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Quality assurance specialist jobs in Howell, NJ - 545 jobs

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  • Quality Management Clinical Outreach Specialist (LMSW/LMHC)

    Metroplushealth

    Quality assurance specialist job in New York, NY

    The OS is responsible for telephonically outreaching members who were recently discharged from Inpatient Care, Emergency Rooms and Outpatient Programs with a principal Behavioral Health diagnosis. The OS will be conducting a bridge visit where they assess the member's current state, review their discharge plan and assist in connecting them to appropriate aftercare services. The OS will also work collaboratively with other teams, such as Behavioral Health Case Management, to ensure the needs of our members are met. To succeed in the role, candidates must be: Self-motivated and able to work in a fast-paced, dynamic work environment Possess strong attention to detail and technical abilities Organized and able to meet deadlines Demonstrate strong communication skills Scope of Role & Responsabilities: Assists members in accessing post-discharge aftercare related appointments/rescheduling new appointments. Interfaces with members and Behavioral Health or Medical Case Management staff to coordinate aftercare activities. Delivers crisis and emotional support when needed during telephonic outreaches. Ability to de-escalate crisis/utilize crisis intervention techniques and motivational interviewing before bridging to proper crisis services. Meets the daily expected call volume and number of bridge visits. Self-monitors productivity and accepts supervision towards a high level of member care. Maintains accurate and complete documentation of required information in compliance with risk management and regulatory requirements. Shares observations and provides feedback regarding workflow to ensure continuous quality improvement. Performs other departmental duties and participates in special/ad-hoc projects as assigned. Required Education, Training & Professional Experience: Master's Degree required. Minimum 3 years of Behavioral Health (Serious Mental Illness & Substance Use Disorder) experience in managed care setting. Minimum of 3 years' post licensing experience working directly with consumers towards their recovery. Understanding of Medication Assisted Treatment process. Pharmacy, Psyckes, E-Paces, HCS (UAS) MAPP knowledge. Working knowledge of current DSM Manual and understanding of Behavioral Health diagnosis. Knowledge HEDIS/QARR strongly preferred. Knowledge of quality improvement methodologies, i.e., PDSA, Six Sigma. Strong technical skills (Microsoft Office, specifically MS Excel and MS Access; ability to navigate multiple computer programs and applications). Bilingual (English/Spanish) strongly preferred. Licensure and/or Certifcation Required: Valid New York State license and current registration to practice as Licensed Clinical Social Worker (LCSW), Licensed Master Social Worker (LMSW), or Licensed Mental Health Counselor (LMHC). Professional Competencies: Integrity and Trust. Customer Focus. Demonstrated ability to communicate effectively, problem solve and work effectively with people. Clear and concise written/oral communications. Exceptional time management and organizational skills. Ability to function in a fast-paced, dynamic work environment. Strong interpersonal skills, the ability to remain calm and poised with challenging situations. Self-starter who is able to perform tasks at a high level with minimal supervision. Ability to work evenings and weekends as needed to meet department goals. #LI-Hybrid #MHP50
    $67k-102k yearly est. 5d ago
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  • Quality Assurance Coordinator

    Invision Staffing Services Inc.

    Quality assurance specialist job in Newark, NJ

    InVision is a Professional Recruitment Firm specializing in Engineering, Industrial/Skilled Trades, Information Technology and Professional Services within Canada and the U.S. We have a successful track record working on both small and large recruitment projects, across North America. Our client is a global expert in electrical specialties and advanced materials for high-tech industries. With more than 50 industrial sites and 16 R&D centers in 35 countries around the world, they develop custom built solutions and delivers key products to its clients in order to meet the new technological challenges shaping tomorrow's world in the wind power, solar power, electronics, electric vehicles, aeronautics, space and countless other industries. They are seeking a Quality Assurance Coordinator to join them on a full-time permanent basis. In this role Your responsibilities will include conducting audits, developing quality control plans, implementing corrective actions, and collaborating with cross-functional teams to drive continuous improvement in quality processes. Key Responsibilities Responsible for Incoming Inspection of specific items and final Inspection of all products Enter all orders inspected into finished goods and generate pick lists. Approve all setups for in house hardware and perform FAI and generate FAIR. Responsible for dealing with quality issues with incoming materials from suppliers. Support QA team in inspection processes whenever needed, and the preparation inspection reports. Support production on questions relating to drawings, visual quality, verifying last off or set-up. Foster positive relationships with stakeholders through effective communication. Follow ISO and Health C Safety policies and procedures. Contribute to the development and maintenance of a positive quality culture within the organization. Perform other duties as directed by the QA manager. Develop and maintain quality control plans, procedures, WI, SOP's, and protocolsto ensure adherence to quality standards. Coordinate and conduct internal audits to assess compliance with quality management systems and identify areas for improvement. Lead the development and implementation of corrective and preventive actions (CAPA) to address quality issues and prevent recurrence. Handle quality issues with incoming materials from suppliers and customer complaints, including initiating Non-Conformance Reports (NCR) and managing Return Material Authorizations (RMA). Handle administrative components of customer complaints and various qualityreports. Monitor Customers portals. Monitor and analyze quality metrics and performance indicators to track progressand identify trends or patterns. Collaborate with production, engineering, and other departments to address quality-related issues and drive product improvements. Prepare and complete quality documentation, such as CONQ, PPAP, FAIR reports, Source Inspection Report & any special inspection report. IQS and QMS drive ownership Manage quarantine cage and maintain its log. Handle on-hold material. Provide guidance and training to staff on quality processes, standards, and best practices. Facilitate communication and collaboration between cross-functional teams to promote a culture of quality excellence. Participate in customer audits and inquiries related to quality assurance processes and procedures. Participate in supplier evaluations and audits to ensure quality standards are met throughout the supply chain. Monitor and analyze quality metrics and performance indicators to drive continuous improvement initiatives. Assist in the preparation and submission of quality-related reports and documentation to regulatory agencies as required. Qualifications 3 college or technical school or Quality Program, and 3+ years of Quality Assurance and Quality Control experience. Experience with completing FAI reports and conducting a supplier audit. Experience with following manufacturing processes: casting, machining, sheet metal work, surface treatment, plastics thermoset processing would be an asset Experience with ISO 9001 standards Ability to communicate in English, both verbally and in writing. French or Spanish would be an asset. ITAR facility must be a US citizen or green card holder Strong leadership and team management capabilities Excellent problem-solving and decision-making skills Knowledge of ERP/MRP systems (JDE, SAP, Oracle, Microsoft Dynamics, etc.) Employment Rewards: Full Time Permanent Benefits (medical, dental, vision) Paid Time Vacation Annual Bonus 401K + Match Application Process: All Qualified candidates will be contacted. InVision is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of Any Kind: It is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment.
    $51k-76k yearly est. 5d ago
  • QC Associate

    Blue Nile 4.3company rating

    Quality assurance specialist job in New York, NY

    Perform detailed inspections of in process jewelry products throughout the manufacturing process, including rings, necklaces, bracelets, earrings, and other accessories, to ensure they meet established quality standards and specifications. Provide fe Associate, QC, Jewelry, Manufacturing
    $36k-51k yearly est. 5d ago
  • Quality Assurance Coordinator

    S S White Burs 4.0company rating

    Quality assurance specialist job in Lakewood, NJ

    Full-time Description SS White Burs is a leading dental device manufacturer that strives to bring high quality dental products to market, enabling practitioners to work more efficiently and to maximize patient comfort and quality. The creation of unique and differentiated products is the cornerstone of SS White Dental. Our footprint has been around for 170 years and makes us one of the most well recognized and trusted names in the industry today. Requirements Manages Customer complaints (RMA: Return Material Authorization): · Receive and organize return product for RMA process · RMA processing which involves receipt/system transaction and proper disposition of material in Epicor as per Procedure PROSP9 · Perform needed testing of product according to complaint and as per Work Instruction WISP901. · Recording of evaluation results for quality complaints · Physical movement/disposition of product · Proper closeout of customer complaints in Epicor · Closeout DMRs generated for quality related complaints Calibration: · Manage calibration program which includes monthly calibration schedule, maintaining calibration records, calibration results entry in GageTrak and conduct calibration inspection when needed as per procedure PROSP5. · Schedule calibration for outsourced calibration equipment which includes obtaining quotes from vendor, completing internal purchase requisition to get Purchase Order from Purchasing Department. Other responsibilities and functions: · Generate and issue COC (Certificate of Compliance) and COA (Certificate of Analysis) as requested by Customer and according to Shipping Pick list · Assist with File Heat Treating as needed · Manage set-up bin (in Epicor and physical inventory) Qualifications: · High school diploma or equivalent · Proficiency using Microsoft Office and other Windows based applications · Demonstrated ability to read, write legibly, and understand English · Highly organized & detail orientated · Ability to communicate and work with all departments and all levels of management
    $52k-78k yearly est. 60d+ ago
  • Clinical QA Auditor

    Cs&S Staffing Solutions

    Quality assurance specialist job in Princeton, NJ

    Please, review and apply for this position through the QCI system following the link below (Copy and Paste): http://jobs.qcitech.com/jobseeker/Clinical_QA_Auditor_J02148106.aspx *You can apply through Indeed using mobile devices with this link. Additional Information
    $72k-120k yearly est. 3d ago
  • Clinical QA Auditor

    CS&S Staffing Solutions

    Quality assurance specialist job in Princeton, NJ

    Please, review and apply for this position through the QCI system following the link below (Copy and Paste): http://jobs.qcitech.com/jobseeker/Clinical_QA_Auditor_J02148106.aspx *You can apply through Indeed using mobile devices with this link. Additional Information
    $72k-120k yearly est. 60d+ ago
  • Quality Assurance Specialist

    Easterseals 4.4company rating

    Quality assurance specialist job in New York, NY

    The Quality Assurance Specialist is responsible for implementing and maintaining effective programs to ensure compliance with applicable quality standards for all components of WeCARE operations. The position is also responsible for identifying, developing, coordinating and facilitating staff training programs designed to enhance operational efficiencies and program outcomes. What You'll Do Develop and initiate standards, tools, processes and methods for evaluating efficiency and effectiveness of program operations and services. Perform internal audits on WeCARE departments in areas of documentation, imaging, phone follow-up, record-keeping, and timeliness of services. Conduct surveys and focus groups of participant satisfaction within different elements of WeCARE services and share results with WeCARE leadership in order to develop plans for improvement. Design, execute and close preventive and corrective action plans resulting from internal and external audits. Identify potential areas of vulnerability and risk and provide general guidance on how to avoid or deal with similar situations in the future. Design, administer, analyze and report the results of staff and participant training needs assessments. Research, identify and recommend external trainers and training curriculum in response to identified staff and participant training needs. Collaborate with other departments to address quality assurance concerns. You're a great fit for this role if you have: A Bachelor's degree from an accredited college in public administration, health administration, nonprofit management, social services, vocational rehabilitation, business administration, or a related field is required. A Master's degree in one of these fields is preferred. Experience working with public assistance recipients, the homeless, formally incarcerated people, and/or those affected by the challenges associated with poverty. Experience in quality assurance practices in New York City social service contracts. Bilingual (English Spanish) preferred. Compensation $64,350-$67,000 annually Equal Opportunity Employer
    $64.4k-67k yearly Auto-Apply 60d+ ago
  • OTC Derivatives Documentation Specialist

    Jane Street 4.4company rating

    Quality assurance specialist job in New York, NY

    We are looking for an OTC Derivatives Lawyer/Documentation Specialist to handle Jane Street's global OTC derivatives confirmations review process. In this role, you'll collaborate closely with our internal Legal, Operations, and Trading teams-and liaise directly with external counterparties-to facilitate prompt, accurate reviews and negotiations of trade confirmations and related documentation. While you'll be based in New York, your daily work will cover activity across our global offices in New York, London, and Hong Kong. Additional responsibilities of this role will include: Drafting, reviewing, and negotiating confirmations for equity, FX, and interest rate derivatives Managing a system for tracking OTC derivatives documentation across all Jane Street offices Working with our Legal and Trading teams to create, maintain, and update confirmation templates, and identifying the appropriate confirmation template for each trade Assisting with legal review of trade confirmations Comparing terms and identifying discrepancies to ensure accuracy and consistency Sending comments to counterparties and negotiating as needed Monitoring communications with counterparties and acting as a point of contact for the desk, Legal, and counterparties Following up to have negotiated confirmations reissued where appropriate Checking coverage under existing master confirmation agreements Obtaining signatures and collecting and returning fully executed copies to and from counterparties Matching counterparty questionnaires on IHS Markit Documenting and improving processes to maximize efficiency across teams About You Have 5+ years of experience working as a negotiator in financial services, or in-depth relevant experience over a shorter period (having a JD is preferred but not required) Deeply familiar with master documentation governing OTC derivatives, including: the Equity Derivatives Definitions, Interest Rate Derivatives Definitions, and the FX and Currency Option Definitions, as well as Master Confirmations and Long Form Confirmations Organized with exceptional attention to detail and accuracy Strong written and verbal communicator Self-motivated professional who is process orientated and has a proven ability to design and implement organizational systems that drive efficiency Reliable, positive, dedicated, and flexible team player Have a strong client service and teamwork mentality Able to handle competing priorities and work effectively in a fast-paced environment If you're a recruiting agency and want to partner with us, please reach out to **********************************.
    $91k-122k yearly est. Auto-Apply 4d ago
  • Senior Coordinator, Quality Assurance

    Us Pharmalab Inc.

    Quality assurance specialist job in North Brunswick, NJ

    The Senior QA Coordinator plays a key role in supporting the Quality Assurance department by ensuring compliance to SOPs, batch records, master manufacturing records, GMP documentation and to 21 CFR Part 111 and 117 and other relevant quality standards in the nutraceutical manufacturing environment. This position will be responsible for coordinating quality assurance programs designed to ensure continuous production of products and includes tracking products, materials, status, and location. Involved in the issuance /review of batch records, on floor collection of samples , preparation of Master compliance documents and participating in audit preparations . Areas of Responsibility Oversee and maintain GMP documentation systems, including SOPs, batch records, deviations, CAPAs, change controls, and training records. Issuance of Manufacturing / Coating / Packaging Batch Cards Collects samples from on floor production for further testing and retention Distributes testing samples to Inhouse testing Analytical , Elemental and Microbiology Lab Preparation of different types of In process Labels for production , QA samples to be provided along with the Batch Records Scanning , photocopy, filing of GMP documents per Batch Product requirements Coordinate Finished Product release in Syspro Performs Sampling of materials / products per procedures as needed Reads and understands approved specifications/standards assigned to the project Keeps up to date with the regulatory requirements around documentation and implements changes if necessary. Work with internal teams to obtain an in-depth understanding of the processes and documentation requirements. Collaborate with Manufacturing, R&D, QC, and Regulatory teams to ensure seamless execution of quality processes. Play an active role on quality management team within the organization Any other duties which may be assigned from time to time 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: Bachelor's degree in Life Sciences, Chemistry, Biology, or a related field. Minimum 3-5 years of QA experience in a nutraceutical, dietary supplement, or pharmaceutical manufacturing environment. Strong knowledge of GMP, 21 CFR Part 111,117 and other relevant quality standards. Detail-oriented with strong organizational and documentation skills. Proficient in Microsoft Office; experience with electronic Quality Management Systems (eQMS) preferred. Excellent communication and problem-solving skills. Certifications, Licenses, Credentials: N/A Skills & Ability 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. Acknowledgement I have read and understand the job requirements, responsibilities, and expectations set forth in the job description provided for my position. I attest that I can perform the essential job functions as outlined with or without any reasonable accommodations. shift schedule :- General Shift 8.30am - 5.00 pm or extended
    $51k-76k yearly est. Auto-Apply 5d ago
  • QA Associate

    Actalent

    Quality assurance specialist job in East Windsor, NJ

    We are seeking a dedicated QA Associate to join our quality assurance team. In this role, you will be responsible for managing and coordinating various quality-related tasks, ensuring compliance with industry standards, and supporting continuous improvement initiatives within our organization. Responsibilities + Coordinate and participate in the investigation of quality deviations and non-conformances, including Deviation, LIR, OOS, and CAPA management. + Assist in implementing Corrective and Preventive Actions (CAPAs) to address root causes and prevent recurrence. + Coordinate change controls by working with the change initiator and evaluating associated risks. + Prepare for and support both internal and external audits, including those conducted by regulatory agencies such as the FDA. + Track and manage quality events within the company's electronic Quality Management System, including change controls, deviations, LIR's, OOS, and product complaints. + Compile, report, and analyze quality metrics to identify trends, compliance risks, and improvement opportunities, presenting findings during biweekly or monthly quality reviews. + Prepare annual product review (APR / APQR) reports. + Participate in the management of the vendor and supplier qualification program. + Communicate with suppliers and vendors for qualification and documents required for regulatory filing. + Support continuous improvement and maintain overall site quality. + Ensure adherence to GMP and good documentation practices. + Comply with all company policies and procedures. Essential Skills + Associates Degree or Bachelors Degree in Chemistry. + 1-2 years of Quality Assurance experience. + Experience on the manufacturing floor, laboratory, wet chemistry, titration, and chromatography. Additional Skills & Qualifications + Technical knowledge in chemistry and wet chemistry. + Proficiency in computer applications and programs related to laboratory applications. + Understanding of mathematics, including statistics. + Knowledge of sample preparation techniques. + Familiarity with spectroscopic techniques and chromatographic systems. + Basic computer knowledge, including MS Excel, Word, and Outlook. Job Type & Location This is a Contract to Hire position based out of East Windsor, NJ. Pay and Benefits The pay range for this position is $30.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in East Windsor,NJ. Application Deadline This position is anticipated to close on Feb 2, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
    $30-35 hourly 9d ago
  • Quality Assurance Associate

    RK Pharma

    Quality assurance specialist job in East Windsor, NJ

    Full-time Description RK Pharma Inc, a vertically integrated pharmaceutical company headquartered in NJ, is seeking an Quality Assurance Associate to work with our growing Quality Assurance Team as we scale towards commercial manufacturing in the next upcoming months.? As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team. This position is located in East Windsor, NJ and is required to be onsite. Requirements If this sounds interesting to you, it's probably because up to this point you have: Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, or a related technical field. 1-3 years of experience in a pharmaceutical or GMP-regulated environment. Solid understanding of cGMP, GDP, and FDA regulations. Experience with batch record review, deviation handling, and change control processes. Familiarity with document management systems (e.g., MasterControl). Strong attention to detail and accuracy in reviewing technical and regulatory documents. Excellent written and verbal communication skills for cross-functional collaboration. Ability to work independently and manage multiple priorities in a fast-paced environment. The main expectations and responsibilities for this position are: Review batch production and packaging records for accuracy, completeness, and GMP compliance prior to product release. Perform in-process line checks and quality inspections to ensure adherence to SOPs and specifications. Support deviation and change control processes, ensuring timely investigation and documentation. Participate in internal audits, walkthroughs, and inspection readiness activities. Maintain and update controlled documents, including SOPs, MBRs, and validation protocols. Collaborate with Quality Control, Production, and Engineering to resolve quality issues and drive continuous improvement. Ensure all QA activities are properly documented in accordance with GDP and data integrity principles. Support training, risk assessments, and compliance reviews as assigned by QA management. WE ARE SLATING THESE HIRES FOR START DATES IN OCTOBER OF 2026 BUT ARE COLLECTING APPLICATIONS NOW, NEXT STEPS WILL BE SENT TO YOU IN EARLY AUGUST 2026 ONSITE INTERVIEWS WILL BE SCHEDULED IN SEPTEMBER 2026 START DATES IN OCTOBER 2026 If this sounds like something that is of interest to you, please don't hesitate to apply to start a conversation. We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc. Salary Description 18+
    $50k-73k yearly est. 24d ago
  • Quality Assurance Associate

    Careers at RK Pharma Inc.

    Quality assurance specialist job in Hightstown, NJ

    Job DescriptionDescription: RK Pharma Inc, a vertically integrated pharmaceutical company headquartered in NJ, is seeking an Quality Assurance Associate to work with our growing Quality Assurance Team as we scale towards commercial manufacturing in the next upcoming months.? As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team. This position is located in East Windsor, NJ and is required to be onsite. Requirements: If this sounds interesting to you, it's probably because up to this point you have: Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, or a related technical field. 1-3 years of experience in a pharmaceutical or GMP-regulated environment. Solid understanding of cGMP, GDP, and FDA regulations. Experience with batch record review, deviation handling, and change control processes. Familiarity with document management systems (e.g., MasterControl). Strong attention to detail and accuracy in reviewing technical and regulatory documents. Excellent written and verbal communication skills for cross-functional collaboration. Ability to work independently and manage multiple priorities in a fast-paced environment. The main expectations and responsibilities for this position are: Review batch production and packaging records for accuracy, completeness, and GMP compliance prior to product release. Perform in-process line checks and quality inspections to ensure adherence to SOPs and specifications. Support deviation and change control processes, ensuring timely investigation and documentation. Participate in internal audits, walkthroughs, and inspection readiness activities. Maintain and update controlled documents, including SOPs, MBRs, and validation protocols. Collaborate with Quality Control, Production, and Engineering to resolve quality issues and drive continuous improvement. Ensure all QA activities are properly documented in accordance with GDP and data integrity principles. Support training, risk assessments, and compliance reviews as assigned by QA management. WE ARE SLATING THESE HIRES FOR START DATES IN OCTOBER OF 2026 BUT ARE COLLECTING APPLICATIONS NOW, NEXT STEPS WILL BE SENT TO YOU IN EARLY AUGUST 2026 ONSITE INTERVIEWS WILL BE SCHEDULED IN SEPTEMBER 2026 START DATES IN OCTOBER 2026 If this sounds like something that is of interest to you, please don't hesitate to apply to start a conversation. We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc.
    $50k-73k yearly est. 27d ago
  • Associate, In-Process QA, MG/PG

    Uspl Nutritionals LLC

    Quality assurance specialist job in North Brunswick, NJ

    Job Description Date 06/2025 Title Associate, In-Process Quality Assurance MFG/PKG Department Quality Assurance Operation Support Reports to Quality Assurance Manager/ VP of QA FLSA (Exempt or Non-Exempt Non-Exempt Role Overview The IPQA performs line inspection as part of the cGMP, SOPs, and policy compliance requirements as per CFR part 111. Performs In-process quality testing in manufacturing and/or packaging areas according to prescribed timelines and accurately captures test results in batch records. The Inspector performs calibrations & measurements on raw materials, bulk products, finished products and packaging components as required in batch records and SOP's. This position reports to the QA Manager and is a key member of the Quality Assurance group. The IPQA Associate is a highly organized self-starter who can work independently, demonstrates a positive attitude, and a bias for action. Areas of Responsibility IPQA - Level 1: To support In-process quality assurance activities by performing routine checks and verifications during manufacturing and/or packaging of nutraceutical products. This role ensures that all processes comply with applicable GMP, SOPs, and regulatory requirements. Key Responsibilities: 🔹 Manufacturing Support Perform line clearance before starting blending, granulation, compression, encapsulation, coating processes. Perform In-process checks: Blend uniformity sampling Tablet/capsule weight variation Hardness, friability, and disintegration tests etc as applicable Verify equipment cleaning and area hygiene as per SOP. Collect and label In-process and stability samples under supervision. 🔹 Packaging Support Ensure line clearance before packaging activities. Perform In-process checks: Batch number and expiry date printing Label application and carton sealing Primary and secondary packaging integrity etc as applicable Assist in reconciliation of packaging materials (e.g., printed cartons, leaflets, labels). 🔹 Documentation Record observations in IPQA checklists, logbooks, and batch records. Maintain GMP documentation in real-time (legible and error-free). Escalate any deviation or abnormality immediately to the QA Executive/Supervisor. 🔹 Compliance & Safety Adhere to company GMP, SOP, and Hygiene policies. Use PPE appropriately. Support during internal/external audits by providing necessary records. Cleans up work following the completion of a shift. Meets all safety expectations and follows all safety practices. Works extended hours and occasional weekend overtime. Other duties as assigned Other Responsibilities Including Safety: IPQA - Level 2: To independently perform and document In-process quality assurance activities at all critical stages of manufacturing and packaging of nutraceutical products, ensuring compliance with GMP, SOPs, and regulatory requirements. Key Responsibilities: 🔹 Manufacturing Stage (Granulation, Blending, Compression, Encapsulation, Coating ) Carry out and document line clearance activities before starting each manufacturing batch. Conduct in-process checks independently: Blend uniformity sampling Tablet/capsule weight variation Hardness, friability, thickness, and disintegration In-process controls as per BMR specifications Verify equipment cleanliness status, calibration, and logbook entries. Monitor and record environmental conditions in production areas (temperature, RH, differential pressure). 🔹 Packaging Stage Conduct line clearance for primary and secondary packaging (bottles, strips, blister, cartons). Perform and document: Batch coding verification (batch no., Mfg/Exp date) Packaging material correctness (labels, leaflets, cartons) Sealing integrity checks (blisters, induction seals) Online rejection bin and reconciliation checks Ensure correct usage of approved packaging materials with status labels. 🔹 Documentation & Compliance Fill Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) in real-time. Record IPQA observations and results as per SOPs ( legible and error free). Initiate and report deviations, OOS/OOT, and non-conformities to QA Supervisor/ Manager. Support CAPA implementation and change controls. 🔹 General QA Duties Ensure compliance with GMP, GLP, and data integrity principles. Follow gowning protocols, hygiene, and safety measures in production areas. Assist during internal audits and regulatory inspections by providing accurate documentation and data. Cleans up work following the completion of a shift. Meets all safety expectations and follows all safety practices. Works extended hours and occasional weekend overtime. Other duties as assigned Other Responsibilities Including Safety: IPQA - Level 3: To lead and monitor In-process QA activities during nutraceutical manufacturing and packaging operations. Ensure compliance with GMP, regulatory standards, and internal SOPs by supervising IPQA teams, reviewing records, and addressing quality deviations. Key Responsibilities: 🔹IPQA Oversight - Manufacturing & Packaging Supervise and verify line clearance activities across all manufacturing and packaging areas. Ensure compliance with critical process parameters (CPPs) and critical quality attributes (CQAs). Review and approval: In-process checks: weight variation, hardness, friability, disintegration etc as applicable Environmental monitoring records Equipment and area cleaning records Coordinate and monitor sampling activities for In-process, finished products and stability studies. 🔹 Review and Verification Review and verify completed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR). Cross-check reconciliation of raw materials and printed packaging materials. Verify proper use of status labels (approved/rejected/quarantine). 🔹 Deviation & CAPA Management Investigate and document process deviations, non-conformances, and OOS/OOT incidents. Lead root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA). Coordinate with cross-functional teams (Production, QC, Regulatory Affairs) to ensure closure of quality events. 🔹 Audit & Compliance Ensure readiness for internal, external, and regulatory audits (FSSAI, WHO-GMP, USFDA, etc.). Conduct routine GMP audits, spot checks, and area inspections. Train shop-floor personnel on data integrity, documentation practices, hygiene, and gowning protocols. 🔹 Team Coordination Guide and mentor IPQA Level 1 and Level 2 personnel. Allocate daily QA responsibilities and monitor adherence to QA procedures. Conduct on-the-job training for new team members Cleans up work following the completion of a shift. Meets all safety expectations and follows all safety practices. Works extended hours and occasional weekend overtime. Other duties as assigned Other Responsibilities Including Safety: Meets all safety expectations and follows all safety practices. Works extended hours and occasional weekend overtime. Other duties as assigned Other Responsibilities Including Safety: N/A Other Responsibilities Including Safety: Works in a safe and responsible manner to create an injury-free and incident-free workplace. Complies with all job-related safety and other training requirements. Keeps management informed of area activities and of any significant problems. Requirements Education & Qualification: IPQA - Level 1: 0-1 year (Freshers with training or internship in QA preferred) Or equivalent combination of education and experience. High School diploma is required; BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus. IPQA - Level 2: Minimum of 3+ years of experience in a QA Inspector within a nutritional's supplements, food, consumer products or pharmaceutical company. Or equivalent combination of education and experience. BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus. IPQA - Level 3: 3-5 years in IPQA or related QA roles in nutraceuticals, pharmaceuticals, or food manufacturing. Or equivalent combination of education and experience. BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus. Certifications, Licenses, Credentials: N/A Skills & Ability IPQA - Level 1: Basic understanding of GMP, nutraceutical processes, and QA principles. Good observation and attention to detail. Willingness to work in production areas (shifts, growing zones). Ability to follow instructions and standard procedures accurately. Basic proficiency in English and documentation practices. IPQA - Level 2: Strong knowledge of IPQA functions, SOPs, and process flow in nutraceuticals. Understanding of basic analytical parameters (weight variation, friability, etc.). Good documentation and observational skills. Proficient in using basic lab and QA tools (weighing balances, disintegration testers). Familiar with regulatory guidelines (FSSAI, WHO-GMP, USFDA, HACCP). IPQA - Level 3: In-depth understanding of nutraceutical manufacturing processes and regulatory compliance. Proficient in QA documentation, process audits, and deviation handling. Strong analytical and decision-making skills. Familiar with QMS tools, GMP documentation, and data integrity principles. Working knowledge of SOP writing, change control, and risk assessment. Physical Requirements (lifting, etc.): Ability to lift up to 35 lbs.; occasionally lift and move up to 50 pounds. Must stand and walk on production floor a minimum of 6 hours per shift Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances. Occasionally works from a rolling ladder or step stool. Must be able to wear all PPE including lab coat, face mask, booties, gloves, safety glasses. Work Environment (Office, Warehouse, temperature extremes, etc.): Work is regularly performed inside a manufacturing and packaging environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment. shift schedule 3rd shift: 11:00 PM - 7:30 AM 3rd Shift - 11:00 PM to 7:30 AM
    $50k-73k yearly est. Auto-Apply 16d ago
  • Assurance Associate, Information Systems Assurance - Summer 2026 (New York)

    BDO USA 4.8company rating

    Quality assurance specialist job in New York, NY

    As an Assurance Associate, Technology Risk Assurance, you will begin to utilize your educational background as well as your organizational skills as you serve the firm's dynamic client base. You will assist in problem solving and fact-finding, working side-by-side with more experienced team members who can provide you with direction, coaching and learning opportunities. You will have the opportunity to gain an understanding of the IT environment during fieldwork by interviewing various client personnel and performing an IT general controls risk assessment in various areas including, but not limited to new hire and terminated user controls testing, user access controls testing, and program change controls testing. Further, you will have an opportunity to work within engagement teams to develop recommendations that will help clients improve their controls environments and help develop audit strategies to respond to controls findings you discover. Job Duties: Assists in performing audit engagements, including risk assessments of various companies' IT environments, consisting of - but not limited to - access administration, program change management, operations, and logical access security Provides input to management leaders on suggestions to improve client internal controls and procedures Maintains relationships with and speaks to key client personnel to obtain an understanding of IT and business operations, processes, and functions Assists the core financial audit team in identifying controls issues, analyzing the potential impacts of those issues on the respective audits, and developing compensating controls and substantive audit strategies to be carried out among the team Document work completed by preparing workpapers Assist engagement teams in applying tools and data analytics to enhance effectiveness and efficiency in audits Other duties as required Supervisory Responsibilities: Opportunities are available to train and mentor interns and incoming associates after your first year as an Associate Qualifications, Knowledge, Skills and Abilities: Education: Bachelor's degree in Accounting, Information Systems, or Information Technology, required Experience: Prior internship or work study experience of information systems and operational auditing experience, preferred License/Certifications: Actively pursuing (or committed to) completion of one of more of the following certification exams: CISA, CISSP, CPA, CITP, CIA, or other relevant certification, required Software: Proficient in the use of Microsoft Office Suite, preferred Exposure to various industry ERP applications, highly preferred Language: N/A Other Knowledge, Skills & Abilities: Excellent verbal and written communication skills Strong analytical and basic research skills Solid organizational skills especially ability to meet project deadlines with a focus on details Ability to successfully multi-task while working independently or within a group environment Proven ability to work in a deadline-driven environment and handle multiple projects simultaneously Basic knowledge of internal controls Ability to travel as necessary Individual salaries that are offered to a candidate are determined after consideration of numerous factors including but not limited to the candidate's qualifications, experience, skills, and geography. California Range: $85,000 - $90,000 Colorado Range: $73,000 - $77,000 Illinois Range: $78,000 - $82,000 Maryland Range: $83,000 - $87,000 Massachusetts Range: $83,000 - $87,000 Minnesota Range: $70,000 - $74,000 New Jersey Range: $78,000 - $82,000 NYC/Long Island/Westchester Range: $83,000 - $87,000 Ohio Range: $71,000 - $75,000 Washington Range: $78,000 - $80,000 Washington DC Range: $83,000 - $87,000
    $85k-90k yearly Auto-Apply 57d ago
  • Quality Assurance Associate

    Proven 3.5company rating

    Quality assurance specialist job in Princeton, NJ

    Proven is an interactive design and development consultancy that blends creative vision with technical expertise to craft digital experiences that matter. We partner with non-profits and mission-driven organizations, leveraging our design, engineering, and strategic capabilities to drive meaningful impact. We're looking for a full-time Quality Assurance Associate to serve as the primary owner for quality assurance across our projects. In this role, you will design and execute test strategies and plans for web applications, working within an Agile framework and collaborating closely with project managers, developers, and clients. You will help ensure that every release meets both functional requirements and Proven's high quality standards. Key Responsibilities Lead and track all QA activities across assigned projects. Create, execute, and maintain test plans and test cases based on user stories, acceptance criteria, and requirements. Perform functional, system, integration, regression, and performance testing to ensure consistency and reliability across environments and systems. Identify, prepare, and manage test data for manual and (when applicable) automated testing. Collaborate with clients and internal teams to define, refine, and validate user acceptance criteria. Validate all tickets resolved by the development team prior to release, ensuring they meet requirements and are production-ready. Automate regression test scripts where appropriate and help evolve our automated testing coverage and standards. Identify, document, and prioritize defects; track them through resolution. Proactively surface risks, dependencies, and quality concerns to the project manager and team. Contribute to improving QA processes, tools, and documentation over time. Qualifications and Experience You are hyper-organized, detail-oriented, and comfortable independently owning your work to ensure quality and client satisfaction. 3+ years of experience working in a QA or testing role at a technology company, digital agency, or similar environment. Experience working as a tester on technical projects within an Agile software development lifecycle. Hands-on experience with several of the following: Functional and regression testing System and integration testing Performance, load, and speed testing User acceptance testing (UAT) Working knowledge of modern web development technology stacks (e.g., common front-end frameworks, APIs, CMS platforms) and how they impact testing. Strong analytical and problem-solving skills; you can not only find bugs, but also help the team understand impact and potential root causes. Excellent written and verbal communication skills; you're comfortable collaborating with cross-functional teams and interacting with senior stakeholders. Experience working remotely with distributed teams. Bachelor's degree in engineering, computer science, or a related field, or equivalent relevant experience. Why Join Proven? Mission-Driven Work: Help organizations that make a real impact in the world. Collaborative Culture: Work alongside talented designers, strategists, and engineers. Growth Opportunities: Shape the future of Proven's technology team and strategy. Remote Flexibility: Work from anywhere while leading a distributed team.
    $52k-75k yearly est. 49d ago
  • Treasury/Chief Investment Office - Quality Assurance - Senior Associate

    JPMC

    Quality assurance specialist job in New York, NY

    Join JPMorgan Chase as a Liquidity Reporting Senior Associate! The Treasury/Chief Investment Office Liquidity Controller Americas group is responsible for oversight of North America & Latin America's liquidity results and related controls. This includes managing the regional liquidity reporting, its operational control environment, and liquidity forecasting and analysis. The group is also involved in projects, including those relating to enhancing the Liquidity Risk Infrastructure platform, conducting strategic analyses, and participating in various governance forums. Additionally, the group is the primary point of contact for Investor Relations and Corporate Reporting where liquidity messaging is involved. As a Liquidity Reporting Senior Associate within the Treasury/Chief Investment Office, you will act as the lead tester for the Liquidity Reporting Quality Assurance Program. You will develop a strong understanding of the Liquidity reporting as well as its production processes and gain insight into the Firm's Liquidity Reporting Infrastructure. Job responsibilities: Test and review transactional Liquidity reporting data for a variety of the Firm's financial products that are used in creating the Firm's external liquidity reports (6G/US LCR/US NSFR) Be responsible for all workpaper documentation, SOP production and senior management reports Present quarterly testing results to Liquidity Senor Management and coordinate testing with our support team in India and our testing team in EMEA Act as additional point of contact with any Internal Audit/Regulator inquiries Support the external Liquidity reporting prepared for disclosure in the Firm's 10-K/10-Q and the Press Release Collaborate in determining, producing, and validating relevant liquidity information and PowerPoint presentations for the CFO's Press Release Q&A preparation, working closely with the Liquidity and Capital Management team and Investor Relations Required qualifications, capabilities, and skills: Bachelors' degree required 3 years work experience in liquidity reporting, control testing, quality assurance, data validation or internal audit General understanding of the bank's externally published LCR and NSFR reporting Working knowledge of Microsoft Suites, strong Excel skills required Strong financial and analytical skills Ability to work independently using initiative and ability to manage your own work Highly numerate with a methodical approach to problem solving Strong relationship building, communication skills, time management, and organization skills Ability to work independently using initiative and ability to manage your own work Preferred qualifications, capabilities, and skills: Alteryx skills preferred Experience with technology project testing a plus
    $52k-76k yearly est. Auto-Apply 60d+ ago
  • Customer Service and Quality Assurance Coordinator - Japanese

    Cinter Career

    Quality assurance specialist job in New York, NY

    Job Description▶︎ Job Details: • Job Title: Customer Service and Quality Assurance Coordinator • Working Location: Long Island City, NY 11101 • Working Style: On-site • Employment Type: Full-time, Non-exempt • Salary: DOE (approximately $20 - 25 per hr) • Language: English (Business level), Japanese (Business level) ▶︎ Position Overview: We are seeking a proactive and detail-oriented professional to take ownership of key responsibilities directly reporting to senior management. This role will be pivotal in enhancing our customer satisfaction, addressing claims, and maintaining effective communication with clients and partners. ▶︎ What will you do: • Client and Supplier Communication: Serve as the main liaison between the company and clients, suppliers, or business partners during the inspection and quality control process. • Claims Management and Issue Resolution: Act as the primary point of contact for claims received from overseas customers. • Negotiation and Relationship Building: Act as the primary point of contact for claims received from overseas customers. • Negotiation and Relationship Building: Collaborating with the estimator, negotiate effectively with partners and suppliers to address and resolve concerns while maintaining positive working. • Quality Assurance Support: Collaborate with the operations team to inspect and review incoming goods, ensuring compliance with quality standards. • Customer Service and Feedback Management: Follow up with customers' post-delivery to ensure satisfaction and address any concerns or returns. ▶︎ Required Qualifications & Skills: • 2 years of customer service experience preferred. • Exceptional communication and interpersonal skills with an ethical mindset. • Detail-oriented with excellent problem-solving abilities. • Ability to work collaboratively with internal teams and external partners. • Experience in a flexible work environment is a plus. • English and Japanese language skills at a business level. • Strong organization and self-motivation skills. • Ability to communicate effectively and work in a team. • Understanding of collaboration in a fast-paced environment. • Proficiency in using computers and technology for inventory and communication purposes. ▶︎ Preferred Qualifications: • Understanding of supply chain logistics, including common obstacles and practical solutions (not required but a plus). ▶︎ Work Environment: • Full-time, on-site position: Work performed in an office environment, requiring the ability to operate standard office equipment and keyboards, with verbal communication. Powered by JazzHR XoG6rjGj36
    $20-25 hourly 22d ago
  • Aprio PH - Associate, Assurance Services (Non-Profit)

    Aprio 4.3company rating

    Quality assurance specialist job in Clark, NJ

    Work with a nationally ranked CPA and advisory firm that is passionate for what's next. Aprio has 30 U.S. office locations, one in the Philippines and more than 2,100 team members that speak 60+ languages across the globe. By bringing together proven expertise, deep understanding, and strategic foresight for fast-growing industries, Aprio ensures clients are prepared for wherever life or business may take them. Discover a top-rated culture, vast growth opportunities and your next big career move with Aprio. Join our Assurance team and you will help support clients maximize their opportunities. Aprio has a career opportunity for an Associate, Assurance Services to join their dynamic group. Position Responsibilities: * Our team of credentialed audit experts work with businesses and industry leaders to avoid financial and business risk that can be distracting, costly, and debilitating if not mitigated. We work with companies to improve financial reporting capabilities, internal controls, evaluate accounting issues, and stay ahead of the curve with new accounting regulations that could have potential impact on long-term business growth. We help companies assess the quality of information they use to make strategic business decisions, and help identify areas where they can improve operating efficiencies. * Skillfully and accurately performing audits * Preparing audit work papers and adjusting trial balances * Compiling financial statements into a written report to be presented * Creating and strengthening relationships with coworkers and clients * 4-year bachelor's degree in Accounting * Master's degree preferred * Licensed CPA or 150 credit hours to sit for the exam * 0-1 year of experience working for an Accounting firm * Understanding and applying Excel skills * Demonstrating exceptional verbal and written communication skills are required * Working effectively and personably with clients and co-workers * Strong time management skills with the ability to prioritize tasks and meet deadlines * Excellent critical thinking and analytical problem-solving abilities Perks/Benefits we offer for full-time team members: * Wellness program * HMO coverage * Rewards and Recognition program * Free shuttle service (provided by CDC | for onsite employees) * Free lunch meal (For onsite employees) * On-demand learning classes * Discretionary time off and Holidays * Performance-based salary increase * Discretionary incentive compensation based on client or individual performance * Hybrid set up to selected roles/location, terms and conditions may apply * CPA & Certification Assistance and Bonus Program What's in it for you: * Working with an industry leader: Be part of a high-growth firm that is passionate for what's next. * A great team: Work with a high-energy, passionate, caring, and ambitious team of professionals in a collaborative culture. * Growth opportunities: Grow professionally in an environment that fosters continuous learning and advancement. * Competitive compensation: You will be rewarded with competitive compensation. EQUAL OPPORTUNITY EMPLOYER Aprio is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race; color; religion; national origin; sex; pregnancy; sexual orientation; gender identity and/or expression; age; disability; genetic information, citizenship status; military service obligations or any other category protected by applicable federal, state, or local law.
    $59k-72k yearly est. 30d ago
  • Quality Assurance Associate

    Lupin Pharmaceuticals

    Quality assurance specialist job in Somerset, NJ

    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
    $45k-63k yearly Auto-Apply 5d ago
  • Associate, In-Process QA, MG/PG

    USPL Nutritionals LLC

    Quality assurance specialist job in North Brunswick, NJ

    Date 06/2025 Title Associate, In-Process Quality Assurance MFG/PKG Department Quality Assurance Operation Support Reports to Quality Assurance Manager/ VP of QA FLSA (Exempt or Non-Exempt Non-Exempt Role Overview The IPQA performs line inspection as part of the cGMP, SOPs, and policy compliance requirements as per CFR part 111. Performs In-process quality testing in manufacturing and/or packaging areas according to prescribed timelines and accurately captures test results in batch records. The Inspector performs calibrations & measurements on raw materials, bulk products, finished products and packaging components as required in batch records and SOP's. This position reports to the QA Manager and is a key member of the Quality Assurance group. The IPQA Associate is a highly organized self-starter who can work independently, demonstrates a positive attitude, and a bias for action. Areas of Responsibility IPQA - Level 1: To support In-process quality assurance activities by performing routine checks and verifications during manufacturing and/or packaging of nutraceutical products. This role ensures that all processes comply with applicable GMP, SOPs, and regulatory requirements. Key Responsibilities: ???? Manufacturing Support Perform line clearance before starting blending, granulation, compression, encapsulation, coating processes. Perform In-process checks: Blend uniformity sampling Tablet/capsule weight variation Hardness, friability, and disintegration tests etc as applicable Verify equipment cleaning and area hygiene as per SOP. Collect and label In-process and stability samples under supervision. ???? Packaging Support Ensure line clearance before packaging activities. Perform In-process checks: Batch number and expiry date printing Label application and carton sealing Primary and secondary packaging integrity etc as applicable Assist in reconciliation of packaging materials (e.g., printed cartons, leaflets, labels). ???? Documentation Record observations in IPQA checklists, logbooks, and batch records. Maintain GMP documentation in real-time (legible and error-free). Escalate any deviation or abnormality immediately to the QA Executive/Supervisor. ???? Compliance & Safety Adhere to company GMP, SOP, and Hygiene policies. Use PPE appropriately. Support during internal/external audits by providing necessary records. Cleans up work following the completion of a shift. Meets all safety expectations and follows all safety practices. Works extended hours and occasional weekend overtime. Other duties as assigned Other Responsibilities Including Safety: IPQA - Level 2: To independently perform and document In-process quality assurance activities at all critical stages of manufacturing and packaging of nutraceutical products, ensuring compliance with GMP, SOPs, and regulatory requirements. Key Responsibilities: ???? Manufacturing Stage (Granulation, Blending, Compression, Encapsulation, Coating ) Carry out and document line clearance activities before starting each manufacturing batch. Conduct in-process checks independently: Blend uniformity sampling Tablet/capsule weight variation Hardness, friability, thickness, and disintegration In-process controls as per BMR specifications Verify equipment cleanliness status, calibration, and logbook entries. Monitor and record environmental conditions in production areas (temperature, RH, differential pressure). ???? Packaging Stage Conduct line clearance for primary and secondary packaging (bottles, strips, blister, cartons). Perform and document: Batch coding verification (batch no., Mfg/Exp date) Packaging material correctness (labels, leaflets, cartons) Sealing integrity checks (blisters, induction seals) Online rejection bin and reconciliation checks Ensure correct usage of approved packaging materials with status labels. ???? Documentation & Compliance Fill Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) in real-time. Record IPQA observations and results as per SOPs ( legible and error free). Initiate and report deviations, OOS/OOT, and non-conformities to QA Supervisor/ Manager. Support CAPA implementation and change controls. ???? General QA Duties Ensure compliance with GMP, GLP, and data integrity principles. Follow gowning protocols, hygiene, and safety measures in production areas. Assist during internal audits and regulatory inspections by providing accurate documentation and data. Cleans up work following the completion of a shift. Meets all safety expectations and follows all safety practices. Works extended hours and occasional weekend overtime. Other duties as assigned Other Responsibilities Including Safety: IPQA - Level 3: To lead and monitor In-process QA activities during nutraceutical manufacturing and packaging operations. Ensure compliance with GMP, regulatory standards, and internal SOPs by supervising IPQA teams, reviewing records, and addressing quality deviations. Key Responsibilities: ????IPQA Oversight - Manufacturing & Packaging Supervise and verify line clearance activities across all manufacturing and packaging areas. Ensure compliance with critical process parameters (CPPs) and critical quality attributes (CQAs). Review and approval: In-process checks: weight variation, hardness, friability, disintegration etc as applicable Environmental monitoring records Equipment and area cleaning records Coordinate and monitor sampling activities for In-process, finished products and stability studies. ???? Review and Verification Review and verify completed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR). Cross-check reconciliation of raw materials and printed packaging materials. Verify proper use of status labels (approved/rejected/quarantine). ???? Deviation & CAPA Management Investigate and document process deviations, non-conformances, and OOS/OOT incidents. Lead root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA). Coordinate with cross-functional teams (Production, QC, Regulatory Affairs) to ensure closure of quality events. ???? Audit & Compliance Ensure readiness for internal, external, and regulatory audits (FSSAI, WHO-GMP, USFDA, etc.). Conduct routine GMP audits, spot checks, and area inspections. Train shop-floor personnel on data integrity, documentation practices, hygiene, and gowning protocols. ???? Team Coordination Guide and mentor IPQA Level 1 and Level 2 personnel. Allocate daily QA responsibilities and monitor adherence to QA procedures. Conduct on-the-job training for new team members Cleans up work following the completion of a shift. Meets all safety expectations and follows all safety practices. Works extended hours and occasional weekend overtime. Other duties as assigned Other Responsibilities Including Safety: Meets all safety expectations and follows all safety practices. Works extended hours and occasional weekend overtime. Other duties as assigned Other Responsibilities Including Safety: N/A Other Responsibilities Including Safety: Works in a safe and responsible manner to create an injury-free and incident-free workplace. Complies with all job-related safety and other training requirements. Keeps management informed of area activities and of any significant problems. Requirements Education & Qualification: IPQA - Level 1: 0-1 year (Freshers with training or internship in QA preferred) Or equivalent combination of education and experience. High School diploma is required; BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus. IPQA - Level 2: Minimum of 3+ years of experience in a QA Inspector within a nutritional's supplements, food, consumer products or pharmaceutical company. Or equivalent combination of education and experience. BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus. IPQA - Level 3: 3-5 years in IPQA or related QA roles in nutraceuticals, pharmaceuticals, or food manufacturing. Or equivalent combination of education and experience. BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus. Certifications, Licenses, Credentials: N/A Skills & Ability IPQA - Level 1: Basic understanding of GMP, nutraceutical processes, and QA principles. Good observation and attention to detail. Willingness to work in production areas (shifts, growing zones). Ability to follow instructions and standard procedures accurately. Basic proficiency in English and documentation practices. IPQA - Level 2: Strong knowledge of IPQA functions, SOPs, and process flow in nutraceuticals. Understanding of basic analytical parameters (weight variation, friability, etc.). Good documentation and observational skills. Proficient in using basic lab and QA tools (weighing balances, disintegration testers). Familiar with regulatory guidelines (FSSAI, WHO-GMP, USFDA, HACCP). IPQA - Level 3: In-depth understanding of nutraceutical manufacturing processes and regulatory compliance. Proficient in QA documentation, process audits, and deviation handling. Strong analytical and decision-making skills. Familiar with QMS tools, GMP documentation, and data integrity principles. Working knowledge of SOP writing, change control, and risk assessment. Physical Requirements (lifting, etc.): Ability to lift up to 35 lbs.; occasionally lift and move up to 50 pounds. Must stand and walk on production floor a minimum of 6 hours per shift Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances. Occasionally works from a rolling ladder or step stool. Must be able to wear all PPE including lab coat, face mask, booties, gloves, safety glasses. Work Environment (Office, Warehouse, temperature extremes, etc.): Work is regularly performed inside a manufacturing and packaging environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment. shift schedule 3rd shift: 11:00 PM - 7:30 AM 3rd Shift - 11:00 PM to 7:30 AM
    $50k-73k yearly est. 18d ago

Learn more about quality assurance specialist jobs

How much does a quality assurance specialist earn in Howell, NJ?

The average quality assurance specialist in Howell, NJ earns between $53,000 and $123,000 annually. This compares to the national average quality assurance specialist range of $41,000 to $97,000.

Average quality assurance specialist salary in Howell, NJ

$81,000

What are the biggest employers of Quality Assurance Specialists in Howell, NJ?

The biggest employers of Quality Assurance Specialists in Howell, NJ are:
  1. Trinity Solar
  2. Above and Beyond Therapy
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