Quality assurance specialist jobs in Ramapo, NY - 230 jobs

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

PRIMARY RESPONSIBILITIES: The Quality Assurance Food Safety Manager functions as a key member of the senior management team by being responsible for leading all aspects of quality, food safety, manufacturing regulations and overall sanitation within the SQF production facility. The QAFSM is responsible for developing, monitoring and maintaining Quality Assurance systems and programs to assure product integrity and compliance with SQF, GMP, HAACP, regulatory, customer standards and company Standard Operating Procedures (SOPs). They must also promote healthy, clean processing standards, documentation, training and employee development. JOB REQUIREMENTS: ● 5+ years of Quality Assurance Management experience ● BA/BS Degree, Food Science, Food Technology, or a related field ● Education and experience in food-related technology, safety and management required ● Certification and training in SQF, HACCP, Food Safety required ● Experience working with regulatory agencies such as USDA, FDA, SQF and BV ● Excellent managerial, organizational, interpersonal skills, attention to detail, and ability to adapt to different needs and working styles of managers ● Must be a self-starter, able to work independently as well as part of a team to help achieve goals and maintain compliance ● Resourceful problem solver with ability to prioritize and tackle tasks each week ● Trustworthy and reliable with confidential communications ● Positive attitude and fortitude to work through an ever-changing, growing, and dynamic operation ● Proficient in Spanish preferred PERFORMANCE RESPONSIBILITIES: ● Work closely with all departments to ensure the facility is always operating at the highest level of food safety standards. Ensure all staff follow and enforce rules, adhering to safety, food safety, and company SOPs. ● Closely support the Sanitation Manager in making sure proper cleaning and sanitation procedures are being followed ● Effectively manage the QA team, keeping all team members on task, and upholding a positive, food-safe culture ●Responsible for overseeing and managing the safe production of all products that meet company objectives. Monitor, report and fix deviations to standards ● Work in collaboration with the production management, operations and R&D teams to ensure standards are being met, and proper data is being collected ● Utilize food safety audit-readiness software to manage day-to-day operations and hold team members accountable ●Maintain supplier and internal documents as required by SQF - including, but not limited to, GFSI Certificates, COAs, COCs, raw material spec sheets, safety data sheets, product integrity logs, temperature tracking, trailer inspections, etc. ●Responsible for implementation and training of SQF rules, GMPs and compliance with regulatory standards ● Respond to and resolve customer quality complaints, conducting investigations and root cause analyses, implementing corrective and preventative actions where necessary ●Hold monthly senior management meetings to discuss complaints, non-conformances and implementation of solutions ● Create and maintain guides, conduct training for team members and visitors on GMPs, sanitation and food safety standards as required by SQF ● Work closely with R&D and production teams to document adherence to product specifications, production runs, results, timing, proper labeling, samples and trials ● Ensure the highest quality standards and good business relations are maintained with customers and governing agency representatives, such as USDA, FDA, and BV ● Verifies food safety and quality from supplier factories from raw material stage to finished product. Verifies texture, visual quality, shelf life, extended shelf life, temperature logs, packing alternatives along with R&D team ● Prepare regular reports and KPI's to establish accomplishments and efforts toward meeting objectives ● Oversee the launch of new products or trials, documenting production run data, customer and employee feedback ● Perform various lab tests to verify and validate food safety ● May participate in sensory and test panels, documenting the results ● May complete a variety of routine office tasks that may include typing, preparing reports, completing research, tracking information and KPI's, preparing or updating spreadsheets, copying, scanning, etc.

Job Title: Mainframe QA Analyst Job Travel Location(s): # Positions: 3 Employment Type: W2 Duration:Long Term # of Layers:0 Work Eligibility:All Work Authorizations are Permitted - No Visa Transfers Key Technology:COBOL, JCL, DB2, CICS Job Responsibilities: Ensure the quality and functionality of mainframe systems and applications, primarily working on COBOL, JCL, CICS and DB2. Design and execute test cases, analyze requirements, troubleshoot issues and improve performance. Develop detailed test cases and test data based on requirements, conduct manual testing focusing on functional, integration, regression and system testing. Execute test cases on mainframe environments and validate data accuracy in DB2. Log, track the defects and perform Root cause analysis of the defect. Collaborate with cross functional team Prepare and present the test results and metrics. Skills and Experience Required: Required: 3 -5 years of experience in Mainframe QA activities Knowledge of COBOL, JCL, DB2, CICS Experience in working with large data sets, data validation and SQL queries Familiarity with mainframe testing tools - automation testing Knowledge of test management tools - JIRA Work experience with Agile methodologies and scrum framework Good analytical skills and attitude to learn newskills Problem solving and troubleshooting skills Strong communication and Interpersonal skills Ability to work independently and as a team. Education: Bachelor's degree in related field or equivalent work experience. #J-18808-Ljbffr

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.

We are seeking an experienced GCP Quality Assurance Auditor to join our rapidly growing biopharmaceutical company specializing in neurology and psychiatry therapies. This role ensures GXP compliance, drives quality management initiatives, and conducts internal and external audits across clinical trials, safety/pharmacovigilance, and vendor operations (CROs, CMOs, investigator sites). The ideal candidate has extensive GCP experience, a strong pharmaceutical QA background, and expertise in radiopharmaceuticals. This is an on-site position in Northern NJ with flexible hours and minimal domestic travel. Key Responsibilities: Plan and perform global clinical process and vendor audits across all clinical trials Conduct risk-based audits of clinical processes and vendors, including IRT and EDC systems Prepare detailed audit reports and manage related non-conformances Ensure compliance with GCP, FDA, EMA, and ICH regulations Support regulatory inspections and quality improvement initiatives Collaborate with clinical teams, QA, and vendor management Qualifications: Bachelor's degree in a scientific, healthcare, or related discipline 5+ years of pharmaceutical industry experience, including 2+ years in radiopharmaceutical QA Extensive GCP and safety/pharmacovigilance experience Proven experience in internal and external GXP audits Familiarity with QMS, SOPs, clinical systems (IRT, EDC), and regulatory documentation Strong communication and cross-functional collaboration skills Up to 10% domestic travel Why Join Us: Be part of a fast-growing biopharma company making a difference in neurology and psychiatry Hybrid work schedule with flexible hours Opportunity for extension or full-time role

Schweid & Sons is a family-owned and operated premium ground beef company with a proud heritage spanning four generations. We supply top-quality beef to Retail, Foodservice, and National Account customers across the U.S. and are committed to quality, customer service, and innovation in protein manufacturing. Summary : This is a leadership role within the organization that is responsible for a broad range of processes, products, and team members over 2 shifts of production as well as the relationship with FSIS and 3rd party sanitation. Essential Job Functions : Food Safety / Regulatory Managing implementation of the HACCP Plan, its associated documents and including reassessments Maintaining records in accordance to the policy / HACCP program Conduct plant GMP inspections and monitor GMP's for compliance Responsible for maintaining the company's compliance with FSIS regulations. Ensure compliance with established policies and procedures such as HACCP, GMP's, SSOP, CAPA, and hold and release of products. Oversee training program for GMP's, HACCP and Food Defense/Food Fraud. Respond to non-compliance reports issued by FSIS. Manage the 3rd party Sanitation program for the facility. Quality / Customer Service Lead 3rd party audits (SQF / Customer Specific) and Customer tours including CAPA's. Strive for continuous improvements of products, process, procedures, and reliability. Maintain data of customer requirements, quality specifications and reporting requirements. Manage quality training program. Ensure specification compliance for raw materials and finished products. Managing implementation of quality programs. Assist with product development and special projects associated with product development. Respond to customer complaints with CAPA's / letters as needed. Establish the raw material and finished product shelf life. Other Contributing to a Safety Culture Manage FSQA Department (Techs, Sanitations, Supervisors) including exempt and non-exempt labor Manage the department to meet budget. Other tasks and projects may be assigned. 10 - 20% travel required Minimum Requirements : Red Meat Experience a Must Bachelor of Science in Food Technology, Food Process Engineering, or related field; MS preferred. 5 plus years' experience working in the Food Industry in a leadership role. HACCP Knowledge and Experience SQF / BRC Knowledge and Experience Ability to think independently and take responsibility for decisions. What We Offer The expected compensation for this role is $100,000 - $130,000 per year, depending on experience and qualifications. Final compensation will be discussed during the interview process. Time Off: PTO, Safe & Sick Time, and Paid Holidays. Health Benefits: Medical, vision, dental, HRA and voluntary disability benefits. Financial Benefits: 401(k) + employer match and life insurance. Location: This is an on-site role located in Carlstadt, NJ . Environment: Our facility is refrigerated. In this role you will be exposed to < 40 degrees for multiple hours of the day.

Paramus, NJ (Onsite) | Contract | Mid -Senior Level | 1 Opening Hourly Rate: $60/hour | No Relocation Assistance | No Visa Sponsorship Travel: Up to 10% A growing biopharmaceutical organization is seeking a GCP Quality Assurance Auditor to support global GXP compliance across clinical development, safety/pharmacovigilance, and vendor oversight. This role is ideal for an experienced QA professional with deep GCP expertise and prior experience in Radiopharmaceuticals. This is a 100% onsite role based in Paramus, NJ, supporting a regulated clinical environment. Position Overview The GCP Quality Assurance Auditor will support the GCP/PVG Quality function by planning, executing, and managing internal and external GXP audits. This role partners closely with Clinical Operations, Non -Clinical, Manufacturing, CROs, CMOs, investigator sites, and vendors to ensure compliance with global regulatory requirements and internal quality systems. Key Responsibilities Plan and conduct global clinical process and vendor audits across all clinical trials Perform risk -based audits of clinical systems, processes, and vendors Conduct vendor audits in collaboration with subject matter experts (e.g., IRT, EDC) Develop, finalize, and distribute audit reports to key stakeholders Own and manage audit findings, CAPAs, and non -conformances Audit compliance with GCP, FDA regulations, ICH guidelines, and internal SOPs Partner with Clinical Sourcing, Supplier Quality, and Clinical teams on vendor oversight Support regulatory agency inspections and inspection readiness activities Contribute to continuous quality improvement initiatives RequirementsKey Responsibilities Plan and conduct global clinical process and vendor audits across all clinical trials Perform risk -based audits of clinical systems, processes, and vendors Conduct vendor audits in collaboration with subject matter experts (e.g., IRT, EDC) Develop, finalize, and distribute audit reports to key stakeholders Own and manage audit findings, CAPAs, and non -conformances Audit compliance with GCP, FDA regulations, ICH guidelines, and internal SOPs Partner with Clinical Sourcing, Supplier Quality, and Clinical teams on vendor oversight Support regulatory agency inspections and inspection readiness activities Contribute to continuous quality improvement initiatives Required Qualifications Bachelor's degree in a scientific, healthcare, or related discipline 5+ years of pharmaceutical industry experience 2+ years of experience in Radiopharmaceuticals 2+ years of Quality Assurance experience Extensive hands -on GCP auditing experience Proven experience conducting internal and external GXP audits, including: Clinical Development Safety / Pharmacovigilance Strong working knowledge of FDA, EMA, ICH GCP, and global regulatory requirements Experience auditing clinical systems such as IRT and EDC Familiarity with QMS, SOPs, and compliance documentation Preferred Qualifications Experience supporting regulatory inspections Exposure to global clinical teams and vendors GCP or Quality Auditor certification (preferred, not required) Work Requirements Must be willing and able to work 100% onsite in Paramus, NJ Monday-Friday onsite schedule Up to 10% travel

The RPT QA Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with cGMP, regulatory requirements, and company quality standards. This role supports the Pharmaceutical Quality System (PQS) by identifying gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution processes. Key Responsibilities: Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers. Prepare detailed audit plans, checklists, and schedules. Ensure adherence to FDA, EMA, ICH, and other applicable regulatory guidelines. Review and approve deviations, CAPAs, and change controls. Document audit observations and issue formal audit reports. Track and verify implementation of corrective and preventive actions (CAPAs). Provide guidance on compliance requirements and audit readiness. Support regulatory inspections and customer audits. Identify systemic issues and recommend process improvements. Stay updated on evolving regulatory requirements and industry best practices. Qualifications: Bachelor's degree in Life Sciences, Pharmacy, or related field. 3-5 years in Radio Pharmaceuticals (Must Have), with at least 2 years in auditing. Strong knowledge of RPT cGMP, GDP, and global regulatory requirements. Excellent attention to detail and analytical skills. Strong communication and report-writing abilities. Ability to travel (up to 10%) for audits. Preferred Certifications: ASQ Certified Quality Auditor (CQA) ISO 9001 Lead Auditor GCP/GMP auditing certifications

GCP Quality Assurance Auditor needed for a 6 month on site contract. No visor sponsorship available. 5 years of experience required. Hybrid schedule. Great hourly rate. Skills: GCP, Quality Assurance, RadioPharmaceutical, Radio Pharmaceutical, Pharmaceutical, Audits, Auditor, GXP, Compliance, Quality Management, Clinical Operations, Non-Clinical, Manufacturing, CROs, CMOs, Investigator Sites, Clinical Trials, Audit, Clinical Development, Safety Pharmacovigilance, IRT, EDC, Regulations, FDA, Safety Background, SOPs, QMS QUALIFICATIONS: 5+ years of pharmaceutical experience 2+ years of RadioPharmaceutical and Quality Assurance experience BS degree in scientific, health care or related discipline Intensive GCP and safety background Experience with both internal and external process and systems audits Strong knowledge of development policies, procedures and standards (SOPs, QMS) Ability to work with global clinical teams in developing objectives for audits of clinical studies 10% Traveling required

In this role you will help enhance practices, policies and tools used by the Audit Department globally. This team offers visibility to senior members of the department! As an Internal Audit Practices Quality Assurance Senior Auditor Associate within the Internal Audit Department, you will play a pivotal role in promoting positive transformations across the global audit department. Your participation in special projects, as needed, will also be a significant part of your role. Reporting to the Quality Assurance Core Team Manager, your contributions will be instrumental in enhancing our audit practices. Job Responsibilities Execute an effective program of quality assurance, including communication of results, analysis of themes, identification of best practices and recommend changes to audit processes Positively and creatively influence department change Seek ways to increase efficiency and effectiveness of work performed Create and maintain key relationships across the Audit department, establishing a culture of engagement and adding value to the department Required Qualifications, Capabilities, and Skills 3 years of audit experience or related financial services experience Bachelor's degree Experience in planning and executing audit projects in accordance with professional standards In-depth understanding of audit methodologies In-depth knowledge of financial services, with ability to evaluate appropriateness of audit results across multiple lines of business Great communication skills, both verbal and written; must be comfortable presenting results and recommendations to senior management. Advanced project management skills; must be able to manage multiple projects concurrently. Preferred qualifications, Capabilities, and skills CIA, CPA or CAMS certification desirable Prior Quality Assurance experience Proven track record regarding ability to maintain good working relationships and influencing change Enthusiastic, self-motivated, effective under pressure and willing to take personal responsibility/accountabilities

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

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

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description 1. The incumbent will have responsibility to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements, the Client Pharma Corporate Quality Manual and Policies, and site procedures and business requirements. 2. Coordinates and performs batch record issuance for internally manufactured products Reviews and approves manufacturing and QC related documents for raw material disposition. 3. Reviews and approves manufacturing and QC related documents for manufactured media Performs administrative functions for filing and maintenance of records between QA operations and Document Control Center Support cGMP and associated OJT training to QA and other departments to improve right the first time (RTFT), high quality performance. 4. Control costs within department to meet budget. Complete job-related training in electronic database system along with GMP, safety, and Ethics & Compliance course requirements. 5. Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed. Skills:0-3 years GMP manufacturing and/or QA related experience 6. Education: BS/BA in Biological Sciences or equivalent relevant career experience Additional Information Regards, Anuj Mehta ************

*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: RK Pharma Inc, a US based company with subsidiaries in India, is seeking multiple Quality Assurance Associates to complement our existing Quality Assurance team as we scale towards commercial manufacturing in the next upcoming months. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team. This position will report to our Quality Assurance Manager and focus heavily on reviewing documentation such as batch records, internal audits, microbiology testing, and ensuring cGMP compliance. Requirements: If this sounds interesting to you, it's probably because up to this point you have: A science degree, specifically in Microbiology. Have worked in a CGMP regulated environment for at least 3 years or similar educational equivalency. Have experience with wet chemistry, HPLC, GC, spectroscopy, or microbiology. Thrived in an environment where growth and change are rapid. Strong Quality Control background preferred. The main responsibilities for this position are: Review Quality Control documentation to ensure compliance with company procedures and cGMP and support issuance of CoAs and stability studies. Revise quality and compliance standard operating procedures as required. Review Quality Control method validation and method transfer protocols/reports. Assist with Internal Audits. Collaborate in management of deviations/CAPAs/change controls. Assist in the supplier qualification of new vendors and periodical review of qualified vendors to maintain compliance. Assist in the preparation and review of the Annual Product Review. If this sounds like something that is of interest to you, please don't hesitate to apply to start a conversation. We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc.

Full-time Description RK Pharma Inc, a US based company with subsidiaries in India, is seeking multiple Quality Assurance Associates to complement our existing Quality Assurance team as we scale towards commercial manufacturing in the next upcoming months. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team. This position will report to our Quality Assurance Manager and focus heavily on reviewing documentation such as batch records, internal audits, microbiology testing, and ensuring cGMP compliance. Requirements If this sounds interesting to you, it's probably because up to this point you have: A science degree, specifically in Microbiology. Have worked in a CGMP regulated environment for at least 3 years or similar educational equivalency. Have experience with wet chemistry, HPLC, GC, spectroscopy, or microbiology. Thrived in an environment where growth and change are rapid. Strong Quality Control background preferred. The main responsibilities for this position are: Review Quality Control documentation to ensure compliance with company procedures and cGMP and support issuance of CoAs and stability studies. Revise quality and compliance standard operating procedures as required. Review Quality Control method validation and method transfer protocols/reports. Assist with Internal Audits. Collaborate in management of deviations/CAPAs/change controls. Assist in the supplier qualification of new vendors and periodical review of qualified vendors to maintain compliance. Assist in the preparation and review of the Annual Product Review. If this sounds like something that is of interest to you, please don't hesitate to apply to start a conversation. We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc. Salary Description 65,000 -75,000

The Quality Assurance Associate II (1st Shift, Tuesday-Saturday, 8:00 am- 4:30 pm) is responsible for performing Quality Assurance activities under direct supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, review of QC data, material releases and final product releases as well as assisting Quality management with department needs. Essential Functions and Responsibilities Regular and reliable attendance on a full-time basis. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices. Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture. Ensures that all procedures and processes meet internal quality standards as well as external regulations specific to pre-clinical, clinical and commercial manufacturing. Read, understand and follow all cGMP and cGTP documentation for Quality System Functions (SOPs,WIs,etc.) Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical and commercial manufacturing. Release raw material in ERP system as well as on paper. Perform Accessioning of incoming Apheresis. Review Batch record and disposition material of finished product to client. Provides information for Out of Specification and deviations to investigator. Performs line clearance prior to manufacturing operations begins. Other duties as assigned. Knowledge, Skills & Ability Relevant computer skills (Microsoft Office, Outlook) Detail-oriented and organized Analytical and problem-solving skills Good written and oral communication skills Ability to multi-task, prioritize, time manage and be adaptable Flexible and able to adapt to company growth and evolving responsibilities Ability to work independently and with a team Education & Experience BS or higher education degree in a scientifically related field Experience in a biologics or biotechnology company (1 -3 years) Working knowledge and technical understanding of the aseptic manufacture of biologics preferred Working knowledge of GMP and TCTP regulations Experience in reviewing GMP/GCTP related documents (validations/qualifications reports, SOPs, etc.) Disclaimer The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.

Quality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. This role manages internal and external audits which may include interaction with Health Authorities and clients Interfaces directly with client and cross functional teams Provides resolutions pertaining to quality for project related issues Independently prioritize, schedule, and manage multiple projects and resources (team) Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements. Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues. Author and review relevant SOPs, validation and other documents. Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports. Responsible for the completion of all client requirements related to cellular product and/or material releases. Master Batch Record Control, distribution and label verification Perform line clearance activities as required. Assignment and maintenance of product Lot numbers as applicable. Perform internal documentation audits as assigned. Materials management nonconformance disposition and release activity as applicable. Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions. Track and trend relevant quality metrics including environmental monitoring data. Provide Quality Assurance related support to various departments. Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies. Electronic Document Control activities as assigned. Provide training to personnel as assigned by supervisor. Travel may be required. REQUIREMENTS BS in biological sciences or other relevant field of study 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics. Working knowledge and technical understanding of aseptic manufacture of biologics Understanding of quality system applications Experience in both clinical and commercial manufacturing is preferred. Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc. Experience in organizing teams for effective and timely completion of projects. Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc. Experience participating in or hosting health authority inspections and/or client audits. Computer skills (Microsoft Office, Outlook) Detail-oriented and organized Analytical and problem-solving skills Good written and oral communication skills Ability to multi-task and be adaptable Flexible and able to adapt to company growth and evolving responsibilities Ability to work independently and with a team Strong Project Management and organization skills Must have the ability to work in a team-oriented environment and with clients Must be able to work during the weekend, holidays and as required by the company May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

A technology company in Morris Plains, NJ is looking for a Mainframe QA Analyst to ensure the quality of mainframe systems. The role requires expertise in COBOL, JCL, DB2, and CICS, alongside 3-5 years of mainframe QA experience. Candidates should have strong analytical skills and experience with test management tools like JIRA. The position calls for both independent and collaborative work, emphasizing problem-solving and communication skills in a fast-paced environment. #J-18808-Ljbffr