Quality assurance specialist jobs in Darien, CT - 142 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

Standard Bot's mission is to significantly lower the barrier to entry to real-world automation, bringing the power of bits to the world of atoms and unlocking productivity for entire new industries and users. We combine advanced engineering, intelligent automation, and world-class manufacturing to create products that redefine what's possible. We are seeking a detail-oriented and experienced Hardware QA Manager to lead our Quality Assurance efforts across all hardware platforms in our fast-paced robotics manufacturing environment. Note: This role will be required to come into our Glen Cove robotics factory 5 days/week We are unable to offer visa sponsorship at this time What you'll do The Hardware QA Manager will be responsible for developing, implementing, and maintaining comprehensive quality assurance systems and protocols for robotic hardware. This individual will lead a team of QA engineers and technicians to ensure all hardware components meet strict reliability, safety, and performance standards before and after release. This role requires close collaboration with cross-functional teams including Engineering, Manufacturing, Supply Chain, and Product Development. Responsibilities Lead the hardware QA team in planning, implementing, and executing test strategies and protocols for robotic hardware systems (mechanical, electrical, and embedded components) Work with the manufacturing and assembly teams to drive improvements in quality and efficiency Define and maintain hardware quality standards and ensure compliance with industry regulations (e.g., ISO, ANSI, IPC, RoHS, etc.) Drive root cause analysis (RCA) and corrective/preventive action (CAPA) for hardware defects or failures Coordinate with Manufacturing and Supply Chain to ensure quality standards are upheld throughout production and vendor operations Develop automated and manual test plans for validation and verification (V&V) of hardware systems at component and system level Participate in design reviews to ensure DFM (Design for Manufacturability) and DFT (Design for Testability) are considered Manage incoming inspection protocols, First Article Inspections (FAIs), and supplier audits Lead internal and external audits and represent the QA function during regulatory inspections or customer visits Build and mentor a high-performing QA team, promoting a culture of quality, accountability, and continuous improvement Skills you'll bring Bachelor's or Master's degree in Electrical Engineering, Mechanical Engineering, Mechatronics, or a related technical field 7+ years of experience in hardware quality assurance, preferably in a robotics, automotive, or high-tech manufacturing environment 3+ years of experience in a management or leadership role within QA Strong understanding of hardware development lifecycles, including prototyping, NPI, production ramp, and sustaining Proficient with quality tools and methodologies such as FMEA, Six Sigma, SPC, 8D, etc Experience with test equipment and diagnostic tools used for electronics, firmware, and electromechanical systems Familiarity with manufacturing processes such as SMT, injection molding, CNC, etc Strong analytical, problem-solving, and communication skills Ability to work in a fast-paced, multidisciplinary team environment Preferred Qualifications Experience with robotics systems, motion control, or autonomous platforms. Bonus for software/firmware experience Experience creating a Quality Management System from scratch (particularly to QA/QC and test generation) Experience working with global suppliers and contract manufacturers Certifications such as ASQ CQE, Six Sigma Black Belt, or ISO 9001 Lead Auditor Compensation and Benefits The salary range for this role is $140,000 to $180,000. We are open to a variety of seniority levels for this role and will build compensation packages that are commensurate with seniority and skill level. Base salary is just one part of the overall compensation at Standard Bots. All Full-Time Employees are eligible for Employee Stock Options. We also offer a package of benefits including paid time off, medical/dental/vision insurance, life insurance, disability insurance, and 401(k) to regular full-time employees.

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.

Description & Requirements Maximus is currently hiring for a Quality Assurance and Training Manager to support our Kansas Eligibility Operations team. This is a remote opportunity. The Quality Assurance and Training Manager will will oversee quality assurance programs, manage remote training teams, and ensure compliance with contractual and regulatory standards. In this role, the Quality Assurance and Training Manager will design and implement training strategies, monitor performance, and leverage standardized quality tools to enhance service delivery and to meet client's needs. *This role is contingent upon contract award* Why joining Maximus? - • Competitive Compensation - Quarterly bonuses based on performance included! - • Comprehensive Insurance Coverage - Choose from various plans, including Medical, Dental, Vision, Prescription, and partially funded HSA. Additionally, enjoy Life insurance benefits and discounts on Auto, Home, Renter's, and Pet insurance. - • Future Planning - Prepare for retirement with our 401K Retirement Savings plan and Company Matching. - • Unlimited Time Off Package - Enjoy UTO, Holidays, and sick leave, - • Holistic Wellness Support - Access resources for physical, emotional, and financial wellness through our Employee Assistance Program (EAP). - • Recognition Platform - Acknowledge and appreciate outstanding employee contributions. - • Tuition Reimbursement - Invest in your ongoing education and development. - • Employee Perks and Discounts - Additional benefits and discounts exclusively for employees. - • Maximus Wellness Program and Resources - Access a range of wellness programs and resources tailored to your needs. - • Professional Development Opportunities- Participate in training programs, workshops, and conferences. Essential Duties and Responsibilities: - Design, develop and implement training curriculum and supporting materials. - Develop training schedules based on the evaluation of the need for new staff. - Develop and deliver training through input and communication with the client and leadership. - Ensure that Client Service Reps are provided with updated knowledge required for the project, which includes management of changes to scope and direction. - Communicate operating policies and procedures and ensure compliance with contractual agreement. - Arrange staff training on a regular and ongoing basis regarding telephone protocols and project information obtained through quality assurance monitoring. - Manage quality operations including planning, implementing, monitoring, and reporting functions. - Manage internal and external customer expectations related to quality management, and effectively communicate corporate quality standards across the project. - Support and improve the Quality Program and provide the leadership and direction to enhance accepted standards of quality practices, continuous improvement, and ethical considerations. - Aggregate and analyze quality data and identify opportunities for improvement in product and service quality, and the design and implementation of key business and quality processes. - Maintain responsibility for developing, implementing, and writing procedures, work instructions and flow-charts for quality management activities and monitoring compliance with contractual agreements. Minimum Requirements - Bachelor's degree in relevant field of study and 5+ years of relevant professional experience required, or equivalent combination of education and experience. - Must be willing and able to travel up to 25% of the time as business need dictates. - Lean Six Sigma experience with a minimum of Yellow Belt Certification required. - Experience managing direct reports remotely required, as well as multiple training sessions virtually. - Experience with designing, implementing and reporting customer satisfaction surveys required. - Experience with standardized quality tools required. - Experience with call and voice monitoring platforms required. - Experience with a large-scale telephony system required. - Experience with Client Relationship Management (CRM) platforms required. - Experience with contract compliance and quality platforms required. - Experience with statistical processes required. - Premium contact center billing experience required. - Financial experience with Oracle preferred. - Medicaid program knowledge and experience highly preferred. Home Office Requirements: - Internet speed of 25mbps or higher required (you can test this by going to ******************* - Connectivity to the internet via either Wi-Fi or Category 5 or 6 ethernet patch cable to the home router. - Must currently and permanently reside in the Continental US. EEO Statement Maximus is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information and other legally protected characteristics. Pay Transparency Maximus compensation is based on various factors including but not limited to job location, a candidate's education, training, experience, expected quality and quantity of work, required travel (if any), external market and internal value analysis including seniority and merit systems, as well as internal pay alignment. Annual salary is just one component of Maximus's total compensation package. Other rewards may include short- and long-term incentives as well as program-specific awards. Additionally, Maximus provides a variety of benefits to employees, including health insurance coverage, life and disability insurance, a retirement savings plan, paid holidays and paid time off. Compensation ranges may differ based on contract value but will be commensurate with job duties and relevant work experience. An applicant's salary history will not be used in determining compensation. Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances. Accommodations Maximus provides reasonable accommodations to individuals requiring assistance during any phase of the employment process due to a disability, medical condition, or physical or mental impairment. If you require assistance at any stage of the employment process-including accessing job postings, completing assessments, or participating in interviews,-please contact People Operations at **************************. Minimum Salary $ 100,000.00 Maximum Salary $ 112,400.00

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 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 Spectrum Vascular is an innovative medical device company focused on vascular access and medication management. Our mission is to improve the lives of patients worldwide by providing caregivers with high quality, innovative products with exceptional customer service. We are a company that was formed through the acquisition of a portfolio of trusted products that have been widely used by customers for decades. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics. This role represents a unique opportunity to join a dynamic and growing team with established products and an entrepreneurial mindset. Role Description: The Quality Manager position will be filled by a professional who possesses knowledge and skills necessary to provide direction and guidance in current Good Manufacturing Practice (cGMP) regulations as well as ISO13485 Quality Management Systems in a medical device company, including coordination with Regulatory Affairs on complaint management, as well as the application of risk management principles. Role Responsibilities: Quality Systems: The Quality Manager has responsibility for working directly with the Contract Manufacturer (CMO) on the implementation, maintenance and improvement of procedures and processes to ensure compliance with current regulations, standards, guidance and state of the art/ industry best practices for medical devices that adhere to cGMP. Quality oversight of various Quality functions as assigned (e.g. Manufacturing Process controls and changes, Verification and Validation) Works to assure the quality, accuracy, and integrity of data in manufacturing, to assure that effective and appropriate Quality Management Systems are in place and followed Ensures manufacturing are completed according to established SOPs, including usage and control of raw materials, components and labels. Maintains and helps improve current quality systems, processes, tools, policies, SOPs and validations to ensure compliance with regulatory requirements. Deviations, Change Control, CAPAS, and Complaints Quality System Subject Matter Expert including leadership and execution to completion of Change Controls, deviations, CAPAs and complaints Works directly with Engineering, Regulatory Affairs, Supply Chain, Manufacturing, and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner Coordination and review of change controls, deviations, CAPAs, and effectiveness checks Leads and/or supports CAPA investigations, implementation, CAPA effectiveness and closure Executes data analysis, trending Audits and Annual Product Reviews, including Management Review Conducts internal audits of company systems to assure compliance with regulatory requirements. Manages the Product Quality Review processes; coordinating cross functionally to ensure regulatory requirements are met and that actions arising are managed to conclusion. Participates in preparation for and hosting of external audits and FDA inspections in collaboration with the Sr. VP Regulatory Affairs. Assures periodic Management Review meetings are held to meet regulatory requirements. Provides comprehensive support for FDA audits and offers global guidance for drug product-related matters. Interacts with representatives from the Food and Drug Administration (FDA) and other regulatory agencies during audits including helping to resolve issues or questions. Helps oversee post-audit activities Assists in coordination of supplier and internal audits and regulatory authority audits Document Control Provides oversight and coordination of all controlled documents including administrative, technical and production documents. Authors and/or supports gap assessments of Quality System and Documents Ensures that the Document Control System is maintained including SOPs, methods, production records, change controls, deviations, validation documents, operation manuals, training documents and any other relevant controlled documents in compliance with cGMPs, and international policies and procedures. Ensures management of documents, including regulating access to controlled documents and obsolescence of documents accordingly. Training Develops training programs as applicable to ensure organization understands and maintains compliance with the regulations, standards and guidance Develop and/or delivers training programs, and administration as required, e.g., GMP, data integrity, good documentation practices, and inspection readiness Helps create, improve and conduct training as needed. Trains and mentors other staff to perform quality duties Role Qualifications: Bachelor's degree in a technical field (e.g., Biology, Chemistry, Engineering) required 5+ years proven experience in quality management, preferably in a manufacturing or production environment Strong analytical skills with the ability to analyze data and identify trends Excellent project management skills with the ability to prioritize tasks and meet deadlines Knowledge of quality control methodologies and tools (e.g., Six Sigma, Lean) Familiarity with regulatory requirements and standards (e.g., ISO, AAMI, FDA, cGMP) Strong communication skills, both verbal and written Attention to detail and a commitment to delivering high-quality results Spectrum Vascular is an Equal Opportunity Employer and committed to creating a diverse and inclusive company culture. Spectrum Vascular does not discriminate against candidates and employees because of their disability, sex, race, gender identity, sexual orientation, religion, national origin, age, veteran status, or any other protected status under the law.

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 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

*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.

An ever growing company is looking for an experienced QA Manager. The ideal candidate has at least 5 years of management experience in the pharmaceutical/nutraceutical/food industry. Pay: $70,000 to $80,000 Responsible for all quality systems for label manufacturer of clinical trials and investigational drug products. Responsible for a staff of 22 individuals, including 3 Managers and 2 supervisors. Develop, write, revise and approve all SOPs. Solely responsible for customer audits, including audit responses. Instituted company-wide calibration program, effectiveness training, mock recalls, AQL statistical sampling plans, line clearance methods and specifications for components. Developed code system for customer complaints, investigations, utilized in trending analysis. Developed training matrices for all employees. Responsible for cGMP and SOP training programs. Write and execute validation protocols - Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification on various equipment Complete customer Quality Agreements, Technical Agreements and questionnaires. Revised and enhanced preventative maintenance program, ensuring overall compliance. Maintain Material Safety Data Sheet (MSDS) manuals, facility pest control and emergency lighting programs. Additional Information All your information will be kept confidential according to EEO guidelines.

The QA Specialist position is responsible for conducting internal audits of OPWDD certified IRAs and WOW Dayhab program. Hourly $28.85 for a maximum of 20 Hours weekly Resonsibilities: Regulatory Compliance: Conduct site visits, provide training, and review documentation to ensure compliance with Federal, State, and agency regulations/policies. QA Audits and Review Participation: Conduct internal audits and program site reviews as needed, ensuring compliance with regulatory requirements. Perform follow-up audits to confirm corrective actions are effective. Develop written reports summarizing findings. Team Collaboration: Partner with program staff, management, and leadership to share findings from site visits, address issues, and implement solutions effectively. Investigator: Assist with conducting investigations into situations which may violate a persons' rights and/or protections in accordance with OPWDD and Justice Center regulations. Assist with incident tracking, monitoring and trend analysis. Conduct internal audits to ensure the agency is prepared for external audits from oversight agency (OPWDD) in conjunction with management, assist with the development and implementation of corrective action plans in response to external audits.

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 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 (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 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.

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

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.