Quality assurance specialist jobs in Plainfield, NJ

Job Title: Sr Quality Specialist - Cell Therapy Mfg./Pharma Duration: 12 Months Pay Rate: Hourly on W2 ONLY - NO C2C 50% onsite required Work Schedule: Mon-Fri(normal business hours) Position Summary: This position is intended to increase compliance with data quality related activities associated with the addition of new fields in SQM and initial migration of data. In addition, ensure supplier records and associated record relationships are complete and accurate. Duties/Responsibilities The position holder is responsible and accountable for the tasks given below (non-exhaustive list): Request supplier objects and complete SQM records for vendors and materials supporting Cell Therapy manufacturing. Create and manage supplier-related change controls associated with supplier and material qualification, data governance and quality type changes, as needed. Evaluate Quality Agreements and audit documentation to ensure proper linkages to the appropriate supplier records within the SQM system and correct gaps/inaccuracies. Cleanse metadata in source documents (BMSDocs) for supplier related records (materials and service providers). Work with stakeholder groups to identify and populate teams, and the lead oversight groups for each GMP/GDP supplier object/profile in SQM to ensure accountability and compliance. Complete transition of material qualifications from heritage forms to current forms. Complete materials qualification transactions in SQM Module. Reporting Relationship Role is an individual contributor reporting to the project lead. Qualifications: Required Bachelor's degree in science, or a related field. 5+ years of experience in a GMP pharmaceutical, biopharmaceutical, or Advanced Therapeutic Modality Products (ATMP) environment including previous QA experience e.g., QA compliance role, Supplier Quality oversight. 2+ yrs experience with supplier management & oversight, material qualification, governance frameworks, and performance metrics. 3+yrs knowledge and experience with core quality processes - including change control, deviations/OOS, CAPA management, investigations. Thorough knowledge of cGMP in the pharma/Biotech industry as well as FDA, EU, and JP regulatory requirements, ICH guidelines. Knowledge of cell therapy manufacturing processes and testing is a plus. Skilled in planning and organizing, building relationships, innovation management and resource allocation. Ability to make independent and objective decisions and to work under minimal supervision with cross functional teams and partners worldwide. Team spirit. Action-oriented and customer-focused. Negotiation and persuasion skills. Good knowledge of common office software. Good verbal and written communication skills in English. Travel- 5% required to other NJ locations nearby

Our client, a leader in ophthalmic pharmaceutical compounding, is expanding our Quality team! We currently have multiple openings within Quality Assurance (QA) and Quality Control (QC). Applicants may be considered for several roles depending on background and interest, including: QA Inspector QA Manufacturing Specialist RESPONSIBILITIES (vary by role): Support QC sample handling, stability studies, and documentation. Perform QA inspections of drug products, materials, and documentation. Oversee manufacturing quality processes, deviations, and CAPAs. Investigate product complaints and ensure timely closure. Review validation and calibration records for compliance. QUALIFICATIONS Prior GMP/cGMP experience in pharma, biotech, or related industry. Strong documentation, QA/QC, and compliance background. Ability to work in an aseptic/cleanroom environment (gowning required). Excellent attention to detail and communication skills. WHY JOIN? Growing company with career advancement opportunities. Stable environment with strong leadership support. Collaborative team culture in a compliant 503B facility.

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.

Quality Manager(Food Manufacturing) Food and beverage industry Certificate, HACCP and PCQI In-depth knowledge of FDA regulations, ISO 9001, ISO 13485, and HACCP principles. Strong experience in QA/QC processes including conducting quality audits. Are you looking to make a career change to a rapidly growing company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance and paid PTO. Does this position match your future career goals? Then this opportunity could be the right fit for you Very Competitive Benefits Package Excellent Growth and advancement opportunities Employment Type: Full-time Job Requirements and Duties: Bachelor's degree in Science 5 plus years of food manufacturing industry experience Certificate, HACCP and PCQI Preventive Controls Qualified Individual (PCQI) in accordance the Food Safety Modernization Act (FSMA) Preventive Controls for Human Food Rule In-depth knowledge of FDA regulations, ISO 9001, ISO 13485, and HACCP principles. Strong experience in QA/QC processes including conducting quality audits. Manage the Food Fraud Program and Plant Security/Vulnerability Programs Assist in New Customer Setups by verifying internal documentation matches customer specification requirements Write, maintain, and improve quality system SOPs Provide oversight and leadership of facility Quality Assurance team. Responsible for hiring and team member development Manage the day to day operation of all quality function Lead the team in the execution of HACCP plans and ensure proper documentation is maintained Ensuring that manufacturing processes comply with standards at both National/ International level Review SOPs & specifications Oversee all aspects of daily quality operations Manage budgeting Ensure compliance with Federal, State and Local food safety regulations Understanding of industry standards of Food Safety and Quality Supports and participate to all the internal/external audits Review test results Provide, and oversee, inspection activity for product throughout production cycle Apply total quality management tools and approaches to analytical and reporting processes Schedule and coordinate preparations for product inspections and testing Work to resolve noncompliance issues with materials or final product Exceptional interpersonal skills and organizational skills Benefits: Great Pay Very Competitive Benefits Package Excellent work environment with growth opportunities Immediate Hire Jasleen Kaur ********************************* Ajulia Executive Search is a search firm specializing in Manufacturing, Finance, IT, Legal and Pharmaceutical positions. This is a confidential search for one of our preferred clients. It is a direct hire position that includes competitive compensation and full comprehensive benefit package. #ZR

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.

NYC Health + Hospitals is the largest public health care system in the nation. We are a network of 11 hospitals, trauma centers, neighborhood health centers, nursing homes, post-acute care centers, and correctional health services. We are a home care agency and a health plan, MetroPlus. Our health system provides essential services to 1.4 million New Yorkers every year in more than 70 locations across the city's five boroughs. Our diverse workforce of more than 42,000 employees are uniquely focused on empowering New Yorkers, without exception, to live the healthiest life possible. Visit us at nychhc.org and stay connected on facebook.com/nyc HHC or Twitter@hhcnyc. NYC Health + Hospitals/Correctional Health Services is one of the nation's leading correctional health care systems in quality of and innovations to care, and access from pre-arraignment through compassionate release. In-jail services include medical, nursing, mental health, substance use treatment, social work, dental and vision care, discharge planning, and reentry support. In addition to providing direct patient care in the jails, CHS leverages the resources of the nation's largest municipal health care system to help discharged patients successfully return to their communities. CHS is also a pivotal partner in New York City's criminal justice reform efforts. Summary of position: The Quality Assurance (QA) Radiological Technologist position encompasses responsible, administrative and clinical activity of varying degrees of latitude. Clinical level judgement is needed in the daily supervision of radiological functions and patient care, and departmental projects. Responsibilities include: Review exam orders, consult with radiologist, schedule patients and arrange for transportation as indicated. Identify patient and document all information pertinent to final report in the RIS and on images (PACS). Prepare allpatients (infants, children,adolescents, adults andgeriatric) for radiological procedures requested bythe clinician. Arrange for proper protection of patients, public andstaff from infectious diseases/materials. Perform allgeneral diagnostic imaging and routine examination in CT and Angiography. Assists inperforming daily checks of radiographic imaging equipment, immobilization devices and other necessary accessories. Enters data and maintains documents and logsas required andmandated by the department QAguidelines and various regulatory agencies. Maintains adequate stocks of supplies andmaterials needed foruse in thedepartment. Checks equipment for defects prior for useand assures proper use of such equipment through instruction and review. Report any unexpected patientincidents in accordance with theoccurrence report protocol. Maintain and exercise all mandated radiation safety regulations. Maintain basic care of all the imaging equipment. All malfunctions are to be reported to management staff whether mechanical, electrical or suspect and service request documentation completed. Maintain a clean and safe work environment for both patients and staff. Perform other duties as deemed necessary (by supervisory oradministrative staff) inthe event of emergencies ordisasters. Continue professional growth and development of job-related skills on an ongoing basis. Participate in continuing education activities. Ensure allexaminations are accessioned, documented and sentto PACS forreading. Monitor PACS and RIS incomplete worklists to ensure all exams arecompleted. In accordance with HIPAA (the Health Insurance Portability and Accountability Act), staff members will exercise due diligence in ensuring patient privacy and confidentiality. Identifies activities thatthe network hasimplemented to promote patient safety andtakes all necessary precautions to ensure a safe environment for patients, visitors andstaff. In addition to the Radiology Technologist job functions, the QA Technologists is responsible for the following: Organize and file maintenance reports for each building in regards to dentistry and radiology x-ray equipment and ensure dentistry and x-ray equipment follow the Department of Health codes, policies and procedures. Participates in quality assurance activities, including coordination, control and maintenance of technical equipment. Establish a daily/weekly/monthly quality control routine for monitoring, evaluating, and maintenance of X-ray equipment to ensure optimal performance and stability. Documenting and maintaining records for the quality control program in accordance with applicable regulations, legal requirements, accrediting agencies and recommendations from equipment manufacturers. Performs research and participates in special projects involving evaluation of equipment and delivery of service. Work with our radiologists to obtain updated documentation of primary diagnostic monitors. Distribute/collect dosimeter badges from each employee/facility that works with x-ray equipment. Recommends area assignment of personnel to coordinate activities within the department with other activities and services and represents the department in interdepartmental operations and meetings. May be assigned duties and responsibilities of X-ray Director in regards to radiology department workflow. Department Preferences: Possession of a current valid license as a General Radiological Technologist issued by the State of New York. A minimum of two years of experience as a Radiological Technologist. A current member of the American Registry of Radiologic Technologists (ARRT). Valid BLS required. Must possess a valid driver's license. Must be proficient in Microsoft Office Suite. Minimum Qualifications: Assignment Level III 1. For Supervisory Assignments: a valid license and current registration to practice Diagnostic Radiography as a Radiologic Technologist issued by the NYSDOH; and two (2) years of Radiologic Technologist experience performing duties consistent with Assignment Levels I and II, one (1) year of which must have been in a supervisory capacity. 2. For Specialized Imaging Assignments: a valid license and current registration to practice Diagnostic Radiography as a Radiologic Technologist issued by the NYSDOH; and possession of a current advanced- level certification for the performance of these procedures.

QA Auditor II- Whitesboro, NY- Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Quality Assurance Auditor II to join our diverse and dynamic team at our bioanalytical lab in Whitesboro NY. As a Quality Assurance Auditor II at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of innovative treatments and therapies. What you will be doing * Assisting in the development and implementation of quality assurance strategies and processes to support clinical trial activities. * Conducting comprehensive quality assessments and audits to ensure compliance with regulatory standards and guidelines. * Collaborating with cross-functional teams to identify and address quality issues and implement corrective actions as needed. * Participating in the review and approval of clinical trial documentation and data to ensure accuracy and completeness. * Contributing to the continuous improvement of quality assurance practices and procedures. Your profile * Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred. * Minimum of 2 years of experience in quality assurance within the pharmaceutical, biotech Nlogy, or CRO industry preferred. * Familiarity with regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations). * Strong attention to detail and analytical skills, with the ability to identify and resolve quality issues effectively. * Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GLCP) * Excellent communication and interpersonal skills, with the ability to collaborate effectively with colleagues and stakeholders at all levels. * Bioanalytical Lab experience (preferred) * MUST be willing to work a hybrid schedule at our Whitesboro, NY facility #LI-MN1 #LI-Hybrid What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Salary range: $68,616.00-$85,770.00 Bonus, Com, Stock, Benefits & Disclaimer verbiage: Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance. Are you a current ICON Employee? Please click here to apply

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.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description The incumbent will have responsibility to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements, the Client Pharma Corporate Quality Manual and Policies, and site procedures and business requirements. Coordinates and performs batch record issuance for internally manufactured products Reviews and approves manufacturing and QC related documents for raw material disposition. Reviews and approves manufacturing and QC related documents for manufactured media Performs administrative functions for filing and maintenance of records between QA operations and Document Control Center Support cGMP and associated OJT training to QA and other departments to improve right the first time (RTFT), high quality performance. Control costs within department to meet budget. Complete job-related training in electronic database system along with GMP, safety, and Ethics & Compliance course requirements. Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed. Skills:0-3 years GMP manufacturing and/or QA related experience Education: BS/BA in Biological Sciences or equivalent relevant career experience Qualifications Skills: 0-3 years GMP manufacturing and/or QA related experience Education: BS/BA in Biological Sciences or equivalent relevant career experience Additional Information Sneha Shrivastava Technical Recruiter (Clinical/Scientific) Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Connect with us on - LinkedIn | Facebook | Twitter

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

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

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

**General Job Description** FreshRealm looking for a Quality Control Technician Level 2 in our Fulfillment Center to inspect and ensure that all ingredients and all items in boxes meet required quality standards.This is working on our Linden site and has a pay range of $21-$25 hr. **Objectives of this Role** + Assist Specialist with Gold Standard and table set up + Audit bins of finished product continuously (each table at least once per hour, each automated prep at least once every 15 minutes) + Assist Specialist with calling the line and ensuring accuracy + Audit pack lines on a continuous basis (at least twice per hour) + Audit finished boxes continuously (at least three boxes per hour) + Document all audits in Quality Tool Suite + Notify Specialist and Quality Auditor of any issues + Attend monthly refresher trainings with Quality team + Speak with Quality during start up communications **Skills and Requirements** + Clear and concise communicator, verbal and written. + Ability to work calmly and effectively under pressure. + Ability to work in fast-paced, deadline-oriented environment. + Flexible availability; we work night and weekend shifts. + Must be able to lift up to 49 pounds repetitively with or without reasonable accommodation + Must be able to handle exposure to temperatures that range from freezing to sub-freezing (coolers, freezers, etc.) + Must be able to stand/walk for up to 10-12 hours with or without reasonable accommodation + Must be willing and able to frequently push, pull, squat, bend, and reach with or without reasonable accommodation **Experience / Education** **What We Offer** + Comprehensive benefits package for full-time employees including medical, dental, vision, pet insurance and legal insurance + 401(k) with company match that is immediately vested + Life and ADD insurance + Opportunities for career growth with a dynamic company that is changing the landscape of fresh meals. **Our Values at Work** We believe that **ACTIONS** speak louder than words and our company values align to those **ACTIONS.** **In Our Daily Work, This Looks Like** + **ACCOUNTABILITY:** Set clear objectives and prioritize your tasks Hold yourself and your teams accountable for meeting deadlines Learn from your mistakes and use it as a learning opportunity to improve next time + **CHALLENGE WITH CURIOSITY** : We challenge and engage with each other through curiosity and a drive to innovate and transform. This encourages us to learn from one another, be open-minded to other perspectives and possibilities, and continuously improve and problem-solve with intensity. We persevere through challenges, observe patterns, and pay attention to the details to make connections others may overlook, allowing us to exceed expectations. + **TRANSPARENCY & HONESTY:** Maintain open and consistent communication. Admit mistakes and take ownership Document decisions to help avoid misunderstandings + **INNOVATION** : Work with the end-user in mind and create solutions that will add value Question existing norms, assumptions, and best practices Experiment and take calculated, data-driven risks + **OBJECTIVITY** : Utilize data and make data-driven decisions at every opportunity + **NIMBLENESS** : Utilize time management to help stay focused and on task with urgency es and make adjustments accordingly Delegate and trust others to handle specific responsibilities with resources and support + **SUCCESS THROUGH OUR CUSTOMERS** : Know your audience and the type of work they expect to receive as the end-result of a project, initiative, or task Seek feedback at different stages to ensure you're on the right track Foster collaboration among cross-functional teams to ensure you're providing the best experience and service to our consumers _Equal Opportunity Employer_ We are an Equal Opportunity Employer. **Job Details** **Job Family** **FreshRealm** **Job Function** **Hourly Site** **Pay Type** **Hourly**

Quality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. This role manages internal and external audits which may include interaction with Health Authorities and clients Interfaces directly with client and cross functional teams Provides resolutions pertaining to quality for project related issues Independently prioritize, schedule, and manage multiple projects and resources (team) Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements. Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues. Author and review relevant SOPs, validation and other documents. Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports. Responsible for the completion of all client requirements related to cellular product and/or material releases. Master Batch Record Control, distribution and label verification Perform line clearance activities as required. Assignment and maintenance of product Lot numbers as applicable. Perform internal documentation audits as assigned. Materials management nonconformance disposition and release activity as applicable. Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions. Track and trend relevant quality metrics including environmental monitoring data. Provide Quality Assurance related support to various departments. Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies. Electronic Document Control activities as assigned. Provide training to personnel as assigned by supervisor. Travel may be required. REQUIREMENTS BS in biological sciences or other relevant field of study 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics. Working knowledge and technical understanding of aseptic manufacture of biologics Understanding of quality system applications Experience in both clinical and commercial manufacturing is preferred. Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc. Experience in organizing teams for effective and timely completion of projects. Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc. Experience participating in or hosting health authority inspections and/or client audits. Computer skills (Microsoft Office, Outlook) Detail-oriented and organized Analytical and problem-solving skills Good written and oral communication skills Ability to multi-task and be adaptable Flexible and able to adapt to company growth and evolving responsibilities Ability to work independently and with a team Strong Project Management and organization skills Must have the ability to work in a team-oriented environment and with clients Must be able to work during the weekend, holidays and as required by the company May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

NYC Health + Hospitals is the largest public health care system in the nation. We are a network of 11 hospitals, trauma centers, neighborhood health centers, nursing homes, post-acute care centers, and correctional health services. We are a home care agency and a health plan, MetroPlus. Our health system provides essential services to 1.4 million New Yorkers every year in more than 70 locations across the city's five boroughs. Our diverse workforce of more than 42,000 employees are uniquely focused on empowering New Yorkers. NYC Health + Hospitals/Correctional Health Services is one of the nation's leading correctional health care systems in quality of and innovations to care, and access from pre-arraignment through compassionate release. In-jail services include medical, nursing, mental health, substance use treatment, social work, dental and vision care, discharge planning, and reentry support. In addition to providing direct patient care in the jails, CHS leverages the resources of the nation's largest municipal health care system to help discharged patients successfully return to their communities. CHS is also a pivotal partner in New York City's criminal justice reform efforts. Work Shifts Time: 8a-4p Days: Mon-Fri Facility: CDU-WF facility on Rikers Island Duties & Responsibilities The Quality Assurance (QA) Radiological Technologist position encompasses responsible, administrative and clinical activity of varying degrees of latitude. Clinical level judgement is needed in the daily supervision of radiological functions and patient care, and departmental projects. Responsibilities include: Review exam orders, consult with radiologist, schedule patients and arrange for transportation as indicated. Identify patient and document all information pertinent to final report in the RIS and on images (PACS). Prepare all patients (infants, children, adolescents, adults and geriatric) for radiological procedures requested by the clinician. Arrange for proper protection of patients, public and staff from infectious diseases/materials. Perform all general diagnostic imaging and routine examination in CT and Angiography. Assists in performing daily checks of radiographic imaging equipment, immobilization devices and other necessary accessories. Enters data and maintains documents and logs as required and mandated by the department QA guidelines and various regulatory agencies. Maintains adequate stocks of supplies and materials needed for use in the department. Checks equipment for defects prior for use and assures proper use of such equipment through instruction and review. Report any unexpected patient incidents in accordance with the occurrence report protocol. Maintain and exercise all mandated radiation safety regulations. Maintain basic care of all the imaging equipment. All malfunctions are to be reported to management staff whether mechanical, electrical or suspect and service request documentation completed. Maintain a clean and safe work environment for both patients and staff. Perform other duties as deemed necessary (by supervisory or administrative staff) in the event of emergencies or disasters. Continue professional growth and development of job-related skills on an ongoing basis. Participate in continuing education activities. Ensure all examinations are accessioned, documented and sent to PACS for reading. Monitor PACS and RIS incomplete worklists to ensure all exams are completed. In accordance with HIPAA (the Health Insurance Portability and Accountability Act), staff members will exercise due diligence in ensuring patient privacy and confidentiality. Identifies activities that the network has implemented to promote patient safety and takes all necessary precautions to ensure a safe environment for patients, visitors and staff. In addition to the Radiology Technologist job functions, the QA Technologists is responsible for the following: Organize and file maintenance reports for each building in regards to dentistry and radiology x-ray equipment and ensure dentistry and x-ray equipment follow the Department of Health codes, policies and procedures. Participates in quality assurance activities, including coordination, control and maintenance of technical equipment. Establish a daily/weekly/monthly quality control routine for monitoring, evaluating, and maintenance of X-ray equipment to ensure optimal performance and stability. Documenting and maintaining records for the quality control program in accordance with applicable regulations, legal requirements, accrediting agencies and recommendations from equipment manufacturers. Performs research and participates in special projects involving evaluation of equipment and delivery of service. Work with our radiologists to obtain updated documentation of primary diagnostic monitors. Distribute/collect dosimeter badges from each employee/facility that works with x-ray equipment. Recommends area assignment of personnel to coordinate activities within the department with other activities and services and represents the department in interdepartmental operations and meetings. May be assigned duties and responsibilities of X-ray Director in regards to radiology department workflow. Minimum Qualifications Assignment Level III 1. For Supervisory Assignments: a valid license and current registration to practice Diagnostic Radiography as a Radiologic Technologist issued by the NYSDOH; and two (2) years of Radiologic Technologist experience performing duties consistent with Assignment Levels I and II, one (1) year of which must have been in a supervisory capacity. 2. For Specialized Imaging Assignments: a valid license and current registration to practice Diagnostic Radiography as a Radiologic Technologist issued by the NYSDOH; and possession of a current advanced- level certification for the performance of these procedures. Department Preferences Possession of a current valid license as a General Radiological Technologist issued by the State of New York. A minimum of two years of experience as a Radiological Technologist. A current member of the American Registry of Radiologic Technologists (ARRT). Valid BLS required. Must possess a valid driver's license. Must be proficient in Microsoft Office Suite. Additional Salary Compensation All Radiologic Technologists in Assignment Levels II and III shall receive a differential of $7,500 per annum to be cross-trained on different modalities of radiologic imaging and to be cross-assigned (once trained) to different imaging settings depending on patient volume and staffing needs within a facility. Benefits NYC Health and Hospitals offers a competitive benefits package that includes: Comprehensive Health Benefits for employees hired to work 20+ hrs. per week Retirement Savings and Pension Plans Paid Holidays and Vacation in accordance with employees' Collectively bargained contracts Loan Forgiveness Programs for eligible employees College tuition discounts and professional development opportunities College Savings Program Union Benefits for eligible titles Multiple employee discounts programs Commuter Benefits Programs

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description 1. The incumbent will have responsibility to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements, the Client Pharma Corporate Quality Manual and Policies, and site procedures and business requirements. 2. Coordinates and performs batch record issuance for internally manufactured products Reviews and approves manufacturing and QC related documents for raw material disposition. 3. Reviews and approves manufacturing and QC related documents for manufactured media Performs administrative functions for filing and maintenance of records between QA operations and Document Control Center Support cGMP and associated OJT training to QA and other departments to improve right the first time (RTFT), high quality performance. 4. Control costs within department to meet budget. Complete job-related training in electronic database system along with GMP, safety, and Ethics & Compliance course requirements. 5. Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed. Skills:0-3 years GMP manufacturing and/or QA related experience 6. Education: BS/BA in Biological Sciences or equivalent relevant career experience Additional Information Regards, Anuj Mehta ************

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

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description 1. The incumbent will have responsibility to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements, the Client Pharma Corporate Quality Manual and Policies, and site procedures and business requirements. 2. Coordinates and performs batch record issuance for internally manufactured products Reviews and approves manufacturing and QC related documents for raw material disposition. 3. Reviews and approves manufacturing and QC related documents for manufactured media Performs administrative functions for filing and maintenance of records between QA operations and Document Control Center Support cGMP and associated OJT training to QA and other departments to improve right the first time (RTFT), high quality performance. 4. Control costs within department to meet budget. Complete job-related training in electronic database system along with GMP, safety, and Ethics & Compliance course requirements. 5. Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed. Skills:0-3 years GMP manufacturing and/or QA related experience 6. Education: BS/BA in Biological Sciences or equivalent relevant career experience Additional Information Regards, Anuj Mehta ************

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