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Quality assurance specialist jobs in Delaware

- 64 jobs
  • Sr Manager, Quality Assurance

    Hologic 4.4company rating

    Quality assurance specialist job in Newark, DE

    Are you a strategic leader with a passion for driving compliance, quality excellence, and continuous improvement in a regulated environment? At Hologic, we are seeking a Senior Manager, Quality Assurance to lead the development, implementation, and maintenance of our divisional Quality Management System (QMS). In this role, you'll oversee key quality processes, including CAPA management, audits, change management, and Quality Management Reviews, while fostering a culture of procedural compliance and continuous improvement. You'll partner cross-functionally, mentor a high-performing team, and ensure adherence to global regulatory standards. If you're ready to make a meaningful impact by ensuring the safety, reliability, and quality of life-saving products, we encourage you to apply! Knowledge: Advanced understanding of Quality Management Systems (QMS) and electronic documentation systems. Expertise in FDA 21 CFR Part 820, ISO 13485:2016, EU MDR 2017/745, and other global regulatory standards. Expertise in managing CAPA processes, risk-based compliance strategies, and change management controls. Familiarity with root cause methodologies, risk management, and compliance-driven processes. Knowledge of Lean Manufacturing principles, Kaizen, Kanban, Poke Yoke, and visual factory ideology. Awareness of quality assurance standards, including statistical data analysis for quality performance. Skills: Proven ability to recruit, lead, and develop a high-performing team with strong mentoring and coaching capabilities. Exceptional leadership skills with the ability to influence and communicate effectively across all levels of the organization. Strong project management skills to lead quality initiatives, manage resources, and meet financial objectives. Analytical skills to collect, compile, and interpret quality data to drive decision-making and improvements. Ability to support audits and regulatory inspections as a Subject Matter Expert (SME) and ensure readiness. Strong collaboration skills to establish cross-functional networks and drive procedural compliance. Preferred skills: Lean or Six Sigma certification for driving process efficiency and continuous improvement. Behaviors: Strategic thinker, with a focus on aligning quality objectives to organizational goals and regulatory requirements. Detail-oriented and proactive, ensuring timely resolution of compliance issues and adherence to QMS processes. Collaborative and relationship-oriented, fostering strong partnerships across operations, R&D, and other functions. Promotes a culture of continuous improvement, identifying lessons learned and implementing new tools and methodologies. Accountable and results-driven, with a commitment to delivering high-quality outcomes while meeting financial objectives. Customer-focused, ensuring products meet the highest standards of safety, quality, and reliability. Experience: Bachelor's degree required; Master's degree or PhD preferred. 8+ years of experience with a Bachelor's degree or 5+ years with a Master's degree in Quality Assurance or a related field. Prior experience in FDA, Notified Body, ISO, or other regulated manufacturing settings is beneficial. Proven success in leading quality initiatives, CAPA processes, audits, and change management in a regulated industry. Experience working with Operations and R&D teams to drive quality and compliance is advantageous. Previous managerial or supervisory experience is preferred Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $134,700-$224,500 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Agency and Third-Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-NT1
    $134.7k-224.5k yearly Auto-Apply 28d ago
  • Quality Assurance Consultant

    Akkodis

    Quality assurance specialist job in Newark, DE

    Akkodis is seeking a Quality Assurance Consultant for a Contract job with a client in Newark DE/Addison, TX(Hybrid). You will play a key role in developing and executing automated test frameworks using Core Java and BDD Cucumber for PEI Claims Automation. Rate Range: $58/hour to $60/hour; The rate may be negotiable based on experience, education, geographic location, and other factors. Quality Assurance Consultant job responsibilities include: * Designing, developing, and executing test automation frameworks using Core Java and BDD Cucumber for PEI Claims Automation. * Collaborating with project teams to ensure that quality standards and practices are followed throughout the testing process. * Conducting end-to-end testing to verify that business, technical, and functional requirements are met. * Creating and executing test scripts based on test strategies and plans to identify defects before production. * Managing risks associated with system test plans and implementing actions to mitigate unacceptable risks. * Communicating effectively with stakeholders, providing executive status updates on testing progress and risks. * Ensuring timely completion of all required testing deliverables while managing multiple competing priorities in a fast-paced environment. Desired Qualifications: * Bachelor's degree in computer science, Engineering, or a related field. * 5-7 years of hands-on experience in automation framework design, specifically in Core Java. * Strong proficiency in Selenium WebDriver and BDD Cucumber framework with hands-on experience in web application automation. * At least 3 years of experience working within an Agile/Scrum team and utilizing CI/CD automation tools such as Jenkins and GitHub. If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at *****************************. Pay Details: $58.00 to $60.00 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled Military connected talent encouraged to apply To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to ************************************************* The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: * The California Fair Chance Act * Los Angeles City Fair Chance Ordinance * Los Angeles County Fair Chance Ordinance for Employers * San Francisco Fair Chance Ordinance Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
    $58-60 hourly Easy Apply 7d ago
  • Specialist Quality & EHS (m/f/x) Job Details | Coloplast A/S

    Coloplast 4.7company rating

    Quality assurance specialist job in Delaware

    Coloplast Distribution GmbH acts as the umbrella organization for the European logistics of Coloplast A/S, a Danish manufacturer of medical products with over 12,000 employees worldwide. Coloplast develops and distributes products for ostomy, continence and wound care, skin care and urology. In addition, Coloplast offers homecare services in Germany.
    $61k-91k yearly est. 3d ago
  • Quality Assurance Nurse / Risk Manager

    The Summit 4.5company rating

    Quality assurance specialist job in Hockessin, DE

    Job Description The Summit, located in Hockessin, is looking for a professional who is passionate about driving change, making a meaningful difference in the lives of the seniors we serve, and being part of a new team committed to doing what's best for our residents. We are seeking a dedicated Quality Assurance Nurse to help us ensure the highest quality of care. In this role, you will focus on quality assurance initiatives, working closely with our care teams to monitor, evaluate, and enhance resident well-being. If you are committed to excellence in senior living and have a keen eye for quality and compliance, we would love for you to join our team. Pay for this position is up to $85k. Position Summary: Responsible for providing leadership and coordination of the health and well being of the residents within the community in coordination with Director of Health & Wellness. Responsibilities: Evaluates and assists with improving resident quality care by assessing nursing practices and suggesting changes to optimize efficiency and safety. Ensures that community follows all federal, state, local laws and regulations as it pertains to clinical care. Partners with Director of Health and Wellness (DHW) and other team members to analyze and maintain all resident and team member health safety. Identifies ongoing needs and services of residents through the assessment/ Service Plan in collaboration with DHW Partners with other department coordinators to identify, review, and discuss potential change in levels of care and service needs Maintains communications with resident's family and/or responsible party regarding changes in care or health concerns. Reviews service plan to learn pertinent information about residents. Assists/observes medications and treatments for each resident using the medication observation record in accordance with state medication administration regulations Maintains confidentiality of all resident information including resident medication. Helps residents maintain independence; promotes dignity and physical safety of each resident. Strives to understand and respond to each resident with empathy, always remaining mindful of the resident's unique communication patterns, history and basic human needs. Practices routinely good standard care precautions of cleanliness, hygiene and health standards that include disposal and handling of biohazard waste. Notifies DHW of any resident and/or family concerns. Actively participates in change of shift reporting of pertinent information. Participates in the development of the Service Plan and monthly updates. Addresses all accidents/incidents immediately and completes incident report. Addresses all unsafe and hazardous conditions/equipment immediately. Addresses occupational exposures to blood, body fluids, infectious materials, sharp sticks and hazardous chemicals immediately. Qualifications: Maintains current state license as a Professional Registered Nurse per state regulations. Experience in assisted living, home health or long-term care industries. Two (2) years' experience as a Licensed Nurse preferred One (1) year nursing management experience preferred Must demonstrate competence in assessment skills, injections/medication administration, follow up and triage. Benefits: In addition to a rewarding career and competitive salary, Discovery offers a comprehensive benefit package. Eligible team members are offered a comprehensive benefit package including medical, dental, vision, life and disability insurances, paid time off and paid holidays. Team members are eligible to participate in our outstanding 401(k) plan with company match our Employee Assistance Program and accident insurance policies. EOE D/V
    $85k yearly 16d ago
  • Bilingual Customer Quality Specialist

    ASM Research, An Accenture Federal Services Company

    Quality assurance specialist job in Dover, DE

    The Quality Assurance (QA) Specialist is responsible for analyzing the efficiency and effectiveness of individual case analysts. The QA Specialist reviews cases, interactions and evaluates them for compliance with standardized process requirements in both English and Spanish languages. **Key Responsibilities:** The QA Specialist reviews cases, emails, and recorded telephonic interactions and evaluates them for compliance with standardized process requirements. Requirements may include soft skills in phone calls, clear communication in emails, and an adherence to directive in case work. Based on the review, the Quality Analyst provides a concise written analysis of the work reviewed along with feedback and coaching recommendations to improve the performance of the program. **Required minimum qualifications:** + Bachelor's Degree or equivalent OR 4 years of relevant experience in lieu of degree. + Experience following defined processes. + Must be a US Citizen or Authorized to work in the US (if not a citizen) and a resident of the US for at least 3 years within the last 5 years. + Must have fluent written and verbal English and must be fluent verbal Spanish. + Candidates that do not meet the required qualifications will not be considered **Preferred qualifications:** + Experience with CMS's 1095-A + Advanced proficiency with MS Office including SharePoint, Teams, Excel, Word, and PowerPoint + Strong verbal and written communication skills + Familiarity with process improvement systems such as Lean Six Sigma, Agile, and others. + Previous Federal Government experience. **Compensation Ranges** Compensation ranges for ASM Research positions vary depending on multiple factors; including but not limited to, location, skill set, level of education, certifications, client requirements, contract-specific affordability, government clearance and investigation level, and years of experience. The compensation displayed for this role is a general guideline based on these factors and is unique to each role. Monetary compensation is one component of ASM's overall compensation and benefits package for employees. **EEO Requirements** It is the policy of ASM that an individual's race, color, religion, sex, disability, age, sexual orientation or national origin are not and will not be considered in any personnel or management decisions. We affirm our commitment to these fundamental policies. All recruiting, hiring, training, and promoting for all job classifications is done without regard to race, color, religion, sex, disability, or age. All decisions on employment are made to abide by the principle of equal employment. Physical Requirements The physical requirements described in "Knowledge, Skills and Abilities" above are representative of those which must be met by an employee to successfully perform the primary functions of this job. (For example, "light office duties' or "lifting up to 50 pounds" or "some travel" required.) Reasonable accommodations may be made to enable individuals with qualifying disabilities, who are otherwise qualified, to perform the primary functions. **Disclaimer** The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. 17.75 EEO Requirements It is the policy of ASM that an individual's race, color, religion, sex, disability, age, gender identity, veteran status, sexual orientation or national origin are not and will not be considered in any personnel or management decisions. We affirm our commitment to these fundamental policies. All recruiting, hiring, training, and promoting for all job classifications is done without regard to race, color, religion, sex, veteran status, disability, gender identity, or age. All decisions on employment are made to abide by the principle of equal employment.
    $55k-86k yearly est. 60d+ ago
  • Global Quality Specialist

    Sunrise Systems 4.2company rating

    Quality assurance specialist job in Newark, DE

    QA Specialist - specifically supporting implementation of a new batch record system This position is responsible for all QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions. Major Responsibilities: Maintains a high level of understanding of relevant production processes and quality systems Performs the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable: • Change Requests • Batch Records and associated documentation • Product and Component Release transactions in SAP • Quality Investigations (Deviations, Product Complaints) • Validation Plans, Protocols and Reports • Standard Operating Procedures Qualifications Bachelor's degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering Excellent oral and written communication skills Strong ability and motivation to learn Additional Information All your information will be kept confidential according to EEO guidelines.
    $69k-92k yearly est. 3h ago
  • Quality Assurance Analyst

    Continental Finance Company

    Quality assurance specialist job in Wilmington, DE

    Job DescriptionSalary: Come join a growing financial technology company thats leading the marketplace in both the marketing and servicing of credit cards! Continental Finance Company specializes in credit card options for those consumers with less than perfect credit. We are seeking a Quality Assurance Analyst to support our Technology team. The Quality Assurance Analyst will be responsible for end-to-end testing to ensure that business, technical, and functional requirements are met throughout the SDLC. Were looking for someone who can design and execute test scripts based upon test strategy/plans to identify defects prior to production. Essential Functions: Design, develop, and maintain test cases, test scenarios, and test data based on product requirements and acceptance criteria. Execute manual functional, regression, smoke, integration, and exploratory testing on web and/or mobile applications. Identify, document, and track defects using bug tracking tools (e.g., Jira, Azure DevOps, or similar). Collaborate with developers to reproduce, isolate, and resolve issues efficiently. Participate in Agile ceremonies (daily stand-ups, sprint planning, retrospectives, and reviews) to provide QA input and feedback. Perform cross-browser and cross-platform testing to ensure consistent user experience. Validate data integrity by running basic SQL queries and performing back-end validation. Conduct API testing using tools such as Postman or Swagger, verifying endpoints, response codes, and payloads. Review product requirements and design documents to identify potential risks or ambiguities. Contribute to continuous improvement of QA processes, tools, and best practices. The ideal candidate will have the following: Minimum 2-5 years of professional experience in manual software testing. Solid understanding of Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC). Strong ability to create clear, detailed, and reusable test documentation. Hands-on experience with test management tools such as Azure devops, Test rail or anything similar. Experience testing web and/or mobile applications in both staging and production environments. Basic knowledge of SQL for performing data checks and validation. Familiarity with API testing tools (Postman, Swagger, Insomnia). Knowledge of Agile/Scrum methodology and sprint-based testing cycles. Excellent analytical thinking and problem-solving capabilities. Strong written and verbal communication skills for effective bug reporting and team collaboration. Attention to detail and a user-focused mindset when validating product functionality. Exposure to test automation tools or frameworks (e.g., Selenium, Cypress, Playwright). Experience with API automation or scripting in Java. Basic understanding of performance testing concepts or tools (e.g., JMeter, k6). ISTQB or similar QA certification. Why Continental Finance? Continental Finance Company (the CFC) is one of Americas leading marketers and servicers of credit cards for consumers with less-than-perfect credit. Since our founding in 2005, we have prided ourselves on corporate responsibility to customers in terms of a strong customer support program and fair treatment. With our success, we have also grown into an innovative financial tech company! With a state-of-the-art consumer marketing and servicing platform, we provide a variety of services to consumers when other financial institutions will not accommodate them. With more than 2.6 million credit cards managed and serviced since our founding, we pride ourselves on putting the customer first.We are not a chartered banking financial institution, nor are we a debt originator or a credit card issuer. CFC is an equal opportunity employer that is committed to inclusion and diversity. Our company provides equal employment opportunity (EEO) regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or veteran status. CFC is seeking bright, energetic individuals that will help us grow and develop together! We uphold a promise to treat our employees with the same care and concern as we do our customers. We offer all employees competitive compensation and benefits in an exciting, fast-paced business casual environment. Join our growing team and apply online today! CFC offers a hybrid work schedule which includes three (3) core days in the office (Tuesday, Wednesday, and Thursday) and two (2) remote workdays (Monday and Friday) #LI-HYBRID
    $64k-84k yearly est. 7d ago
  • QC Analytical Lead

    WuXi Apptec

    Quality assurance specialist job in Middletown, DE

    The QC Analytical Lead is responsible for establishing and managing all analytical operations for the QC function at WuXi STA's new drug product manufacturing site in Middletown, DE. This role will oversee laboratory build-out during site startup, including equipment procurement and qualification, method transfers from global R&D and client facilities, and the implementation of GMP-compliant systems for testing drug products, raw materials, and components. The QC Analytical Lead will ensure timely and accurate execution of release and stability testing to support manufacturing and packaging operations, and will provide analytical support for process validation, cleaning validation, and packaging verification. This position serves as the subject matter expert (SME) for analytical techniques, ensuring regulatory compliance, data integrity, and inspection readiness at all times. Responsibilities Analytical Laboratory Leadership • Lead the setup and day-to-day operations of the QC Analytical laboratory for drug product manufacturing, ensuring alignment with corporate quality standards. • Oversee procurement, installation, qualification, calibration, and maintenance of analytical equipment including HPLC, GC, TOC, dissolution testers, UV-Vis, KF titrators, and related instruments. • Develop, implement, and maintain SOPs, test methods, and analytical procedures in compliance with ICH, USP, EP, and JP requirements. • Establish and manage workflows to ensure analytical testing supports manufacturing and packaging schedules. Method Transfer, Validation, and Testing Support • Lead method transfers and validations from WuXi STA global R&D sites and client facilities, ensuring robustness, reproducibility, and regulatory compliance. • Oversee execution and review of analytical testing for finished dosage forms, stability studies, and raw materials. • Provide technical support for process validation, cleaning validation, and packaging verification activities. • Ensure timely review and approval of analytical data to meet batch release and stability program timelines. Regulatory Compliance • Ensure all analytical testing meets FDA, EMA, and ICH regulatory requirements for drug product QC. • Maintain compliance with data integrity principles (ALCOA+), ensuring accurate and complete documentation. • Prepare analytical teams for client and regulatory inspections, acting as the primary analytical SME during audits. • Monitor industry trends, regulatory updates, and compendial changes, ensuring methods and procedures remain compliant. Technical Leadership • Serve as SME for analytical techniques such as HPLC, GC, TOC, dissolution testing, UV-Vis, and other compendial methods relevant to drug product QC. • Troubleshoot complex analytical issues, driving investigations, deviations, and CAPA implementation. • Collaborate closely with QC Microbiology and QC Operations to coordinate workflows, sample management, and shared resources. • Recommend and implement new technologies to improve testing efficiency, accuracy, and throughput. People Management & Leadership • Build, lead, and develop the analytical laboratory team, defining roles, responsibilities, and performance expectations. • Provide coaching, technical training, and career development opportunities for team members. • Conduct regular performance evaluations, manage staffing levels, and ensure adequate coverage for operations. • Foster a culture of accountability, collaboration, and continuous improvement within the team. Qualifications • PhD in Chemistry or related field preferred; Master's or Bachelor's degree with extensive relevant experience will also be considered. • Minimum 7 years of analytical QC experience in GMP-regulated drug product manufacturing, with demonstrated leadership or supervisory responsibilities. • Proven expertise in analytical method transfer, validation, and compendial testing for finished dosage forms. • Strong understanding of ICH, USP, EP, JP, FDA, and EMA regulatory requirements for drug product QC. • Demonstrated ability to manage teams in a fast-paced manufacturing environment with multiple client projects. 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 based on disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
    $68k-101k yearly est. Auto-Apply 60d+ ago
  • QA Technician I

    Allen Harim

    Quality assurance specialist job in Delaware

    Responsibilities include but are not limited to: assisting with product quality evaluation program, product quality complaint system and vendor (food and packaging) files. Assist in various quality and food safety initiatives as directed/needed. Support Product Development initiatives related to development of new products. Essential Duties and Responsibilities Support the Vision, Mission, and Values of the Organization. Implementation and record keeping of HACCP Programs, Sanitation Standard Operating Procedures, Pest Control, Good Manufacturing Practices, Foreign Material Control, Plant Sanitation, Chemical Control, Product Quality Assurance, FSQA Customer Complaints Assist Employee Training of FSQA Programs, Policies and Procedures Assist in Independent FSQA Audit Program - GMP/Food Safety & SQF Audits Assist in implementation of the QA Program - Quality Management, supplier quality conformance and customer compliant process. Provide assistance when necessary for product evaluations and supplier/customer interactions with other staff members Perform quality checks to ensure food quality, food safety and performance standards of food, packaging and operating products. Audit manufacturing and distributor facilities for quality and food safety systems; attend initial production of products. Develop internal product specifications. Support Supply Management with supplier related opportunities Support development of new product, processes and procedures. All other related duties as assigned. Qualifications To Perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Note for level: Basic: Incumbent is able to use their knowledge/skill with support by more experienced individuals. Advanced: Incumbent is able to independently use their knowledge/skill. Expert: Incumbent is able to train others on their knowledge/skill. Possess superior interpersonal and communication skills. Education and/or Experience High School Diploma or GED or two years of equivalent work experience Must possess basic analytical, oral and written skills SQF, GMP, HAACP: 2 years Knowledge/Skills Ability to exercise sound judgment and make decisions in a manner that is consistent with the essential job functions. Supervisory Responsibilities List the supervisory responsibilities the position must perform; include the department or position titles responsible for and the level of authority exercised in performing the responsibilities. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have the ability to enter all areas of the plant and offices. Must be able to communicate with all level of employees as well as outside vendors and government agencies. Must be able to use hands, wrist and fingers Must be able to lift at least 40lbs on a regular basis Will be standing for long periods at a time Work Environment Work environment is predominantly wet and exposed to a variety of odors as well as presenting with hot and cold temperatures. Safety protection is provided.
    $28k-49k yearly est. Auto-Apply 48d ago
  • Senior Manager, QA Biologics & Combination Products Manufacturing

    Incyte 4.8company rating

    Quality assurance specialist job in Wilmington, DE

    Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary (Primary function) The Senior Manager, Quality Assurance (QA) provides oversight for biological and combination products from clinical development through commercial manufacturing. This position ensures that manufacturing, packaging, labeling, and testing operations are performed in compliance with GMP requirements, regulatory submissions, and Incyte's Global Quality standards and procedures. The Senior Manager serves as a key quality partner to internal and external stakeholders, supporting the advancement of Incyte's biologics and combination product portfolio throughout the product lifecycle. Essential Functions of the Job (Key responsibilities) · Provide QA leadership and oversight for biologics and combination products across both clinical and commercial stages of development and manufacturing. · Support the execution and integration of Incyte's Quality Management Systems (QMS), ensuring consistent application across product lines and manufacturing sites. · Serve as the primary QA representative for internal and external partners, providing input on quality and operational decisions. · Review and approve critical GMP documents such as master batch records, specifications, test procedures, and reports. · Support process validation and transportation qualification activities. · Review and disposition executed cell bank, drug substance and drug product batches for biologics and combination products in both clinical and commercial stages. · Provide oversight of supplier and contract manufacturing organization (CMO) quality performance, including Quality Agreement negotiation, supplier qualification, and ongoing compliance monitoring. · Lead internal and external cGMP audits to ensure compliance and drive continuous improvement. · Lead QA management of supplier quality events, including investigations, change controls, CAPAs, and complaints, ensuring timely closure and effective root cause analysis. · Manage internal Quality Events (deviations, CAPAs, continuous improvement, and change controls) in Veeva QMS and ensure adherence to procedural timelines. · Identify, escalate, and assist in resolving internal and external quality system issues, driving robust corrective and preventive actions. · Review and contribute to regulatory submissions (INDs, IMPDs, BLAs) and responses to Health Authority inquiries as needed. · QA lead for Design History File (DHF) preparation and / or Product Specification File (PSF) as applicable. · Support Incyte combination product quality system procedures review and approval. · Monitor and report key Quality System metrics and identify trends or risks that require management attention. · Oversee controlled document management and distribution to external partners and CMOs. · Coordinate the collection of APQR/YBPR data and lead the issuance of Incyte Annual Product Quality Reviews for the assigned Commercial products. Qualifications (Minimal acceptable level of education, work experience, and competency) · Degree (such as Bachelor's, Master's, or Ph. D. )in a scientific or engineering discipline (e. g. , Pharmacy, Chemistry, Biotechnology, or related field), or equivalent relevant experience. · Typically requires 5-7 years of relevant experience in the pharmaceutical or biopharmaceutical industry, with at least 5 years in a GMP quality or regulatory function, or the equivalent combination of education, training, and experience. · Proven experience in managing GMP operations and quality oversight for biological and combination products throughout clinical development and commercial manufacturing. · Sound awareness and understanding of the pharmaceutical business, especially with regards to quality and international regulatory requirements (including but not limited to US, EU, CH, MHRA, CA, JP). · Demonstrated leadership in managing CMO/partner quality relationships, including audits, investigations, and performance governance. · Strong problem-solving skills with the ability to make sound quality and compliance decisions. · Excellent organizational, project management, and interpersonal skills, with the ability to lead cross-functional quality initiatives, fostering an inclusive environment. · Strong written and verbal communication skills, including experience collaborating with Health Authorities and senior management. · Ability to travel 15-20% or more as required, both domestic and international, with reasonable accommodation made for qualified individuals with disabilities. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: *********** incyte. com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact privacy@incyte. com if you have any questions or concerns or would like to exercise your rights.
    $115k-146k yearly est. 17d ago
  • Quality Intern

    Steel Partners Holdings 4.4company rating

    Quality assurance specialist job in Camden, DE

    JOB SPECIFICATION Quality Engineer Intern : Steel Partners Holdings L.P. (NYSE: SPLP; ********************** is a publicly-traded diversified global holding company that has significant interests in leading companies in various industries including diversified industrial products, energy, defense, banking, insurance, food products and services, oilfield services, sports, training, education, and the entertainment and lifestyle industries. As long-term investors, Steel Partners has focused on enhancing value through the implementation of operational excellence, corporate strategic restructuring programs and other components of the Steel Partners culture - what we call “The Steel Way.” Together, Steel Partners businesses generate $3.4 billion in revenue and employ more than 13,000 people in 18 countries. To find out more about the company, please visit ********************** HandyTube Corporation is a seamless specialty tubing manufacturer based in Camden, Delaware. As a premium manufacturer, HandyTube provides customer-specific solutions for the flow of gas, steam, and liquids in the most harsh and demanding environments. The Company's process allows it to produce made-to-order, seamless, stainless steel and specialty alloy tubing ranging from one inch in diameter to finer than a human hair, and in continuous lengths that can exceed a mile. Dedicated to high-quality service and products. HandyTube's highly experienced engineers provide expertise on new product development through continuous improvement and lean manufacturing and work successfully with customers globally to take products and projects from initial concept to full scale implementation. We are committed to our values, Safety, Quality, Customer Focused and Innovation, and are our guiding principles we live by in everything we do. To find out more about HandyTube, please visit ****************** Position Reporting to the Quality Manager, the Quality Engineer will provide guidance and technical support to Manufacturing Engineers, Process Engineers, Maintenance Technicians, and Operations Personnel. This position requires strong analytical and problem-solving skills, teamwork, collaboration, and effective communication. The Quality Engineer utilizes prior experience, current research, and creativity to develop ideal solutions to manufacturing and product needs. The Quality Engineer will assist in the planning, development, implementation, communication and maintenance of the company's quality management systems, polices, documentation, data, and customer-specific requirements. Responsibilities Promote Safety as the Number One Priority of all HandyTube employees Drive a culture that educates and promotes quality processes and responsibilities for all Execute root cause analysis and timely resolutions on customer complaints, returns and scrap Plans and conducts analysis, inspections, tests and integration of quality assurance into processes Applies statistical process control methods to analyze data to make improvements to current processes Ensure process and practices conform to various ASTM and customer specifications, as well as, ISO9001, BV, AS9100, NADCAP, Norsok and other certifications and procedures. Creates, develops, updates, trains, and inspects SOP's and visual work instructions. Preparation of inspection reports Coordination and performance of internal process/product audits Conduct new supplier quality onsite audits Log and follow-up supplier quality complaints Evaluate the effectiveness of supplier corrective/preventive actions Performs other tasks as assigned Create and update SOPs and VWI Overall support of the quality department Evaluating current processes Assist with action items Creating reports and slides Requirements Currently pursuing a Bachelor's degree in material science, mechanical or industrial engineering or a related field. Junior, or Senior in Engineering Program Effective communication and interpersonal skills. Excellent problem-solving skills and attention to detail. Strong academic background in mechanical engineering principles and design Ability to work both independently and collaboratively in a team environment Uses strong, creative critical thinking and problem solving skills Analytical- capable of designing experiments, data collection, analysis and interpretation Technical writing capability Can do attitude Analytical skills Able to understand the needs of the total organization- “Big Picture” Intermediate Microsoft Office skills required Ability to learn and utilize ERP and other software systems Knowledge of manufacturing processes and willingness to learn Ability to use hands to finger, handle or feel objects and tools, reach with hands and arms, and regularly lift and/or move up to 50 pounds Knowledge and or ability to learn operating measurement equipment Willingness to spend time on the manufacturing floor and have a hand on approach. Positive attitude, good judgment and excellent time management skills Less than 15% travel may be required Must work a minimum of 20 hours a week
    $31k-47k yearly est. 12h ago
  • Quality Systems Engineer, Kalrez

    Dupont de Nemours Inc. 4.4company rating

    Quality assurance specialist job in Newark, DE

    Are you looking to power the next leap in the exciting world of advanced electronics? Do you want to help solve problems that drive success in the rapidly evolving technology and connectivity landscape? Then bring your problem-solving, passion, and creativity to help us power the next leap in electronics. At Qnity, we're more than a global leader in materials and solutions for advanced electronics and high-tech industries - we're a tight-knit team that is motivated by new possibilities, and always up for a challenge. All our dedicated teams contribute to making cutting-edge technology possible. We value forward-thinking challengers, boundary-pushers, and diverse perspectives across all our departments, because we know we play a critical role in the world enabling faster progress for all. Learn how you can start or jumpstart your career with us. Are you looking to power the next leap in the exciting world of advanced electronics? Do you want to help solve problems that drive success in the rapidly evolving technology and connectivity landscape? Then bring your problem-solving, passion, and creativity to help us power the next leap in electronics. At Qnity, we're more than a global leader in materials and solutions for advanced electronics and high-tech industries - we're a tight-knit team that is motivated by new possibilities, and always up for a challenge. All our dedicated teams contribute to making cutting-edge technology possible. We value forward-thinking challengers, boundary-pushers, and diverse perspectives across all our departments, because we know we play a critical role in the world enabling faster progress for all. Learn how you can start or jumpstart your career with us. Join Our Team as a Kalrez Quality Systems Engineer! Are you passionate about driving excellence and ensuring world-class quality standards? We're looking for a Quality Systems Engineer to lead critical initiatives that keep our Kalrez Business Quality Management System (QMS) strong, compliant, and continuously improving. In this role, you'll be the go-to expert for quality systems, spearheading CAPA processes, audits, management reviews, and quality planning. You'll collaborate across teams, influence change, and foster a culture where quality isn't just a requirement - it's a mindset. What You'll Do * Ensure compliance with ISO9001, AS9100D, Nadcap, AS13100, and other key standards. * Lead the CAPA process from investigation to effectiveness verification. * Plan and execute internal audits, support external audits with confidence. * Organize management reviews to evaluate QMS performance and drive improvements. * Develop quality plans for new products and process changes. * Analyze data to identify trends and implement proactive solutions. * Promote quality awareness and accountability across the organization. * Support product recall activities and regulatory interactions. * Mentor and motivate team members, fostering collaboration and growth. What We're Looking For * Bachelor's degree + 5 years in the Semiconductor Technology, Aerospace & Defense industry (or equivalent experience). * Strong knowledge of ISO 9001, ISO 17025, AS9100, AS13100. * Internal Auditor Certification required; Lead Auditor preferred. * Proven experience leading root cause analysis RCA, managing CAPA /SCAR processes and conducting audits. * Excellent organizational, analytical, and leadership skills. * Clear communicator with a proactive, hands-on approach. Skills That Set You Apart * Expertise in QMS and continuous improvement tools (SPC, Six Sigma). * Strategic thinker who thrives in a collaborative environment. * Understanding Process control systems & deploying PCS Tools (C&E, FMEAs, Control Charts) * Ability to influence and drive changes across global teams. Why You'll Love Working Here * Be part of a team that values innovation, quality, and continuous improvement. * Opportunities for professional growth and certification advancement. * A culture that encourages collaboration, accountability, and making an impact. #LI-RS1 Join our Talent Community to stay connected with us! Qnity is an equal opportunity employer. Qualified applicants will be considered without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability or any other protected class. If you need a reasonable accommodation to search or apply for a position, please visit our Accessibility Page for Contact Information. Qnity offers a comprehensive pay and benefits package. To learn more visit the Compensation and Benefits page.
    $83k-98k yearly est. Auto-Apply 32d ago
  • Clinical Documentation Specialist Auditor

    Intermountain Health 3.9company rating

    Quality assurance specialist job in Dover, DE

    The goal of the Clinical Documentation Specialist-Auditor is to improve the accuracy of the overall clinical picture and the representation of the complexity and severity of illness of patients through improved clinical documentation and diagnostic coding practices. We are committed to offering flexible work options where approved and stated in the job posting. However, we are currently not considering candidates who reside or plan to reside in the following states: **California, Connecticut, Hawaii, Illinois, New York, Rhode Island, Vermont, Washington** **Please note that a video interview through Microsoft Teams will be required as well as potential onsite interviews and meetings.** Job Essentials Reviews medical records documentation for reimbursement, severity of illness and risk of mortality, identifies opportunities for improving the quality of medical record documentation, and confers with the caregiver regarding additional documentation required using existing procedures. Collects statistics from the reviews and maintains accurate records to document costs and benefits. Facilitates and enhances the coding and diagnosis-related group between physician and coding staff. **Minimum Qualifications** Bachelor's degree in a clinical field (e.g. RN, RRT, PT, OT, SLP, LCSW). Education must be obtained through an accredited institution. Degree will be verified. Clinical license in state of practice (e.g. RN, RRT, PT, OT, SLP, LCSW). Depending upon your clinical licensure, equivalent experience may substitute the degree requirement. **Preferred Qualifications** Experience with Microsoft Office products. - and - Clinical experience in ICU, CCU, primary care, or intermediate care. - and - Experience with Clinical Documentation Integrity. - and - Knowledge of iCentra and Help2 systems. **Physical Requirements:** Interact with others requiring employee to verbally communicate as well as hear and understand spoken information. - and - Operate computers, telephones, office equipment, including manipulating paper requiring the ability to move fingers and hands. - and - See and read computer monitors and documents. - and - Remain sitting or standing for long periods of time to perform work on a computer, telephone, or other equipment. **Location:** Employee Service Center **Work City:** Murray **Work State:** Utah **Scheduled Weekly Hours:** 40 The hourly range for this position is listed below. Actual hourly rate dependent upon experience. $35.25 - $54.39 We care about your well-being - mind, body, and spirit - which is why we provide our caregivers a generous benefits package that covers a wide range of programs to foster a sustainable culture of wellness that encompasses living healthy, happy, secure, connected, and engaged. Learn more about our comprehensive benefits package here (***************************************************** . Intermountain Health is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. At Intermountain Health, we use the artificial intelligence ("AI") platform, HiredScore to improve your job application experience. HiredScore helps match your skills and experiences to the best jobs for you. While HiredScore assists in reviewing applications, all final decisions are made by Intermountain personnel to ensure fairness. We protect your privacy and follow strict data protection rules. Your information is safe and used only for recruitment. Thank you for considering a career with us and experiencing our AI-enhanced recruitment process. All positions subject to close without notice.
    $31k-37k yearly est. 3d ago
  • Quality Control Specialist, Vault

    Limited 4.7company rating

    Quality assurance specialist job in New Castle, DE

    Collectors is the leading creator of innovative technology that provides value-added services for collectors worldwide. We grade, authenticate, vault, and sell millions of record-setting collectibles, all while modernizing and digitalizing the process to further our mission of helping collectors pursue their passions. We're always on the lookout for talented people to join our growing team. Our services span collectible coins, trading cards, Funko Pops!, video games, event tickets, autographs, and memorabilia. Our subsidiaries include PSA, PCGS, SGC, WATA, and Card Ladder. Since our founding in 1986, we have graded and authenticated millions of items. We employ more than 1,900 people across our headquarters in Santa Ana and offices in Jersey City, Tokyo, Shanghai, Hong Kong, Toronto, Guadalajara, Dallas, and Paris. Collectors is the leading creator of innovative technology that provides value-added services for collectors worldwide. We grade, authenticate, vault and sell millions of record-setting collectibles, all while modernizing and digitalizing the process to further our mission of helping collectors pursue their passions. We're always on the lookout for talented people to join our growing team. Our services span collectible coins, trading cards, Funko Pops!, video games, event tickets, autographs, and memorabilia. Our subsidiaries include PSA, PCGS, WATA, Card Ladder, and the Long Beach Expo collectibles trade show. Since our founding in 1986, we have graded and authenticated millions of items. We employ more than 1,700 people across our headquarters in Santa Ana and offices in Jersey City, Seattle, Hong Kong, Paris, Shanghai, and Tokyo. We're looking for a Quality Control Specialist who will work out of The Collectors Vault. They will help conduct audits throughout the building and check on overall accuracy for each department. This role will partner with the operations team to assure all products are received and shipped at a zero % defect rate. This role reports to our General Manager at The Collectors Vault and will work out of our New Castle, DE office. The position schedule will be Wednesday To Saturday from 7:00am - 5:30pm. What You'll Do: Train new hires on procedures, standards, and protocols to ensure consistency and adherence to quality requirements. Work with the operations manager on unique day-to-day projects that arise. Assist the operation manager in tracking and locating exception orders to maintain accurate records while simultaneously updating spreadsheets and identifying problem orders. Responsible for auditing inbound packages to ensure compliance with quality standards and specifications, identifying any discrepancies and initiating corrective actions as necessary. Create and maintain spreadsheets and perform data manipulation. Act as the operations liaison between the operation and customer care teams. Investigate customer complaints and non-conformance issues. Conduct routine audits and inspections across the inbound and outbound processes. Demonstrate meticulous attention to detail in performing day-to-day tasks, including data entry, documentation, and quality control activities, to maintain accuracy and consistency in all aspects of quality assurance operations. Who You Are: Working knowledge of the collections hobby with specialized or detailed understanding of professional sports teams, players, entertainment, pop culture, and historical figures is a plus Ability to work under strict deadlines (Overtime needed depending on the auction cycle) Organizational skill and attention to detail are essential Strong time management skills required Enthusiasm, a willingness to learn and adaptability Common computer software: Microsoft Office, Google Documents, Internet High School or equivalent education background Physical Requirements: Computer Use: Typing, mouse work, and sitting and looking at a computer potentially for long periods of time. Exposure to Machinery: Exposure to machinery noise, which may include noise from forklifts, injection presses, or other machinery. Lifting and Carrying: Ability to lift, carry, and move materials up to 25 pounds. Hand Use: Regular hand use for various tasks. Hearing Requirements: Ability to hear alarms, signals, and verbal instructions. Hourly Rate: The reasonable estimated hourly rate for this position is $19. Actual compensation varies based on a variety of non-discriminatory factors, including location, job level, prior experience and skill set. Reasons To Join Us: Health Insurance: All full-time employees are eligible to enroll in Medical, Dental, and Vision Additional Benefits: Full-time employees are eligible for fertility, commuter, and educational assistance benefits. 401(K) Matching Plan: We are proud to offer a competitive 401k matching plan to our employees to support their future financial goals Vacation: All full-time employees are eligible for paid vacation Holiday Pay: All regular, full-time employees are eligible for ten company paid holidays Employee Discounts: Employees receive discounts on select grading services for approved submissions Flexible Hours: Many of our teams offer flexible schedules with varying shifts and will work with you to accommodate your needs Fun Working Environment: Our team members are invited to participate in celebrations, holiday events, and team building activities Collectors uses e-Verify to validate your ability to work legally in the United States. We are aware that there are instances where individuals are receiving job offers that fraudulently allege to be from Collectors or one of our business units. This type of fraud can be carried out through false websites, through fake e-mails claiming to be from the company or through social media. We never ask for personal information such as your bank account, Social Security numbers or National IDs, nor do we send or request payments for the purchase of business-related equipment. If you suspect fraud, please reach out to *******************. We are committed to equal employment opportunity regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, veteran status, or other class protected by applicable law. We believe that a team that represents a variety of backgrounds, perspectives, and skills will better service the diverse community of collectors we support. If you require an accommodation to apply or interview with us due to a disability or special need, please email ********************* . U.S. residents: for disclosures relating to personal information we collect during the employment application and recruitment process, please see our Privacy Notice for U.S. Applicants . If you are based in California, you can read information for California residents here .
    $19 hourly Auto-Apply 60d+ ago
  • Clinical QA Specialist

    Hologic 4.4company rating

    Quality assurance specialist job in Newark, DE

    Newark, DE, United States Are you passionate about ensuring the highest standards of quality and compliance in the medical device industry? We are seeking a dedicated and dynamic **Clinical QA Specialist** to join our team onsite in Newark, DE! In this pivotal role, you will be responsible for the timely and thorough investigation and reporting of Potential Adverse Events, Adverse Events, and other regulatory reporting required due to complaints analysis. You will work closely with Technical Service, Marketing, Sales, Legal, and potentially Customers, fostering seamless communication and collaboration. This role requires your presence onsite, allowing you to make a tangible impact and drive excellence in our operations. Apply today! **Knowledge:** + In-depth understanding of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14971 standards. + Familiarity with medical procedures and expected outcomes related to the portfolio of products. + Knowledge of complaint handling, post-market surveillance processes, and regulatory reporting requirements. **Skills:** + Strong analytical and investigative skills to assess adverse events and identify next steps. + Exceptional verbal and written communication skills to collaborate with internal teams, regulatory bodies, and external stakeholders. + Proficiency in managing and innovating processes to improve compliance and efficiency in post-market surveillance. + Ability to work independently while meeting deadlines in a fast-paced environment. + Adept in handling metrics, indicators, and quality reports related to reportable events. **Behaviors:** + High attention to detail and a commitment to accuracy in reporting and documentation. + Proactive mindset with a focus on continuous improvement and innovation. + Collaborative and team-oriented approach to problem-solving. + Resilient and adaptable, thriving under pressure and regulatory scrutiny. + Ethical and customer-focused, ensuring patient safety is the top priority. **Experience:** + A minimum of 5 years' experience in a similar role involving post-market surveillance, adverse event reporting, and regulatory compliance. + Hands-on experience working with cross-functional teams such as Technical Service, Marketing, Sales, and Legal. + Track record of successful participation in internal and external audits, as well as regulatory agency interactions. + Experience in executing investigations like CAPAs, NCEs, and IACAs to resolution. The individual fulfilling this role must possess the physical capability to sit for extended periods, handle, or manipulate objects, tools, or controls with precision. Additionally, they should be able to stand, walk, reach with hands and arms, stoop, kneel, crouch, and be prepared to engage in domestic and international travel as required by the position. **Why join Hologic?** We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is$83,000 - $129,700and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. **Agency and Third-Party Recruiter Notice** Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. **Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.** \#LI-NT1
    $83k-129.7k yearly 60d+ ago
  • QC Microbiology Lead

    WuXi Apptec

    Quality assurance specialist job in Middletown, DE

    The QC Microbiology Lead will manage all microbiology laboratory activities at WuXi STA's drug product manufacturing site in Middletown, DE. This role is responsible for establishing, maintaining, and continuously improving GMP-compliant microbiological testing programs for drug product manufacturing, including environmental monitoring (EM), water system monitoring, bioburden, endotoxin, and identification testing. The QC Microbiology Lead will play a key role in site startup by building the micro lab infrastructure, qualifying equipment, and establishing EM programs. In steady-state operations, this role will ensure timely execution of microbiology testing to support manufacturing, product release, cleaning validation, and regulatory readiness. **Responsibilities** Microbiology Laboratory Leadership - Lead the setup and daily operations of the QC Microbiology laboratory for drug product manufacturing, ensuring alignment with corporate quality standards. - Oversee procurement, installation, qualification, calibration, and maintenance of microbiology equipment including biosafety cabinets (BSCs), incubators, autoclaves, particle counters, endotoxin testing systems, and microbial identification instruments. - Develop, implement, and maintain SOPs, test methods, and microbiological procedures in compliance with ICH, USP , , , , EP, and JP requirements. - Establish and manage workflows to ensure microbiological testing supports manufacturing and packaging schedules. Method Transfer, Validation, and Testing Support - Lead microbiological method transfers and validations from WuXi STA global R&D sites and client facilities for drug product testing. - Ensure robustness, reproducibility, and regulatory compliance of validated microbiology methods. - Oversee and review microbiology data for environmental monitoring (EM), water system monitoring, bioburden, endotoxin, and microbial identification testing. - Provide microbiological support for process validation, cleaning validation, and contamination control strategy implementation. - Provide timely review and approval of microbiological data to meet batch release and stability program timelines. Regulatory Compliance - Ensure all analytical testing meets FDA, EMA, and ICH regulatory requirements for drug product QC. - Maintain compliance with data integrity principles (ALCOA+), ensuring accurate and complete documentation. - Prepare microbiology teams for client and regulatory inspections, acting as the primary microbiology SME during audits. - Monitor industry trends, regulatory updates, and compendial changes, ensuring methods and procedures remain compliant. Technical Leadership - Act as SME for microbiological techniques including EM, endotoxin testing (USP ), microbial limits testing (USP /), microbial identification, and water system monitoring. - Lead troubleshooting of complex microbiological issues, overseeing root cause analysis and CAPA implementation. - Collaborate with QC Analytical and QC Operations to optimize sample management, workflows, and shared resources. - Identify and recommend new microbiological technologies or automation to improve efficiency, accuracy, and throughput. People Management & Leadership - Build, lead, and develop the microbiology laboratory team, defining roles, responsibilities, and performance expectations. - Provide coaching, technical training, and career development opportunities for team members. - Conduct regular performance evaluations, manage staffing levels, and ensure adequate coverage for operations. - Foster a culture of accountability, collaboration, and continuous improvement within the team. **Qualifications** - PhD in Microbiology or related field preferred; Master's or Bachelor's degree with extensive relevant experience will also be considered. - Minimum 7 years of microbiology QC experience in GMP-regulated drug product manufacturing, with demonstrated leadership or supervisory responsibilities. - Proven expertise in microbiology method transfer, validation, and compendial testing for finished dosage forms. - Strong understanding of ICH, USP , , , , EP, JP, FDA, and EMA regulatory requirements for drug product QC. - Demonstrated ability to manage teams in a fast-paced manufacturing environment with multiple client projects. 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 based on disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management. **Need help finding the right job?** We can recommend jobs specifically for you! 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 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 (************************************************************************************************** **Job Locations** _US-DE-Middletown_ **Job ID** _2025-13806_
    $68k-101k yearly est. 60d+ ago
  • Quality Assurance Analyst - Journeyman

    ASM Research, An Accenture Federal Services Company

    Quality assurance specialist job in Dover, DE

    ASM Research provides services in support of the Military OneSource Program for military members and their families, similar to a commercial Employee Assistance Program (EAP). This program provides a broad array of information, resources, referrals, and counseling to about 4.7 million persons or "participants," which includes military service members, their families, and eligible civilians at locations worldwide. Services are provided through a 24/7 contact center accessible via internet website, toll free telephone, secure real-time text/video chat, email, or postal mail and include non-medical counseling; financial counseling; tax assistance; spouse education and career information; adoption information; child care; Exceptional Family Member Programs (EFMPs); deployment support; disability information; elder care; educational services for adults, children, and youth; relocation services; pet care; health and wellness coaching; housing assistance; legal service referrals; single service member services; lodging; military benefits; relationship support; skill building services for parenting; spouse relocation and transition; peer-to-peer support; and support for everyday issues (e.g., locating a plumber or automobile mechanic). Quality Assurance Analysts provide QA support to monitor performance for all Military OneSource operations to meet minimum standards in the SLAs and Performance Metrics. In this role they will monitor customer interactions and review/analyze customer feedback to evaluate overall customer experience. Assigns root cause and identifies systemic quality problems. Uses data from call observations to create quality improvement action plans and drive projects working with team and third-party vendors. Accurately compares measurements between team, vendors and client partners. Reports findings from complaints and call monitoring to the client, internal, and vendor teams. Makes recommendations on quality initiatives. **Job Responsibilities** + Conducts audits and reviews using scoring protocols for calls and/or case records using a pre-determined set of criteria, documenting results in a detailed report. + Supports data entry and analysis following URAC minimum standards and defined SOPs as specified in the Quality Management Plan. + Maintains and provides all records and reports pertaining to QA documentation. + QA Analysts adhere to and promote auditing standards, participate in team meetings, training requirements and calibration sessions. + Supports analysis of Duty to Warn, Adverse Incidents, and Mandated Reporting in compliance with defined processes and reporting standards + Monitors customer interactions for timeliness of answer, active listening, request/issue identification, correct call hold, professionalism, compliance requirements, request/issue resolution, and appropriate closing. + Analyzes survey results for improving communication process and providing feedback to the communication owners. + Utilizes quality monitoring program to compile and track performance at individual, functional, and program levels. + Provides feedback to agents and managers based on observed strengths and improvement opportunities. + Analyzes readership, comprehension and application of communicated actions. + Serves as a resource and escalation point for all lines of business so that reviews of calls are accurate for technical content and employees are provided with the correct policies, procedures, and/or reference materials. + Identifies trends in service and provides that data to the training team to enhance current training. + Documents customer/call communications processes and makes recommendations. + Implements operational process improvement initiatives on a regular basis, as well as through long-term projects. + Provides call quality metrics data to generate and maintain volume forecasts to support management with scheduling and staffing needs. + Leads brainstorming sessions to improve call system, communications processes, customer satisfaction, agent processes and agent effectiveness. + Completes activities related to deploying communications including but not limited to creating checkpoints based on important points, creating surveys for reader feedback and continuous improvement, and providing recommendations for communications process improvement. + Coordinates with client to create content for agent communications. + Develops and distributes new agent communications, researching content and obtaining appropriate feedback and reviews as needed. + Creates and implements training plans to orient new hires and ensure a smooth transition from learning environment to daily production environment. + Identifies agent communication needs and makes recommendations to Call Center management. **Minimum Qualifications** + U.S. citizen and fluent English speaker + Possess strong written and verbal communication skills + Must submit to and successfully pass a DoD-initiated Tier 2 - Public Trust Background Investigation + Bachelor's degree and 5 years of contact center quality assurance experience (additional 4 years of work experience may be considered in lieu of Bachelor's degree) + Solid working knowledge of standard computer software (Microsoft Office business suite to include Outlook, Word, Excel, PowerPoint, and Project) **Other Job Specific Skills** + Demonstrated ability to contribute to quality assurance program creation or execution. + Experience with call center call monitoring/recording software. + Exceptional customer service and problem-solving skills. + Ability to explain and present ideas clearly and concisely to diverse audiences, using appropriate language. + Excellent analytical skills and strong decision-making abilities. + Proven ability to achieve and maintain departmental quality standards. + Strong Internet software and Windows operating systems and software skills. + Demonstrated ability to train and develop new and existing support agents. + Excellent interpersonal, facilitation, and relationship management skills. + Demonstrated ability to effectively communicate and interact with interdepartmental staff and across organizational lines. + Critical thinker with the ability to solve complex problems; able to apply quality improvement techniques. + Great coordination skills across multiple departments of the Customer system. **Compensation Ranges** Compensation ranges for ASM Research positions vary depending on multiple factors; including but not limited to, location, skill set, level of education, certifications, client requirements, contract-specific affordability, government clearance and investigation level, and years of experience. The compensation displayed for this role is a general guideline based on these factors and is unique to each role. Monetary compensation is one component of ASM's overall compensation and benefits package for employees. **EEO Requirements** It is the policy of ASM that an individual's race, color, religion, sex, disability, age, sexual orientation or national origin are not and will not be considered in any personnel or management decisions. We affirm our commitment to these fundamental policies. All recruiting, hiring, training, and promoting for all job classifications is done without regard to race, color, religion, sex, disability, or age. All decisions on employment are made to abide by the principle of equal employment. Physical Requirements The physical requirements described in "Knowledge, Skills and Abilities" above are representative of those which must be met by an employee to successfully perform the primary functions of this job. (For example, "light office duties' or "lifting up to 50 pounds" or "some travel" required.) Reasonable accommodations may be made to enable individuals with qualifying disabilities, who are otherwise qualified, to perform the primary functions. **Disclaimer** The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. $25.00 EEO Requirements It is the policy of ASM that an individual's race, color, religion, sex, disability, age, gender identity, veteran status, sexual orientation or national origin are not and will not be considered in any personnel or management decisions. We affirm our commitment to these fundamental policies. All recruiting, hiring, training, and promoting for all job classifications is done without regard to race, color, religion, sex, veteran status, disability, gender identity, or age. All decisions on employment are made to abide by the principle of equal employment.
    $64k-84k yearly est. 60d+ ago
  • QA Technician

    Allen Harim

    Quality assurance specialist job in Dagsboro, DE

    QA TechnicianREQUIREMENTS: Must possess a high school diploma or equivalent. Previous poultry experience is required. Excellent communication skills, basic PC skills and attention to detail. The ability to lift up to 40 pounds. RESPONSIBILITIES:The responsibilities of this position completing regular quality checks, inspect and monitor processes and product, conduct and document bacteriological inspections of equipment and surrounding areas, audit processes by using specifications, monitor egg and chick quality processes and procedures, monitor egg and chick quality, input quality data, perform hatch breakouts and monitor team members for Best Hatchery Practices.
    $28k-49k yearly est. Auto-Apply 9d ago
  • Quality Intern

    Steel Partners Group 4.4company rating

    Quality assurance specialist job in Camden, DE

    JOB SPECIFICATION Quality Engineer Intern : Steel Partners Holdings L.P. (NYSE: SPLP; ********************** is a publicly-traded diversified global holding company that has significant interests in leading companies in various industries including diversified industrial products, energy, defense, banking, insurance, food products and services, oilfield services, sports, training, education, and the entertainment and lifestyle industries. As long-term investors, Steel Partners has focused on enhancing value through the implementation of operational excellence, corporate strategic restructuring programs and other components of the Steel Partners culture - what we call “The Steel Way.” Together, Steel Partners businesses generate $3.4 billion in revenue and employ more than 13,000 people in 18 countries. To find out more about the company, please visit ********************** HandyTube Corporation is a seamless specialty tubing manufacturer based in Camden, Delaware. As a premium manufacturer, HandyTube provides customer-specific solutions for the flow of gas, steam, and liquids in the most harsh and demanding environments. The Company's process allows it to produce made-to-order, seamless, stainless steel and specialty alloy tubing ranging from one inch in diameter to finer than a human hair, and in continuous lengths that can exceed a mile. Dedicated to high-quality service and products. HandyTube's highly experienced engineers provide expertise on new product development through continuous improvement and lean manufacturing and work successfully with customers globally to take products and projects from initial concept to full scale implementation. We are committed to our values, Safety, Quality, Customer Focused and Innovation, and are our guiding principles we live by in everything we do. To find out more about HandyTube, please visit ****************** Position Reporting to the Quality Manager, the Quality Engineer will provide guidance and technical support to Manufacturing Engineers, Process Engineers, Maintenance Technicians, and Operations Personnel. This position requires strong analytical and problem-solving skills, teamwork, collaboration, and effective communication. The Quality Engineer utilizes prior experience, current research, and creativity to develop ideal solutions to manufacturing and product needs. The Quality Engineer will assist in the planning, development, implementation, communication and maintenance of the company's quality management systems, polices, documentation, data, and customer-specific requirements. Responsibilities Promote Safety as the Number One Priority of all HandyTube employees Drive a culture that educates and promotes quality processes and responsibilities for all Execute root cause analysis and timely resolutions on customer complaints, returns and scrap Plans and conducts analysis, inspections, tests and integration of quality assurance into processes Applies statistical process control methods to analyze data to make improvements to current processes Ensure process and practices conform to various ASTM and customer specifications, as well as, ISO9001, BV, AS9100, NADCAP, Norsok and other certifications and procedures. Creates, develops, updates, trains, and inspects SOP's and visual work instructions. Preparation of inspection reports Coordination and performance of internal process/product audits Conduct new supplier quality onsite audits Log and follow-up supplier quality complaints Evaluate the effectiveness of supplier corrective/preventive actions Performs other tasks as assigned Create and update SOPs and VWI Overall support of the quality department Evaluating current processes Assist with action items Creating reports and slides Requirements Currently pursuing a Bachelor's degree in material science, mechanical or industrial engineering or a related field. Junior, or Senior in Engineering Program Effective communication and interpersonal skills. Excellent problem-solving skills and attention to detail. Strong academic background in mechanical engineering principles and design Ability to work both independently and collaboratively in a team environment Uses strong, creative critical thinking and problem solving skills Analytical- capable of designing experiments, data collection, analysis and interpretation Technical writing capability Can do attitude Analytical skills Able to understand the needs of the total organization- “Big Picture” Intermediate Microsoft Office skills required Ability to learn and utilize ERP and other software systems Knowledge of manufacturing processes and willingness to learn Ability to use hands to finger, handle or feel objects and tools, reach with hands and arms, and regularly lift and/or move up to 50 pounds Knowledge and or ability to learn operating measurement equipment Willingness to spend time on the manufacturing floor and have a hand on approach. Positive attitude, good judgment and excellent time management skills Less than 15% travel may be required Must work a minimum of 20 hours a week
    $31k-47k yearly est. 12h ago
  • Clinical QA Specialist

    Hologic 4.4company rating

    Quality assurance specialist job in Newark, DE

    Are you passionate about ensuring compliance and patient safety in the medical device industry? At Hologic, we are seeking a Clinical QA Specialist to play a critical role in the investigation and reporting of potential and actual adverse events, as well as other regulatory reporting activities. In this role, you'll collaborate with cross-functional teams, including Technical Service, Marketing, Sales, and Regulatory, to ensure timely and thorough documentation, analysis, and reporting. If you thrive in a fast-paced, collaborative environment and have a strong background in regulatory compliance and quality assurance, this is your opportunity to make a meaningful impact on healthcare innovation. Knowledge: Comprehensive understanding of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14971 for risk management. Strong knowledge of medical procedures and the expected and potential outcomes related to Hologic's product portfolio. Familiarity with post-market surveillance requirements, adverse event reporting, and health risk assessments. Awareness of regulatory reporting processes, including MedWatch reports, notified body communications, and external notifications. Skills: Proven ability to independently collect, analyze, and assess information associated with adverse events and determine appropriate next steps. Effective communication skills to interact with internal teams, sales personnel, customers, patients, and regulatory agencies. Strong organizational skills to ensure timely documentation, reporting, and follow-up of adverse events and regulatory submissions. Analytical skills to support and lead investigations, including CAPAs, nonconformances, and other quality system processes. Experience in developing metrics and quality reports related to reportable events and identifying potential excursions. Ability to innovate and improve processes to enhance efficiency and compliance with post-market surveillance requirements. Proficient in leading or participating in internal and external audits, inspections, and assessments. Behaviors: Proactive and detail-oriented, ensuring compliance with regulatory requirements and internal procedures. Collaborative and team-oriented, fostering strong relationships across functions to support investigations and reporting activities. Customer-focused, ensuring communications and responses are timely, accurate, and aligned with patient safety goals. Resilient and adaptable, thriving in a fast-paced and evolving environment. Problem-solving mindset, with a commitment to driving resolution and continuous improvement in quality processes. Experience: Bachelor's degree in Medicine, Nursing, Biomedical Engineering, Electromedical Engineering, or a related field. Risk Managers will also be considered. 5+ years of experience in a similar role, preferably within the medical device or healthcare industry. Hands-on experience with adverse event reporting, regulatory communications, and health risk assessments. Proven track record in supporting or leading CAPAs, nonconformances, and quality investigations. Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $83,000 - $129,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Agency and Third-Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-NT1
    $83k-129.7k yearly Auto-Apply 23h ago

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