Quality assurance specialist jobs in Bensalem, PA

Duration: 6 Months Contract We are seeking a Data Exchange Quality Readiness Lead to drive enterprise-level quality governance, data integrity, and release readiness across complex data exchange platforms. This role is responsible for aligning programs, validating end-to-end data flows, ensuring high-quality releases, and enabling operational readiness through governance, testing leadership, and data lineage insights. The ideal candidate brings deep expertise in quality strategy, data systems, cross-functional collaboration, and analytical problem solving. Key Responsibilities Program Alignment & Quality Governance Establish quality governance practices aligned with strategic initiatives and ART delivery models. Partner with ART teams to connect Epics, Product Increments, and scope items. Ensure traceability between acceptance criteria and test plans to guarantee full coverage. Document and enforce Definition of Done across teams. Provide oversight for strategic initiatives including GDE, Workday Wellness, EE Navigator, and OBF integrations (CMC, Event Hub, ADP APIs). Testing Strategy & Execution Define testing strategy across DevQA, Production Simulation, and Production environments. Establish best practices for end-to-end system validation. Ensure release readiness by enforcing quality gates and exit criteria. Champion a quality-first and defect-prevention culture. Data Quality & Lineage Perform hands-on data analysis of inbound source files (Workday, EE Navigator, ADP). Trace processing through Group Data Exchange (GDE) and Group Data Hub (GDH). Validate outbound data flows through routers, APIs, and file processors. Maintain complete data lineage documentation for transparency and auditing. Known Issues & Release Transparency Maintain and publish Known Issues Logs for each release. Track accepted defects and known data differences across GDE, ENE, LADE, and Fineos. Ensure stakeholders have clear visibility into risks before production releases. Training & Enablement Develop operational training materials and business-ready documentation. Enable ITSM, business operations, and configurators with guides and release notes. Drive knowledge transfer to accelerate adoption and reduce production issues. GenAI-Driven Quality Insights Design AI-enabled solutions for automated data profiling and anomaly detection. Leverage GenAI tools (e.g., ChatGPT) for reporting automation and quality insights. Convert outputs into easy-to-understand business communications. Reporting & Intelligence Build release dashboards and quality health reports. Provide predictive insights using GenAI and trend analysis. Deliver executive-ready summaries with recommendations. Collaboration & Stakeholder Engagement Work closely with: Product Managers RTE / STE Quality Engineering & Systems Teams Data Exchange Teams ITSM and Business Operations Required Qualifications Bachelor's degree in Computer Science, Information Systems, Business, or related field. 7+ years of experience in: Quality Engineering Data Systems Release Readiness Governance or QA Leadership Strong understanding of: Data pipelines and ETL flows API integrations Enterprise data platforms Experience with Agile / SAFe / ART frameworks. Proficient in test strategy development and execution. Strong analytical, documentation, and communication skills. Ability to convert technical findings into business-level insights. Comfortable working with senior leadership and cross-functional teams.

JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

The primary responsibilities include data collection and presentation for regulatory compliance, assistance with site visit preparation for United Network of Organ Sharing (UNOS), Centers for Medicaid and Medicare Services (CMS), and the Joint commission (TJC), and creating action plans through to completion with the Transplant clinical and operational teams. This position works with the Transplant Director of Quality and partners with TUH's Performance Excellence Department and the Department of Regulatory Affairs. Directly responsible for action plans and performance improvement projects to maintain regulatory compliance. Provides training on regulatory requirements and defines Transplant measures of success. Provides input on the performance of transplant team members regarding timeliness and accuracy of data reporting and documentation within regulatory compliance. Education Master's Degree Health care discipline, informatics or related field of study Required Other Graduate certificate in Healthcare Quality and Safety or equivalent Preferred Experience 3 years experience in Transplant and/or Healthcare Quality or Regulatory Required General Experience General knowledge of CMS, TJC and UNOS regulations Required Schedule: Monday - Friday Day Shifts, no on-call, no weekends Our Hospital/Organization Descriptions Your Tomorrow is Here! Temple University Hospital is a nationally respected teaching hospital on Temple University's bustling Health Sciences Center campus. The hospital provides a comprehensive array of healthcare services both basic and complex to patients from around the corner, across the country and around the world. As the chief clinical training site for the Lewis Katz School of Medicine at Temple University, the hospital provides a dynamic environment for high-quality care, teaching, and cutting edge research. Health System Descriptions Your Tomorrow is Here! Temple Health is a dynamic network of outstanding hospitals, specialty centers, and physician practices that is advancing the fight against disease, pushing the boundaries of medical science, and educating future healthcare professionals. Temple Health consists of Temple University Hospital (TUH), Fox Chase Cancer Center, TUH-Jeanes Campus, TUH-Episcopal Campus, TUH-Northeastern Campus, Temple Physicians, Inc., and Temple Transport Team. Temple Health is proudly affiliated with the Lewis Katz School of Medicine at Temple University. To support this mission, Temple Health is continuously recruiting top talent to join its diverse, 10,000 strong workforce that fosters a healthy, safe and productive environment for its patients, visitors, students and colleagues alike. At Temple Health, your tomorrow is here! Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Schedule: 6pm to 6am (Overnight) (Will cover onsite interview and relocation cost) Key Responsibilities As the Quality Supervisor, you will oversee and manage a team of Quality Technicians to ensure our products meet the highest standards of quality, food safety, and regulatory compliance. Responsibilities include: 1. Interim Management of Quality Technicians Lead and manage the Quality Technician team to ensure product conformity with customer, company, and regulatory standards Oversee work schedules, timecard approvals, job assignments, training, and time-off requests 2. Internal Audits & Corrective Actions Participate in internal audits to identify areas of non-conformance Lead implementation of corrective actions and ensure timely resolution Track, document, and maintain records for compliance 3. Food Safety & Quality Issue Management Take prompt action to resolve food safety and quality issues Coordinate and support food safety and quality training for plant personnel Oversee the collection and submission of product samples for quality testing Ensure accurate documentation of test results and sample status 5. Quality Improvement Activities Lead initiatives to improve product quality and reliability Collaborate with production shift leaders to ensure quality and consistency Conduct root-cause analysis for product holds or customer complaints and implement corrective actions to prevent recurrence 6. Compliance Reporting Maintain detailed and organized quality control records Prepare and submit reports related to food safety, quality issues, corrective actions, and ongoing improvement initiatives Requirements Proven experience in Quality Control or Quality Assurance, ideally within food manufacturing or another regulated environment Better Process Control Aseptic Certification (preferred, not required) Strong problem-solving abilities, particularly in food safety and quality-control-related issues Experience conducting audits and implementing corrective actions Familiarity with compliance reporting and quality improvement processes

12-month contract Hybrid in Princeton, NJ - onsite on Wednesday Responsibilities: Shadow and support quality oversight activities for 10+ ongoing clinical studies (from planning to reporting stages), ensuring best practices are identified and followed. Partner and communicate with Clinical Managers (CMs) and Functional Area (FA) stakeholders to provide cross-functional team support and attend project/study-level meetings. With guidance from senior GCP auditors, consult on and escalate major/critical quality issues, serious breaches, data integrity concerns, and protocol deviations to senior management. Conduct periodic resolution checks and follow-ups on quality issues for assigned studies. Contribute to risk assessments and development of the annual GQM Audit Plan by recommending the number and type of site/vendor audits based on study risk. Gather and provide study-related documentation and insights to the audit team and GCP Level 2 auditors in preparation for audits. Participate in the risk evaluation of preferred and active vendors to support the annual GQM Vendor Audit Plan. Support CAPA (Corrective and Preventive Action) reviews stemming from quality issues, audits, inspections, and eTMF (electronic Trial Master File) assessments. Engage in weekly, monthly, and quarterly GQM GCP team meetings, as well as QA:QA and Quality Council meetings alongside senior audit team members. Assist in the review and harmonization of controlled documents including protocols, informed consent forms (ICFs), clinical study reports (CSRs), amendments, SOPs, and templates. Participate in ongoing GCP training, including ICH E6 R3 guidelines, 21 CFR modules, and team-led educational sessions. Provide support across portfolio-wide inspection readiness activities (sponsor, site, CRO), including delivery of Do & Don't training, interview preparation, debriefs, and findings analysis. Review and assess the Pharmacovigilance System Master File (PSMF) and conduct PV-related quality activities as assigned. Qualifications: Bachelor's degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related field. 1-2 years of experience in clinical research, clinical quality assurance, or GxP-related functions preferred. Familiarity with GCP guidelines (ICH E6) and FDA 21 CFR Part 11 and 312 regulations. Strong organizational and communication skills with the ability to work cross-functionally. Analytical mindset with the ability to identify and assess quality risks. Demonstrated ability to learn in a fast-paced, collaborative environment. Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook). Previous exposure to TMF systems, CAPA processes, or audit support is a plus. Interest in building a career in clinical quality, auditing, or compliance.

If you need assistance with the application process, please notify IB Abel's Human Resources Department. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. About Us IB Abel's 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 Professional-shape 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 company's 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 We're 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.

Title: Quality Assurance Compliance Technical Specialist Department: Quality Assurance Job Type: Regular Full Time Shift: Monday through Friday - 1st NMS Labs has developed an extensive menu of more than 2,500 Clinical and Forensic toxicology tests to support clients in healthcare, public health, and public safety fields. For over 50 years, our clients have relied on NMS Labs for unique testing solutions that demonstrate our company core values of Quality, Integrity, Service, Innovation and Engagement. As we work to increase the company's positive impact on the diverse markets we serve, we are seeking talented professionals to join us for the journey! We invite you to learn more about our company by visiting NMSLabs.com. Job Summary: Under limited supervision, the Quality Assurance Compliance Technical Specialist will assist in monitoring regulated work conducted at NMS Labs for compliance with study protocols, internal processes, procedures, company contracts, company quality standards, and company-controlled documents. This Quality Assurance Compliance Specialist will report directly to the Quality Assurance Compliance Supervisor and will be completely independent of any laboratory operations. Requirements: * Bachelor's degree in a chemical, physical or biological science with a minimum of 3+ years diverse laboratory experience * Or * Master's degree in chemistry, physical or biological science with 1-year diverse laboratory experience * 3 years' experience in QA auditing involvement. Preferred: * Experience with leading a project. Major Duties and Responsibilities: * Participate in activities designed to assure regulatory compliance with licensing/accrediting agencies such as personnel licenses (tracking and submission to agency), external proficiencies (tracking, data submission, data entry for grading), and/or document control within the compliance software. * Perform scheduled internal audits at a frequency to assure compliance with applicable processes and procedures. * Observe work practices and report any deviations from protocol, method, SOP, or regulations. Notify Supervisor and appropriate personnel of the audit findings by documenting the scope of audit and findings in a written report. * Perform follow-up audits as necessary to verify that appropriate corrective action has been completed. * Participates in Continuous Quality Improvement efforts. * Approved to be a lead auditor in the NMS Labs Internal Audit Program. Writes reports of audit findings and makes recommendations to technical staff on corrective actions for findings. * Participate in updates to the audit matrix and/or design and scheduling of internal audits. * Reviews proficiency data prior to submission. * Reviews and grades proficiency survey results and issues reports for management review. * Assist project managers and testing supervisors (as needed) in setup and continuation of laboratory procedures in compliance with established laboratory processes and procedures. * Attend professional meetings and/or conferences on QA activities and relay information gained to the QA group. * Remains current in compliance trends for those areas of responsibility. * Participates/presents in laboratory continuing education program as needed. * Ensure that pertinent information is entered into and maintained in the appropriate QA files. * Assists QA Regulatory with external audits/inspections, as applicable. * Other duties as assigned. Knowledge, Skills, and Abilities: * Ability to define and resolve problems, collect data, establish facts, and draw valid conclusions. * Ability to read and audit complex technical data and procedures to determine compliance with established processes and procedures. * Ability to make effective and persuasive speeches and presentations to peers and management for the purpose of effecting changes necessary for regulatory compliance. * Ability to identify operationally efficient strategies to adhere to quality compliance requirements. * Ability to effectively present information and respond to questions from all co-workers. * Ability to effectively prioritize assignments to meet long and short-term deadlines. * Strong organization, documentation skills, attention to detail, and able to prioritize assignments to meet deadlines. * Possess good computer skills (to include Excel and Word) and internet usage. * Ability to travel, including out of state. * Maintains regular and reliable attendance. Physical Demands: * Ability to talk, hear, stand, reach with hands and arms, and use hands and fingers to manipulate computer keyboard, objects, tools, or controls. Specific vision abilities (with correction) include close and distance vision. * Walking and carrying objects from one work location to another and sitting and standing sometimes for periods of time. Offers of employment are made contingent upon a nationwide background investigation and urine drug screen with results satisfactory to standards of employment at NMS. We are an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, creed, sexual orientation, color, religion, sex, national origin, age, marital status, citizenship status, otherwise qualified disability, or protected veteran status (disabled Armed Forces Service medal, recently separated, active duty or campaign badge), domestic violence victim status, arrest record, or predisposing genetic characteristics.

Full-time Description The Quality Assurance Coordinator will perform under the supervision of the Quality Assurance Manager, and at times will take instruction and tasks from the Center Manager and Director of Quality Assurance. The Quality Assurance Coordinator will ensure product integrity, and the continued good health of donors through the compliance with Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company and any other applicable regulatory standards Essential Duties and Responsibilities (the following list is intended to be a guideline. Other duties and responsibilities may be assigned): Organize product in storage freezer, ensuring freezer organization is complete and consistent Perform the QA review of product to be shipped to the consignee Set up, operate, and maintain instruments used for manipulating, monitoring, and storing plasma products (Quality Control), supply management and determining when to release in FIFO process Maintain instruments/equipment used for processing and/or qualifying and storage of donor samples and products. This includes ensuring the instruments/equipment is functioning/cleaned properly Document operational and maintenance activities when necessary Assists Quality Assurance Manager in ensuring all center operations, product storage, documentation, facility maintenance, quality control, and training are current and consistent with the Company's Standard Operating Procedures Manual (the “SOP”), current State and Federal guidelines, OSHA, CLIA, cGMP, and any other internal Company procedures Oversees and performs destruction of unsuitable units. Quarantine and discard unacceptable samples and products Oversees release and shipment of biohazardous waste Performs internal audits and quality checks on-site Assists Quality Assurance Manager and Center Manager with employee training and counseling as needed Oversees receipt of center inventory, including donation softgood supplies and QC reagents Oversees management of lot-controlled supplies, ensuring appropriate use and appropriate storage of supplies per SOP. Ensures supplies are used on a first in, first out basis. QA Approves and releases new supply lots as needed and ensures availability of supplies at the center Oversee the daily management of samples to the testing lab. Responsible to pack and ship samples to the testing lab Assists in the performance of final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications, and ensures the integrity and quality of the product shipped Assists in shipment of product from the center. Completes and reviews shipment paperwork required for each product shipment Reports to the Quality Manager any deviations or quality concerns observed at the center Assists with qualifying and reviewing equipment Available to travel up to 25 miles to other facility(ies) for training or assisting other center's staffing needs Other duties, as assigned Requirements Education: High School Diploma, required; Associate's or Bachelor's degree, preferred in Management, Business, Nursing, Finance, or science related field Skills and Qualifications: Excellent verbal and written communication skills. Excellent interpersonal and customer service skills. Excellent organizational skills and attention to detail. Consultation. Ethical Practice. Cultural Awareness. Business Acumen. Relationship Management. Strong computer skills; Familiarity with Microsoft Office applications. Physical Requirements: Read computer screens, procedure manuals and other documents Hear doorbells, alarms, telephone, and other mechanical devices Work confidently while being observed during frequent quality inspections Work in walk in - Subzero freezer(s) Ability to lift, pull, tug up to 50 pounds to stock supplies and/or move or support donors Regularly required to use hands and fingers, to handle & feel objects, tools and controls; reach with hands and arms. Vision abilities required by this job, including close vision. Required to stand for extended intervals, walk, climb and balance; stoop, kneel and crouch. Physical ability to operate equipment used that may require repetitive motion and manual dexterity. Ability to read while standing or sitting in front of a computer for extended periods of time (2-3 hours). Must wear personal protective equipment (PPE) required such as eyewear, lab coats, and gloves B Positive Plasma Offers: Competitive Wages Flexible scheduling Positive Work Environment Paid training opportunities Comprehensive Medical and Dental Benefits Paid Time Off 401(K)

Title: Quality Assurance Compliance Technical Specialist Department: Quality Assurance Job Type: Regular Full Time Shift: Monday through Friday - 1st NMS Labs has developed an extensive menu of more than 2,500 Clinical and Forensic toxicology tests to support clients in healthcare, public health, and public safety fields. For over 50 years, our clients have relied on NMS Labs for unique testing solutions that demonstrate our company core values of Quality, Integrity, Service, Innovation and Engagement. As we work to increase the company's positive impact on the diverse markets we serve, we are seeking talented professionals to join us for the journey! We invite you to learn more about our company by visiting NMSLabs.com. Job Summary: Under limited supervision, the Quality Assurance Compliance Technical Specialist will assist in monitoring regulated work conducted at NMS Labs for compliance with study protocols, internal processes, procedures, company contracts, company quality standards, and company-controlled documents. This Quality Assurance Compliance Specialist will report directly to the Quality Assurance Compliance Supervisor and will be completely independent of any laboratory operations. Requirements: Bachelor's degree in a chemical, physical or biological science with a minimum of 3+ years diverse laboratory experience Or Master's degree in chemistry, physical or biological science with 1-year diverse laboratory experience 3 years' experience in QA auditing involvement. Preferred: Experience with leading a project. Major Duties and Responsibilities: Participate in activities designed to assure regulatory compliance with licensing/accrediting agencies such as personnel licenses (tracking and submission to agency), external proficiencies (tracking, data submission, data entry for grading), and/or document control within the compliance software. Perform scheduled internal audits at a frequency to assure compliance with applicable processes and procedures. Observe work practices and report any deviations from protocol, method, SOP, or regulations. Notify Supervisor and appropriate personnel of the audit findings by documenting the scope of audit and findings in a written report. Perform follow-up audits as necessary to verify that appropriate corrective action has been completed. Participates in Continuous Quality Improvement efforts. Approved to be a lead auditor in the NMS Labs Internal Audit Program. Writes reports of audit findings and makes recommendations to technical staff on corrective actions for findings. Participate in updates to the audit matrix and/or design and scheduling of internal audits. Reviews proficiency data prior to submission. Reviews and grades proficiency survey results and issues reports for management review. Assist project managers and testing supervisors (as needed) in setup and continuation of laboratory procedures in compliance with established laboratory processes and procedures. Attend professional meetings and/or conferences on QA activities and relay information gained to the QA group. Remains current in compliance trends for those areas of responsibility. Participates/presents in laboratory continuing education program as needed. Ensure that pertinent information is entered into and maintained in the appropriate QA files. Assists QA Regulatory with external audits/inspections, as applicable. Other duties as assigned. Knowledge, Skills, and Abilities: Ability to define and resolve problems, collect data, establish facts, and draw valid conclusions. Ability to read and audit complex technical data and procedures to determine compliance with established processes and procedures. Ability to make effective and persuasive speeches and presentations to peers and management for the purpose of effecting changes necessary for regulatory compliance. Ability to identify operationally efficient strategies to adhere to quality compliance requirements. Ability to effectively present information and respond to questions from all co-workers. Ability to effectively prioritize assignments to meet long and short-term deadlines. Strong organization, documentation skills, attention to detail, and able to prioritize assignments to meet deadlines. Possess good computer skills (to include Excel and Word) and internet usage. Ability to travel, including out of state. Maintains regular and reliable attendance. Physical Demands: Ability to talk, hear, stand, reach with hands and arms, and use hands and fingers to manipulate computer keyboard, objects, tools, or controls. Specific vision abilities (with correction) include close and distance vision. Walking and carrying objects from one work location to another and sitting and standing sometimes for periods of time. Offers of employment are made contingent upon a nationwide background investigation and urine drug screen with results satisfactory to standards of employment at NMS. We are an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, creed, sexual orientation, color, religion, sex, national origin, age, marital status, citizenship status, otherwise qualified disability, or protected veteran status (disabled Armed Forces Service medal, recently separated, active duty or campaign badge), domestic violence victim status, arrest record, or predisposing genetic characteristics.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description The Laboratory Quality Assurance (QA) Coordinator is responsible for ensuring that DPT's quality system is well-documented, traceable, and compliant. This role focuses specifically on regulatory readiness documentation and inspection support. Role is critical in tracking, organizing, and executing the administrative an procedural backbone of the laboratories' quality program.. This position ensures compliance with federal, state, and local regulations (e.g., CLIA, CAP, ISO, FDA) and drives continuous quality improvement initiatives. The QA Coordinator develops and maintains policies, conducts audits, manages documentation, and trains staff on quality procedures. Key Responsibilities: Quality Management System (QMS) Oversight: Develops, implements, and maintains the laboratory's comprehensive quality management system, including the Quality Manual, policies, and procedures. Regulatory Compliance: Monitor and ensure continuous compliance with all applicable accreditation and regulatory standards (e.g., CAP, CLIA, ISO 15189, GxP, FDA). Audits and Inspections: Coordinate and participate in internal and external audits/inspections, manage the response to findings, and implement corrective and preventive actions (CAPAs). Assist in preparing audit schedules and checklists. Track corrective actions and verify closures. Organize and maintain documentation needed for audits and inspections. Assist in preparing materials and responses for regulatory and accrediting inspections and client audits. Documentation and Record Control: Oversees the documentation control system.. Logs and tracks nonconformances, deviations and incident reports. Ensures completeness and accuracy of quality records. Change Management Support: Log and monitor change requests. Track approval workflows and implementation timelines. Assist in collecting / reminding of required objective evidence for activity / file closure. Ensure related documentation is complete before closure. Training and Education: Develop and conduct training sessions for staff on quality standards, new procedures, and best practices to promote a quality culture. Send reminders for upcoming and overdue training, as applicable. Event and Risk Management: Assist in investigation of non-conformances, errors, and incidents; perform root cause analysis; and determine corrective actions to mitigate future risks. Ensure timeliness of all activities to meet regulatory expectations. Develop tools to assist with tracking activities / actions. Communication and Coordination: Schedule QA Meetings and take meeting minutes. Communicate deadlines, updates and quality-related notifications. Serve as liaison between QA and other departments. Supplier Qualification Program: Develop schedule to ensure Approved Supplier List (ASL) is kept up-to-date. Ensure qualification / re-qualification documentation is current and filed appropriately. Participate in vendor-related SCAR issuance, receipt of responses and assuring documentation meets DPT's requirements. Qualifications Required Qualifications and Skills: Education: Bachelor's degree, preferably in a chemical, physical, biological science, or Medical Laboratory Science (MLS/MT) from an accredited institution. Experience: Minimum of 5-7 years of experience in a clinical or analytical laboratory environment, with demonstrated experience in quality assurance or quality control. Knowledge: Strong knowledge of quality management systems (e.g., ISO, CLIA, CAP) and relevant federal/state regulations. Skills: Excellent attention to detail and strong organizational skills. Strong analytical and problem-solving abilities, with an aptitude for data interpretation and statistical analysis. Excellent written and verbal communication skills, with the ability to effectively communicate with diverse staff and management. Proficiency with laboratory information management systems (LIMS) and Microsoft Office Suite. Ability to work both independently and collaboratively in a fast-paced environment. Preferred Qualifications: Certification in quality management (e.g., Certified Quality Auditor (CQA) or Six Sigma certification). Experience with specific laboratory certifications/standards relevant to the lab's specialty (e.g., ASHI, CAP, CLIA,) Additional Information Schedule: Monday - Friday 8:00am-4:30pm What we offer: Excellent full time benefits including comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holidays Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description The Laboratory Quality Assurance (QA) Coordinator is responsible for ensuring that DPT's quality system is well-documented, traceable, and compliant. This role focuses specifically on regulatory readiness documentation and inspection support. Role is critical in tracking, organizing, and executing the administrative an procedural backbone of the laboratories' quality program.. This position ensures compliance with federal, state, and local regulations (e.g., CLIA, CAP, ISO, FDA) and drives continuous quality improvement initiatives. The QA Coordinator develops and maintains policies, conducts audits, manages documentation, and trains staff on quality procedures. Key Responsibilities: Quality Management System (QMS) Oversight: Develops, implements, and maintains the laboratory's comprehensive quality management system, including the Quality Manual, policies, and procedures. Regulatory Compliance: Monitor and ensure continuous compliance with all applicable accreditation and regulatory standards (e.g., CAP, CLIA, ISO 15189, GxP, FDA). Audits and Inspections: Coordinate and participate in internal and external audits/inspections, manage the response to findings, and implement corrective and preventive actions (CAPAs). Assist in preparing audit schedules and checklists. Track corrective actions and verify closures. Organize and maintain documentation needed for audits and inspections. Assist in preparing materials and responses for regulatory and accrediting inspections and client audits. Documentation and Record Control: Oversees the documentation control system.. Logs and tracks nonconformances, deviations and incident reports. Ensures completeness and accuracy of quality records. Change Management Support: Log and monitor change requests. Track approval workflows and implementation timelines. Assist in collecting / reminding of required objective evidence for activity / file closure. Ensure related documentation is complete before closure. Training and Education: Develop and conduct training sessions for staff on quality standards, new procedures, and best practices to promote a quality culture. Send reminders for upcoming and overdue training, as applicable. Event and Risk Management: Assist in investigation of non-conformances, errors, and incidents; perform root cause analysis; and determine corrective actions to mitigate future risks. Ensure timeliness of all activities to meet regulatory expectations. Develop tools to assist with tracking activities / actions. Communication and Coordination: Schedule QA Meetings and take meeting minutes. Communicate deadlines, updates and quality-related notifications. Serve as liaison between QA and other departments. Supplier Qualification Program: Develop schedule to ensure Approved Supplier List (ASL) is kept up-to-date. Ensure qualification / re-qualification documentation is current and filed appropriately. Participate in vendor-related SCAR issuance, receipt of responses and assuring documentation meets DPT's requirements. Qualifications Required Qualifications and Skills: Education: Bachelor's degree, preferably in a chemical, physical, biological science, or Medical Laboratory Science (MLS/MT) from an accredited institution. Experience: Minimum of 5-7 years of experience in a clinical or analytical laboratory environment, with demonstrated experience in quality assurance or quality control. Knowledge: Strong knowledge of quality management systems (e.g., ISO, CLIA, CAP) and relevant federal/state regulations. Skills: Excellent attention to detail and strong organizational skills. Strong analytical and problem-solving abilities, with an aptitude for data interpretation and statistical analysis. Excellent written and verbal communication skills, with the ability to effectively communicate with diverse staff and management. Proficiency with laboratory information management systems (LIMS) and Microsoft Office Suite. Ability to work both independently and collaboratively in a fast-paced environment. Preferred Qualifications: Certification in quality management (e.g., Certified Quality Auditor (CQA) or Six Sigma certification). Experience with specific laboratory certifications/standards relevant to the lab's specialty (e.g., ASHI, CAP, CLIA,) Additional Information Schedule: Monday - Friday 8:00am-4:30pm What we offer: Excellent full time benefits including comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holidays Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.

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 ************

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Ensure that highest standards of data quality and study participant safety are maintained, as well as adherence to study protocols, CenExel SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines. Essential Responsibilities and Duties: Assists the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines Reviews follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis. Performs ongoing review of a percentage sampling of study inclusion/exclusion, study procedure records, and laboratory reports to ensure that they are conducted according to the protocol, applicable SOPs, ICH/GCP guidelines and federal regulations. Performs quality review of initially created source documentation, including amendments, to ensure all protocol required procedures are present. Provides training and education on SOPs, GCP, and federal regulations as appropriate. Prepares for internal and external audits and FDA inspections. Attends staff meetings. Attends site initiation visits, as needed. Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Must be able to effectively communicate verbally and in writing. Must have proper experience and demonstrate mastery of Quality Assurance Coordinator I position. Minimum 2 years quality assurance experience. Knowledge/Skills/Abilities: Must be self-directed and able to work with minimal supervision; Must have in depth knowledge of FDA regulations. GCP, and ICH guidelines; Able to take a flexible approach to shifting priorities; Able to manage multiple projects and responsibilities; Motivated to work consistently in a fast paced and rapidly changing environment; Must be detail oriented and have exceptional computer, organizational, and communication skills - both written and oral. Must reflect the professional image of the company, upholding the company vision in actions, demeanor, and appearance. Must be able to clearly communicate through written and verbal means with sponsors and staff. Working Conditions Indoor, Office environment. Essential physical requirements include sitting, typing, standing, walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. On site work arrangement. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

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. 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.

Job Details Warminster, PA Full Time 4 Year Degree $55000.00 - $55000.00 Salary/year Up to 50% Description Join us at Delta Community Supports, Inc. (“Delta”), where every day brings the opportunity to make a difference in the lives of others! As a leading provider of support services for individuals with intellectual and developmental disabilities, we're on a mission to empower and enrich the lives of those we serve. Are you passionate about fostering independence, promoting inclusion, and creating meaningful connections? If so, come be a part of our dynamic team where innovation, compassion, and dedication drive our every endeavor. Embark on a rewarding career journey with Delta Community Supports, Inc., and help us shape a brighter future for all! Delta Community Supports, Inc. is seeking a Quality Assurance Coordinator to support our Quality Assurance department in upholding Delta's mission of delivering high-quality services to the individuals we serve. The Quality Assurance Coordinator will be responsible for monitoring the operational integrity of our residential and vocational programs. Acting as a key liaison between the local and national offices, this role ensures that all programs operate in full compliance with applicable state regulations, agency policies, and procedural standards. The Coordinator will play a critical role in evaluating program performance, driving continuous improvement, and ensuring consistent implementation of best practices across all service areas. Requirements: Proven ability to build collaborative relationships with individuals from diverse cultural, socioeconomic, and educational backgrounds. Strong commitment to diversity, equity, and inclusion. Excellent organizational, time management, and multitasking abilities with a capacity to meet deadlines under pressure. Effective interpersonal skills to support individual growth and team development. Solid understanding of supervisory and administrative practices. Strong verbal and written communication skills; proficiency in English and basic arithmetic. Technologically proficient, including Microsoft Office and the ability to adapt to new tools. Capable of operating standard office equipment and vehicles, with a valid driver's license and compliance with applicable regulations. 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 Benefits: 401 (k) Match program, with a generous match of 3%. Comprehensive healthcare coverage, including medical, dental, and vision insurance plans. Company-paid life Insurance coverage for full-time employees Voluntary supplemental Insurance options for additional coverage. Company paid holidays, sick time, and vacation time. Employee Assistance Program (EAP) provides eligible employees with confidential counseling, support services, and resources to enhance well-being and maintain work-life balance. Professional development and internal advancement opportunities. Please note that participation in the listed benefits is contingent upon eligibility criteria.. Please Visit Our Website to complete an Online Application at **************** EOE M/F/D/V

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.

Job Description The Quality Assurance Associate, under the direction of the Chief Compliance & Quality Officer and working in cooperation with the Lead Quality Assurance Associate, utilizes a combination of excellent customer service, administrative, and analytical skills to ensure the agency can deliver high-quality client care services. This role is focused on investigating, managing, and resolving incidents that affect quality care. ESSENTIAL DUTIES AND RESPONSIBILITIES: 1. Conducts investigations for both the Personal Care and Developmental Care service lines. These investigations involve obtaining witness statements and interviews, securing evidence, retrieving information from electronic surveillance, reviewing staff schedules, compiling information from the agency's EHR system, and developing a chronological summary of factual findings from occurrence to closure. Depending on the incident, investigations may require traveling into the field to client homes to conduct investigations. (Coverage area: Philadelphia, Bucks, Montgomery, Delaware and Chester counties) 2. Completes and maintains Certified Investigator credential status from the PA Office of Development Program (ODP). Conducts investigations in accordance with ODP regulations. 3. Complies with required incident management reporting timeframes, ensuring investigations are filed, finalized or extended according to the timelines set forth by regulatory and agency standards to maintain speed, objectivity, and thoroughness. 4. Attends to all reportable data entry in the PA Enterprise Incident Management (EIM) System and documents all case activity for internal records. 5. Investigates potential fraud events and complaints involving client or caregiver safety. Makes recommendations for resolution, documents actions taken, and analyzes issues to prevent recurrence. 6. Provides education, guidance, and training to employees regarding incidents, complaints, and potential fraud events. 7. Engages in Administrative Reviews and Certified Investigation Peer Reviews to ensure processes meet regulatory standards. 8. Establishes rapport with staff, caregivers, clients, providers, families, and outside agencies to coordinate investigations. 9. Compiles, trends and reports quality data to analyze why incidents occur and how recurrences can be prevented. 10. Assists the Director of Quality & Clinical Management in the administration of the agency's quality improvement plans, infection control program, and accreditation standards. 11. Assists the Compliance Officer in monitoring the agency's compliance with regulatory mandates. Assists with the preparation of plans of correction for state surveys and auditing bodies. 12. Performs other duties as assigned by the Chief Compliance Officer. COMPLIANCE AS REQUIREMENT OF PERFORMANCE: Compliance with AmeriBest policies and procedures is a responsibility of all AmeriBest associates. It is a part of each associate's performance to follow these requirements: All associates are expected to participate in any investigatory activities All associates are expected to report any violation of AmeriBest policies and procedures All associates are expected to conduct themselves in an ethical manner consistent with the AmeriBest mission statement and Standards of Conduct All associates are expected to protect the privacy of protected records and must conduct themselves consistent with all applicable laws and policies regarding privacy protection, including HIPAA and state specific privacy laws COMPETENCIES/SKILLS: Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Process Building - seeks to develop better efficiencies in agency processes. Actively engages in the use of technology to automate and enhance day-to-day workflows. Problem solving - effective at identifying root causes and creative solutions to issues. Analytical - strong quantitative and analytical skills. Apply critical thinking to make informed, data driven decisions. Teamwork - ability to work effectively as part of a team Communication - Communicates effectively and concisely; Strong ability to create effective visual summations of data. Customer focused - strong customer service skills, able to deal with people in a polite and caring manner. Strong Computer Proficiency- Uses Microsoft 365 applications with proficiency. Intermediate to advanced skillset preferred in Word, Excel, Forms, and PowerPoint, Familiarity with EMR and data repository systems. Some Clinical Knowledge- Knowledge of medical terminology, familiarity with medical notes and discharge reports, and common chronic illnesses. Attention to Detail with Quality Focus. Deadline Oriented EDUCATION AND/OR EXPERIENCE: A bachelor's degree in social work, behavior sciences, human services, or a related field. At least one (1) years' experience in home care, social work, case management, or hospital discharge planning. PREFERRED EXPERIENCE: Associates Degree Prior experience working for a Home Health Care Agency One (1) year of experience in a healthcare organization ADDITIONAL REQUIREMENTS: Must have and maintain a valid Driver's License, a good driving record, maintain automobile insurance coverage, and have access to a reliable automobile. Ability to work occasional evenings and weekends to conduct investigations in client homes. Currently hold a PA-Office of Development Program (ODP) Certified Investigator certificate or must successfully complete this certification within 12 months of hire. PHYSICAL DEMANDS: Regular requirement to sit; use hands to touch, handle or feel. Regular requirement to stand; kneel, squat, walk and reach with hands and arms. Occasional requirement to lift and/or move up to 10 pounds. Vision abilities include close vision, peripheral vision, depth perception and the ability to adjust focus. Able to travel throughout Philadelphia and surrounding counties and enter clients' homes. WORK ENVIRONMENT: Location: In-office position (Philadelphia office) Business Office Environment The noise level is usually moderate Local travel to client homes in the five county Philadelphia area Benefits: PTO Medical, Dental, and Vision Insurance 401(k) and HSA AmeriBest Home Care is an equal opportunity employer. We value and encourage diversity in our workforce and provide equal employment opportunities to all individuals protected by applicable laws.

The Document Specialist is an integral part of our team, transcribing and revising various types of documents and contributing to our commitment to providing the highest quality legal service. Minimum 3 years of word processing experience. Typing speed of 50+ words per minute. Proficiency in Windows 10 and 11, Microsoft Office 2016, Outlook, and iManage Work (or comparable Document Management System). High school diploma. Document Transcription and Revision: Accurately transcribe and revise correspondence, pleadings, discovery materials, memos, reports, special forms, voicemails, and hard copy documents. Proficiency in Adobe Pro, including converting PDFs to Word, reducing file sizes, and using editing tools. Utilize the typewriter tool for text changes, insert signatures, and create JPEGs/images within PDFs. Apply Bates labeling and make documents OCR text searchable. Learn how to create PDF Portfolios for efficient bulk bates labeling. Document Formatting and Organization: Prepare mass mailing mail merges. Clean and format documents using DocXtools, ensuring consistent application of firm styles. Expertise in cross-referencing and blacklining using Litera or comparable software. Create table of contents, table of authorities, and points and authorities using Best Authority. Generate bookmarks and assist in creating closing binders, including hyperlinking embedded documents. Craft professional PowerPoint presentations and format complex Excel spreadsheets. Time Management and Technology Skills: Input attorney time using Intapp. Create timelines and organizational charts using Word, Visio, or PowerPoint. Learn the E-Notary and DocuSign processes. Familiarity with scanning equipment, Dictaphone, and general office technology.