Quality assurance specialist jobs in Levittown, PA - 371 jobs

Aramark Healthcare+ has an immediate need for a System Food Service Quality and Standards Manager for The Children's Hospital of Philadelphia. The System Food Service Quality and Standards Manager will be responsible for engaging with front line managers and front line associates to manage safety, sanitation and compliance in the food service operation, and to develop corrective action plans and assist with implementing these plans. Position may also facilitate training on a 1:1 or group basis. Job Responsibilities Conduct regular on-site Quality Assurance Audits utilizing the Aramark Productivity Portal Develop and implement corrective action plans for locations identified as not meeting Aramark Standards as it relates to food ordering, production and service Focus on implementation and training of Aramark's 5 P's of Food Management Work with client constituents to develop training material for client front line staff Work with VPO, DM's and Director of Culinary to develop various training material to assist in driving operational outcomes to the operating locations Continually seek to improve performance; hold staff accountable for challenging goals Provide leadership in the implementation and maintenance of internal control and business process improvement initiatives. Develop and be accountable for a culture that creates a safe work environment. Develop and execute a process for monitoring, testing and reporting compliance. Identify risks or opportunities to strengthen internal controls and present recommendations for process improvement initiatives. At Aramark, developing new skills and doing what it takes to get the job done make a positive impact for our employees and for our customers. In order to meet our commitments, job duties may change or new ones may be assigned without formal notice. Qualifications Bachelor's degree or equivalent experience Requires at least 1-3 years of experience in a food service management role Healthcare experience required Strong interpersonal skills Ability to maintain effective client and customer rapport for mutually beneficial business relationships Ability to demonstrate excellent customer service using Aramark's standard service model Ability to maintain an effective working relationship with other departments to a unified food service experience for all customers Education About Aramark Our Mission Rooted in service and united by our purpose, we strive to do great things for each other, our partners, our communities, and our planet. At Aramark, we believe that every employee should enjoy equal employment opportunity and be free to participate in all aspects of the company. We do not discriminate on the basis of race, color, religion, national origin, age, sex, gender, pregnancy, disability, sexual orientation, gender identity, genetic information, military status, protected veteran status or other characteristics protected by applicable law. About Aramark The people of Aramark proudly serve millions of guests every day through food and facilities in 15 countries around the world. Rooted in service and united by our purpose, we strive to do great things for each other, our partners, our communities, and our planet. We believe a career should develop your talents, fuel your passions, and empower your professional growth. So, no matter what you're pursuing - a new challenge, a sense of belonging, or just a great place to work - our focus is helping you reach your full potential. Learn more about working here at ***************************** or connect with us on Facebook, Instagram and Twitter. Nearest Major Market: Philadelphia

Piramal Pharma Solutions is seeking an experienced Manager, Quality Systems & Compliance to lead and maintain robust quality systems and ensure compliance with global regulatory requirements at our Sellersville site. This role is critical in supporting cGMP and regulatory compliance across manufacturing, testing, warehousing, and distribution operations for pharmaceutical drug products. The successful candidate will ensure quality systems are effectively implemented, aligned with company quality policies, and continuously improved to meet evolving regulatory and business needs. Key Responsibilities Quality Systems Leadership Serve as system administrator for electronic Quality Management Systems (eQMS), including ComplianceWire, TrackWise, Ensur, eBMR, and eForms. Ensure effective use of quality systems to support site compliance and continuous improvement initiatives. Review and approve quality system records, including deviations, CAPAs, change controls, and training records. Training Program Management Oversee all site training activities and ensure compliance with regulatory and internal requirements. Partner with department heads and SMEs to develop, implement, and maintain training curricula. Provide guidance and training to end users on quality systems and processes. Document Control Manage the site SOP program and overall document control lifecycle. Oversee document management activities, including Master Batch Records and protocols. Compliance & Governance Lead Quality System Committees (QSCs) and review boards, including Deviation, CAPA, and Change Control Review Boards. Provide quality system metrics on a weekly, monthly, and quarterly basis. Manage Annual Product Reviews (APRs). Oversee complaint, FAR, and recall management processes. Manage Quality Technical Agreements (QTAs). Audit & Supplier Management Lead the Supplier Management Program. Manage internal, external, client, and regulatory audits. Actively support regulatory inspections and client audits. Data Integrity & Computer Systems Serve as Site Data Integrity Compliance Officer (DICO). Manage the site Data Integrity Program. Oversee the Computer System Validation (CSV) program. Support implementation and upgrades of electronic systems. Continuous Improvement Collaborate with the corporate quality team to implement global policies and procedures. Support site quality improvement initiatives and special projects. Ensure adherence to site safety standards. Perform additional Quality Systems & Compliance activities as assigned. Required Qualifications Education Bachelor's degree or higher in a scientific, quality assurance, or technical discipline. Experience Minimum of 10+ years in a manufacturing environment with QA, Quality Systems, and/or Compliance experience in a cGMP/FDA-regulated industry. At least 5 years in a supervisory or managerial role. Technical & Functional Skills In-depth knowledge of global pharmaceutical regulations (FDA, EMA, PDMA, ANVISA, TGA, DEA). Strong understanding of Quality Management Systems for non-sterile pharmaceutical manufacturing. Hands-on experience with eQMS platforms (DMS, LMS, eBMR). Proven experience in audits, supplier management, and data integrity. Excellent organizational, communication, and cross-functional collaboration skills. Proficient in Microsoft Office and standard business systems. Ability to manage multiple projects and priorities simultaneously.

Please, review and apply for this position through the QCI system following the link below (Copy and Paste): http://jobs.qcitech.com/jobseeker/Clinical_QA_Auditor_J02148106.aspx *You can apply through Indeed using mobile devices with this link. Additional Information

Moravia Health is seeking a qualified candidate for a Quality Assurance Assistant (full time) position. This position at Moravia Health provides an introduction or continuation of professional development in the Home Healthcare field. Job Description Summary: The Quality Assurance Assistant is under the direction of the Quality Assurance Director. QAA will provide assistance with caseload. Responsibilities will include: Staying current with state regulations and industry -related information to ensure 100% compliance with state licensure regulations and Moravia Health policies and procedures. Audit Participant files to ensure quality and compliance. Conducting quality assurance calls with all actively enrolled participants. Review Records in relation to investigation of problems including fraud, complaints, critical incidents, criminal activity, noncompliance with regulations, etc. Provide exceptional internal and external customer service which supports our value of providing high quality home care while meeting the needs of Participants Other duties as assigned.

Full-time Description 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. WE ARE SLATING THESE HIRES FOR START DATES IN OCTOBER OF 2026 BUT ARE COLLECTING APPLICATIONS NOW, NEXT STEPS WILL BE SENT TO YOU IN EARLY AUGUST 2026 ONSITE INTERVIEWS WILL BE SCHEDULED IN SEPTEMBER 2026 START DATES IN OCTOBER 2026 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. Salary Description 18+

Job Title: QA AssociateJob Description We are seeking a dedicated QA Associate to join our quality assurance team. In this role, you will be responsible for managing and coordinating various quality-related tasks, ensuring compliance with industry standards, and supporting continuous improvement initiatives within our organization. Responsibilities * Coordinate and participate in the investigation of quality deviations and non-conformances, including Deviation, LIR, OOS, and CAPA management. * Assist in implementing Corrective and Preventive Actions (CAPAs) to address root causes and prevent recurrence. * Coordinate change controls by working with the change initiator and evaluating associated risks. * Prepare for and support both internal and external audits, including those conducted by regulatory agencies such as the FDA. * Track and manage quality events within the company's electronic Quality Management System, including change controls, deviations, LIR's, OOS, and product complaints. * Compile, report, and analyze quality metrics to identify trends, compliance risks, and improvement opportunities, presenting findings during biweekly or monthly quality reviews. * Prepare annual product review (APR / APQR) reports. * Participate in the management of the vendor and supplier qualification program. * Communicate with suppliers and vendors for qualification and documents required for regulatory filing. * Support continuous improvement and maintain overall site quality. * Ensure adherence to GMP and good documentation practices. * Comply with all company policies and procedures. Essential Skills * Associates Degree or Bachelors Degree in Chemistry. * 1-2 years of Quality Assurance experience. * Experience on the manufacturing floor, laboratory, wet chemistry, titration, and chromatography. Additional Skills & Qualifications * Technical knowledge in chemistry and wet chemistry. * Proficiency in computer applications and programs related to laboratory applications. * Understanding of mathematics, including statistics. * Knowledge of sample preparation techniques. * Familiarity with spectroscopic techniques and chromatographic systems. * Basic computer knowledge, including MS Excel, Word, and Outlook. Work Environment The position operates within a laboratory setting, typically with a team of around 10 people. The facility is part of a growing CMO with a focus on high performance and cutting-edge developments in a new facility. Job Type & Location This is a Contract to Hire position based out of East Windsor, NJ. Pay and Benefits The pay range for this position is $30.00 - $35.00/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 • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in East Windsor,NJ. Application Deadline This position is anticipated to close on Jan 26, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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. WE ARE SLATING THESE HIRES FOR START DATES IN OCTOBER OF 2026 BUT ARE COLLECTING APPLICATIONS NOW, NEXT STEPS WILL BE SENT TO YOU IN EARLY AUGUST 2026 ONSITE INTERVIEWS WILL BE SCHEDULED IN SEPTEMBER 2026 START DATES IN OCTOBER 2026 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.

Holman is a family-owned, global automotive services organization anchored by our deeply rooted core values and principles that have enabled us to continue Driving What's Right throughout the last century. Our teams deliver the Holman Experience by treating our customers and each other as we would like to be treated, and creating positive, rewarding relationships all around. The automotive markets Holman serves include fleet management and leasing; vehicle fabrication and upfitting; component manufacturing and productivity solutions; powertrain distribution and logistics services; commercial and personal insurance and risk management; and retail automotive sales as one of the largest privately owned dealership groups in the United States. What will you be doing? Intakes, catalogues, and scans Licensing documents, and upload the scans to client Licensing cases Maps inbound Licensing documents to corresponding client cases Engages with clients regarding Licensing documents Outbounds physical Licensing documents to clients Assists and supports team members (e.g., Document Specialist I - Storage) depending on capacity and development goals Monitor and Update Case Progress Create and Manage Ghost Cases Client Outreach and Communication Outbound Registration and Plate Management Administrative Support Perform all other duties and special projects as assigned What are we looking for? High School Diploma or equivalent required, a degree in Business Administration or relevant field preferred. Additional education, certifications, or experience are a plus. Strong problem-solving skills and the ability to handle multiple tasks simultaneously Previous experience in case management, administrative support, or customer service is a plus. Proficient in various desktop tools including MS Office Programs (i.e. Outlook, Excel, Word, PowerPoint, Project, Visio, SharePoint etc.) Ability to work independently and as part of a team Familiarity with office technology and equipment, including computers, fax machines, scanners, printers, phone systems, etc. 2-4 years' experience in case management, administrative support, or customer service related fields Proficiency in a technical or functional area; knowledge of work processes and tools is generally limited to own area of responsibility or department Understanding of accounting principles and bookkeeping software may be required Reviewing and improving processes, methods, and tools to increase efficiency, accuracy, and security #LI-CD1 At Holman, we exist to provide rewarding careers and better lives for employees and their families. We hire, train, empower, and reward exceptional people. Our journey is guided by our desire to get it right every time and the acknowledgement that we have an opportunity to be better. To be better, we have to do better, and to do better we must know better. That's why we are listening, open to learning new things - about ourselves and each other. We will never stop striving for improved diversity, equity, and inclusion because we are successful together when we feel trusted and supported. It's The Holman Way. At Holman, your total compensation goes beyond your paycheck. To position you for success and provide a rewarding career and better life for you and your family, Holman is proud to offer you the benefits you deserve; including protection against illness, disability, loss of work, or preparation for retirement. Below is a brief overview of the programs available to full-time employees (programs may vary by country or worker type): Health Insurance Vision Insurance Dental Insurance Life and Disability Insurance Flexible Spending and Health Savings Accounts Employee Assistance Program 401(k) plan with Company Match Paid Time Off (PTO) Paid Holidays, Bereavement, and Jury Duty Paid Pregnancy/Parental leave Paid Military Leave Tuition Reimbursement Benefits: Regular Full-Time We offer excellent benefits including health, vision, dental, life and disability insurance, and 401(k) with company match. Our time off benefits include Paid Time Off (PTO), paid holidays, bereavement, and jury duty. In addition, we offer paid pregnancy and parental leave, and supplemental paid military leave to eligible employees. Temporary or Part-Time In geographic areas with statutory paid sick leave, part-time and temporary employees will receive a paid sick leave benefit that meets the mandated requirements. Artificial Intelligence Statement To maintain the integrity and authenticity of our hiring process, we kindly request that all candidates refrain from using artificial intelligence (AI) tools to generate, assist with, or enhance any part of their application materials (including resumes, cover letters, written and verbal responses, and images) or during any stage of the interview process. We value genuine, original work that reflects your personal experience, skills, and communication style. As part of our commitment to a fair and transparent evaluation process, please be advised that we may use technology to detect AI-generated content submitted by candidates. Candidates found to have used AI assistance in violation of this policy may be disqualified from consideration. Equal Opportunity Employment and Accommodations: Holman provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. If you are a person with a disability needing assistance with the application process, please contact ************* This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

The Public Housing Finance Consultant partners with Senior Consultants and Managers on client projects and engagements to assist in delivering accounting, audit and management consulting services for Public Housing Agencies client base. Job Duties: Performs outsource accounting function for clients including entering trial balances, making entry adjustments as needed, verifying trial balance amounts, and setting up electronic files to support client Performs detailed account analysis and may rebuild general ledgers and prepare financial reports including balance sheets, income statements and cash flow statements, as needed Interprets and applies knowledge of Public Housing Authority (PHA) Finance standards to guide effective and efficient delivery of quality services and products such as bank reconciliations, audit support workpapers, and board financial reports Provides strong written work products including workpapers that meets the client's requirements and PHA Finance quality standards Regularly interacts with clients to complete general ledgers, account analysis as well as to answer basic client questions and consults with seniors to provide responses to more complex questions Applies principles and knowledge of Generally Accepted Accounting Principles (GAAP) and of Government Accounting Standards Board (GASB) to provide guidance to clients on adherence to requirements in accounting records and financial reporting. Documents and communicates an understanding and application of all professional standards on an engagement to follow required grant reporting and compliance with grant requirements Makes basic constructive suggestions to improve the client's programs and policies, as needed Researches Housing and Urban Development (HUD) accounting and operational guidance and assists clients in making financial and operational decisions based on issued Accounting Briefs and PIH notices published Other duties as required Supervisory Responsibilities: N/A Qualifications, Knowledge, Skills and Abilities: Education: Bachelor's degree with a focus in Accounting or Finance, required Experience: Leadership experience, preferred Accounting based internship, preferred License/Certifications: N/A Software: Proficient in Microsoft Office Suite, specifically Word, Excel and PowerPoint, required Prior experience with various assurance applications and research tools, preferred Language: N/A Other Knowledge, Skills, & Abilities: Strong written and verbal communication skills Ability to follow instructions as directed Ability to work effectively in a team setting Takes appropriate actions without being asked Solid organizational skills especially ability to meet project deadlines with a focus on details Ability to successfully multi-task while working independently or within a group environment Proven ability to work in a deadline-driven environment and handle multiple projects simultaneously Ability to learn general ledger software programs Individual salaries that are offered to a candidate are determined after consideration of numerous factors including but not limited to the candidate's qualifications, experience, skills, and geography. California Range: $85,000 - $90,000 Colorado Range: $73,000 - $77,000 Illinois Range: $78,000 - $82,000 Maryland Range: $83,000 - $87,000 Massachusetts Range: $83,000 - $87,000 Minnesota Range: $70,000 - $74,000 New Jersey Range: $74,000 - $82,000 NYC/Long Island/Westchester Range: $83,000 - $87,000 Washington Range: $78,000 - $80,000 Washington DC Range: $83,000 - $87,000

Job Description 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

Here at The Arc Gloucester, we offer the unique opportunity to combine your professional experience with your passion to help individuals with intellectual or development disabilities For 67 years The Arc Gloucester has provided innovative programs and services to individuals with intellectual and developmental disabilities. We have made a difference in the lives of many people and are very proud of that. But it's the individuals we service who bring our programs to life with their creativity, excitement, humor, talent, and so much more! Summary: The Quality Assurance Coordinator audits and assesses programs' performance and compliance to ensure the establishment and continuity of standards of operations that meet or exceed those established by The Arc Gloucester, in compliance with regulatory standards. Position: Full-time (40 hours), exempt. Typical hours are Monday-Friday 9am - 5pm. This position operates primarily in an office setting with travel to locations throughout Gloucester County. This position is supervised by the Managing Director of Compliance. Essential Duties and Responsibilities: Strong focus on the review of program and individual financial ledgers, spendings, SNAP Card usage and inventory Conduct and attend regular meetings with program management to share financial findings on the program and individual level. Training new management on processes and regulations, ensuring compliance with agency financial policies and procedures Performs unannounced quality assurance checks of programs, citing staff shortages, health/safety and facility concerns, as well as speaking with staff about their knowledge of regulations, protocols, etc. Database management (Therap) Supports recruiting, reviewing resumes, screening candidates and scheduling interviews Conducts and completed investigations, confidentiality and reports findings as required Maintains an accurate paper and electronic filing system for audits conducted Communicates program performance and compliance through documented reporting to the respective Residential Manager, Director, and/or Administrator Will be required to travel to agency sites for auditory reviews and assessment Primary department, work location and schedule may vary Maintain confidentiality Comply with the DDD Program Manual, The Arc Gloucester Policies and Procedures Manual and applicable state, local and federal regulations, including any COVID-19 vaccination mandates & policies Must cooperate and participate in reviews, investigations, and inspections, including but not limited to cooperation with the licensee and Department of Human Services staff in any inspection, inquiry or investigation Occasional management responsibilities, including assisting with trainings, planning, workflow, and problem solving Additional responsibilities as required Qualifications: High School Diploma, and must be 18 years of age or older 5+ years experience with supporting individuals with intellectual and developmental disabilities is preferred Knowledgeable of DHS Licensing Standards for Community Residences Strong computer skills, particularly with Microsoft Word, Excel, and Outlook Strong analytical and problem-solving abilities, organizational skills, and attention to detail Excellent verbal and written communication skills Interest and ability for math and financial systems Must be able to communicate effectively and professionally with staff, leadership, families, State and Federal agencies, and most importantly the individuals served Must have a current, non-probationary driver's license with 5 points or less, and deemed acceptable to drive by The Arc Gloucester's liability insurance company, valid in the state of New Jersey Proficient in basic computer, math, reading comprehension and verbal and written communication skills Successfully pass initial and ongoing Federal & State Criminal Background checks, Fingerprinting, Central Registry, Motor Vehicle Record (MVR), Child Abuse Record Information (CARI), Health Screenings, Employment Verifications & References & Drug testing/ All employees must submit to a criminal background check, and be determined to be not disqualified by the Department of Human Services prior to working with individuals served, agree to have their name checked against the Central Registry of Offenders Against Individuals with Developmental Disabilities, shall complete an application to have their name checked against the Child Abuse Registry Information (CARI), shall submit to drug testing conducted randomly and for cause. All employees hired after 6/15/18 shall submit to drug testing prior to employment Certified in CPR/First Aid Successfully complete and demonstrate proficiency in all areas of required training Physical Requirements: While performing the essential functions of this position, the following are required, with or without reasonable accommodation: Ability to sit, drive, stand and walk for extended periods of time Ability to operate a computers, phone and other relevant technology Talk, hear and communicate in person, over the phone and using other technologies Physical duties, including but not limited to carrying, driving, general lifting (at least 25 lbs,), bending, twisting, squatting, and climbing stairs

Job Description Come work for a great company at APluscare! The Quality assurance Coordinator is responsible for preserving the standard of the services of the agency. Quality assurance personnel are accountable for assisting to create and execute quality control and management methods and systems. Personnel are accountable for monitoring that the services of the agency meet the standard and are error free. Job Duties: The principal responsibility of quality assurance personnel is to make sure quality of the services provided by APluscare is at the highest level. Quality assurance employees must review the business statistics and then determine areas requiring enhancement. A quality assurance employee should also inspect the samples and formulate policies concerning improvement of the present quality standards. Personnel should ensure that the services take place in accordance with the standards established. Additional responsibilities include all other duties as assigned by APluscare. The Quality Assurance Coordinator is required to: Oversee and ensure agency's compliance with DDD regulations at all levels of operations. Demonstrate broad knowledge of New Jersey Division of Developmental Disabilities (DDD) and Department of Human Services (DHS) licensing standards, regulations, and circulars. Maintain agency's residential/other programs compliance with DDD, DHS, Medicaid, and other applicable state and federal regulations. Cooperate and coordinate with state and other relevant officials during investigations of incidents that involve APluscare and/or its personnel. Ensure agency's compliance with applicable federal and state laws, regulations, and licensing requirements. Ensure agency's compliance with applicable accrediting bodies. Suggest and participate in policy and procedure development, modification, renewal, as well as adherence while maintaining compliance with applicable requirements. Provide weekly training and In-service to all staff involved in providing services and supports to clients of APluscare. Conduct weekly visits and audits of all DDD licensed programs in order to maintain continuous compliance with DDD licensing standards. Identify program deficiencies for all residential programs on a weekly basis and supervise program staff as needed to correct deficiencies. Maintain DDD licensure renewal for all agency programs that are licensed by the division. Maintains all company vehicles including registration, insurance, preventative maintenance, repairs, and equipment inventory according to APluscare policies and licensing standards. Maintains all licenses/certificates for each APluscare program and prepares homes on a regular basis and for licensing inspections. Prepare new programs for initial DDD licensing inspection and secure licensure. Maintain continuous program integrity for all agency programs through quality assurance surveys and reviews. Track and report on quality-related indicators, including areas of risk management and compliance. Conduct weekly quality assurance surveys for all DDD licensed programs Maintain agency compliance with all local, state, and federal regulations for all agency programs Conduct monthly visits and audits of all residential and other programs Prepare and submit program integrity and quality assurance weekly report to the Executive Director Identify program deficiencies for all residential and other programs on a monthly basis and supervise program staff as needed to correct deficiencies All other duties as assigned by APluscare Qualifications: The Quality Assurance Coordinator is expected to posse s excellent interpersonal skills, including the ability to communicate effectively with in individuals with intellectual and developmental disabilities and their families, colleagues, and other parties as necessary for employment with APluscare. Outstanding negotiation skills, customer-oriented approach, excellent analytical skills, effective leadership capability to lead projects, fundamental knowledge of operational software and understanding concerning concepts, equipment and various other quality management techniques. Employee must cooperate with the officer of licensing and/or any department of Human Service staff in any inspection or investigation Employee must successfully complete and demonstrate proficiency in all areas of required training. Valid Driver's License Must be at least 18 years of age Physical Demands/Working Conditions: Handles detailed, basic to complex, and specialized concepts and problems, balancing multiple tasks simultaneously. The ability to effectively communicate (orally and written) and interact with others, including diverse, interdisciplinary, cross-functional teams The ability to read, concentrate and learn Physical requirements include sitting, standing, walking, and computer work for long periods of time Pushing, pulling, and lifting up to 50lbs Driving and travel locally and between agency sites and other required locations Support and maintain all corporate policies, procedures, and quality and confidentiality standards Duties and responsibilities may be added, deleted or changed to meet the needs of the organization

This is a Temp onsite position based at our East Brunswick, NJ facility. The hours are 8:00 am - 4:30 pm, Mon-Fri with the occasional Sat. if needed. • Determine whether quality activities and related QC-QA audits and processes comply with the cGMP requirement. • Review of all the raw data including chromatograms and certificate of analysis generated during various testing in Quality control lab such as Raw material testing, packaging material testing, in-process testing, stability testing, equipment cleaning samples testing, Process validation samples analytical method validation/verification testing, etc. • Review of protocols, raw data, and Reports related to instrument calibration and qualification. • Review of raw data and Reports related to working standard qualification. • Review the audit trails and ensure proper integration on Empower software as a basis of soft version review prior to the release of any certificate of analysis. • Release of all the data on the SAP system and performing user decisions were ever required (example raw material/packaging material). • Review of Deviation and out of specification related raw data and respective reports • Review of daily calibrations like an oven, balance, pH meter, etc. • Issuance of quality documents like Protocols, certificate of analysis, Laboratory Notebooks etc to QC. • Performing Sample log in for all samples that are received in QC for testing. • Preserving all the quality document related to testing and submitting to QA department for Archival as a part of document control. • Provide support for Operations, Regulatory affairs, R & D and Quality Control objectives. • Review of data and report related to Analytical method validation as required. Reporting Relationships • This will be more of individual contributor and working in a team of QA auditors responsible for review of analytical data generated in QC department and releasing of the material and reporting to Manager of QA. Essential Functions: • The person will record the analytical package received from QC for auditing • The person will review the raw data received including not limited to data package, lab notebook, protocol pages etc. from QC related to testing and calibration. • He will review the data with respect to the standard operating procedure and quality control methods. • He will suggest correction and will ensure that the corrections are made prior to release of the material. • Once raw data is audited, he will review the accompanying COA and will sign off the COA, if required. • He will evaluate the results (perform 2 to 5) in SAP and then will give UD as required. • They will collect and store the raw data (folders and lab notebook) and will submit to QA for archival. • In case if there is Lab event, deviation or out of specification, the role will review all data generated as a part of investigation. • The person will review the investigation report to ensure that there are no transcription errors in They report and will sign-off the report. • The person will perform periodic audit trial review and will generate the report. • The person will assist the department will upgrading / creating new SOPs as required. • The person will assist the department by providing the requested data / document and by participation in any type of audit (internal and/or external). Adhere to all safety and cGMP standards and guidelines, and report unsafe conditions, near misses, and/or injuries in a timely manner Specialized Skills and Knowledge: • A bachelor's degree with chemistry/pharmacy as major is required. • Knowledge of handling HPLC and Empower chromatographic Software and minimum 3 years of experience in auditing of QC documents • Knowledge of other QC testing. • Knowledge of current cGMP Guidelines as needed for effective function of role. • Reviewing and Auditing Skills. • Basic knowledge of working on computers. • Knowledge of various pharmacopeia Key Competencies: 1. Effective Communication (Written and Verbal). 2. Analytical and Problem solving ability. 3. Document / Report drafting. Physical Demands/Factors: Work is primarily sedentary in nature; routine bending, walking, lifting and reaching are required. The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions. Based on the highly regulated workplace at Avet, employees will be required to meet minimum English proficiency requirements. All applicants must be legally authorized to work in the U.S. for any employer. We are unable to sponsor any applicants for a work visa or take over sponsorship of a work visa for any applicants, at this time. Avet is proud to be an Equal Opportunity Employer. This job description is not all-inclusive. It acts as a guideline and is subject to change. Additional duties may be assigned based on business needs. Compensation Compensation: This is a non-exempt position that pays $27 - 32 per hour.

Delta Mission and Values Delta's Mission: To enrich the lives of individuals and families through outstanding community-based support and mutually rewarding relationships. Values: Customer Focus, Performance Excellence, Learning and Growth Position Summary The Quality Assurance Coordinator is responsible for monitoring the systematic operations of the residential and vocational programs. This person will serve as a liaison between the local office and the national office. This person will be held accountable for ensuring the appropriate implementation of policies and procedures and ensuring programs are completely in compliance with state rules, regulations and agency policies. Reports to: The Director of Quality Assurance Principal Duties and Responsibilities To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The duties listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Schedule and conduct Quality Assurance audits of individual financial records and personnel files to include training records, medication administration records, medical records. Conduct comprehensive record reviews. Conduct physical site inspections of homes and program locations. Submit a quarterly report card to the Quality Assurance Director and Regional/State Director. Conduct a 30-day initial audit of all new homes and programs. Audit individuals' in-house accounts to verify that required documentation is maintained, accounts are monitored by the designated staff and balances are correct Communicate findings of audits to the State Director, RegionalDirector and Quality Assurance Director. Recommends any necessary changes in current policy and procedures. Conduct staff training as needed. Complete required training to become a Certified Investigator. Conduct investigations as required. Maintain a master file of all audit findings. Cooperate with the Department of Human Services staff in any investigation or inspection. Cooperate with all internal or external audits or investigations as a condition of continued employment. Maximize the development and capacity of staff to advance the mission and values of Delta. Ensure the full capacity of programmatic resources. Promote and demonstrate ethical and professional conduct at all times ensuring employees conduct. themselves in an ethical and professional manner. Promote continuous quality improvement projects and ongoing performance measures. Promote and address Delta's Risk Management Program for the health and safety of individuals and employees. Perform other duties as assigned. Qualifications Requirements Ability to form collaborative working relationships with diverse populations, including working with individuals of diverse cultures, ethnicities, gender, age, sexual orientation, socioeconomic status, religion, education background, etc. Ability to develop knowledge of, respect for, and skills to engage with those of other cultures or backgrounds. Demonstrated commitment to diversity, equity and inclusion. Aptitude for balancing multiple priorities with strong organization, time management and prioritization skills. Ability to self-direct, self-pace, multi-task and function well under the pressure of deadlines and conflicting priorities. Ability to work effectively with people, facilitating their growth and development. Ability to use acquired knowledge of supervisory and administrative principles and methods. Ability to read, write and speak English and communicate effectively with all constituencies of a diverse community; perform arithmetic calculations. Ability to use telephone, voice mail, copier, facsimile machine, calculator, computer and other office equipment. Fully proficient in Microsoft Office, software applications and the ability to learn new and emerging technologies. Ability to operate vehicles with a valid driver's license in accordance with applicable state laws, insurance provider requirements and company policies and procedures. Position Qualifications Bachelor's degree from an accredited college or university. Associates degree or sixty (60) credit hours from an accredited university or college and four (4) years' experience working with persons with intellectual disabilities may be substituted for Bachelor's degree. Two (2) years' work experience working directly with persons with intellectual disabilities Two (2) years' work experience using electronic health records and database management. Valid driver's license in the state of residence with a satisfactory driving record. Commitment to and knowledge of community-based support for persons with disabilities Working knowledge of management of an effective Quality assurance program Ability to present facts and recommendations effectively in oral and written form Independent judgment is required to plan, prioritize, and organize diversified workload Knowledge and understanding of local regulatory agency operations

Proven is an interactive design and development consultancy that blends creative vision with technical expertise to craft digital experiences that matter. We partner with non-profits and mission-driven organizations, leveraging our design, engineering, and strategic capabilities to drive meaningful impact. We're looking for a full-time Quality Assurance Associate to serve as the primary owner for quality assurance across our projects. In this role, you will design and execute test strategies and plans for web applications, working within an Agile framework and collaborating closely with project managers, developers, and clients. You will help ensure that every release meets both functional requirements and Proven's high quality standards. Key Responsibilities Lead and track all QA activities across assigned projects. Create, execute, and maintain test plans and test cases based on user stories, acceptance criteria, and requirements. Perform functional, system, integration, regression, and performance testing to ensure consistency and reliability across environments and systems. Identify, prepare, and manage test data for manual and (when applicable) automated testing. Collaborate with clients and internal teams to define, refine, and validate user acceptance criteria. Validate all tickets resolved by the development team prior to release, ensuring they meet requirements and are production-ready. Automate regression test scripts where appropriate and help evolve our automated testing coverage and standards. Identify, document, and prioritize defects; track them through resolution. Proactively surface risks, dependencies, and quality concerns to the project manager and team. Contribute to improving QA processes, tools, and documentation over time. Qualifications and Experience You are hyper-organized, detail-oriented, and comfortable independently owning your work to ensure quality and client satisfaction. 3+ years of experience working in a QA or testing role at a technology company, digital agency, or similar environment. Experience working as a tester on technical projects within an Agile software development lifecycle. Hands-on experience with several of the following: Functional and regression testing System and integration testing Performance, load, and speed testing User acceptance testing (UAT) Working knowledge of modern web development technology stacks (e.g., common front-end frameworks, APIs, CMS platforms) and how they impact testing. Strong analytical and problem-solving skills; you can not only find bugs, but also help the team understand impact and potential root causes. Excellent written and verbal communication skills; you're comfortable collaborating with cross-functional teams and interacting with senior stakeholders. Experience working remotely with distributed teams. Bachelor's degree in engineering, computer science, or a related field, or equivalent relevant experience. Why Join Proven? Mission-Driven Work: Help organizations that make a real impact in the world. Collaborative Culture: Work alongside talented designers, strategists, and engineers. Growth Opportunities: Shape the future of Proven's technology team and strategy. Remote Flexibility: Work from anywhere while leading a distributed team.

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

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.

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 3rd shift: 11:00 PM - 7:30 AM 3rd Shift - 11:00 PM to 7:30 AM