Quality assurance specialist jobs in Bensalem, PA - 325 jobs

Aramark Healthcare+ has an immediate need for a System Food Service Quality and Standards Manager for The Children's Hospital of Philadelphia. The System Food Service Quality and Standards Manager will be responsible for engaging with front line managers and front line associates to manage safety, sanitation and compliance in the food service operation, and to develop corrective action plans and assist with implementing these plans. Position may also facilitate training on a 1:1 or group basis. Job Responsibilities Conduct regular on-site Quality Assurance Audits utilizing the Aramark Productivity Portal Develop and implement corrective action plans for locations identified as not meeting Aramark Standards as it relates to food ordering, production and service Focus on implementation and training of Aramark's 5 P's of Food Management Work with client constituents to develop training material for client front line staff Work with VPO, DM's and Director of Culinary to develop various training material to assist in driving operational outcomes to the operating locations Continually seek to improve performance; hold staff accountable for challenging goals Provide leadership in the implementation and maintenance of internal control and business process improvement initiatives. Develop and be accountable for a culture that creates a safe work environment. Develop and execute a process for monitoring, testing and reporting compliance. Identify risks or opportunities to strengthen internal controls and present recommendations for process improvement initiatives. At Aramark, developing new skills and doing what it takes to get the job done make a positive impact for our employees and for our customers. In order to meet our commitments, job duties may change or new ones may be assigned without formal notice. Qualifications Bachelor's degree or equivalent experience Requires at least 1-3 years of experience in a food service management role Healthcare experience required Strong interpersonal skills Ability to maintain effective client and customer rapport for mutually beneficial business relationships Ability to demonstrate excellent customer service using Aramark's standard service model Ability to maintain an effective working relationship with other departments to a unified food service experience for all customers Education About Aramark Our Mission Rooted in service and united by our purpose, we strive to do great things for each other, our partners, our communities, and our planet. At Aramark, we believe that every employee should enjoy equal employment opportunity and be free to participate in all aspects of the company. We do not discriminate on the basis of race, color, religion, national origin, age, sex, gender, pregnancy, disability, sexual orientation, gender identity, genetic information, military status, protected veteran status or other characteristics protected by applicable law. About Aramark The people of Aramark proudly serve millions of guests every day through food and facilities in 15 countries around the world. Rooted in service and united by our purpose, we strive to do great things for each other, our partners, our communities, and our planet. We believe a career should develop your talents, fuel your passions, and empower your professional growth. So, no matter what you're pursuing - a new challenge, a sense of belonging, or just a great place to work - our focus is helping you reach your full potential. Learn more about working here at ***************************** or connect with us on Facebook, Instagram and Twitter. Nearest Major Market: Philadelphia

Piramal Pharma Solutions is seeking an experienced Manager, Quality Systems & Compliance to lead and maintain robust quality systems and ensure compliance with global regulatory requirements at our Sellersville site. This role is critical in supporting cGMP and regulatory compliance across manufacturing, testing, warehousing, and distribution operations for pharmaceutical drug products. The successful candidate will ensure quality systems are effectively implemented, aligned with company quality policies, and continuously improved to meet evolving regulatory and business needs. Key Responsibilities Quality Systems Leadership Serve as system administrator for electronic Quality Management Systems (eQMS), including ComplianceWire, TrackWise, Ensur, eBMR, and eForms. Ensure effective use of quality systems to support site compliance and continuous improvement initiatives. Review and approve quality system records, including deviations, CAPAs, change controls, and training records. Training Program Management Oversee all site training activities and ensure compliance with regulatory and internal requirements. Partner with department heads and SMEs to develop, implement, and maintain training curricula. Provide guidance and training to end users on quality systems and processes. Document Control Manage the site SOP program and overall document control lifecycle. Oversee document management activities, including Master Batch Records and protocols. Compliance & Governance Lead Quality System Committees (QSCs) and review boards, including Deviation, CAPA, and Change Control Review Boards. Provide quality system metrics on a weekly, monthly, and quarterly basis. Manage Annual Product Reviews (APRs). Oversee complaint, FAR, and recall management processes. Manage Quality Technical Agreements (QTAs). Audit & Supplier Management Lead the Supplier Management Program. Manage internal, external, client, and regulatory audits. Actively support regulatory inspections and client audits. Data Integrity & Computer Systems Serve as Site Data Integrity Compliance Officer (DICO). Manage the site Data Integrity Program. Oversee the Computer System Validation (CSV) program. Support implementation and upgrades of electronic systems. Continuous Improvement Collaborate with the corporate quality team to implement global policies and procedures. Support site quality improvement initiatives and special projects. Ensure adherence to site safety standards. Perform additional Quality Systems & Compliance activities as assigned. Required Qualifications Education Bachelor's degree or higher in a scientific, quality assurance, or technical discipline. Experience Minimum of 10+ years in a manufacturing environment with QA, Quality Systems, and/or Compliance experience in a cGMP/FDA-regulated industry. At least 5 years in a supervisory or managerial role. Technical & Functional Skills In-depth knowledge of global pharmaceutical regulations (FDA, EMA, PDMA, ANVISA, TGA, DEA). Strong understanding of Quality Management Systems for non-sterile pharmaceutical manufacturing. Hands-on experience with eQMS platforms (DMS, LMS, eBMR). Proven experience in audits, supplier management, and data integrity. Excellent organizational, communication, and cross-functional collaboration skills. Proficient in Microsoft Office and standard business systems. Ability to manage multiple projects and priorities simultaneously.

Job DescriptionSalary: If you need assistance with the application process, please notify IB Abels Human Resources Department. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. About Us IB Abels 110-year history is a testament to its adaptability, forward-thinking leadership, commitment to safety, and stellar service and project delivery process. Our core values Responsible, Integrity, Results-Oriented, Ownership, and Professionalshape everything that we do at all levels of the company and are purposefully incorporated into all company communications, meetings, and strategic planning. Our use of the EOS model (Entrepreneurial Operating System) also provides structure and clarity among all levels of the company to maintain focus on our shared goals. IB Abel (IBA) is committed to providing ample learning and career development opportunities to its team members via our Associate's Program in Project Management, Estimating, and Accounting and our growing Learning Management System. The Opportunity We are seeking an experienced Quality Assurance Manager who is responsible for establishing, implementing, and maintaining the companys Quality Assurance and Quality Control program across all transmission, distribution, substation, and civil construction projects. This role ensures all work is performed to contract requirements, industry standards, and customer specifications. The QA/QC Manager partners closely with Safety, Operations, Project Management, and Field Leadership to drive consistency, reduce rework, promote right-first-time execution, and support a culture of continuous improvement. Key Responsibilities Quality Program Leadership - Develop, implement, and manage the company-wide QA/QC program tailored for utility construction (T&D, substation, and civil); establish quality standards, inspection processes, checklists, and documentation that align with utility customer requirements; and maintain quality manuals, procedures, and work instructions in alignment with industry best practices. Project Support & Field Oversight - Conduct field QA/QC audits, inspections, and work observations to verify compliance with engineered drawings, specifications, construction standards, and work methods; ensure crews understand and apply proper installation practices for poles, structures, conductors, and all related civil work; support project teams in interpreting drawings, standards, and technical requirements; and review and approve ITPs (Inspection & Test Plans), hold points, material submittals, and commissioning documentation. Documentation & Reporting - Maintain accurate QA/QC records, including inspection reports, NCRs (Non-Conformance Reports), corrective actions, testing results, photos, and QA/QC logs; prepare quality reports for leadership and customers, identifying trends, recurring deficiencies, and recommended improvements; and oversee turnover documentation and quality packages for customers. Non-Conformance & Corrective Action - Lead investigations into quality-related issues, rework events, or specification deviations; develop corrective and preventive action plans with field leadership and project teams; and track closure of NCRs to ensure accountability and lessons learned. Training & Continuous Improvement - Deliver training for foremen, line workers, operators, and civil crews on quality standards and proper installation techniques; support onboarding of new field leaders by reinforcing customer-specific construction standards; collaborate with Safety, Operations, and L&D to develop technical guidance, SOPs, and best practices; and lead quality-focused continuous improvement initiatives to reduce defects and rework. Customer & Regulatory Interface - Serve as the QA/QC point of contact for utility clients, inspectors, and third-party engineering firms; coordinate with customer QA reps, attend pre-construction meetings, and support project QC reviews; and ensure compliance with all customer requirements, environmental guidelines, and applicable regulatory standards. Who Were Looking For An acceptable combination of education and/or work experience including 7+ years of experience in electric utility construction (transmission, distribution, or substation) as well as 3+ years in a QA/QC, construction management, or field leadership role. Experience with civil construction related to utility infrastructure (foundations, excavation, concrete, site work). Familiarity with utility standards (e.g., IEEE, NESC, ASTM, utility-specific specifications). Proficient in quality documentation systems such as SiteDocs, Aclaimant, Procore, or similar. Local to Pennsylvania but with regular travel to other offices, customer facilities, jobsites and yard locations for offsite meetings (flexibility to work from home when appropriate). A can-do attitude, strong work ethic, excellent attention to detail, and ability to collaborate effectively with various teams. Why Choose IBA Culture of Growth: Many of our leaders started in entry-level field roles and advanced within the company. Flexibility & Autonomy: We empower our team to succeed without micromanagement. Competitive Compensation & Benefits: Includes competitive salary, vehicle allowance program, 401(k) with company matching, tuition reimbursement, and comprehensive benefits package including medical, dental, and vision. Stability & Variety: Work for multi-generational family-oriented business on diverse, fast-paced projects without the stress of a large corporate structure. Incentives: Performance-based bonuses/incentives and a progressive PTO programs that grows with your tenure! Collaboration: A team environment where we work together to solve challenges and celebrate wins. Step Into a Career That Powers the Future! IB Abel is an equal opportunity employer, all qualified applicants are encouraged to apply.

Step into a pivotal leadership role at Clemens Food Group, where your impact on food safety, people leadership, and product quality will be seen daily. Internally, this role is called a Superintendent, but externally we're seeking an Assistant FSQA Manager-a role often known in other organizations as a Food Safety Manager, Quality Assurance Manager, or FSQA Manager. In this role, you'll lead a team of QA supervisors and technicians in a USDA-regulated meat processing facility, ensuring compliance with HACCP, SSOPs, GMPs, and audit readiness. As the senior-most FSQA authority on second shift, you'll balance hands-on floor leadership with root cause analysis, corrective actions, and continuous improvement projects in one of our largest protein production plants. Shift Details Shift starts at 3:00 PM and runs for 9 hours As a management-level position, flexibility is expected-shifts may start or end an hour earlier or later based on operational needs On-call approximately one out of every four weekends The Impact You'll Make You'll own the shift. Literally. From running handoffs and leading root cause investigations to coaching your team and making critical decisions during audits or equipment failures-this role gives you end-to-end visibility and influence. Your leadership will drive our KPIs around safety, first pass quality, and regulatory compliance. What You'll Do Lead and develop a second-shift FSQA team (multiple supervisors and techs) Be the point of contact for USDA, customer complaints, and urgent investigations Review and act on trend data to improve quality and reduce CPMs Collaborate cross-functionally with Ops, R&D, and Sanitation Manage issue resolution, floor presence, audits, and on-call response (1 in 4 weekends) Prioritize food safety and people leadership at every turn What Makes This Role Exciting? You're the top FSQA decision-maker on your shift Gain experience in a high-capacity, 1.3M sq. ft. protein facility Every day brings new projects, challenges, and growth moments Room to grow-this role is a stepping stone to FSQA Manager What We're Looking For Proven FSQA leadership, meat/poultry/seafood industry required Proven ability to lead teams and manage performance Strong background in USDA, HACCP, audits, and corrective actions Comfortable with ambiguity, fast pace, and solving complex floor issues Skills & Mindset High initiative: confident in making decisions without constant direction Project-focused: can organize chaos into action plans and results People-first: builds trust, holds people accountable, and develops others Strong communicator: connects across functions, listens well, and presents data clearly Your Future at Clemens This isn't just a shift job-it's a career-building leadership role. We'll support your onboarding, help you get grounded in our culture, and give you visibility that sets the stage for broader advancement within FSQA. Application Note: Clemens Food Group is not accepting unsolicited resumes from search or staffing firms. All resumes submitted by search or staffing firms to any employee at Clemens Food Group via email, the Internet, or directly without a valid written search agreement for this role, and without having been asked to participate in this by Talent Acquisition, will be deemed the sole property of Clemens Food Group, and no fee will be paid in the event the candidate is hired. Firms not authorized to submit candidates will not be eligible for any fee or ownership claim. #LG-AG1 Keywords Food Safety, Quality Assurance, Food Safety Supervisor, FSQA Manager, Assistant Food Safety Manager, Meat Processing QA, USDA Compliance, HACCP, SQF, Food Manufacturing, Protein Industry, QA Team Leader, Quality Systems, Food Safety and Sanitation, Second Shift Food Safety, Regulatory Compliance, Food Plant QA, FSQA Superintendent, Assistant QA Manager. #LI-AG1

Please, review and apply for this position through the QCI system following the link below (Copy and Paste): http://jobs.qcitech.com/jobseeker/Clinical_QA_Auditor_J02148106.aspx *You can apply through Indeed using mobile devices with this link. Additional Information

Moravia Health is seeking a qualified candidate for a Quality Assurance Assistant (full time) position. This position at Moravia Health provides an introduction or continuation of professional development in the Home Healthcare field. Job Description Summary: The Quality Assurance Assistant is under the direction of the Quality Assurance Director. QAA will provide assistance with caseload. Responsibilities will include: Staying current with state regulations and industry -related information to ensure 100% compliance with state licensure regulations and Moravia Health policies and procedures. Audit Participant files to ensure quality and compliance. Conducting quality assurance calls with all actively enrolled participants. Review Records in relation to investigation of problems including fraud, complaints, critical incidents, criminal activity, noncompliance with regulations, etc. Provide exceptional internal and external customer service which supports our value of providing high quality home care while meeting the needs of Participants Other duties as assigned.

Established in 2000, A Minority Business Enterprise (MBE), LanceSoft Inc. is a pioneer in providing premium end-to-end Professional IT/Non-IT Contingent Workforce Solutions and IT Services to diverse clients across various domains. Core Service Offerings We offer a gamut of services across diverse domains, categories, skill sets with varying lengths of assignments, that include, but are not just limited to: - Temporary Staffing - Permanent Staffing - Payrolling - Recruitment Process Outsourcing (RPO) - Back-office Services - Application Design and Development - Website Design and Development - Program/Project Management Our Domain Strength With currently over 1000+ staff serving over 49 clients worldwide including “Fortune” companies, LanceSoft serves a wide array of industries including Healthcare/Pharma, Clinical/Medical Devices, Technology, Telecom, Retail and Distribution, Energy & Utilities, Banking, Finance, Insurance, Manufacturing, Automobile, Media, Transportation, and Government Sectors. Geographic Coverage LanceSoft is headquartered in Herndon, Virginia and has a network of branch offices across the US in Chicago (IL), Irving (TX), Basking Ridge (NJ), Atlanta (GA) and San Diego (CA). We also have an International footprint with two country offices in Canada (ON and BC) along with three delivery centers in India- Bangalore, Indore and Hyderabad to further help serve our clients better. We currently operate and recruit in 49 US states catering to diverse Contingent Workforce needs of our clients. Awards and Accolades Following are some of our awards and accolades in the US Contingent Workforce space: - Manpower “Premier Vendor” - 2014 - Kelly's “Supplier Innovation Award” - 2012 - Kelly's “Supplier of the Year” Award - 2012 and 2011 - Kelly's “Service Excellence Award” - 2010 and 2009 - “Stewardship Recognition” from Johnson & Johnson's (J&J) Kelly Work sense program Specialties IT/Non-IT Contingent Workforce Services, Creative Solutions, Temporary/Permanent Staffing, Recruitment Process Outsourcing, Payrolling, Application Design and Development, Back-office Services, Program/Project Management, Website Design and Development Job Description Title: Document Control Specialist-III Location: Horsham- PA PV Controlled Documents is a member of the Training & Document Control Center of Excellence (TDC CoE) group within Compliance Strategy and Analytics and is responsible for development and delivery of Global Medical Organization (GMO), Office of Consumer Medical Safety (OCMS) and Dual-sector medical safety procedural documents. The Senior Associate, PV Documents is responsible for assigned deliverables to promote regulatory compliance with respect to pharmacovigilance. This involves procedural document development on GMO, OCMS, and Dual-Sector Pharmacovigilance (PV) processes and pharmacovigilance-focused regulations. The Senior Associate, PV Controlled Documents identifies and supports improvement activities for a document management department of the highest standards that may be leveraged to support other Client's organizations and sectors as appropriate by actively interacting with Client colleagues. The Senior Associate, PV Documents supports projects that ensures document development requirements are identified and aligned to overall strategic objectives. The Senior Associate, PV Controlled Documents may participate on functional teams for projects in order to support achieving program deliverables. Support the development and delivery of assigned procedural documents by actively partnering with GMO/OCMS functional areas, other partners and Medical Safety Organizations as needed to ensure that desired outcomes and deliverables are met. Support procedural document initiatives and projects of moderate complexity. Facilitates Cross-pharma Reviews and Impact Assessments as needed. Provide Audits and Inspections support and litigation request support. Facilitate Procedural Document Committee meetings. Other duties as assigned. Qualifications The position requires the ability to: · Manage multiple, moderately complex procedural document assignments within timeframes with minimal guidance. · Communicate, both verbal and written, and collaborate effectively and professionally with internal colleagues and external parties · Lead committee meetings and projects/initiatives professionally · Foster consensus and make decisions independently appropriate to subject matter and responsibilities · Experience in procedural document development or quality role for a minimum of 5 years preferably in pharmaceutical industry · Demonstrated experience in Electronic Document Management System(s) · Proficient in Microsoft Word, PowerPoint, Excel, and Visio. · Pharmacovigilance knowledge or experience preferred. · Demonstrated strong Credo values. · Excellent oral and written communication skills, including formal presentation skills. · Commitment to providing excellent customer service. · Ability to work independently and successfully manage multiple priorities simultaneously. · Ability to establish successful working relationships with staff at all levels within the organization during the development of procedures. Additional Information Thanks and Regards Dishant Nagar ************

Here at The Arc Gloucester, we offer the unique opportunity to combine your professional experience with your passion to help individuals with intellectual or development disabilities For 67 years The Arc Gloucester has provided innovative programs and services to individuals with intellectual and developmental disabilities. We have made a difference in the lives of many people and are very proud of that. But it's the individuals we service who bring our programs to life with their creativity, excitement, humor, talent, and so much more! Summary: The Quality Assurance Coordinator audits and assesses programs' performance and compliance to ensure the establishment and continuity of standards of operations that meet or exceed those established by The Arc Gloucester, in compliance with regulatory standards. Position: Full-time (40 hours), exempt. Typical hours are Monday-Friday 9am - 5pm. This position operates primarily in an office setting with travel to locations throughout Gloucester County. This position is supervised by the Managing Director of Compliance. Essential Duties and Responsibilities: Strong focus on the review of program and individual financial ledgers, spendings, SNAP Card usage and inventory Conduct and attend regular meetings with program management to share financial findings on the program and individual level. Training new management on processes and regulations, ensuring compliance with agency financial policies and procedures Performs unannounced quality assurance checks of programs, citing staff shortages, health/safety and facility concerns, as well as speaking with staff about their knowledge of regulations, protocols, etc. Database management (Therap) Supports recruiting, reviewing resumes, screening candidates and scheduling interviews Conducts and completed investigations, confidentiality and reports findings as required Maintains an accurate paper and electronic filing system for audits conducted Communicates program performance and compliance through documented reporting to the respective Residential Manager, Director, and/or Administrator Will be required to travel to agency sites for auditory reviews and assessment Primary department, work location and schedule may vary Maintain confidentiality Comply with the DDD Program Manual, The Arc Gloucester Policies and Procedures Manual and applicable state, local and federal regulations, including any COVID-19 vaccination mandates & policies Must cooperate and participate in reviews, investigations, and inspections, including but not limited to cooperation with the licensee and Department of Human Services staff in any inspection, inquiry or investigation Occasional management responsibilities, including assisting with trainings, planning, workflow, and problem solving Additional responsibilities as required Qualifications: High School Diploma, and must be 18 years of age or older 5+ years experience with supporting individuals with intellectual and developmental disabilities is preferred Knowledgeable of DHS Licensing Standards for Community Residences Strong computer skills, particularly with Microsoft Word, Excel, and Outlook Strong analytical and problem-solving abilities, organizational skills, and attention to detail Excellent verbal and written communication skills Interest and ability for math and financial systems Must be able to communicate effectively and professionally with staff, leadership, families, State and Federal agencies, and most importantly the individuals served Must have a current, non-probationary driver's license with 5 points or less, and deemed acceptable to drive by The Arc Gloucester's liability insurance company, valid in the state of New Jersey Proficient in basic computer, math, reading comprehension and verbal and written communication skills Successfully pass initial and ongoing Federal & State Criminal Background checks, Fingerprinting, Central Registry, Motor Vehicle Record (MVR), Child Abuse Record Information (CARI), Health Screenings, Employment Verifications & References & Drug testing/ All employees must submit to a criminal background check, and be determined to be not disqualified by the Department of Human Services prior to working with individuals served, agree to have their name checked against the Central Registry of Offenders Against Individuals with Developmental Disabilities, shall complete an application to have their name checked against the Child Abuse Registry Information (CARI), shall submit to drug testing conducted randomly and for cause. All employees hired after 6/15/18 shall submit to drug testing prior to employment Certified in CPR/First Aid Successfully complete and demonstrate proficiency in all areas of required training Physical Requirements: While performing the essential functions of this position, the following are required, with or without reasonable accommodation: Ability to sit, drive, stand and walk for extended periods of time Ability to operate a computers, phone and other relevant technology Talk, hear and communicate in person, over the phone and using other technologies Physical duties, including but not limited to carrying, driving, general lifting (at least 25 lbs,), bending, twisting, squatting, and climbing stairs

Job DescriptionDescription: RK Pharma Inc, a vertically integrated pharmaceutical company headquartered in NJ, is seeking an Quality Assurance Associate to work with our growing 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 is located in East Windsor, NJ and is required to be onsite. Requirements: If this sounds interesting to you, it's probably because up to this point you have: Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, or a related technical field. 1-3 years of experience in a pharmaceutical or GMP-regulated environment. Solid understanding of cGMP, GDP, and FDA regulations. Experience with batch record review, deviation handling, and change control processes. Familiarity with document management systems (e.g., MasterControl). Strong attention to detail and accuracy in reviewing technical and regulatory documents. Excellent written and verbal communication skills for cross-functional collaboration. Ability to work independently and manage multiple priorities in a fast-paced environment. The main expectations and responsibilities for this position are: Review batch production and packaging records for accuracy, completeness, and GMP compliance prior to product release. Perform in-process line checks and quality inspections to ensure adherence to SOPs and specifications. Support deviation and change control processes, ensuring timely investigation and documentation. Participate in internal audits, walkthroughs, and inspection readiness activities. Maintain and update controlled documents, including SOPs, MBRs, and validation protocols. Collaborate with Quality Control, Production, and Engineering to resolve quality issues and drive continuous improvement. Ensure all QA activities are properly documented in accordance with GDP and data integrity principles. Support training, risk assessments, and compliance reviews as assigned by QA management. WE ARE SLATING THESE HIRES FOR START DATES IN OCTOBER OF 2026 BUT ARE COLLECTING APPLICATIONS NOW, NEXT STEPS WILL BE SENT TO YOU IN EARLY AUGUST 2026 ONSITE INTERVIEWS WILL BE SCHEDULED IN SEPTEMBER 2026 START DATES IN OCTOBER 2026 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.

Holman is a family-owned, global automotive services organization anchored by our deeply rooted core values and principles that have enabled us to continue Driving What's Right throughout the last century. Our teams deliver the Holman Experience by treating our customers and each other as we would like to be treated, and creating positive, rewarding relationships all around. The automotive markets Holman serves include fleet management and leasing; vehicle fabrication and upfitting; component manufacturing and productivity solutions; powertrain distribution and logistics services; commercial and personal insurance and risk management; and retail automotive sales as one of the largest privately owned dealership groups in the United States. What will you be doing? Intakes, catalogues, and scans Licensing documents, and upload the scans to client Licensing cases Maps inbound Licensing documents to corresponding client cases Engages with clients regarding Licensing documents Outbounds physical Licensing documents to clients Assists and supports team members (e.g., Document Specialist I - Storage) depending on capacity and development goals Monitor and Update Case Progress Create and Manage Ghost Cases Client Outreach and Communication Outbound Registration and Plate Management Administrative Support Perform all other duties and special projects as assigned What are we looking for? High School Diploma or equivalent required, a degree in Business Administration or relevant field preferred. Additional education, certifications, or experience are a plus. Strong problem-solving skills and the ability to handle multiple tasks simultaneously Previous experience in case management, administrative support, or customer service is a plus. Proficient in various desktop tools including MS Office Programs (i.e. Outlook, Excel, Word, PowerPoint, Project, Visio, SharePoint etc.) Ability to work independently and as part of a team Familiarity with office technology and equipment, including computers, fax machines, scanners, printers, phone systems, etc. 2-4 years' experience in case management, administrative support, or customer service related fields Proficiency in a technical or functional area; knowledge of work processes and tools is generally limited to own area of responsibility or department Understanding of accounting principles and bookkeeping software may be required Reviewing and improving processes, methods, and tools to increase efficiency, accuracy, and security #LI-CD1 At Holman, we exist to provide rewarding careers and better lives for employees and their families. We hire, train, empower, and reward exceptional people. Our journey is guided by our desire to get it right every time and the acknowledgement that we have an opportunity to be better. To be better, we have to do better, and to do better we must know better. That's why we are listening, open to learning new things - about ourselves and each other. We will never stop striving for improved diversity, equity, and inclusion because we are successful together when we feel trusted and supported. It's The Holman Way. At Holman, your total compensation goes beyond your paycheck. To position you for success and provide a rewarding career and better life for you and your family, Holman is proud to offer you the benefits you deserve; including protection against illness, disability, loss of work, or preparation for retirement. Below is a brief overview of the programs available to full-time employees (programs may vary by country or worker type): Health Insurance Vision Insurance Dental Insurance Life and Disability Insurance Flexible Spending and Health Savings Accounts Employee Assistance Program 401(k) plan with Company Match Paid Time Off (PTO) Paid Holidays, Bereavement, and Jury Duty Paid Pregnancy/Parental leave Paid Military Leave Tuition Reimbursement Benefits: Regular Full-Time We offer excellent benefits including health, vision, dental, life and disability insurance, and 401(k) with company match. Our time off benefits include Paid Time Off (PTO), paid holidays, bereavement, and jury duty. In addition, we offer paid pregnancy and parental leave, and supplemental paid military leave to eligible employees. Temporary or Part-Time In geographic areas with statutory paid sick leave, part-time and temporary employees will receive a paid sick leave benefit that meets the mandated requirements. Artificial Intelligence Statement To maintain the integrity and authenticity of our hiring process, we kindly request that all candidates refrain from using artificial intelligence (AI) tools to generate, assist with, or enhance any part of their application materials (including resumes, cover letters, written and verbal responses, and images) or during any stage of the interview process. We value genuine, original work that reflects your personal experience, skills, and communication style. As part of our commitment to a fair and transparent evaluation process, please be advised that we may use technology to detect AI-generated content submitted by candidates. Candidates found to have used AI assistance in violation of this policy may be disqualified from consideration. Equal Opportunity Employment and Accommodations: Holman provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. If you are a person with a disability needing assistance with the application process, please contact ************* This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

The Public Housing Finance Consultant partners with Senior Consultants and Managers on client projects and engagements to assist in delivering accounting, audit and management consulting services for Public Housing Agencies client base. Job Duties: Performs outsource accounting function for clients including entering trial balances, making entry adjustments as needed, verifying trial balance amounts, and setting up electronic files to support client Performs detailed account analysis and may rebuild general ledgers and prepare financial reports including balance sheets, income statements and cash flow statements, as needed Interprets and applies knowledge of Public Housing Authority (PHA) Finance standards to guide effective and efficient delivery of quality services and products such as bank reconciliations, audit support workpapers, and board financial reports Provides strong written work products including workpapers that meets the client's requirements and PHA Finance quality standards Regularly interacts with clients to complete general ledgers, account analysis as well as to answer basic client questions and consults with seniors to provide responses to more complex questions Applies principles and knowledge of Generally Accepted Accounting Principles (GAAP) and of Government Accounting Standards Board (GASB) to provide guidance to clients on adherence to requirements in accounting records and financial reporting. Documents and communicates an understanding and application of all professional standards on an engagement to follow required grant reporting and compliance with grant requirements Makes basic constructive suggestions to improve the client's programs and policies, as needed Researches Housing and Urban Development (HUD) accounting and operational guidance and assists clients in making financial and operational decisions based on issued Accounting Briefs and PIH notices published Other duties as required Supervisory Responsibilities: N/A Qualifications, Knowledge, Skills and Abilities: Education: Bachelor's degree with a focus in Accounting or Finance, required Experience: Leadership experience, preferred Accounting based internship, preferred License/Certifications: N/A Software: Proficient in Microsoft Office Suite, specifically Word, Excel and PowerPoint, required Prior experience with various assurance applications and research tools, preferred Language: N/A Other Knowledge, Skills, & Abilities: Strong written and verbal communication skills Ability to follow instructions as directed Ability to work effectively in a team setting Takes appropriate actions without being asked Solid organizational skills especially ability to meet project deadlines with a focus on details Ability to successfully multi-task while working independently or within a group environment Proven ability to work in a deadline-driven environment and handle multiple projects simultaneously Ability to learn general ledger software programs Individual salaries that are offered to a candidate are determined after consideration of numerous factors including but not limited to the candidate's qualifications, experience, skills, and geography. California Range: $85,000 - $90,000 Colorado Range: $73,000 - $77,000 Illinois Range: $78,000 - $82,000 Maryland Range: $83,000 - $87,000 Massachusetts Range: $83,000 - $87,000 Minnesota Range: $70,000 - $74,000 New Jersey Range: $74,000 - $82,000 NYC/Long Island/Westchester Range: $83,000 - $87,000 Washington Range: $78,000 - $80,000 Washington DC Range: $83,000 - $87,000

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Job Requirement • Create and establish a scientific approach to the company quality system. • Perform review and release of API and excipients in support of manufacturing., • Establish training and audit programs, as well as the review of SOPs, investigations, specifications, methods, validation reports, cleaning verification reports, analytical reports and manufacturing records. • Review and approve Master documents such as Master Batch Records, In-process forms, Method Qualification Protocols, Method Validation Protocols, test methods, reference standards and other related documents. • Provides guidance and training for other Quality Assurance staff in the accomplishment of Quality Assurance operation activities. • Act as company's representative during regulatory agencies and customer inspections Qualifications Qualifications • BS degree in Chemistry, Life Science or related discipline and a minimum 1-5 years of QA/validation experience in an FDA regulatory Industry. • Familiar to solid dosage pharmaceutical manufacturing process with thorough understanding in GMP • Strong technical writing skills and the ability to clearly express ideas in English. • Local Candidates preferred. Additional Information 732-429-1858 eayache @ irionline.com http://www.irionline.com

Full-time Description RK Pharma Inc, a vertically integrated pharmaceutical company headquartered in NJ, is seeking an Quality Assurance Associate to work with our growing 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 is located in East Windsor, NJ and is required to be onsite. Requirements If this sounds interesting to you, it's probably because up to this point you have: Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, or a related technical field. 1-3 years of experience in a pharmaceutical or GMP-regulated environment. Solid understanding of cGMP, GDP, and FDA regulations. Experience with batch record review, deviation handling, and change control processes. Familiarity with document management systems (e.g., MasterControl). Strong attention to detail and accuracy in reviewing technical and regulatory documents. Excellent written and verbal communication skills for cross-functional collaboration. Ability to work independently and manage multiple priorities in a fast-paced environment. The main expectations and responsibilities for this position are: Review batch production and packaging records for accuracy, completeness, and GMP compliance prior to product release. Perform in-process line checks and quality inspections to ensure adherence to SOPs and specifications. Support deviation and change control processes, ensuring timely investigation and documentation. Participate in internal audits, walkthroughs, and inspection readiness activities. Maintain and update controlled documents, including SOPs, MBRs, and validation protocols. Collaborate with Quality Control, Production, and Engineering to resolve quality issues and drive continuous improvement. Ensure all QA activities are properly documented in accordance with GDP and data integrity principles. Support training, risk assessments, and compliance reviews as assigned by QA management. WE ARE SLATING THESE HIRES FOR START DATES IN OCTOBER OF 2026 BUT ARE COLLECTING APPLICATIONS NOW, NEXT STEPS WILL BE SENT TO YOU IN EARLY AUGUST 2026 ONSITE INTERVIEWS WILL BE SCHEDULED IN SEPTEMBER 2026 START DATES IN OCTOBER 2026 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 18+

Job Title: QA AssociateJob Description We are seeking a dedicated QA Associate to join our quality assurance team. In this role, you will be responsible for managing and coordinating various quality-related tasks, ensuring compliance with industry standards, and supporting continuous improvement initiatives within our organization. Responsibilities * Coordinate and participate in the investigation of quality deviations and non-conformances, including Deviation, LIR, OOS, and CAPA management. * Assist in implementing Corrective and Preventive Actions (CAPAs) to address root causes and prevent recurrence. * Coordinate change controls by working with the change initiator and evaluating associated risks. * Prepare for and support both internal and external audits, including those conducted by regulatory agencies such as the FDA. * Track and manage quality events within the company's electronic Quality Management System, including change controls, deviations, LIR's, OOS, and product complaints. * Compile, report, and analyze quality metrics to identify trends, compliance risks, and improvement opportunities, presenting findings during biweekly or monthly quality reviews. * Prepare annual product review (APR / APQR) reports. * Participate in the management of the vendor and supplier qualification program. * Communicate with suppliers and vendors for qualification and documents required for regulatory filing. * Support continuous improvement and maintain overall site quality. * Ensure adherence to GMP and good documentation practices. * Comply with all company policies and procedures. Essential Skills * Associates Degree or Bachelors Degree in Chemistry. * 1-2 years of Quality Assurance experience. * Experience on the manufacturing floor, laboratory, wet chemistry, titration, and chromatography. Additional Skills & Qualifications * Technical knowledge in chemistry and wet chemistry. * Proficiency in computer applications and programs related to laboratory applications. * Understanding of mathematics, including statistics. * Knowledge of sample preparation techniques. * Familiarity with spectroscopic techniques and chromatographic systems. * Basic computer knowledge, including MS Excel, Word, and Outlook. Work Environment The position operates within a laboratory setting, typically with a team of around 10 people. The facility is part of a growing CMO with a focus on high performance and cutting-edge developments in a new facility. Job Type & Location This is a Contract to Hire position based out of East Windsor, NJ. Pay and Benefits The pay range for this position is $30.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in East Windsor,NJ. Application Deadline This position is anticipated to close on Jan 26, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Marketing Job Sub Function: Advertising & Promotions Job Category: Professional All Job Posting Locations: Danvers, Massachusetts, United States of America Job Description: We are searching for the best talent for a Technical Documentation Specialist. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech This person will work closely with the IFU Operations team, Product Managers, and project originators across the enterprise to assist in global company growth by providing documentation that serves our customers and meets local, federal and international regulations and guidance. The Technical Documentation Specialist will prepare instructions for use manuals and other supporting documents that communicate complex and technical information to customers. This position has overall responsibility for producing and maintaining IFUs and ensuring the accuracy and visual quality of layouts, graphics, and copy. This position may also work with Regulatory, Advanced Clinical Training & Support, Product Management, Engineering, Quality, and other functions. Key components of the position include: Adheres to brand and style guides Creates new IFUs and updates existing IFUs based on drafts and redlines provided by project originators Creates new graphics as required and stores appropriately in Veeva Vault Creates translated sections of IFUs based on translated copy provided by certified translation vendor Checks quality of own work including copy editing for grammar, punctuation, consistency, clarity, and style as defined by the company guidelines, and incorporates feedback from proofreaders Receives task assignments in Roadmunk tool, dispositioning and updating status to ensure tracking is always up to date Stores and distributes design files and final documents in accordance with operational processes and procedures Prepares documents for printing, including reviewing proofs Drafts and communicates release notes as IFUs are produced or updated Exercises excellent service standards and maintains high customer satisfaction through resolving problems by explaining the best solution, expediting corrections or adjustments to provide resolution Develops knowledge of other roles and responsibilities on the team, and provides support and coverage for other team members as needed Participates in team and project meetings, and contributes to continuous improvement of processes, tools, and workflows as a member of a small but mission-critical team Qualifications: Associate's or Bachelor's degree in graphic design or a related discipline 1-3 years' experience with graphic design and technical document creation in a regulated product development environment Demonstrated strong project management skills and multi-tasking capabilities Strong attention to detail Ability to clearly communicate ideas and information (oral and written) and work collaboratively. Ability to adopt new tools and technologies Adobe InDesign experience required Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is 79,000 to 127,650. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401k).This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year. Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year. Holiday pay, including Floating Holidays - up to 13 days per calendar year. Work, Personal and Family Time - up to 40 hours per calendar year. For additional general information on Company benefits, please go to: - ********************************************* This job posting is anticipated to close on January 11, 2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. Required Skills: Preferred Skills: Advertising, Analytical Reasoning, Brand Identity, Brand Positioning Strategy, Brand Recognition, Business Behavior, Communication, Content Marketing, Customer Intelligence, Data Analysis, Data Reporting, Design Mindset, Execution Focus, Financial Analysis, Integrated Media Planning, Leverages Information, Marketing Campaign Management, Organizing, Problem Solving, Researching, Sales Promotions

Delta Mission and Values Delta's Mission: To enrich the lives of individuals and families through outstanding community-based support and mutually rewarding relationships. Values: Customer Focus, Performance Excellence, Learning and Growth Position Summary The Quality Assurance Coordinator is responsible for monitoring the systematic operations of the residential and vocational programs. This person will serve as a liaison between the local office and the national office. This person will be held accountable for ensuring the appropriate implementation of policies and procedures and ensuring programs are completely in compliance with state rules, regulations and agency policies. Reports to: The Director of Quality Assurance Principal Duties and Responsibilities To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The duties listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Schedule and conduct Quality Assurance audits of individual financial records and personnel files to include training records, medication administration records, medical records. Conduct comprehensive record reviews. Conduct physical site inspections of homes and program locations. Submit a quarterly report card to the Quality Assurance Director and Regional/State Director. Conduct a 30-day initial audit of all new homes and programs. Audit individuals' in-house accounts to verify that required documentation is maintained, accounts are monitored by the designated staff and balances are correct Communicate findings of audits to the State Director, RegionalDirector and Quality Assurance Director. Recommends any necessary changes in current policy and procedures. Conduct staff training as needed. Complete required training to become a Certified Investigator. Conduct investigations as required. Maintain a master file of all audit findings. Cooperate with the Department of Human Services staff in any investigation or inspection. Cooperate with all internal or external audits or investigations as a condition of continued employment. Maximize the development and capacity of staff to advance the mission and values of Delta. Ensure the full capacity of programmatic resources. Promote and demonstrate ethical and professional conduct at all times ensuring employees conduct. themselves in an ethical and professional manner. Promote continuous quality improvement projects and ongoing performance measures. Promote and address Delta's Risk Management Program for the health and safety of individuals and employees. Perform other duties as assigned. Qualifications Requirements Ability to form collaborative working relationships with diverse populations, including working with individuals of diverse cultures, ethnicities, gender, age, sexual orientation, socioeconomic status, religion, education background, etc. Ability to develop knowledge of, respect for, and skills to engage with those of other cultures or backgrounds. Demonstrated commitment to diversity, equity and inclusion. Aptitude for balancing multiple priorities with strong organization, time management and prioritization skills. Ability to self-direct, self-pace, multi-task and function well under the pressure of deadlines and conflicting priorities. Ability to work effectively with people, facilitating their growth and development. Ability to use acquired knowledge of supervisory and administrative principles and methods. Ability to read, write and speak English and communicate effectively with all constituencies of a diverse community; perform arithmetic calculations. Ability to use telephone, voice mail, copier, facsimile machine, calculator, computer and other office equipment. Fully proficient in Microsoft Office, software applications and the ability to learn new and emerging technologies. Ability to operate vehicles with a valid driver's license in accordance with applicable state laws, insurance provider requirements and company policies and procedures. Position Qualifications Bachelor's degree from an accredited college or university. Associates degree or sixty (60) credit hours from an accredited university or college and four (4) years' experience working with persons with intellectual disabilities may be substituted for Bachelor's degree. Two (2) years' work experience working directly with persons with intellectual disabilities Two (2) years' work experience using electronic health records and database management. Valid driver's license in the state of residence with a satisfactory driving record. Commitment to and knowledge of community-based support for persons with disabilities Working knowledge of management of an effective Quality assurance program Ability to present facts and recommendations effectively in oral and written form Independent judgment is required to plan, prioritize, and organize diversified workload Knowledge and understanding of local regulatory agency operations

Proven is an interactive design and development consultancy that blends creative vision with technical expertise to craft digital experiences that matter. We partner with non-profits and mission-driven organizations, leveraging our design, engineering, and strategic capabilities to drive meaningful impact. We're looking for a full-time Quality Assurance Associate to serve as the primary owner for quality assurance across our projects. In this role, you will design and execute test strategies and plans for web applications, working within an Agile framework and collaborating closely with project managers, developers, and clients. You will help ensure that every release meets both functional requirements and Proven's high quality standards. Key Responsibilities Lead and track all QA activities across assigned projects. Create, execute, and maintain test plans and test cases based on user stories, acceptance criteria, and requirements. Perform functional, system, integration, regression, and performance testing to ensure consistency and reliability across environments and systems. Identify, prepare, and manage test data for manual and (when applicable) automated testing. Collaborate with clients and internal teams to define, refine, and validate user acceptance criteria. Validate all tickets resolved by the development team prior to release, ensuring they meet requirements and are production-ready. Automate regression test scripts where appropriate and help evolve our automated testing coverage and standards. Identify, document, and prioritize defects; track them through resolution. Proactively surface risks, dependencies, and quality concerns to the project manager and team. Contribute to improving QA processes, tools, and documentation over time. Qualifications and Experience You are hyper-organized, detail-oriented, and comfortable independently owning your work to ensure quality and client satisfaction. 3+ years of experience working in a QA or testing role at a technology company, digital agency, or similar environment. Experience working as a tester on technical projects within an Agile software development lifecycle. Hands-on experience with several of the following: Functional and regression testing System and integration testing Performance, load, and speed testing User acceptance testing (UAT) Working knowledge of modern web development technology stacks (e.g., common front-end frameworks, APIs, CMS platforms) and how they impact testing. Strong analytical and problem-solving skills; you can not only find bugs, but also help the team understand impact and potential root causes. Excellent written and verbal communication skills; you're comfortable collaborating with cross-functional teams and interacting with senior stakeholders. Experience working remotely with distributed teams. Bachelor's degree in engineering, computer science, or a related field, or equivalent relevant experience. Why Join Proven? Mission-Driven Work: Help organizations that make a real impact in the world. Collaborative Culture: Work alongside talented designers, strategists, and engineers. Growth Opportunities: Shape the future of Proven's technology team and strategy. Remote Flexibility: Work from anywhere while leading a distributed team.

Who you are: Knowledge of Quality Assurance/Quality control/Operations in a regulated environment Familiar with lab equipment operation and set-up. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports and procedures. Ability to successfully present information and respond to questions from groups of managers, clients, customers, and the public. Great Teammate and good social skills Must be able to interface effectively with all levels of the company employees How you will thrive and create an impact Issuance of controlled manufacturing and testing documents to Manufacturing and Quality Control as per the production schedule. Issuance of controlled labels used for labelling finished goods and other related samples. Monitor the equipment program including calibration and preventative maintenance timelines and complete quality assurance sign-off for equipment workorders. Issuance and reconciliation of equipment and room logbooks. Coordinate the release of raw materials after completion of review and approval of supporting documentation including supplier and quality control testing records. Conduct reconciliation, filing and archiving of all quality-controlled records. Store completed documents in the appropriate data files and coordinate off-site document storage with third party as necessary. May provide pre-run line clearance to manufacturing. Consult with document originators to resolve discrepancies. Work closely with internal departments to assure commitment to customer is met in a timely manner. Management of Label Program. Includes development of master labels, maintain controlled label stock, setting inventory safety stocks, printer supplies, and coordinating reorders. May provide batch record review support. Writing and revising SOPs as part of process improvement initiatives or as needed to support the department. Coordination of document control activities and delegating with other quality coordinators to drive workload completion at the direction of quality management. Actively participate and drive the quality and safety culture of the site. Performs other duties as assigned Environment Typically works in an office environment with adequate lighting and ventilation and a normal range oftemperature and noise level. May also work in warehouse setting with appropriate protective wear if performing pre-fill, in-process, and final inspections on product. Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems. A frequent volume of work and deadlines impose strain on routine basis. Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.

Our client is a medical device company dedicated to offering innovative solutions for treatment of chronic heart failure. The Company's developments are based on its proprietary technology for administrating Cardiac Contractility Modulation therapy. Job Description Write and review of SOPs and other quality assiuance related technical data forms and quality documents proper maintenance of control documents in Quality Assurance Control documents to differents departments Review validation protocols for GMP compliance Assist in carrying out internal quality audits on company systems and documentations perform investigations on non-conformances and customer complaint close out and corrective actions Audit on-going vendors, systems and documents to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines Provide GCP/ QA support and avdvice to internal and external clients Ensure the timely and effective follow up to all identified or assigned quality issues Maintains and demonstrates understanding of global standards, regulation and regulatory bodies to include but not limited to ISO13485, 21FR; part 820 AIMD Assist in the maintenance ogf Quality Management System under direction of Director, Quality Assurance Participate in Mock inspections for FDA inspection preparation Qualifications Ability to work independently with little or no supervision Exeptional oral and written communication capabilities Advance computer knowledge in MS Office programs Bachelors's Dregree in related field 4-6 years related experience Experience working in regulated environment with medical devices Experience with FDA inspections and /or Notified Bodies Audits desirable Additional Information All your information will be kept confidential according to EEO guidelines.