Quality assurance specialist jobs in Norwalk, CT - 146 jobs

Quality Control Supervisor Our client, a leading biopharmaceutical company, is seeking an experienced Quality Control Supervisor to join their team. This role is responsible for overseeing QC operations in a GMP-regulated environment, ensuring compliance with regulatory standards and internal procedures. Key Responsibilities: Supervise and mentor QC analysts; provide technical guidance and support. Ensure compliance with cGMP, USP, and 21 CFR Parts 210 & 211. Review and approve analytical data, investigations, and CAPAs. Troubleshoot analytical instruments (HPLC, GC, PSD) and support method validation and transfers. Manage testing schedules for raw materials, finished products, stability, and validation samples. Qualifications: BS in a scientific discipline with 5+ years of experience or MS with 3+ years. Hands-on experience with HPLC and Empower software. Strong knowledge of cGMP, USP, and ICH guidelines. Supervisory experience required. This is an excellent opportunity to join a growing organization and make an impact, please apply in directly for more information!

360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT solutions. 360 IT Professionals work along with its clients to deliver high-performance results, based exclusively on the one of a kind requirement. Our services are vast and we produce software and web products. We specialize in Mobile development, i.e. iPhone and Android apps. We use Objective C and Swift programming languages to create native applications for iPhone, whereas we use Android Code to develop native applications for Android devices. To create applications that work on cross-platforms, we use a number of frameworks such as Titanium, PhoneGap and JQuery mobile. Furthermore, we build web products and offer services such as web designing, layouts, responsive designing, graphic designing, web application development using frameworks based on model view controller architecture and content management system. Our services also extend to the domain of Cloud Computing, where we provide Salesforce CRM to effectively manage one's business and ease out all the operations by giving an easy platform. Apart from this, we also provide IT Staffing services that can help your organization to a great extent as you can hire highly skilled personnel's through us. We make sure that we deliver performance driven products that are optimally developed as per your organization's needs. Take a shot at us for your IT requirements and experience a radical change. Job Description Responsibilities: · Provide necessary definition, development and deployment of software quality assurance strategy and roadmap. · Develop and maintain current and comprehensive test plans for Navigators applications. · Act as Subject Matter Expert on the technical aspects, and tools related to testing end to end processes. · Lead and develop the execution of manual and automation test cases and scripts. · Lead and perform various types of testing including functional, regression, performance, user acceptance, etc. · Identify, document and track quality issues through to completion. · Responsible for maintaining up-to-date test plans. · Supervise quality assurance team who may be both internal and external resources and who may be geographically dispersed to ensure the delivery of the QA department goals and objectives · Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment in production environments. · Responsible embedding for QA as part of the SDLC · Meet target deployment schedules. · Measure and evaluate product and QA team performance; recommend improvements. · Identify risks and manage contingencies. · Gather and communicate testing results. · Work with Internal Audit to test and evaluate the design and operating effectiveness of internal controls. Requirements: · Bachelor's Degree or equivalent experience · 7+ years of software testing experience · 4+ years of team leadership · Thorough understanding of formalized QA process and concepts · Proven track record of delivering projects on time and within budget · Experience with Software Development Life Cycle (SDLC) · Strong analytical and problem solving abilities · Additional Information Thanks & Regards Vikas Kumar vikas.kumar(@)360itpro.com

One of our clients, a major electronics manufacturer is looking for a talented Sr. Manager of Quality Assurance with excellent compensation package and benefits. Salary Range: $155,000 - $180,000 per year ** Must be authorized to work for ANY employer in US Sorry, No H1B candidates Please read the description below and to be considered immediately email your resume to barryr @brainsworkgroup.com Sr. Manager of Quality Assurance Position Summary: The Sr. Manager of Quality Assurance is responsible for promotes and implements the Quality Management System by means of monitoring, evaluating and reporting of all Quality related activities. These tasks are to be accomplished in accordance with the Quality Management System Manual. All Quality Assurance activities shall be directed towards customer satisfaction and continuous quality improvement. Job Function: Manage Quality related activities in all areas of the company including the following: Inspection Internal Auditing Calibration Failure Analysis Corrective and preventive action / Root Cause Analysis Reliability Analysis and Stress Testing Non-Conforming Material Raw Material/Finish Product Qualification ESD Control Rohs Compliance Schedule, monitor and report on internal auditing and other major areas of Quality & Reliability activity. Present summary reports at periodic Management Review meetings. Monitor and support subcontractor-related activities (e.g., Qualification, Performance, Corrective Action). Monitor and report on effectiveness of internal and external corrective and preventive action activities. Monitor and report on inspection yield analysis. Provide appropriate customer support, including surveys and RMA support. Champion continuous implementation of all systems and procedures to achieve and maintain an ISO 9001/AS9100 registration. Promote and implement use of SPC. Lean, 8D Problem Solving, Root Cause Analysis. Promote and support activities related to establishing product reliability expressed as MTTF and as stress capability, including on-line monitoring of reliability. Verify effectiveness of member training. Approve ECNs and assign reviewers based on review matrix. Control further processing, delivery or installation of nonconforming products or services until the deficiency or unsatisfactory condition has been corrected. To certify Internal Auditors. Qualifications: Bachelor's Degree (or equivalent) in Electrical Engineering; training in statistical techniques and quality management. Minimum of 10 years in relevant activities at similar companies. Experience managing teams in roles of increased responsibility. Experience in statistical methods, (i.e. sampling, control charts, SPC, etc.) Should have had training in leadership skills, statistical techniques, internal auditing and ISO 9000. Additional Requirements/Skills: Comply, understand, and support corporate safety initiatives to ensure a safe work environment Ability and willingness to abide by Company's Code of Conduct Occasional travel, some overnight, as Use this link to apply directly: **************************************************************************** OrderID=16764301 Or email: ************************** Check ALL our Jobs: ******************************************

Certified Group partners with customers to deliver innovative scientific solutions and expertise - So The World Can Trust In What It Consumes. As a leading provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group includes Food Safety Net Services (FSNS), FSNS Certification & Audit, Certified Laboratories, EAS Consulting Group, and Labstat International Inc. Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries. We are seeking a highly skilled Quality Assurance Specialist to join our team! In this key role you will work on ensuring compliance with FDA regulations within our industry. The ideal candidate will have extensive experience in managing electronic Quality Management Systems (eQMS), particularly in areas such as Corrective and Preventive Actions (CAPA), Customer Complaints, Out of Specification (OOS) investigations, and conducting Internal Audits. The Quality Assurance Specialist will play a pivotal role in maintaining and improving our quality management processes to uphold the highest standards of product quality and regulatory compliance. Responsibilities: * Assist in the implementation, maintenance, and continuous improvement of the electronic Quality Management System (eQMS) to ensure compliance with FDA regulations. * Lead and coordinate Corrective and Preventive Action (CAPA) processes, including investigation, root cause analysis, implementation of corrective actions, and effectiveness checks. * Handle Customer Complaints and Out of Specification (OOS) investigations, ensuring timely resolution and documentation according to regulatory requirements. * Conduct thorough Internal Audits to assess compliance with established quality procedures, identify areas for improvement, and develop corrective actions as needed. * Collaborate with cross-functional teams to provide quality assurance guidance and support throughout all stages of operation. * Develop and maintain quality-related documentation, including Standard Operating Procedures (SOPs), work instructions, and quality records, equipment maintenance records in accordance with FDA regulations. * Verify that all laboratory instruments and equipment are calibrated and maintained according to established schedules and regulatory standards to ensure accuracy and compliance. Assist in the preparation and hosting of regulatory agency inspections and audits, as well as follow-up activities to address any findings or observations. * Stay abreast of regulatory requirements and industry best practices related to quality assurance and quality management systems and proactively implement necessary changes to ensure compliance. Requirements: * Bachelor's degree in a scientific or technical field, such as Chemistry, Biology, Engineering, or related discipline. * 3-5 years of experience in a quality assurance role within an FDA regulated industry, preferably in pharmaceuticals, medical devices, or biotechnology. * Strong understanding of FDA regulations and guidelines, including cGMP, 21 CFR Part 11, and ICH guidelines. * Proven experience in managing electronic Quality Management Systems (eQMS), such as Qualtrax, Intact, or similar platforms. * Proficiency in conducting investigations, root cause analysis, and implementing corrective actions for CAPA, Customer Complaints, and OOS events. * Experience in conducting Internal Audits and familiarity with audit processes and methodologies. * Excellent communication skills, with the ability to effectively collaborate with cross-functional teams and communicate quality requirements to stakeholders at all levels of the organization. * Strong attention to detail and analytical skills, with the ability to analyze complex data sets and identify trends or areas for improvement. * Ability to work independently, prioritize tasks, and manage multiple projects simultaneously in a fast-paced environment. BENEFITS: * Progressive 401k Retirement Savings Plan * Employer Paid Short- Term and Long-Term Disability, and Life Insurance * Group Medical * Tuition Reimbursement * Flexible Spending Accounts * Dental * Paid Holidays and Time Off * Many positions which qualify for the company bonus program Certified Group values diversity in its workforce. The company is firmly committed to a policy of Equal Opportunity and will administer its policies in a manner that treats each employee and applicant for employment on the basis of merit. Certified Group will take affirmative action to seek out qualified applicants without regard to race, color, religion, sex, national origin, age, handicap, or veteran status.

Job DescriptionDescription: We are seeking to hire a Quality Assurance Specialist to monitor, inspect, write, execute and propose measures to improve and correct the quality of a company's final product and processes in order to meet the company's standards. Job Responsibilities for Quality Assurance Specialist As a quality assurance specialist, you must be well versed with the company's standards in order to ensure that the quality of products and services conform with the company's standards. The main duties and responsibilities of a quality assurance specialist are as follows- · Ensure products meet customer demands and expectations · Help with operations and quality function in tracking, documenting, and reporting quality levels as well as looking into other KPIs · Perform regular inspections and quality tests · Preparing and implementing quality assurance policies and standards · Provide creative solutions for reviewing data and solving problems identified · Work closely with the development team to continuously improve the quality of existing products and services · Create Audit reports and make recommendations for improvement · Create training materials Quality Assurance Job Qualifications The basic qualifications required to be considered for the position of a quality assurance specialist include: · 2 years degree in quality related field · 3-5 years prior experience with quality assurance · 3-5 years of experience in the production industry Quality Assurance Specialist Skills Required · Knowledge of quality assurance standards (ISO9001:2015) · Working knowledge of the tools and methodologies (5S, 5 WHY, 8D) · Good numeracy skills and analytical understanding of statistics · Excellent communication and interpersonal skills, both verbal and written · Familiar with Microsoft Suite · Excellent data collection and analysis skills · Meticulous and diligent attributes · Good team player with ability to work in a team with no or little supervision · Resourcefulness and troubleshooting aptitude Requirements:

Must Have Technical/Functional Skills We're seeking a QA Automation Testing Manager (SDET) with 10+ years leading multiteam QA programs, to drive engineering-quality practices across complex banking platforms and integrations. You will architect automation frameworks, embed quality into CI/CD, and lead a team of SDETs/QA engineers to deliver reliable, compliant releases at speed. Experience in BFSI systems (core banking, payments, digital channels) and hands-on coding for test automation is essential. Job description * Automation Architecture & Delivery * Design, implement, and scale UI/API/DB automation frameworks (Selenium java/UFT, RestAssured/Postman, Cucumber/BDD, TestNG/JUnit). * Integrate automated suites into CI/CD (Azure DevOps/Jenkins/GitLab) with quality gates, parallelization, test impact analysis, and artifact publishing. * Establish coding standards for test harnesses, mocks, data builders, and service virtualization; enforce code reviews and static analysis for test code. Domain‑Focused Testing (Banking) * Translate banking use cases (core deposits/loans, ACH/wires, card/payments, digital banking) into robust automated scenarios and data validations. * Partner with product owners and vendor teams (e.g., Fiserv, internal platforms) to triage defects, validate patches/hotfixes, and maintain regression beds. Program Leadership & Governance * Lead a squad of SDETs/QA engineers-capacity planning, mentoring, and upskilling on advanced automation topics. * Orchestrate defect triage, root‑cause analysis, and risk‑based test planning; own release readiness (go/no‑go) and rollback validation. * Drive shift‑left practices (contract testing, API first, early data checks) and shift‑right observability (synthetic monitoring, production validation dashboards). * Compliance & Security * Ensure test evidence meets BFSI regulatory/audit needs (SOX); automate traceability from user stories to test results and logs. Required Qualifications * 10-12+ years in software testing/quality engineering, with 5+ years leading SDET/automation teams. * Strong hands‑on coding in Java/C# (or equivalent) for test automation (frameworks, utilities, custom drivers). * Proven delivery of CI/CD‑integrated automation at scale; expert in test design for microservices, REST APIs, and event‑driven systems. * BFSI domain experience-core banking or payments-and vendor/platform collaboration (e.g., Fiserv) for patch/regression cycles. * Solid grasp of SQL and data validation; familiarity with logs/metrics (Splunk/Sumo/Grafana) for test diagnostics. Preferred Skills * Experience with OSAT‑style regression accelerators or similar enterprise frameworks; comfortable with shift‑left/shift‑right test strategies. * Performance testing (JMeter/LoadRunner) * ISTQB (Advanced), Agile/SAFe, or cloud certifications (Azure/AWS). Generic Managerial Skills, If any * Tools & Stack (Illustrative) * Automation: Selenium, Cypress, Playwright, RestAssured, Postman, Cucumber/BDD, Appium (mobile) * CI/CD & SCM: Azure DevOps, Jenkins, GitLab, GitHub Actions; Git * Test Management : Azure Test Plans, ALM/Octane, Zephyr/Xray * Data/DB: SQL Server, Oracle, PostgreSQL; TDM/masking tools * Observability: Splunk/Sumo, Grafana/Prometheus; quality dashboards Education Bachelor's in computer science/engineering or related field (advanced degree a plus). TCS Employee Benefits Summary: * Discretionary Annual Incentive. * Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans. * Family Support: Maternal & Parental Leaves. * Insurance Options: Auto & Home Insurance, Identity Theft Protection. * Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement. * Time Off: Vacation, Time Off, Sick Leave & Holidays. * Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing. Salary Range : $100,000-$120,000 a year

*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.

This role supports production, R&D, and QA by ensuring the accuracy, control, and compliance of all quality-related documents such as batch records, controlled documents, training files, and audit-related documentation within the Quality Management System. Responsibilities:• Create and Issue batch production documentation in alignment with schedule requests.• Review and close production tickets upon completion.• Update the production schedule as needed to reflect workflow changes.• Collaborate with R&D on trial batches and ensure proper documentation.• Perform MBR (Master Batch Record) revisions and manage change control activities.• Updates formulas and master batch record instructions.• Maintain and revise SOPs and OPLs as required.• Distribute updated SOPs/OPLs to appropriate personnel and departments.• Maintain and update the training matrix for the QA department and other functions.• Issues required paperwork for new hire training and orientation.• Support internal audit activities, including collecting documents and preparing files.• File and archive controlled documentation in accordance with document retention policies.• Order and maintain office supplies for the QA department.• Provide general clerical and organizational support to ensure smooth QA operations.• Help maintain a professional and organized workspace.• Perform other tasks as needed. Qualifications:• Must comply with GMP requirements; specific functions will be discussed in GMP and on the job training.• Bachelor's in science preferred. High school diploma or equivalency required.• Strong computer knowledge with Microsoft Office is required.• Project Management skills are required.• Must have excellent verbal, written and interpersonal communication skills.• Must have excellent mathematical.• Must be organized and able to keep records.• Experience in R&D, QA or Production in the Dietary Supplement, Food or Pharmaceutical Industry is a plus.• Experience with FDA, GMP regulated industries a plus. Role's Physical Requirements:• Must be able to lift 50lbs.• Must be able to sit or stand for 8 hours.• Ability to work in a physically challenging environment, including bending, twisting, and standing for up to 8 hours• Work environment - may be exposed to powders, chemicals, and allergens (peanuts, tree nuts, milk, dairy, eggs, wheat, gluten, soy, fish, and shellfish) We proudly offer: Medical, Dental, Vision, 401K with Company Match, Pet insurance and more! We reward the hard work of our team members with fun and exciting company events, Summer Picnic, Festive Packages, Holiday Celebrations, and associate referral bonuses! Founded in 2011, Piping Rock Health Products has gone on to win Long Island's Top Workplaces Award 7 years in a row & securing the spot as Top Supplement Manufacturing Company 2024 by Food Business Review! Supported by a group of vitamin visionaries with over 40 years of industry experience and a carefully curated team of talented associates. Piping Rock is a global vitamin and supplement manufacturer with an unwavering commitment to creating quality wellness products. We believe that family always comes first, and that the dedication of our associates is the key ingredient to our success. We are drug free workplace, regulated by the FDA, required to follow Federal Guidelines; therefore in order to start as well as maintain employment, you must be able to successfully clear drug screening processes, which include testing for all illegal substances per Federal Guidelines. Piping Rock Health Products, INC. is an Equal Opportunity Employer.

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.

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.

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. ****************************

▶︎ 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.

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.

Job DescriptionDescription: RK Pharma Inc, a US based company with subsidiaries in India, is seeking multiple Quality Assurance Associates to complement our existing 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 will report to our Quality Assurance Manager and focus heavily on reviewing documentation such as batch records, internal audits, microbiology testing, and ensuring cGMP compliance. Requirements: If this sounds interesting to you, it's probably because up to this point you have: A science degree, specifically in Microbiology. Have worked in a CGMP regulated environment for at least 3 years or similar educational equivalency. Have experience with wet chemistry, HPLC, GC, spectroscopy, or microbiology. Thrived in an environment where growth and change are rapid. Strong Quality Control background preferred. The main responsibilities for this position are: Review Quality Control documentation to ensure compliance with company procedures and cGMP and support issuance of CoAs and stability studies. Revise quality and compliance standard operating procedures as required. Review Quality Control method validation and method transfer protocols/reports. Assist with Internal Audits. Collaborate in management of deviations/CAPAs/change controls. Assist in the supplier qualification of new vendors and periodical review of qualified vendors to maintain compliance. Assist in the preparation and review of the Annual Product Review. 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.

Full-time Description RK Pharma Inc, a US based company with subsidiaries in India, is seeking multiple Quality Assurance Associates to complement our existing 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 will report to our Quality Assurance Manager and focus heavily on reviewing documentation such as batch records, internal audits, microbiology testing, and ensuring cGMP compliance. Requirements If this sounds interesting to you, it's probably because up to this point you have: A science degree, specifically in Microbiology. Have worked in a CGMP regulated environment for at least 3 years or similar educational equivalency. Have experience with wet chemistry, HPLC, GC, spectroscopy, or microbiology. Thrived in an environment where growth and change are rapid. Strong Quality Control background preferred. The main responsibilities for this position are: Review Quality Control documentation to ensure compliance with company procedures and cGMP and support issuance of CoAs and stability studies. Revise quality and compliance standard operating procedures as required. Review Quality Control method validation and method transfer protocols/reports. Assist with Internal Audits. Collaborate in management of deviations/CAPAs/change controls. Assist in the supplier qualification of new vendors and periodical review of qualified vendors to maintain compliance. Assist in the preparation and review of the Annual Product Review. 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 65,000 -75,000

America Networks is a leading sensor and networking solutions partner for companies in any Industrial, Manufacturing, and Waste management space. We design and manufacture sensors for storage tanks, water metering, energy metering, gas monitoring, and asset management. Our founders are hardcore telecommunications engineers with combined 200 + years of experience in designing, optimizing and performance engineering; for several mid - large wireless carriers internationally - that saw a need to provide low power, cost efficient sensors to collect data, create alerts, and predict needed actions. We have combined these sensors with low power, wide area (LPWA) networking technologies to provide clients various options to decrease re-occurring costs associated with operating an IoT network of sensors and connected devices. We specialize in design, deployment, optimization, and support of these Networks. Whether an off-the-shelf or custom solution is needed, we'll create a solution and push the data on the best cloud platform to fit your needs, including your own. Job Description Plans, directs, and coordinates preparation of project documentation, such as engineering drawings, production specifications and schedules, and contract modifications, to ensure customer contract requirements are met: Reviews contract to determine documentation required for each phase of project, applying knowledge of engineering and manufacturing processes. Schedules due dates for drawings, specifications, software, technical manuals, and other documents. Monitors status of project to ensure documentation is submitted according to schedule. Reviews and verifies project documents for completeness, format, and compliance with contract requirements. Submits project documentation to management for approval, and transmits approved documents to customer. 5 to 7 years of experience. Additional Information Vivek Salvatore vivek.salvatore(@)americanetworks.com **************

Job Description Certified Group partners with customers to deliver innovative scientific solutions and expertise - So The World Can Trust In What It Consumes™. As a leading provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group includes Food Safety Net Services (FSNS), FSNS Certification & Audit, Certified Laboratories, EAS Consulting Group, and Labstat International Inc. Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries. We are seeking a highly skilled Quality Assurance Specialist to join our team! In this key role you will work on ensuring compliance with FDA regulations within our industry. The ideal candidate will have extensive experience in managing electronic Quality Management Systems (eQMS), particularly in areas such as Corrective and Preventive Actions (CAPA), Customer Complaints, Out of Specification (OOS) investigations, and conducting Internal Audits. The Quality Assurance Specialist will play a pivotal role in maintaining and improving our quality management processes to uphold the highest standards of product quality and regulatory compliance. Responsibilities: Assist in the implementation, maintenance, and continuous improvement of the electronic Quality Management System (eQMS) to ensure compliance with FDA regulations. Lead and coordinate Corrective and Preventive Action (CAPA) processes, including investigation, root cause analysis, implementation of corrective actions, and effectiveness checks. Handle Customer Complaints and Out of Specification (OOS) investigations, ensuring timely resolution and documentation according to regulatory requirements. Conduct thorough Internal Audits to assess compliance with established quality procedures, identify areas for improvement, and develop corrective actions as needed. Collaborate with cross-functional teams to provide quality assurance guidance and support throughout all stages of operation. Develop and maintain quality-related documentation, including Standard Operating Procedures (SOPs), work instructions, and quality records, equipment maintenance records in accordance with FDA regulations. Verify that all laboratory instruments and equipment are calibrated and maintained according to established schedules and regulatory standards to ensure accuracy and compliance. Assist in the preparation and hosting of regulatory agency inspections and audits, as well as follow-up activities to address any findings or observations. Stay abreast of regulatory requirements and industry best practices related to quality assurance and quality management systems and proactively implement necessary changes to ensure compliance. Requirements: Bachelor's degree in a scientific or technical field, such as Chemistry, Biology, Engineering, or related discipline. 3-5 years of experience in a quality assurance role within an FDA regulated industry, preferably in pharmaceuticals, medical devices, or biotechnology. Strong understanding of FDA regulations and guidelines, including cGMP, 21 CFR Part 11, and ICH guidelines. Proven experience in managing electronic Quality Management Systems (eQMS), such as Qualtrax, Intact, or similar platforms. Proficiency in conducting investigations, root cause analysis, and implementing corrective actions for CAPA, Customer Complaints, and OOS events. Experience in conducting Internal Audits and familiarity with audit processes and methodologies. Excellent communication skills, with the ability to effectively collaborate with cross-functional teams and communicate quality requirements to stakeholders at all levels of the organization. Strong attention to detail and analytical skills, with the ability to analyze complex data sets and identify trends or areas for improvement. Ability to work independently, prioritize tasks, and manage multiple projects simultaneously in a fast-paced environment. BENEFITS: Progressive 401k Retirement Savings Plan Employer Paid Short- Term and Long-Term Disability, and Life Insurance Group Medical Tuition Reimbursement Flexible Spending Accounts Dental Paid Holidays and Time Off Many positions which qualify for the company bonus program Certified Group values diversity in its workforce. The company is firmly committed to a policy of Equal Opportunity and will administer its policies in a manner that treats each employee and applicant for employment on the basis of merit. Certified Group will take affirmative action to seek out qualified applicants without regard to race, color, religion, sex, national origin, age, handicap, or veteran status.

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.

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.