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Quality assurance specialist jobs in North Amityville, NY - 490 jobs

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Quality Assurance Specialist
Quality Assurance Associate
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Quality Assurance Analyst
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Senior Quality Assurance Analyst/Lead
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Quality Assurance Assistant
  • Senior Compliance Testing Lead

    Interactive Brokers Group, Inc. 4.8company rating

    Quality assurance specialist job in Greenwich, CT

    A global financial services company is seeking a Head of Compliance Testing to manage their compliance testing program. The ideal candidate has over 5 years of experience with SEC or CFTC regulations and a strong background in compliance testing or audit roles. Responsibilities include coordinating compliance reviews, drafting testing specifications, and reporting findings. The position offers competitive salary and excellent benefits including health, wellness, and education reimbursement. #J-18808-Ljbffr
    $96k-121k yearly est. 3d ago
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  • NG911 Telephony SME - Systems & Testing Lead

    Priority Cares Home Services

    Quality assurance specialist job in New York, NY

    A New York-based agency is seeking a NG911 Telephony Subject Matter Expert (SME) to provide expert guidance for the Next Generation 911 emergency call system. The role includes managing telephony components, validating configurations, and ensuring compliance with industry standards. Candidates must have at least 12 years of experience in relevant areas, strong troubleshooting skills, and the ability to develop call-flow diagrams. This position offers a hybrid work environment, requiring occasional on-site presence. #J-18808-Ljbffr
    $89k-118k yearly est. 1d ago
  • Quality Assurance Specialist

    DSJ Global

    Quality assurance specialist job in Jersey City, NJ

    Quality Assurance Specialist - for Leading Food & Beverage Manufacturer Jersey City, NJ Area Quality Assurance Specialist Are you a detail-driven, proactive professional passionate about food safety and quality excellence? Join a dynamic, fast-paced team at a leading food manufacturing facility where innovation, integrity, and continuous improvement are at the heart of everything we do. We are seeking a Quality Assurance Specialist who thrives in a collaborative environment and is committed to upholding the highest standards of product quality, regulatory compliance, and operational efficiency. Key Responsibilities: Champion quality assurance initiatives across manufacturing and support facilities. Lead and optimize quality control processes to ensure product safety and consistency. Conduct inspections, audits, and testing aligned with FDA, USDA, and internal standards. Drive compliance with food safety regulations including HACCP, SQF, and GMP protocols. Analyze quality data, identify trends, and implement corrective/preventive actions. Collaborate cross-functionally to enhance quality systems and continuous improvement efforts. Develop and deliver training programs on QA procedures and food safety standards. Manage vendor relationships and coordinate external support when needed. Monitor regulatory changes and assess operational impact. Qualifications & Skills: Bachelor's Degree preferred (Food Science, Microbiology, or related field). HACCP, SQF, or equivalent certification highly desirable. 2-5 years of hands-on experience in QA within the food and beverage sector. Strong knowledge of FDA, USDA, and state/local regulatory frameworks. Proficiency in Microsoft Office and QA software tools. Exceptional analytical, organizational, and communication skills. Bilingual in English and Spanish is a strong plus.
    $65k-100k yearly est. 2d ago
  • Quality Assurance Manager

    Planet Pharma 4.1company rating

    Quality assurance specialist job in New York, NY

    Experience Requirements: Life Sciences Degree or related discipline Minimum x (8) years of collective experience in quality management. 4 years in pharmaceuticals, or biotechnology. Demonstrate knowledge of TGA, FDA, and EU GMP and other quality related systems (e.g., ISO Standards, ICH, PIC/s) Job Purpose: Accountable for providing QA Ops management of contractors to ensure compliance with quality and cGMP/cGTP standards, oversight of ongoing manufacturing campaigns and introduction of new product lines
    $81k-116k yearly est. 3d ago
  • GIS QA/QC Analyst (Utilities)

    Equiliem

    Quality assurance specialist job in New York, NY

    QA/QC Support Specialist Brooklyn. NY Hybrid 8am-4:30pm PERFORMANCE DETAILS What are the major objectives of the role? The team is looking for another contractor as the electric eGIS team has undertaken a project to replace the legacy mapping systems with ArcFM, Schneiders mapping platform Responsibilities/Job Description: The candidate will be responsible to do multiple queries to validate the accuracy of legacy mapping data that was migrated to an Esri mapping system. Candidate will review land base symmetry, connectivity at structures and assuring cable connectivity is intact. Candidates responsibly is to check attribute data of all linear and point data features for Electric and Gas components Candidate should perform map symbology updates and provide symbology solutions as is necessary. Lead testing efforts for vendor deliverables, including factory acceptance, system acceptance, and user acceptance testing. Ensure that vendor-provided solutions meet the specified requirements. Advocate for the customer throughout the testing process, ensuring that GIS solutions meet user expectations. Collaborate with development teams to address customer feedback and enhance system usability. Conduct thorough reviews of project documentation related to test plan and execution. Offer insightful comments to enhance the quality of test plan documentation and provide approval. Review test plan and scripts to ensure alignment with project goals. Utilize Azure DevOps or other testing software for effective test planning, execution, and reporting. Maintain testing documentation and artifacts in testing tools. Demonstrate decisiveness in signing off on testing-related requirements and planning documentations ensuring alignment with project goals Assist in other eGIS projects as the need arises Develop understanding of Client eGIS project. Develop a basic understanding of the Client mapping systems Develop understanding of company mapping process, documents, and a wide variety of software programs Develop ability to read various types of electrical and gas map What are the MUST HAVE Professional or Technical skills for this position? GIS Experience is a must have Qualified candidates must have a Bachelor's degree. Must have at least (2) years' experience using ESRI ArcMap and demonstrate knowledge in Esri GIS is preferred Candidate must be able to demonstrate knowledge in MXD building, spatial queries and spatial analysis Candidate should hold experience within the utility environment Candidates must be a self-starter, highly motivated with a high degree of attentiveness, integrity, energy, initiative and resourcefulness. Candidate should be a quick learner and can carry out task to completion with minimum supervision Must possess good analytical skills with a technical background, strong organizational skills and be able to use Microsoft office applications. Education or Certification Requirement: Bachelor's Degree
    $65k-85k yearly est. 2d ago
  • Regulatory Compliance Specialist

    Allstem Connections

    Quality assurance specialist job in Freeport, NY

    We are seeking a detail-oriented QA / Regulatory Compliance Specialist to support vendor compliance, food safety documentation, and product commercialization activities in a fast-paced food manufacturing environment. This role plays a key part in ensuring regulatory, customer, and religious certification compliance. Key Responsibilities Maintain approved vendor and raw material documentation per internal policies Support Sales & Marketing with nutritional data using Genesis software Create and manage product specifications, labeling, and artwork approvals Complete customer food safety questionnaires and manage QA regulatory platforms Ensure audit-ready documentation for vendors, ingredients, and traceability Support HACCP programs, FSMA compliance, and ingredient hazard analyses Manage kosher and other religious certifications, including audits and training Coordinate cross-functional projects from initiation through completion Qualifications Associate degree required; Food Science, Baking & Pastry, or Food Engineering preferred 3+ years of experience in QA, regulatory, or compliance within food manufacturing HACCP Certification required; strong knowledge of FSMA, GMPs, and food safety standards Experience with Genesis Nutritional Software and labeling systems Familiarity with ERP, traceability systems, and regulatory documentation Strong organizational, communication, and project coordination skills Bilingual Spanish preferred
    $51k-80k yearly est. 1d ago
  • Control Room Compliance Associate

    Northbound Executive Search

    Quality assurance specialist job in New York, NY

    A leading investment bank is seeking a Control Room Compliance Associate to join its growing Compliance team. This role will focus on maintaining information barriers, managing restricted lists, and supporting regulatory compliance across trading and investment activities. This is an excellent opportunity for a detail-oriented compliance professional to work closely with front-office teams. Responsibilities Maintain and update restricted and ensuring timely and accurate additions and removals Monitor firm-wide information barriers and ensure compliance across business units Partner with trading, investment, and deal teams to provide real-time compliance guidance Review and clear personal account trading and employee disclosures Conduct surveillance and investigations related to potential conflicts of interest Liaise with Legal, Surveillance, and Regulatory teams on escalations and audits Support regulatory exams, internal audits, and policy updates Track KPIs and prepare reporting for senior management Assist with special projects to enhance compliance processes and controls Qualifications 2-6+ years of experience in Control Room, Compliance, Surveillance, or Regulatory Advisory Excellent communication and stakeholder management skills Highly organized with strong attention to detail Ability to thrive in a fast-paced, deadline-driven environment
    $50k-90k yearly est. 4d ago
  • QA & Sustainability Coordinator

    Foodmatch

    Quality assurance specialist job in New York, NY

    Come join a growing team! FOODMatch is searching for a QA & Sustainability Coordinator to join our Quality Assurance team. FOODMatch is a producer and importer of Mediterranean specialty foods with a focus on olives, antipasti, and ingredients. Founded in 1996, FOODMatch is a producer and importer of Mediterranean specialty foods with a distinct expertise in traditionally and responsibly crafted olives, antipasti, spreads, sauces, and ingredients. FOODMatch plays an integral role in ensuring the quality of our products. The FOODMatch difference begins in the fields and groves. We are vertically integrated with our partners to ensure that each step along the production chain is completed to meticulous standards: from irrigation and pruning, to harvesting, sorting and stuffing by hand, to expertly curing and preserving, we ensure each ingredient delivers its natural flavor, color, and texture. Simply put, no detail is spared. Through the hands of our growers we create great tasting, responsibly produced, authentic foods that nurture community and enhance your quality of life. Job Description The QA & Sustainability Supervisor plays a key role in ensuring FOODMatch products meet the highest standards of quality, safety, and compliance while driving forward the company's sustainability goals. This position oversees product specification management, supplier compliance, and sustainability initiatives across the supply chain. The QA & Sustainability Supervisor serves as a cross-functional link between Quality Assurance, Operations, Procurement, and Marketing teams to uphold regulatory, environmental, and ethical standards. Essential Functions Quality Assurance Oversight Ensure timely completion of product reviews, labeling, and documentation Oversee product specification maintenance, ensuring all products are accurately documented and compliant with FDA and customer requirements. Partner with suppliers and internal departments to review and approve new product documentation, labels, and certifications. Review testing and analytical data to confirm products are within specification and meet FOODMatch quality standards. Support root cause analysis and corrective actions related to product quality concerns. Conduct facility and warehouse visits as needed to audit quality practices, verify corrective actions, and collect samples for evaluation. Regulatory Compliance Ensure ongoing compliance with FDA, FSMA, HACCP, and third-party certification requirements. Manage and maintain customer portals and documentation systems to ensure all certifications and specifications are current. Lead cold chain verification, carrier audits, and record-keeping to ensure product integrity throughout distribution. Sustainability Leadership Develop, implement, and monitor sustainability initiative projects aligned with FOODMatch's environmental and social responsibility goals. Collaborate with Procurement and Supply Chain teams to assess supplier sustainability practices and maintain sustainability-related certifications (e.g., Non-GMO, organic, fair trade). Track and report sustainability metrics, including packaging initiatives, waste reduction, and energy efficiency programs. Support communication of sustainability achievements for internal reporting and external marketing purposes. Continuous Improvement Identify opportunities to enhance QA systems, documentation workflows, and sustainability processes. Lead or participate in cross-departmental projects focused on process optimization and environmental impact reduction. Provide training and guidance to internal teams and suppliers on QA and sustainability standards. Qualifications Background Requirements Bachelor's degree in Food Science, Environmental Science, or a related STEM field preferred. 3+ years of experience in food quality assurance, compliance, or sustainability roles. Strong understanding of FDA labeling, food safety regulations, and sustainability best practices. HACCP and/or PCQI certification preferred. Skills & Abilities Strong leadership and project management skills with the ability to manage multiple priorities. Exceptional attention to detail and organizational skills. Analytical mindset with a passion for both product quality and environmental impact. Effective communication and cross-functional collaboration skills. Proficiency in Microsoft Office and online customer/partner portals. Genuine enthusiasm for food, sustainability, and continuous improvement. Additional Information Travel Requirements This role requires moderate travel In-Office 4x a week FOODMatch offers a comprehensive benefits package and competitive compensation based on experience. We are an equal opportunity employer and value diversity. All employment decisions are made on the basis of qualifications, merit, and business need. All your information will be kept confidential according to EEO guidelines. Job Type: Full-time Benefits: 401(k) Dental insurance Health insurance Paid time off Travel reimbursement Vision insurance
    $60k-89k yearly est. 57d 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. Easy Apply 60d+ ago
  • Quality Assurance Assistant (Food Manufacturing Experience)

    Sourcepro Search

    Quality assurance specialist job in Northvale, NJ

    SourcePro Search is seeking a Quality Assurance Assistant with a Bachelor's Degree in Quality Assurance, Food Science, Biology, Microbiology, Operations Management, or a related field. The ideal candidate will have experience in USDA and FDA food manufacturing, and be bilingual in English and Spanish. The Quality Assurance Assistant is responsible for ensuring that food products meet standards set by both the company and regulatory authorities. The QA Assistant will assist the Director of Food Safety & Compliance to further quality and safety policies and procedures. Must be knowledgeable about food safety standards that are customary within the food industry and mandated by government regulations. The Quality Assurance Assistant is expected to be familiar with the Hazard Analysis and Critical Control Points (HACCP) management system required by the Food and Drug Administration (FDA) and some other standards like SQF or BRC. What You'll Do: ·Perform Daily Product Evaluations and Cook Study Validations. Follow through with the team for corrective actions. ·Understand and implement quality assurance policies and procedures ·Collect and maintain supplier documentation ·Evaluate adequacy of quality assurance standards ·Investigate customer complaints and non-conformance issues ·Collect and compile statistical quality data ·Analyze data to identify areas for improvement in the quality system ·Monitor corrective and preventive actions ·Prepare reports to communicate outcomes of quality activities ·Identify training needs and organize training interventions to meet quality standards ·Monitor risk management activities ·Assure ongoing compliance with quality and industry regulatory requirements What You'll Bring: ·Bachelor's Degree in Quality Assurance, Food Science, Biology, Microbiology, Operations Management or a related field. ·USDA and FDA food manufacturing experience ·Bilingual (Spanish) ·PCQI (Preferred) ·HACCP Certified (Preferred) ·Strong verbal and written English communication skills ·Strong implementation and execution skills ·Good organizational and planning skills ·Ability to be relatable, personable, and productive within a team environment Work Relationships and Scope: ·Reports directly to the Director of Food Safety & Compliance Director. ·Develops good working relationships with the management, co-workers, and other employees. ·Develops working knowledge of the production environment, equipment and can respond to change. ·Develops knowledge of federal, state, and local food safety regulations. Working Conditions: ·This position works in a production environment with the risk of injury. Physical Demands: To successfully perform the essential functions of this role the individual must be able to meet the following requirements, though reasonable accommodation may be made to enable and individual with disabilities. ****************************
    $44k-86k yearly est. 60d+ ago
  • QA Coordinator (Korean Bilingual)

    Bluu, Inc.

    Quality assurance specialist job in Hackensack, NJ

    Location: Hackensack, NJ Employment Type: Full-time About the Role: We are seeking a detail-oriented and motivated QA Coordinator to join our team. The ideal candidate will be responsible for creating, documenting, and executing system test plans and test scripts, as well as validating data and analyzing test results. This role involves identifying, reporting, and tracking software issues, and communicating findings and progress updates with our software development team in Korea. Key Responsibilities: Develop, document, and execute comprehensive system test plans and test scripts. Perform data validation and analyze test results to ensure software quality. Record, report, track, and retest bugs found during testing. Collaborate and communicate effectively with software developers in Korea to resolve issues. Support continuous improvement of testing processes and documentation. Qualifications: Bachelor's degree in Computer Science or a related field. Bilingual proficiency in Korean and English (both written and verbal). 1-2 years of experience in system testing of Windows-based Point of Sales (POS) software. Hands-on experience with PC POS peripherals such as printers, barcode scanners, customer displays (CDP), and dot matrix printers. Strong analytical, problem-solving, and communication skills. High attention to detail and ability to work in a fast-paced environment. Benefits: Group Health Insurance (Medical, Dental, Vision) Employer paid Life Insurance Paid Sick and Vacation 401K with 3% matching Gym Reimbursement Company Lunch Please visit our website ************* for more information
    $51k-76k yearly est. Auto-Apply 60d+ ago
  • Quality Assurance Coordinator

    Harvest Hill Beverage Company 4.3company rating

    Quality assurance specialist job in Stamford, CT

    *This role is geared toward an entry level candidate (i.e. recent college graduate who possesses 1-3 years of professional work experience) About Harvest Hill: Harvest Hill Beverage Company is one of the nation's largest independent branded beverage producers, delivering consistent annual revenue growth, with sales of over $1 billion. The company was formed in June 2014 with the acquisition of Juicy Juice and further expanded with 3 subsequent acquisitions which were consolidated into one company in May 2017. Our portfolio of iconic brands includes Juicy Juice , SunnyD , Veryfine , Fruit2O , Little HUG , Daily's Cocktails , and Nutrament . We manufacture, market, and distribute across multi-channels including Grocery, Mass Merchandisers, Warehouse Clubs, Convenience, Foodservice, and Liquor Distributors. Harvest Hill is headquartered in Stamford, CT with a nationwide network of manufacturing and distribution facilities, employing over 1,000 employees in the United States. For more information visit harvesthill.com. Position Summary: The QA Coordinator posts files to appropriate internal/external sites and ensures corresponding databases are maintained and up to date. Creates, maintains and ensures all internal HHBC finished product quality documentation is current, accurate and project timelines for the QA team are maintained. The QA Coordinator creates updates & sustains Customer Portal and program documentation; carries out follow-up activities with customers and generates finished product standards as necessary. Directly assist in customer, consumer and field complaint support activities. Primary Position Responsibilities: • Maintain and update internal/external databases (TraceGains/Repositrak/Others) with customer documentation through active engagement in customer portal processes. Generate monthly reports defining completeness, gaps and goals. • Preserve the Harvest Hill customer list identifying products and manufacturing locations with a routine engagement of the gap assessment and resolution activities. • Efficiently coordinate the tracking of consumer, customer and field complaints with weekly reports. • Issue ongoing consumer investigation requests and maintain logs with timeline completion rates. Follow-up with sites on investigations. Support QA Mgr in trends and Complaint rates by categories. • Assists QA Mgr in developing concise feedback on status of field CAPA's and associated timelines. • Supports retrieval of technical details in the development of external and internal technical specifications for finished goods. Meanwhile adhering to HH, FDA, State and Local Regulations and Co-Manufacturing Alliance agreements. • Update and sustain Customer Portal with appropriate program documentation. Ensure through management engagement that customers receive the correct and accurate information. (no more no less). Foster meetings and communication with sales, customer service and QA to ensure accuracy. • Illustrate QA meetings as assigned, document activities and initiate follow-up. • Manage the receipt of new products, trial samples, consumer complaints that are delivered to the CT office. Track and photo packages received, identify location to store and act on disposal as required. Reach out to Sr Director or QA Mgr for direction. • Generate quarterly project timelines for the QA department corporate team. • Analyze & support QA Mgr in recommended next steps as it relates to handling and transportation deficiencies of finished goods. • AX acumen for the HHBC QA team. Within the first 180 days, train on AX, develop tutorials and train all members of our CT staff. • Review all co manufacturer requests for destruction of surplus, expired or defunct finished goods. • As a back-up to cross-functional QA team, learn documentation OOSR, ATS, shelf-life update process. • Support Co-Man and DC Trace exercises which occur a few times a year. • Support product manual upkeep with direct supervision by Head of FSQA. • Additional duties that may be assigned. Position Qualifications: • Candidate should possess a BS/BA degree in science, project management or related field and a minimum preferred of two years of professional career experience. • Proven experience of working with databases, include inputting and extracting data. • Excellent attention to detail with organizational and planning skills. • Ability to self-manage, prioritize and work under pressure to tight deadlines. • Ability to communicate effectively with colleagues, participants and external stakeholders. • Ability to work effectively as part of a team. • Undertake any training and professional development as and when required. • Proficient in Microsoft Office, particularly Access, Word and Excel. Systems experience may include: Microsoft Access, TRACEGAINS, Sharepoint and Red Zone.
    $50k-75k yearly est. Auto-Apply 60d+ ago
  • AQA QA Associate II, Central Islip

    5 Star Recruitment 3.8company rating

    Quality assurance specialist job in Central Islip, NY

    Job Title: QA Associate II AQA FLSA Classification: Professional, Exempt Purpose: This position requires a strong analytical chemistry/lab background and experience. The job duties for this position include but are not limited to the following: Scope: The Analytical Quality Assurance (AQA) associate II O III position is an team or individual contributor role and reports to the Supervisor Analytical Quality Assurance for InvaGen Pharmaceuticals, Inc., a Cipla subsidiary located at Happauge, NY. The job duties for this position include but are not limited to the following: Reviewing and confirming the compliance related to raw materials, in process and finished product analytical documents. Monitoring and ensuring of current Good Laboratory Practices (cGLP) followed by laboratory personnel during routine operation to ensure adherence to procedure. Confirming and ensuring compliance of the protocols and reports of method validations / verifications / comparison reports and any other study reports. Prepare and review laboratory investigation (OOS/OOT/Deviation) reports and ensure compliance of same. Verifying the laboratory chemicals/reagents, standards for completeness of the labels against standard operating procedures (SOPs). Assessing and implementing Pharmacopoeia changes whenever any new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect. Review of laboratory audit trials during data review against standard operating procedures (SOPs). Coordinating with the Analytical Laboratory Teams to arrange required documents to cross functional teams. Maintaining all the incoming documents with proper tracking, recording, storage and archival of the documents. Reviewing and identifying the gaps within the system during routine monitoring and informing the supervisor of necessary improvements in the identified areas. Actively participating in review of data related to laboratory investigations and incidents and ensuring proper compliance. Performing other departmental and cross-functional projects and assignments given by the manager/supervisor. Education and Experience Possess a minimum bachelors degree in chemistry, Pharmaceutical Sciences, or related field of study from an accredited institution. Masters degree in the above and/or related fields of study as noted above preferred. A minimum of 4-8 years in analytical (preferably in analytical quality assurance for minimum 3years). Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs. Strong knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP)/Good documentation Practices (GDP), USP monograph requirements,. Technical Knowledge and Computer Systems Skills Understanding of laboratory equipment operation, qualification and calibrations which includes their software audit trial reviews. E.g. HPLC, UV Vis Spectrophotometer, GC, Potentiometer, pH meter, Stability chambers, etc. Strong knowledge on USP monograph requirements, FDA & ICH guidance requirements, etc. Effective interpersonal relationship skills and the ability to work in a team environment. Experience in Inhalation products (DPI) is a plus. Ability to work in a fast-paced, dynamic environment within a manufacturing operation setting. Must be able to communicate clearly and concisely across all levels of the organization and possess a solid command of English language communication skills verbally, written, and interpersonally. Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices. Must be able to work under minimal supervision and able to work independently and in a team environment. Professional and Behavioral Competencies Proficiently speak English as a first or second language and ability to read, write and communicate effectively the same. Must be a self-starter and demonstrate initiative to seek additional training or direction as needed. Must be willing and able to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday. Knowledge of good manufacturing practices and good documentation practices preferred. Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously. Excellent organizational skills with the ability to focus on details. Work Schedule and Other Position Information: General shift but must be willing and able to work any assigned first or second shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs. Must be willing to work some weekends based on business needs as required by management. Relocation negotiable. No remote work available. This role works in cGMP laboratory or manufacturing environment, where personal protective equipment (PPEs) is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc. The role may be assigned on a work-shift basis where required (Day, Evening, Night). Weekend or Holiday work may be requested or required based on business needs.
    $53k-77k yearly est. 60d+ ago
  • Analytical QA Associate II

    Cipla Ltd.

    Quality assurance specialist job in Central Islip, NY

    NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates. Job Title: QA Associate II AQA FLSA Classification: Professional, Exempt Work Hours: General: 8:30AM - 5:00PM (may vary based on business needs) Reports To: Quality Assurance Manager Purpose: This position requires a strong analytical chemistry/lab background and experience. The job duties for this position include but are not limited to the following: Scope: The Analytical Quality Assurance (AQA) associate II and III position is a team or individual contributor role and reports to the Supervisor Analytical Quality Assurance for InvaGen Pharmaceuticals, Inc., a Cipla subsidiary located at Hauppauge, NY. The job duties for this position include but are not limited to the following: * Reviewing and confirming the compliance related to raw materials, in process and finished product analytical documents. * Monitoring and ensuring of current Good Laboratory Practices (cGLP) followed by laboratory personnel during routine operation to ensure adherence to procedure. * Confirming and ensuring compliance of the protocols and reports of method validations / verifications / comparison reports and any other study reports. * Prepare and review laboratory investigation (OOS/OOT/Deviation) reports and ensure compliance of same. * Verifying the laboratory chemicals/reagents, standards for completeness of the labels against standard operating procedures (SOPs). * Assessing and implementing Pharmacopoeia changes whenever any new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect. * Review of laboratory audit trials during data review against standard operating procedures (SOPs). * Coordinating with the Analytical Laboratory Teams to arrange required documents to cross functional teams. * Maintaining all the incoming documents with proper tracking, recording, storage and archival of the documents. * Reviewing and identifying the gaps within the system during routine monitoring and informing the supervisor of necessary improvements in the identified areas. * Actively participating in review of data related to laboratory investigations and incidents and ensuring proper compliance. * Performing other departmental and cross-functional projects and assignments given by the manager/supervisor. Education and Experience * Possess a minimum bachelor's degree in chemistry, Pharmaceutical Sciences, or related field of study from an accredited institution. Master's degree in the above and/or related fields of study as noted above preferred. * A minimum of 4-8 years in analytical (preferably in analytical quality assurance for minimum 3 years). * Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs. * Strong knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP)/Good documentation Practices (GDP), USP monograph requirements,. Technical Knowledge and Computer Systems Skills * Understanding of laboratory equipment operation, qualification and calibrations which includes their software audit trial reviews. E.g. HPLC, UV Vis Spectrophotometer, GC, Potentiometer, pH meter, Stability chambers, etc. * Strong knowledge on USP monograph requirements, FDA & ICH guidance requirements, etc. * Effective interpersonal relationship skills and the ability to work in a team environment. * Experience in Inhalation products (DPI) is a plus. * Ability to work in a fast-paced, dynamic environment within a manufacturing operation setting. * Must be able to communicate clearly and concisely across all levels of the organization and possess a solid command of English language communication skills verbally, written, and interpersonally. * Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices. * Must be able to work under minimal supervision and able to work independently and in a team environment. Professional and Behavioral Competencies * Proficiently speak English as a first or second language and ability to read, write and communicate effectively the same. * Must be a self-starter and demonstrate initiative to seek additional training or direction as needed. * Must be willing and able to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday. * Knowledge of good manufacturing practices and good documentation practices preferred. * Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously. * Excellent organizational skills with the ability to focus on details. Work Schedule and Other Position Information: * General shift but must be willing and able to work any assigned first or second shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs. * Must be willing to work some weekends based on business needs as required by management. * Relocation negotiable. * No remote work available. * This role works in cGMP laboratory or manufacturing environment, where personal protective equipment (PPEs) is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc. * The role may be assigned on a work-shift basis where required (Day, Evening, Night). Weekend or Holiday work may be requested or required based on business needs. GLOBAL COMPANY Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.) About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.
    $52k-76k yearly est. 28d ago
  • AQA QA Associate II

    Cipla

    Quality assurance specialist job in Central Islip, NY

    NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates. Job Title: QA Associate II AQA FLSA Classification: Professional, Exempt Work Location: Central Islip, NY Work Hours: General: 8:30AM - 5:00PM (may vary based on business needs) Reports To: Quality Assurance Manager Purpose: This position requires a strong analytical chemistry/lab background and experience. The job duties for this position include but are not limited to the following: Scope: The Analytical Quality Assurance (AQA) associate II O III position is an team or individual contributor role and reports to the Supervisor Analytical Quality Assurance for InvaGen Pharmaceuticals, Inc., a Cipla subsidiary located at Happauge, NY. The job duties for this position include but are not limited to the following: Reviewing and confirming the compliance related to raw materials, in process and finished product analytical documents. Monitoring and ensuring of current Good Laboratory Practices (cGLP) followed by laboratory personnel during routine operation to ensure adherence to procedure. Confirming and ensuring compliance of the protocols and reports of method validations / verifications / comparison reports and any other study reports. Prepare and review laboratory investigation (OOS/OOT/Deviation) reports and ensure compliance of same. Verifying the laboratory chemicals/reagents, standards for completeness of the labels against standard operating procedures (SOPs). Assessing and implementing Pharmacopoeia changes whenever any new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect. Review of laboratory audit trials during data review against standard operating procedures (SOPs). Coordinating with the Analytical Laboratory Teams to arrange required documents to cross functional teams. Maintaining all the incoming documents with proper tracking, recording, storage and archival of the documents. Reviewing and identifying the gaps within the system during routine monitoring and informing the supervisor of necessary improvements in the identified areas. Actively participating in review of data related to laboratory investigations and incidents and ensuring proper compliance. Performing other departmental and cross-functional projects and assignments given by the manager/supervisor. Education and Experience Possess a minimum bachelor's degree in chemistry, Pharmaceutical Sciences, or related field of study from an accredited institution. Master's degree in the above and/or related fields of study as noted above preferred. A minimum of 4-8 years in analytical (preferably in analytical quality assurance for minimum 3years). Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs. Strong knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP)/Good documentation Practices (GDP), USP monograph requirements,. Technical Knowledge and Computer Systems Skills Understanding of laboratory equipment operation, qualification and calibrations which includes their software audit trial reviews. E.g. HPLC, UV Vis Spectrophotometer, GC, Potentiometer, pH meter, Stability chambers, etc. Strong knowledge on USP monograph requirements, FDA & ICH guidance requirements, etc. Effective interpersonal relationship skills and the ability to work in a team environment. Experience in Inhalation products (DPI) is a plus. Ability to work in a fast-paced, dynamic environment within a manufacturing operation setting. Must be able to communicate clearly and concisely across all levels of the organization and possess a solid command of English language communication skills verbally, written, and interpersonally. Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices. Must be able to work under minimal supervision and able to work independently and in a team environment. Professional and Behavioral Competencies Proficiently speak English as a first or second language and ability to read, write and communicate effectively the same. Must be a self-starter and demonstrate initiative to seek additional training or direction as needed. Must be willing and able to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday. Knowledge of good manufacturing practices and good documentation practices preferred. Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously. Excellent organizational skills with the ability to focus on details. Work Schedule and Other Position Information: General shift but must be willing and able to work any assigned first or second shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs. Must be willing to work some weekends based on business needs as required by management. Relocation negotiable. No remote work available. This role works in cGMP laboratory or manufacturing environment, where personal protective equipment (PPEs) is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc. The role may be assigned on a work-shift basis where required (Day, Evening, Night). Weekend or Holiday work may be requested or required based on business needs. GLOBAL COMPANY Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.) About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.
    $52k-76k yearly est. 60d+ 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 6d 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 60d+ ago
  • QA Associate IT - DPI

    Cipla

    Quality assurance specialist job in Hauppauge, NY

    NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates. Job Title: QA Associate (IT) Employment Type: Full Time - Salaried/Exempt Salary Range: $72,800-$93,600 Work Hours/Shift: 8:30AM - 5:00PM Job Overview: The QA Associate (IT) is responsible for review of batch production records, ensuring that all documentation complies with Good Manufacturing Practices (GMP), regulatory standards, and internal quality assurance procedures. This role ensures the integrity, accuracy, and completeness of batch records related to pharmaceutical manufacturing processes, providing assurance that products are produced according to the approved methods and specifications. Responsibilities: Review batch production records (BPRs), including associated documents (e.g., manufacturing instructions, protocols, and equipment logs), to ensure they are complete, accurate, and compliant with GMP and regulatory guidelines. Verify that all entries are properly documented, signed, and dated by the relevant personnel, and ensure that any discrepancies are resolved before approval. Ensure batch records and associated documentation meet regulatory requirements from agencies such as the FDA, EMA, and other relevant authorities. Review, creation and revision of BPRs, SOPs, and other documents related to manufacturing processes. Ensure batch records are audit-ready and fully compliant for both internal and external audits (e.g., FDA, GMP inspections). Assist audit teams by providing required batch documentation and responding to audit queries related to manufacturing processes and batch records Recommend process improvements to enhance the batch review process, reduce review time, and ensure better compliance. Address any issues or concerns related to batch records raised by cross-functional teams and ensure timely resolution. Ensure completion of individual training assigned and follow company policies, safety requirements, cGMP and SOP's. Review of engineering records (temperature and humidity data, calibration reports and PMP records). To take daily Quality rounds at shop floor to ensure shop floor is maintained in state of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during batch manufacturing and packing. Other duties [additional support] that management may assign from time to time. Skills: Familiarity with document management systems (e.g., Master Control). Ability to analyze and resolve batch documentation issues in a timely and efficient manner. Experience in preparing for regulatory inspections and audits. Excellent organization skills with the ability to focus on details Strong organizational and time-management skills to handle multiple batch reviews simultaneously. Educational Qualification: Bachelor's degree in pharmacy, Life Sciences, Chemistry, or a related field. Work Experience: Minimum 2-3 years of experience in batch record review or quality assurance in the pharmaceutical industry. Strong knowledge of GMP, regulatory requirements (FDA, EMA), and pharmaceutical manufacturing processes. High attention to detail and accuracy in reviewing complex documentation. Strong communication skills and the ability to collaborate effectively across departments. About Cipla Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Driven by the purpose ‘Caring for Life', Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division. InvaGen Pharmaceuticals, Inc. InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla's respiratory business in the United States. Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter. About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.
    $72.8k-93.6k yearly 26d ago
  • QA Associate IT - DPI

    Cipla Ltd.

    Quality assurance specialist job in Hauppauge, NY

    NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates. Job Title: QA Associate (IT) Employment Type: Full Time - Salaried/Exempt Salary Range: $72,800-$93,600 Work Hours/Shift: 8:30AM - 5:00PM Job Overview: The QA Associate (IT) is responsible for review of batch production records, ensuring that all documentation complies with Good Manufacturing Practices (GMP), regulatory standards, and internal quality assurance procedures. This role ensures the integrity, accuracy, and completeness of batch records related to pharmaceutical manufacturing processes, providing assurance that products are produced according to the approved methods and specifications. Responsibilities: * Review batch production records (BPRs), including associated documents (e.g., manufacturing instructions, protocols, and equipment logs), to ensure they are complete, accurate, and compliant with GMP and regulatory guidelines. * Verify that all entries are properly documented, signed, and dated by the relevant personnel, and ensure that any discrepancies are resolved before approval. * Ensure batch records and associated documentation meet regulatory requirements from agencies such as the FDA, EMA, and other relevant authorities. * Review, creation and revision of BPRs, SOPs, and other documents related to manufacturing processes. * Ensure batch records are audit-ready and fully compliant for both internal and external audits (e.g., FDA, GMP inspections). * Assist audit teams by providing required batch documentation and responding to audit queries related to manufacturing processes and batch records * Recommend process improvements to enhance the batch review process, reduce review time, and ensure better compliance. * Address any issues or concerns related to batch records raised by cross-functional teams and ensure timely resolution. * Ensure completion of individual training assigned and follow company policies, safety requirements, cGMP and SOP's. * Review of engineering records (temperature and humidity data, calibration reports and PMP records). * To take daily Quality rounds at shop floor to ensure shop floor is maintained in state of compliance and per GMP requirement. * Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during batch manufacturing and packing. * Other duties [additional support] that management may assign from time to time. Skills: * Familiarity with document management systems (e.g., Master Control). * Ability to analyze and resolve batch documentation issues in a timely and efficient manner. * Experience in preparing for regulatory inspections and audits. * Excellent organization skills with the ability to focus on details * Strong organizational and time-management skills to handle multiple batch reviews simultaneously. Educational Qualification: Bachelor's degree in pharmacy, Life Sciences, Chemistry, or a related field. Work Experience: * Minimum 2-3 years of experience in batch record review or quality assurance in the pharmaceutical industry. * Strong knowledge of GMP, regulatory requirements (FDA, EMA), and pharmaceutical manufacturing processes. * High attention to detail and accuracy in reviewing complex documentation. * Strong communication skills and the ability to collaborate effectively across departments. About Cipla Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Driven by the purpose 'Caring for Life', Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division. InvaGen Pharmaceuticals, Inc. InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla's respiratory business in the United States. Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter. About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.
    $72.8k-93.6k yearly 30d ago

Learn more about quality assurance specialist jobs

How much does a quality assurance specialist earn in North Amityville, NY?

The average quality assurance specialist in North Amityville, NY earns between $48,000 and $109,000 annually. This compares to the national average quality assurance specialist range of $41,000 to $97,000.

Average quality assurance specialist salary in North Amityville, NY

$72,000

What are the biggest employers of Quality Assurance Specialists in North Amityville, NY?

The biggest employers of Quality Assurance Specialists in North Amityville, NY are:
  1. Certified Laboratories
  2. U.S. Dynamics
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