Quality assurance specialist jobs in Hauppauge, NY - 127 jobs

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

The Quality Registered Nurse plays a vital role in advancing the hospital ' s journey toward the ANCC Pathway to Excellence designation. This position supports the development of a positive practice environment by leading quality improvement initiatives, promoting nursing excellence, and ensuring alignment with the six Pathway Standards: Shared Decision-Making, Leadership, Safety, Quality, Well-Being, and Professional Development. Lead and coordinate quality improvement projects that align with Pathway standards, focusing on patient safety, clinical outcomes, and nursing practice. Support shared governance structures by facilitating nurse-led councils and promoting frontline nurse involvement in decision-making. Monitor and report on nursing-sensitive indicators, including infection rates, falls, medication errors, and readmissions. Conduct audits and root cause analyses to identify opportunities for improvement and ensure compliance with evidence-based practices. Collaborate with nursing leadership to develop and implement strategies that foster a respectful, safe, and empowering work environment. Educate staff on Pathway standards, quality initiatives, and professional development opportunities. Assist in preparing documentation for the Pathway application, including narratives, outcome data, and survey coordination. Promote nurse well-being by supporting initiatives that address physical and mental health, recognition, and work-life balance. How This Role Supports Pathway to Excellence: The Pathway to Excellence designation requires hospitals to demonstrate excellence across six standards: [********************* Shared Decision-Making - Quality Nurses help facilitate nurse-led councils and shared governance. Leadership - They collaborate with nurse leaders to promote transparency, accountability, and mentorship. Safety - They lead initiatives to reduce harm and foster a respectful workplace. Quality - They monitor outcomes and drive continuous improvement. Well-Being - They support programs that promote nurse wellness and recognition. Professional Development - They help create learning opportunities and career advancement pathways. Requirements Bachelor's degree in Nursing (BSN) required, Master's preferred Minimum of 3-5 years of clinical experience in a hospital setting. Experience in quality improvement, patient safety, or nursing excellence programs preferred. Familiarity with ANCC Pathway to Excellence standards and survey process. Strong analytical, communication, and project management skills. Proficiency in data analysis tools and electronic health records. Registered Nurse (RN) with active New York State licensure.

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: ******************************************

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:

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.

Nature and Scope Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with the internal audit program. Interacts with all levels of the organization and maintains on-going dialogue with management. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Under supervision, assist with documentation for the closure of investigations. * Assist in gathering data for reports, metrics, Annual Product reviews, Quarterly reports and external requests. * Scheduling departmental meetings, maintaining meeting minutes and attendance. * Maintain departmental records and files (both electronic and manual). * Participate in cross-functional project teams as required. * Support, coordinate, and assist with regulatory agency audit tasks as required in support of regulatory agency inspections. * Support and maintain quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP). * Keep training curriculum current. * Ensure all work is performed and documented in accordance with existing company policies and procedures. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * High School or GED diploma required. Associate's degree or equivalent years of experience preferred. * Experience working in a Quality role within a cGMP manufacturing environment required. * Knowledge and understanding of quality assurance principles, controls and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. * Strong attention to detail, adherence to SOPs. * Ability to work effectively in a collaborative environment. * Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. * Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. * PC Skills Required (MS Word, Excel). * Ability to work overtime as needed. Physical Environment and Requirements * Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary Range: $70,100 - $85,000 The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Job Overview of Compliance and QA Specialist The Compliance & QA Specialist plays a critical role in ensuring organizational compliance and adherence to standards of care across all programs. The person in this position is responsible for managing and reviewing incidents, conducting internal investigations, and monitoring programs' alignment with regulatory requirements and contractual obligations. The Compliance & QA Specialist must be able to work collaboratively with interdisciplinary teams, including administrators, program supervisors, and direct care staff. The role requires analytical skills, attention to detail, and a proactive approach to promoting a culture of safety, accountability, and excellence throughout the agency. Also, vital in this role is the ability to take continuous quality improvement initiatives, facilitate corrective action planning, and contribute to the agency's accreditation and renewal processes. Essential Duties of Compliance and QA Specialist Daily and ongoing monitoring of incident reports to ensure they are managed appropriately Liaise with programs and oversight agencies to facilitate incident review Conduct internal incident investigations Prepare for monthly Incident Review Committee Meetings Coordinate completion and timely submission of corrective action plans and performance improvement plans in relation to quality assurance incident management Assist with chart/record reviews for compliance and quality improvement purposes Manage internal as well as external incident reporting and management systems Provide direct assistance to programs with managing incidents in line with relevant rules and regulations Help with reviewing case records (manual/electronic) for compliance with Medicaid standards and billing requirements Runn and write reports on incident trends and status of programs' compliance with performance improvement plans Lead ongoing physical plant inspection, as well as health hazards and safety reviews Provide training on incident reporting/management, as needed Serve on committees relevant to the position Respond positively to all reasonable requests from leadership in a timely manner Ensure adherence to the agency's mission, policies, core values and commitments, notably the Sanctuary model. Essential Qualifications of compliance and QA Specialist Key qualifications include: Knowledge of Compliance and incident management in the Human Services field Ability to gather, read and analyze data. Proficient computer skills including Microsoft Suites Effective verbal and writing skills in English. Adeptness to learn new software and systems for electronic health records. Associate's degree in social science or related field, Bachelor's degree preferred Ability to access and utilize ADP app on smartphone or other device for access to agency programs Benefits of Compliance and QA Specialist Generous PTO, 4 weeks of vacation, floating holidays, holidays, personal and sick time Health Insurance Dental Insurance Vision Benefits 401(k) Employer Contributions Tuition Reimbursement Flex Spending Accounts Employer Paid STD, LTD and Life Insurance Professional Development Physical/Travel Requirements Must be able to ambulate, sit, stand, see, speak, climb stairs and carry up to 30lbs. Disclaimer Nothing in this job description restricts Andrus' right to modify the duties/responsibilities of this job at any time, with or without advanced notice. EEO Statement Andrus is an equal opportunity employer.

Job Description We're working with a well-established, leading manufacturer of personal care and household cleaning items that is searching for a Quality Manager. This person will ensure compliance with FDA OTC drug and cosmetic regulations, GMP standards, and internal quality requirements. The QA Manager will drive a culture of quality, maintain inspection readiness, and lead continuous improvement initiatives. This role will report to the Director of Quality Systems. Location : Long Island, NY Job Responsibilities: Develop, implement, and maintain the Quality Management System covering document control, CAPA, deviation management, audits, and supplier qualification. • Ensure compliance with FDA OTC regulations. • Review and approve GMP documentation including master batch records, production records, testing protocols, and validation documents. • Lead investigations, root cause analysis, and corrective/preventive actions. • Prepare for and manage internal, supplier, and external (FDA or customer) audits. • Support new product introductions ensuring compliance with quality and regulatory requirements. • Oversee supplier quality performance, raw material specifications, and incoming inspection processes. • Collaborate cross-functionally with manufacturing, R&D, packaging, and regulatory teams to ensure product quality at every stage. • Maintain calibration and maintenance programs for testing and inspection equipment. • Lead, train, and develop the QA team, fostering a proactive quality culture. Required Skills/Qualifications: Bachelor's degree in Microbiology, Chemistry, Life Sciences, Engineering, or related discipline required. 5+ years of progressive experience in Quality Assurance or Quality Systems within FDA-regulated industries. 2+ years of leadership experience managing quality teams and laboratories in a cGMP-compliant manufacturing environment, ideally within OTC or personal care products. Strong knowledge of FDA OTC regulations, GMP, and quality systems management. Excellent communication, leadership, and problem-solving skills. Familiarity with root cause analysis, CAPA management, and continuous improvement tools. ASQ or equivalent quality certification is a plus. Effective communicator. #zr

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.

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.

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: Happauge, 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 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.

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

▶︎ 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.

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.

*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.

Job DescriptionDescription: JOB TITLE: Quality Assurance Specialist Job Summary: We are seeking a Quality Assurance Specialist to join our team. The Quality Assurance Specialist is responsible for supporting and maintaining the highest quality standards in all manufacturing processes and products. This role involves overseeing first article inspections, and quality management systems, while acting as the focal point for customer interactions related to quality. The ideal candidate will have experience in aerospace manufacturing, ISO 9001/AS9100 standards, and an eye for detail in product audits and documentation. Key Responsibilities : · Review contracts from Quality Assurance perspective to ensure all quality requirements are met. Manage, schedule and host customer source inspections when required by contract. · Serve as the primary interface for First Article Inspections. Create and manage First Article Inspections and coordinate with internal/external teams to obtain first article approvals. · Maintain and report the status of the government's inventory assets. Create and affix customer returned material tags to customer assets upon receipt. Support quality aspects of the shipping process by creating and maintaining the organization's Certificate of Conformance documents, Shipping Authorization form and test data (when required by contract). · Maintain a centralized system for managing and controlling access to First Article documents. · Manage the Quality Management System (QMS) and ensure proper document control. · Schedule and conduct internal audits to maintain compliance with ISO 9001 and AS9100 standards. · Conduct scheduled and random production audits to maintain adherence to quality standards. · Review and analyze customer performance ratings for accuracy and work with customers to adjust customer performance ratings when there is a discrepancy with the customer's delivery and/or quality data. · Maintain an active supplier quality delivery and quality performance matrix and interface with the supplier if the supplier's quality performance falls below the QMS documented levels. · Perform the organization's FSO (Facility Security Officer) requirements and ensure that the organization is meeting or exceeding the standards that are defined by FC-PO-001 Security Manual, FC-PO-002B Classified Material Receiving & FC-PR-003 Security Debriefing. Required Qualifications : · Minimum of 5 years of experience in Quality Assurance, preferably within aerospace or related industries. · Hands-on experience with ISO 9001 and AS9100 standards. · Expertise in First Article Inspection (FAI) documentation and processes. · Proficiency in using inspection equipment such as calipers, micrometers, optical comparators, Micro-Hite, and microscopes. · Ability to read and interpret engineering drawings, with a strong understanding of Geometric Dimensioning & Tolerancing (GD&T). · Strong attention to detail and the ability to work independently in a fast-paced environment. · Excellent verbal and written communication skills. · Proficiency in MS Office (Excel, Word, Outlook). · Must be able to obtain a U.S. government security clearance (clean criminal record required). Why Join U.S Dynamics Corporation? At U.S Dynamics Corporation, you will be a part of a supportive and innovative environment that fosters growth and values your professional development. We offer competitive compensation, comprehensive benefits, and opportunities for advancement. Join us in shaping the future with your talent and expertise. Requirements:

Nature and Scope The QA Specialist - Deviations will be responsible for effectively ensuring non-routine events are investigated and documented in accordance with company SOPs, policies and cGMPs. This is a cross-functional position that interacts with all departments at American Regent. Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with regulatory requirements and company procedures. The role is responsible for authoring, reviewing, and providing the final Quality approval for investigations into manufacturing and laboratory events/deviations. The role interacts with all levels of the organization and is expected to use professional judgment in appropriate issue escalation to management. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Ensures any non-routine events associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated and documented in accordance with company SOPs, policies and cGMPs and within assigned timelines. Identify trends, evaluate metrics, and provide support for internal audits under the direction of the QA Deviations Supervisor. * Ensure deviation timelines are maintained through inter-department communication. * Facilitate and lead assigned investigations involving multiple investigation areas. * Facilitate and participate in initiatives to address compliance gaps identified during investigations with minimal assistance. Provide quality system level assessments and reviews, author and facilitate change requests. * Initiate and complete or assign investigations and CAPAs related to Quality departments (Quality Operations, Quality Control, Quality Systems). * Perform and guide root-cause analysis for events utilizing investigation tools (e.g., 5 whys, 6M, Fishbone Diagrams). * Perform the QA review and final approval signature for assigned deviations/events, confirming the completeness, accuracy, and consistency of all work so that it meets the standards of quality. Identify errors and inconsistencies and initiate resolution to ensure high quality. * Coordinate/provide oversight for the investigations system, including follow up with cross-functional stakeholders (assignees, internal customers, reviewers, and approvers). Act as a liaison between Operations and Quality in all matters related to investigations and CAPA. * Under supervision assist with documentation for the closure of complaint investigations. * Gather data for reports, metrics, Annual Product reviews and external requests. Generate and analyze metrics as assigned, employing statistical techniques as appropriate. * Scheduling departmental meetings, maintaining meeting minutes and attendance. * Maintain departmental records and files (both electronic and manual). * Participate in cross-functional project teams as required. * Support, coordinate, and assist with regulatory agency audits and inspections as required. * Support and maintain quality programs, policies, processes, procedures, and controls ensuring compliance with current Good Manufacturing Practices (cGMP). * Keep training curriculum current in ISO train. * Ensure all work is performed and documented in accordance with existing company policies and procedures. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * Bachelor's degree in a science or engineering field. * ASQ Certification as a Quality Engineer or Six Sigma Black belt preferred. * Minimum of 2-5 years of experience working in a Quality role within a cGMP manufacturing environment required. * Knowledge and understanding of quality assurance principles, controls, and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. * Strong attention to detail, adherence to SOPs. * Ability to work effectively in a collaborative environment. * Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. * Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. * Ability to apply critical thinking to scientific problems and demonstrated knowledge. * Ability to apply statistical quality management concepts. * PC Skills Required (MS Word, Excel). Preference will be given to candidates with demonstrated knowledge of Quality software such as TrackWise, Veeva and Minitab. * Excellent English communication skills, both oral and written, and comprehension are required. Ability to effectively present information to top management, employees, or customers. Physical Environment and Requirements * Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary range: $79,900-$85,000 The salary range displayed is the minimum and maximum salary range for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

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.

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.