP-related functions preferred. Familiarity with GCP guidelines (ICH E6) and FDA 21 CFR Part 11 and 312 regulations. Strong organizational and communication skills with the ability to work cross-functionally. Analytical mindset with the ability to identify and assess quality risks. Demonstrated ability to learn in a fast-paced, collaborative environment. Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook). Previous exposure to TMF systems, CAPA processes, or audit support is a plus. Interest in building a career in clinical quality, auditing, or compliance.

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Ensure that highest standards of data quality and study participant safety are maintained, as well as adherence to study protocols, CenExel SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines. Essential Responsibilities and Duties: Assists the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines Reviews follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis. Performs ongoing review of a percentage sampling of study inclusion/exclusion, study procedure records, and laboratory reports to ensure that they are conducted according to the protocol, applicable SOPs, ICH/GCP guidelines and federal regulations. Performs quality review of initially created source documentation, including amendments, to ensure all protocol required procedures are present. Provides training and education on SOPs, GCP, and federal regulations as appropriate. Prepares for internal and external audits and FDA inspections. Attends staff meetings. Attends site initiation visits, as needed. Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Must be able to effectively communicate verbally and in writing. Must have proper experience and demonstrate mastery of Quality Assurance Coordinator I position. Minimum 2 years quality assurance experience. Knowledge/Skills/Abilities: Must be self-directed and able to work with minimal supervision; Must have in depth knowledge of FDA regulations. GCP, and ICH guidelines; Able to take a flexible approach to shifting priorities; Able to manage multiple projects and responsibilities; Motivated to work consistently in a fast paced and rapidly changing environment; Must be detail oriented and have exceptional computer, organizational, and communication skills - both written and oral. Must reflect the professional image of the company, upholding the company vision in actions, demeanor, and appearance. Must be able to clearly communicate through written and verbal means with sponsors and staff. Working Conditions Indoor, Office environment. Essential physical requirements include sitting, typing, standing, walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. On site work arrangement. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Job DescriptionDescription: RK Pharma Inc, a vertically integrated pharmaceutical company headquartered in NJ, is seeking an Quality Assurance Associate to work with our growing Quality Assurance Team as we scale towards commercial manufacturing in the next upcoming months.? As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team. This position is located in East Windsor, NJ and is required to be onsite. Requirements: If this sounds interesting to you, it's probably because up to this point you have: Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, or a related technical field. 1-3 years of experience in a pharmaceutical or GMP-regulated environment. Solid understanding of cGMP, GDP, and FDA regulations. Experience with batch record review, deviation handling, and change control processes. Familiarity with document management systems (e.g., MasterControl). Strong attention to detail and accuracy in reviewing technical and regulatory documents. Excellent written and verbal communication skills for cross-functional collaboration. Ability to work independently and manage multiple priorities in a fast-paced environment. The main expectations and responsibilities for this position are: Review batch production and packaging records for accuracy, completeness, and GMP compliance prior to product release. Perform in-process line checks and quality inspections to ensure adherence to SOPs and specifications. Support deviation and change control processes, ensuring timely investigation and documentation. Participate in internal audits, walkthroughs, and inspection readiness activities. Maintain and update controlled documents, including SOPs, MBRs, and validation protocols. Collaborate with Quality Control, Production, and Engineering to resolve quality issues and drive continuous improvement. Ensure all QA activities are properly documented in accordance with GDP and data integrity principles. Support training, risk assessments, and compliance reviews as assigned by QA management. If this sounds like something that is of interest to you, please don't hesitate to apply to start a conversation. We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc.

Date 06/2025 Title Associate, In-Process Quality Assurance MFG/PKG Department Quality Assurance Operation Support Reports to Quality Assurance Manager/ VP of QA FLSA (Exempt or Non-Exempt Non-Exempt Role Overview The IPQA performs line inspection as part of the cGMP, SOPs, and policy compliance requirements as per CFR part 111. Performs In-process quality testing in manufacturing and/or packaging areas according to prescribed timelines and accurately captures test results in batch records. The Inspector performs calibrations & measurements on raw materials, bulk products, finished products and packaging components as required in batch records and SOP's. This position reports to the QA Manager and is a key member of the Quality Assurance group. The IPQA Associate is a highly organized self-starter who can work independently, demonstrates a positive attitude, and a bias for action. Areas of Responsibility IPQA - Level 1: To support In-process quality assurance activities by performing routine checks and verifications during manufacturing and/or packaging of nutraceutical products. This role ensures that all processes comply with applicable GMP, SOPs, and regulatory requirements. Key Responsibilities: 🔹 Manufacturing Support Perform line clearance before starting blending, granulation, compression, encapsulation, coating processes. Perform In-process checks: Blend uniformity sampling Tablet/capsule weight variation Hardness, friability, and disintegration tests etc as applicable Verify equipment cleaning and area hygiene as per SOP. Collect and label In-process and stability samples under supervision. 🔹 Packaging Support Ensure line clearance before packaging activities. Perform In-process checks: Batch number and expiry date printing Label application and carton sealing Primary and secondary packaging integrity etc as applicable Assist in reconciliation of packaging materials (e.g., printed cartons, leaflets, labels). 🔹 Documentation Record observations in IPQA checklists, logbooks, and batch records. Maintain GMP documentation in real-time (legible and error-free). Escalate any deviation or abnormality immediately to the QA Executive/Supervisor. 🔹 Compliance & Safety Adhere to company GMP, SOP, and Hygiene policies. Use PPE appropriately. Support during internal/external audits by providing necessary records. Cleans up work following the completion of a shift. Meets all safety expectations and follows all safety practices. Works extended hours and occasional weekend overtime. Other duties as assigned Other Responsibilities Including Safety: IPQA - Level 2: To independently perform and document In-process quality assurance activities at all critical stages of manufacturing and packaging of nutraceutical products, ensuring compliance with GMP, SOPs, and regulatory requirements. Key Responsibilities: 🔹 Manufacturing Stage (Granulation, Blending, Compression, Encapsulation, Coating ) Carry out and document line clearance activities before starting each manufacturing batch. Conduct in-process checks independently: Blend uniformity sampling Tablet/capsule weight variation Hardness, friability, thickness, and disintegration In-process controls as per BMR specifications Verify equipment cleanliness status, calibration, and logbook entries. Monitor and record environmental conditions in production areas (temperature, RH, differential pressure). 🔹 Packaging Stage Conduct line clearance for primary and secondary packaging (bottles, strips, blister, cartons). Perform and document: Batch coding verification (batch no., Mfg/Exp date) Packaging material correctness (labels, leaflets, cartons) Sealing integrity checks (blisters, induction seals) Online rejection bin and reconciliation checks Ensure correct usage of approved packaging materials with status labels. 🔹 Documentation & Compliance Fill Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) in real-time. Record IPQA observations and results as per SOPs ( legible and error free). Initiate and report deviations, OOS/OOT, and non-conformities to QA Supervisor/ Manager. Support CAPA implementation and change controls. 🔹 General QA Duties Ensure compliance with GMP, GLP, and data integrity principles. Follow gowning protocols, hygiene, and safety measures in production areas. Assist during internal audits and regulatory inspections by providing accurate documentation and data. Cleans up work following the completion of a shift. Meets all safety expectations and follows all safety practices. Works extended hours and occasional weekend overtime. Other duties as assigned Other Responsibilities Including Safety: IPQA - Level 3: To lead and monitor In-process QA activities during nutraceutical manufacturing and packaging operations. Ensure compliance with GMP, regulatory standards, and internal SOPs by supervising IPQA teams, reviewing records, and addressing quality deviations. Key Responsibilities: 🔹IPQA Oversight - Manufacturing & Packaging Supervise and verify line clearance activities across all manufacturing and packaging areas. Ensure compliance with critical process parameters (CPPs) and critical quality attributes (CQAs). Review and approval: In-process checks: weight variation, hardness, friability, disintegration etc as applicable Environmental monitoring records Equipment and area cleaning records Coordinate and monitor sampling activities for In-process, finished products and stability studies. 🔹 Review and Verification Review and verify completed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR). Cross-check reconciliation of raw materials and printed packaging materials. Verify proper use of status labels (approved/rejected/quarantine). 🔹 Deviation & CAPA Management Investigate and document process deviations, non-conformances, and OOS/OOT incidents. Lead root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA). Coordinate with cross-functional teams (Production, QC, Regulatory Affairs) to ensure closure of quality events. 🔹 Audit & Compliance Ensure readiness for internal, external, and regulatory audits (FSSAI, WHO-GMP, USFDA, etc.). Conduct routine GMP audits, spot checks, and area inspections. Train shop-floor personnel on data integrity, documentation practices, hygiene, and gowning protocols. 🔹 Team Coordination Guide and mentor IPQA Level 1 and Level 2 personnel. Allocate daily QA responsibilities and monitor adherence to QA procedures. Conduct on-the-job training for new team members Cleans up work following the completion of a shift. Meets all safety expectations and follows all safety practices. Works extended hours and occasional weekend overtime. Other duties as assigned Other Responsibilities Including Safety: Meets all safety expectations and follows all safety practices. Works extended hours and occasional weekend overtime. Other duties as assigned Other Responsibilities Including Safety: N/A Other Responsibilities Including Safety: Works in a safe and responsible manner to create an injury-free and incident-free workplace. Complies with all job-related safety and other training requirements. Keeps management informed of area activities and of any significant problems. Requirements Education & Qualification: IPQA - Level 1: 0-1 year (Freshers with training or internship in QA preferred) Or equivalent combination of education and experience. High School diploma is required; BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus. IPQA - Level 2: Minimum of 3+ years of experience in a QA Inspector within a nutritional's supplements, food, consumer products or pharmaceutical company. Or equivalent combination of education and experience. BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus. IPQA - Level 3: 3-5 years in IPQA or related QA roles in nutraceuticals, pharmaceuticals, or food manufacturing. Or equivalent combination of education and experience. BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus. Certifications, Licenses, Credentials: N/A Skills & Ability IPQA - Level 1: Basic understanding of GMP, nutraceutical processes, and QA principles. Good observation and attention to detail. Willingness to work in production areas (shifts, growing zones). Ability to follow instructions and standard procedures accurately. Basic proficiency in English and documentation practices. IPQA - Level 2: Strong knowledge of IPQA functions , SOPs , and process flow in nutraceuticals. Understanding of basic analytical parameters (weight variation, friability, etc.). Good documentation and observational skills. Proficient in using basic lab and QA tools (weighing balances, disintegration testers). Familiar with regulatory guidelines (FSSAI, WHO-GMP, USFDA, HACCP). IPQA - Level 3: In-depth understanding of nutraceutical manufacturing processes and regulatory compliance. Proficient in QA documentation, process audits, and deviation handling. Strong analytical and decision-making skills. Familiar with QMS tools, GMP documentation, and data integrity principles. Working knowledge of SOP writing, change control, and risk assessment. Physical Requirements (lifting, etc.): Ability to lift up to 35 lbs.; occasionally lift and move up to 50 pounds. Must stand and walk on production floor a minimum of 6 hours per shift Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances. Occasionally works from a rolling ladder or step stool. Must be able to wear all PPE including lab coat, face mask, booties, gloves, safety glasses. Work Environment (Office, Warehouse, temperature extremes, etc.): Work is regularly performed inside a manufacturing and packaging environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment. First shift $24.00 to $30.50 Second Shift $24.00 to $31.00

Date 06/2025 Title Associate, In-Process Quality Assurance MFG/PKG Department Quality Assurance Operation Support Reports to Quality Assurance Manager/ VP of QA FLSA (Exempt or Non-Exempt Non-Exempt Role Overview The IPQA performs line inspection as part of the cGMP, SOPs, and policy compliance requirements as per CFR part 111. Performs In-process quality testing in manufacturing and/or packaging areas according to prescribed timelines and accurately captures test results in batch records. The Inspector performs calibrations & measurements on raw materials, bulk products, finished products and packaging components as required in batch records and SOP's. This position reports to the QA Manager and is a key member of the Quality Assurance group. The IPQA Associate is a highly organized self-starter who can work independently, demonstrates a positive attitude, and a bias for action. Areas of Responsibility IPQA - Level 1: To support In-process quality assurance activities by performing routine checks and verifications during manufacturing and/or packaging of nutraceutical products. This role ensures that all processes comply with applicable GMP, SOPs, and regulatory requirements. Key Responsibilities: ???? Manufacturing Support Perform line clearance before starting blending, granulation, compression, encapsulation, coating processes. Perform In-process checks: Blend uniformity sampling Tablet/capsule weight variation Hardness, friability, and disintegration tests etc as applicable Verify equipment cleaning and area hygiene as per SOP. Collect and label In-process and stability samples under supervision. ???? Packaging Support Ensure line clearance before packaging activities. Perform In-process checks: Batch number and expiry date printing Label application and carton sealing Primary and secondary packaging integrity etc as applicable Assist in reconciliation of packaging materials (e.g., printed cartons, leaflets, labels). ???? Documentation Record observations in IPQA checklists, logbooks, and batch records. Maintain GMP documentation in real-time (legible and error-free). Escalate any deviation or abnormality immediately to the QA Executive/Supervisor. ???? Compliance & Safety Adhere to company GMP, SOP, and Hygiene policies. Use PPE appropriately. Support during internal/external audits by providing necessary records. Cleans up work following the completion of a shift. Meets all safety expectations and follows all safety practices. Works extended hours and occasional weekend overtime. Other duties as assigned Other Responsibilities Including Safety: IPQA - Level 2: To independently perform and document In-process quality assurance activities at all critical stages of manufacturing and packaging of nutraceutical products, ensuring compliance with GMP, SOPs, and regulatory requirements. Key Responsibilities: ???? Manufacturing Stage (Granulation, Blending, Compression, Encapsulation, Coating ) Carry out and document line clearance activities before starting each manufacturing batch. Conduct in-process checks independently: Blend uniformity sampling Tablet/capsule weight variation Hardness, friability, thickness, and disintegration In-process controls as per BMR specifications Verify equipment cleanliness status, calibration, and logbook entries. Monitor and record environmental conditions in production areas (temperature, RH, differential pressure). ???? Packaging Stage Conduct line clearance for primary and secondary packaging (bottles, strips, blister, cartons). Perform and document: Batch coding verification (batch no., Mfg/Exp date) Packaging material correctness (labels, leaflets, cartons) Sealing integrity checks (blisters, induction seals) Online rejection bin and reconciliation checks Ensure correct usage of approved packaging materials with status labels. ???? Documentation & Compliance Fill Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) in real-time. Record IPQA observations and results as per SOPs ( legible and error free). Initiate and report deviations, OOS/OOT, and non-conformities to QA Supervisor/ Manager. Support CAPA implementation and change controls. ???? General QA Duties Ensure compliance with GMP, GLP, and data integrity principles. Follow gowning protocols, hygiene, and safety measures in production areas. Assist during internal audits and regulatory inspections by providing accurate documentation and data. Cleans up work following the completion of a shift. Meets all safety expectations and follows all safety practices. Works extended hours and occasional weekend overtime. Other duties as assigned Other Responsibilities Including Safety: IPQA - Level 3: To lead and monitor In-process QA activities during nutraceutical manufacturing and packaging operations. Ensure compliance with GMP, regulatory standards, and internal SOPs by supervising IPQA teams, reviewing records, and addressing quality deviations. Key Responsibilities: ????IPQA Oversight - Manufacturing & Packaging Supervise and verify line clearance activities across all manufacturing and packaging areas. Ensure compliance with critical process parameters (CPPs) and critical quality attributes (CQAs). Review and approval: In-process checks: weight variation, hardness, friability, disintegration etc as applicable Environmental monitoring records Equipment and area cleaning records Coordinate and monitor sampling activities for In-process, finished products and stability studies. ???? Review and Verification Review and verify completed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR). Cross-check reconciliation of raw materials and printed packaging materials. Verify proper use of status labels (approved/rejected/quarantine). ???? Deviation & CAPA Management Investigate and document process deviations, non-conformances, and OOS/OOT incidents. Lead root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA). Coordinate with cross-functional teams (Production, QC, Regulatory Affairs) to ensure closure of quality events. ???? Audit & Compliance Ensure readiness for internal, external, and regulatory audits (FSSAI, WHO-GMP, USFDA, etc.). Conduct routine GMP audits, spot checks, and area inspections. Train shop-floor personnel on data integrity, documentation practices, hygiene, and gowning protocols. ???? Team Coordination Guide and mentor IPQA Level 1 and Level 2 personnel. Allocate daily QA responsibilities and monitor adherence to QA procedures. Conduct on-the-job training for new team members Cleans up work following the completion of a shift. Meets all safety expectations and follows all safety practices. Works extended hours and occasional weekend overtime. Other duties as assigned Other Responsibilities Including Safety: Meets all safety expectations and follows all safety practices. Works extended hours and occasional weekend overtime. Other duties as assigned Other Responsibilities Including Safety: N/A Other Responsibilities Including Safety: Works in a safe and responsible manner to create an injury-free and incident-free workplace. Complies with all job-related safety and other training requirements. Keeps management informed of area activities and of any significant problems. Requirements Education & Qualification: IPQA - Level 1: 0-1 year (Freshers with training or internship in QA preferred) Or equivalent combination of education and experience. High School diploma is required; BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus. IPQA - Level 2: Minimum of 3+ years of experience in a QA Inspector within a nutritional's supplements, food, consumer products or pharmaceutical company. Or equivalent combination of education and experience. BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus. IPQA - Level 3: 3-5 years in IPQA or related QA roles in nutraceuticals, pharmaceuticals, or food manufacturing. Or equivalent combination of education and experience. BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus. Certifications, Licenses, Credentials: N/A Skills & Ability IPQA - Level 1: Basic understanding of GMP, nutraceutical processes, and QA principles. Good observation and attention to detail. Willingness to work in production areas (shifts, growing zones). Ability to follow instructions and standard procedures accurately. Basic proficiency in English and documentation practices. IPQA - Level 2: Strong knowledge of IPQA functions, SOPs, and process flow in nutraceuticals. Understanding of basic analytical parameters (weight variation, friability, etc.). Good documentation and observational skills. Proficient in using basic lab and QA tools (weighing balances, disintegration testers). Familiar with regulatory guidelines (FSSAI, WHO-GMP, USFDA, HACCP). IPQA - Level 3: In-depth understanding of nutraceutical manufacturing processes and regulatory compliance. Proficient in QA documentation, process audits, and deviation handling. Strong analytical and decision-making skills. Familiar with QMS tools, GMP documentation, and data integrity principles. Working knowledge of SOP writing, change control, and risk assessment. Physical Requirements (lifting, etc.): Ability to lift up to 35 lbs.; occasionally lift and move up to 50 pounds. Must stand and walk on production floor a minimum of 6 hours per shift Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances. Occasionally works from a rolling ladder or step stool. Must be able to wear all PPE including lab coat, face mask, booties, gloves, safety glasses. Work Environment (Office, Warehouse, temperature extremes, etc.): Work is regularly performed inside a manufacturing and packaging environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment. shift schedule 1st shift: 7:00 AM - 3:30 PM, 2nd shift: 3:00 PM - 11:30 PM and 3rd shift: 11:00 PM - 7:30 AM

Our client is a medical device company dedicated to offering innovative solutions for treatment of chronic heart failure . The Company's developments are based on its proprietary technology for administrating Cardiac Contractility Modulation therapy. Job Description Write and review of SOPs and other quality assiuance related technical data forms and quality documents proper maintenance of control documents in Quality Assurance Control documents to differents departments Review validation protocols for GMP compliance Assist in carrying out internal quality audits on company systems and documentations perform investigations on non-conformances and customer complaint close out and corrective actions Audit on-going vendors, systems and documents to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines Provide GCP/ QA support and avdvice to internal and external clients Ensure the timely and effective follow up to all identified or assigned quality issues Maintains and demonstrates understanding of global standards, regulation and regulatory bodies to include but not limited to ISO13485, 21FR; part 820 AIMD Assist in the maintenance ogf Quality Management System under direction of Director, Quality Assurance Participate in Mock inspections for FDA inspection preparation Qualifications Ability to work independently with little or no supervision Exeptional oral and written communication capabilities Advance computer knowledge in MS Office programs Bachelors's Dregree in related field 4-6 years related experience Experience working in regulated environment with medical devices Experience with FDA inspections and /or Notified Bodies Audits desirable Additional Information All your information will be kept confidential according to EEO guidelines.

Lupin U.S. is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Somerset, New Jersey is home to one of eighteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin. Somerset, New Jersey is also the location for Lupin's U.S. Sales Operations and Marketing divisions, as well as internal Product Development teams. Lupin has a significant generic pipeline and a growing Specialty Brand presence in the U.S. Our Inhalation Research and Development facility is located in Coral Springs, Florida focusing on generic and branded orally inhaled and nasal drug products. Key shared service functions are found at our beautiful harbor side location in Baltimore, Maryland. Adding to Lupin's U.S. footprint is a robust team of Clinical Operations experts in Blue Bell, Pennsylvania and a high performing Specialty salesforce located across the country. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Join our U.S. team and become part of an organization that encourages professional development and innovation! We are looking for passionate and driven individuals who will help us to continue making medicine widely accessible to patients, and who strive to work by Lupin's Core Values of Teamwork, Passion for Excellence, Entrepreneurial Spirit, Respect and Care, Integrity, and Customer Focus. Responsibilities Role Summary The QA Associate is responsible for the assurance of the manufacturing activities within the Lupin Somerset sites. This position is responsible for working in the warehouse, process rooms, and packaging lines and evaluates all activities meets the acceptance criteria. This position will require 2nd shift hours: 2:00 p.m. - 10:30 p.m. Monday - Friday Essential Duties and Responsibilities Sample, inspect incoming raw materials, components, in-process, intermediates, and finished products and submits samples to the QC laboratory for analysis. Inspect the manufacturing equipment/rooms and packaging lines/ equipment for cleanliness and approve them for use before the start of the operation Perform QA in-process checks (Beginning, Middle and End) for manufacturing/packaging operations and determine the results meets against pre-determined standards and batch record Conduct AQL inspections on incoming materials and finished dosage forms against pre-determined Quality attributes. Collect and maintain QA Retain samples from all products manufactured. Assure that all retains are stored appropriately for accountability, annual inspection Sample and proofread all pharmaceutical labeling for conformance to the standard. Issues approved labels to the packaging lines for use. Inform immediately any manufacturing/packaging issue to the QA supervisor Assure all activities are following the batch records, departmental SOP's, GMP, and DEA regulations. Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation/yields. Ensure the proper isolation of rejected or defective product/ material generated during the batch process and accountability in the batch record. Monitor facility and product environmental operating conditions. Provide necessary support to conduct root cause analysis for any incidents generated at the facility during all phases of the production and packaging process. Perform other QA duties as assigned Qualifications Education & Experience An Associate Degree or a Bachelor's Degree in a scientific field is preferred Minimum 3+ years' experience in a Quality Assurance role in the pharmaceutical industry Knowledge of the pharmaceutical manufacturing and/or packaging process Communication skills: Excellent command of written and spoken English Attention to detail is paramount Desire to achieve a high quality of work and diligent about following Standard Operating Procedures Knowledge and understanding of cGMPs, keeping up to date with current industry issues and changing regulations. SAP, Trackwise, LIMS or similar QMS system knowledge preferred Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran status, or any other classification as required by applicable law. The anticipated annual base salary range for this position in New Jersey is $45,000 to $63,000, plus a discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, the type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states. Physical Requirements The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally, work is performed in a manufacturing environment. Search Firm Representatives Please Read Carefully Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails. #LI-CC #LI-DNI

Job Description The Quality Assurance Associate, under the direction of the Chief Compliance & Quality Officer and working in cooperation with the Lead Quality Assurance Associate, utilizes a combination of excellent customer service, administrative, and analytical skills to ensure the agency can deliver high-quality client care services. This role is focused on investigating, managing, and resolving incidents that affect quality care. ESSENTIAL DUTIES AND RESPONSIBILITIES: 1. Conducts investigations for both the Personal Care and Developmental Care service lines. These investigations involve obtaining witness statements and interviews, securing evidence, retrieving information from electronic surveillance, reviewing staff schedules, compiling information from the agency's EHR system, and developing a chronological summary of factual findings from occurrence to closure. Depending on the incident, investigations may require traveling into the field to client homes to conduct investigations. (Coverage area: Philadelphia, Bucks, Montgomery, Delaware and Chester counties) 2. Completes and maintains Certified Investigator credential status from the PA Office of Development Program (ODP). Conducts investigations in accordance with ODP regulations. 3. Complies with required incident management reporting timeframes, ensuring investigations are filed, finalized or extended according to the timelines set forth by regulatory and agency standards to maintain speed, objectivity, and thoroughness. 4. Attends to all reportable data entry in the PA Enterprise Incident Management (EIM) System and documents all case activity for internal records. 5. Investigates potential fraud events and complaints involving client or caregiver safety. Makes recommendations for resolution, documents actions taken, and analyzes issues to prevent recurrence. 6. Provides education, guidance, and training to employees regarding incidents, complaints, and potential fraud events. 7. Engages in Administrative Reviews and Certified Investigation Peer Reviews to ensure processes meet regulatory standards. 8. Establishes rapport with staff, caregivers, clients, providers, families, and outside agencies to coordinate investigations. 9. Compiles, trends and reports quality data to analyze why incidents occur and how recurrences can be prevented. 10. Assists the Director of Quality & Clinical Management in the administration of the agency's quality improvement plans, infection control program, and accreditation standards. 11. Assists the Compliance Officer in monitoring the agency's compliance with regulatory mandates. Assists with the preparation of plans of correction for state surveys and auditing bodies. 12. Performs other duties as assigned by the Chief Compliance Officer. COMPLIANCE AS REQUIREMENT OF PERFORMANCE: Compliance with AmeriBest policies and procedures is a responsibility of all AmeriBest associates. It is a part of each associate's performance to follow these requirements: All associates are expected to participate in any investigatory activities All associates are expected to report any violation of AmeriBest policies and procedures All associates are expected to conduct themselves in an ethical manner consistent with the AmeriBest mission statement and Standards of Conduct All associates are expected to protect the privacy of protected records and must conduct themselves consistent with all applicable laws and policies regarding privacy protection, including HIPAA and state specific privacy laws COMPETENCIES/SKILLS: Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Process Building - seeks to develop better efficiencies in agency processes. Actively engages in the use of technology to automate and enhance day-to-day workflows. Problem solving - effective at identifying root causes and creative solutions to issues. Analytical - strong quantitative and analytical skills. Apply critical thinking to make informed, data driven decisions. Teamwork - ability to work effectively as part of a team Communication - Communicates effectively and concisely; Strong ability to create effective visual summations of data. Customer focused - strong customer service skills, able to deal with people in a polite and caring manner. Strong Computer Proficiency- Uses Microsoft 365 applications with proficiency. Intermediate to advanced skillset preferred in Word, Excel, Forms, and PowerPoint, Familiarity with EMR and data repository systems. Some Clinical Knowledge- Knowledge of medical terminology, familiarity with medical notes and discharge reports, and common chronic illnesses. Attention to Detail with Quality Focus. Deadline Oriented EDUCATION AND/OR EXPERIENCE: A bachelor's degree in social work, behavior sciences, human services, or a related field. At least one (1) years' experience in home care, social work, case management, or hospital discharge planning. PREFERRED EXPERIENCE: Associates Degree Prior experience working for a Home Health Care Agency One (1) year of experience in a healthcare organization ADDITIONAL REQUIREMENTS: Must have and maintain a valid Driver's License, a good driving record, maintain automobile insurance coverage, and have access to a reliable automobile. Ability to work occasional evenings and weekends to conduct investigations in client homes. Currently hold a PA-Office of Development Program (ODP) Certified Investigator certificate or must successfully complete this certification within 12 months of hire. PHYSICAL DEMANDS: Regular requirement to sit; use hands to touch, handle or feel. Regular requirement to stand; kneel, squat, walk and reach with hands and arms. Occasional requirement to lift and/or move up to 10 pounds. Vision abilities include close vision, peripheral vision, depth perception and the ability to adjust focus. Able to travel throughout Philadelphia and surrounding counties and enter clients' homes. WORK ENVIRONMENT: Location: In-office position (Philadelphia office) Business Office Environment The noise level is usually moderate Local travel to client homes in the five county Philadelphia area Benefits: PTO Medical, Dental, and Vision Insurance 401(k) and HSA AmeriBest Home Care is an equal opportunity employer. We value and encourage diversity in our workforce and provide equal employment opportunities to all individuals protected by applicable laws.

Who you are: Knowledge of Quality Assurance/Quality control/Operations in a regulated environment Familiar with lab equipment operation and set-up. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports and procedures. Ability to successfully present information and respond to questions from groups of managers, clients, customers, and the public. Great Teammate and good social skills Must be able to interface effectively with all levels of the company employees How you will thrive and create an impact Issuance of controlled manufacturing and testing documents to Manufacturing and Quality Control as per the production schedule. Issuance of controlled labels used for labelling finished goods and other related samples. Monitor the equipment program including calibration and preventative maintenance timelines and complete quality assurance sign-off for equipment workorders. Issuance and reconciliation of equipment and room logbooks. Coordinate the release of raw materials after completion of review and approval of supporting documentation including supplier and quality control testing records. Conduct reconciliation, filing and archiving of all quality-controlled records. Store completed documents in the appropriate data files and coordinate off-site document storage with third party as necessary. May provide pre-run line clearance to manufacturing. Consult with document originators to resolve discrepancies. Work closely with internal departments to assure commitment to customer is met in a timely manner. Management of Label Program. Includes development of master labels, maintain controlled label stock, setting inventory safety stocks, printer supplies, and coordinating reorders. May provide batch record review support. Writing and revising SOPs as part of process improvement initiatives or as needed to support the department. Coordination of document control activities and delegating with other quality coordinators to drive workload completion at the direction of quality management. Actively participate and drive the quality and safety culture of the site. Performs other duties as assigned Environment Typically works in an office environment with adequate lighting and ventilation and a normal range oftemperature and noise level. May also work in warehouse setting with appropriate protective wear if performing pre-fill, in-process, and final inspections on product. Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems. A frequent volume of work and deadlines impose strain on routine basis. Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.

The Document Specialist is an integral part of our team, transcribing and revising various types of documents and contributing to our commitment to providing the highest quality legal service. Minimum 3 years of word processing experience. Typing speed of 50+ words per minute. Proficiency in Windows 10 and 11, Microsoft Office 2016, Outlook, and iManage Work (or comparable Document Management System). High school diploma. Document Transcription and Revision: Accurately transcribe and revise correspondence, pleadings, discovery materials, memos, reports, special forms, voicemails, and hard copy documents. Proficiency in Adobe Pro, including converting PDFs to Word, reducing file sizes, and using editing tools. Utilize the typewriter tool for text changes, insert signatures, and create JPEGs/images within PDFs. Apply Bates labeling and make documents OCR text searchable. Learn how to create PDF Portfolios for efficient bulk bates labeling. Document Formatting and Organization: Prepare mass mailing mail merges. Clean and format documents using DocXtools, ensuring consistent application of firm styles. Expertise in cross-referencing and blacklining using Litera or comparable software. Create table of contents, table of authorities, and points and authorities using Best Authority. Generate bookmarks and assist in creating closing binders, including hyperlinking embedded documents. Craft professional PowerPoint presentations and format complex Excel spreadsheets. Time Management and Technology Skills: Input attorney time using Intapp. Create timelines and organizational charts using Word, Visio, or PowerPoint. Learn the E-Notary and DocuSign processes. Familiarity with scanning equipment, Dictaphone, and general office technology.

JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

Date 7/2025 Title Associate, QA Operation Support Department Quality Assurance Reports to Manager, QA Operations FLSA (Exempt or Non-Exempt Exempt This position is one of high regulatory responsibility that provides direct quality oversight for the cGMP production of Dietary Supplements and nutraceuticals. This position will help ensure compliance to SOPs, batch records, master manufacturing records, and to 21 CFR Part 111 and 117. Areas of Responsibility Level 1 - Associate, QA Operations Support Summary of the Role: Entry-level position in the QA department focused on supporting sampling and/or dispensing activities under supervision. Intended for fresh graduates or new entrants to the pharmaceutical QA function. ???? Key Responsibilities: Assist with material sampling and dispensing under guidance. Support line clearance and hygiene compliance checks. Label and transport sampled materials as per SOPs. Maintain basic records and area cleanliness. Learn cGMP and SOP requirements. Level 2 - Associate, QA Operations Support ???? Summary of the Role: Responsible for performing QA-related sampling and/or releasing , dispensing activities in compliance with SOPs and regulatory requirements. Ensures proper documentation and real-time quality assurance during material handling. ???? Key Responsibilities: Execute material sampling , releasing , dispensing as per approved procedures as needed. Perform line clearance and ensure area readiness. Label materials correctly and ensure segregation of sampled vs. un-sampled. Maintain logbooks, records, and data entries accurately. Report deviations or incidents to the coordinator promptly. Level 3 - Associate, QA Operations Support ???? Summary of the Role: Mid-level QA role with responsibility for overseeing sampling and dispensing operations. Ensures compliance, accuracy, and efficiency of all QA activities in the function. ???? Key Responsibilities: Supervise and coordinate QA sampling releasing , dispensing as per approved procedures as needed. Review documentation completed by associates. Ensure timely and compliant execution of sampling plans. Conduct training and mentoring for junior staff. Support audits, investigations, and CAPA implementation. Performs issuance of batch cards of Manufacturing, Coating and Packaging. Collects samples from on floor production for further testing and retention. Distributes testing samples to In-house Analytical , Elemental and Microbiology Labs Prepares In process Labels for production ,and QA samples to be provided along with the Batch Records Other Responsibilities Including Safety: Works in a safe and responsible manner in order to create an injury-free and incident-free workplace. Complies with all job-related safety and other training requirements. Keeps management informed of area activities and of any significant problems. Requirements Education & Qualification: Level 1 - Associate, QA Operations Support B.Sc. / B.Pharm. or equivalent in a science-related field. Relevant QA experience working within a GMP and/or with GCP regulations. Level 2 - Associate, QA Operations Support B.Sc. / B.Pharm. (required) 1-3 years of experience in QA or related area preferred working within a GMP and/or with GCP regulations. Level 3 - Associate, QA Operations Support B.Sc. / B.Pharm. (minimum); M.Sc. / M.Pharm. preferred 3-6 years of relevant QA experience working within a GMP and/or with GCP regulations. Certifications, Licenses, Credentials: N/A Skills & Ability Level 1 - Associate, QA Operations Support Willingness to learn and follow instructions. Basic understanding of GMP (preferred). Good observational and documentation skills. Teamwork and adaptability. Level 2 - Associate, QA Operations Support Working knowledge of cGMP and SOPs. Attention to detail and strong documentation habits. Familiarity with quality systems (e.g., logbooks, traceability). Communication and coordination abilities Level 3 - Associate, QA Operations Support Strong knowledge of cGMP and quality systems. Leadership and team management skills. Effective communication and problem-solving. Ability to handle audits, deviations, and cross-functional coordination. Good documentation and review capabilities. Physical Requirements (lifting, etc.): Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds. Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances. Occasionally works from a rolling ladder or step stool. Must be able wear all PPE including lab coat, face mask, booties, gloves, safety glasses. Work Environment (Office, Warehouse, temperature extremes, etc.): Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employee can be exposed daily to chemicals and cleaning agents. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment. shift schedule 1st shift: 7:00 AM - 3:30 PM, 2nd shift: 3:00 PM - 11:30 PM and 3rd shift: 11:00 PM - 7:30 AM