CHEF, SOUS - Merck - Rahway NJ

Posted today
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Job Description
**Salary:** $58000 to $65000
**Other Forms of Compensation:**
**What makes FLIK click**
_What makes FLIK click? Our people. The decisions, actions and attitudes of our associates earn the trust and loyalty of our clients every day. We know how to pick them and we know how to grow them. It starts with hiring people who share our passion for food and hospitality. Once we find the right talent, we encourage, value and recognize their contributions._
_We keep our people renewed, excited and engaged by providing hands-on training and educating them about the latest trends. We give them a stake in successfully raising the bar. Our people love what they do and they love sharing their passion. Join our team and see the FLIK difference. Where a job isn't merely a job but the start of a career where you can flourish._
**Job Summary**
**Job Summary:**
**Working as the Sous Chef,** you will be responsible for the successful operation of the Culinary Department for a facility. You will assist in the supervision, preparation, and cooking of various food items, developing daily menu items and their preparation and garnishment. You may supervise hourly associates and you work with Executive Chef/Chef to develop new menus and assist with ordering. This is an exciting opportunity for an energetic, entrepreneurial Culinary professional.
**Key Responsibilities:**
+ Assists the Executive Chef with managing cost controls and control expenditures for the account
+ Assists the Executive Chef with planning and creating menus
+ Produces and execute catering events
+ Rolls out new culinary programs in conjunction with Company marketing and culinary team
**Preferred Qualifications:**
+ A.S. or equivalent experience
+ Some progressive culinary/kitchen management experience, depending upon formal degree or training
+ Catering experience a plus
+ High volume, complex foodservice operations experience - highly desirable
+ Institutional and batch cooking experiences helpful
+ Comprehensive knowledge of food and catering trends with a focus on quality, production, sanitation, food cost controls, and presentation
+ Must be experienced with computers; to include Microsoft Office (Word, Excel and Power Point), Outlook, E-mail and the Internet
+ Must be willing to participate in client satisfaction programs/activities
+ ServSafe certified - highly desirable
**Apply to Flik today!**
_Flik is a member of Compass Group USA_
Click here to Learn More about the Compass Story ( Group is an equal opportunity employer. At Compass, we are committed to treating all Applicants and Associates fairly based on their abilities, achievements, and experience without regard to race, national origin, sex, age, disability, veteran status, sexual orientation, gender identity, or any other classification protected by law.**
**Qualified candidates must be able to perform the essential functions of this position satisfactorily with or without a reasonable accommodation. Disclaimer: this job post is not necessarily an exhaustive list of all essential responsibilities, skills, tasks, or requirements associated with this position. While this is intended to be an accurate reflection of the position posted, the Company reserves the right to modify or change the essential functions of the job based on business necessity. We will consider for employment all qualified applicants, including those with a criminal history (including relevant driving history), in a manner consistent with all applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the New York Fair Chance Act.**
Applications are accepted on an ongoing basis.
Flik maintains a drug-free workplace.
**Associates at Flik Hospitality are offered many fantastic benefits.**
+ Medical
+ Dental
+ Vision
+ Life Insurance/ AD
+ Disability Insurance
+ Retirement Plan
+ Paid Time Off
+ Holiday Time Off (varies by site/state)
+ Associate Shopping Program
+ Health and Wellness Programs
+ Discount Marketplace
+ Identity Theft Protection
+ Pet Insurance
+ Commuter Benefits
+ Employee Assistance Program
+ Flexible Spending Accounts (FSAs)
+ Paid Parental Leave
+ Personal Leave
Associates may also be eligible for paid and/or unpaid time off benefits in accordance with applicable federal, state, and local laws. For positions in Washington State, Maryland, or to be performed Remotely, click here ( for paid time off benefits information.
**Req ID:**
Flik Hospitality Group
Shane Tirpak
((req_classification))
Quality Assurance Manager
Posted today
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Job Description
About the Company:
Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcar e, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company.
Celltrion Healthca re provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world.
POSITION SUMMARY
Responsible for management of quality assurance department of Celltrion USA. Operate and maintain a quality system for the distribution of biopharmaceutical products, ensuring full compliance with Good Distribution Practice (GDP), including 21 CFR Part 210/211 or 21 CFR Part 820
KEY ROLES AND RESPONSIBILITIES
- Make decisions related to Quality issues in support of company’s business and operational objectives
- Report directly to the Quality Assurance Director routinely to ensure that Quality Assurance Director is adequately and timely informed of the status of the quality system
- Review and approve all quality activities, including review and approval of all quality system SOPs
- Review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the applicable requirements of the Quality System Regulation (QSR) as set forth under 21 C.F.R. Part 820 and CELLTRION USA's established quality policies, procedures, and objectives
- Ensure quality system procedures and instructions are established and maintained
- Provide quality compliance guidance and training to all staff on QMS SOPs and its applicable provisions
- Lead initiatives for the continuous improvement of the quality system and ensure that measurable results are achieved
- Stay current on industry best practices, trends, and relevant regulatory intelligence
- Provide regular communication across all divisions, including the marketing and sales organizations, regarding Quality System management for Good Distribution Practice(GDP)
- Manage routine quality meetings with staff and Celltrion’s Corporate QA team
- Collaborate with Celltrion’s Corporate QA team on the management of quality systems at Celltrion USA
- Conduct on-site or remote audits of Third-Party Logistics(3PL) sites and other services providers.
WORK EXPERIENCE
- 10+ years’ experience in quality assurance (QA) at a pharmaceutical company
- Prefer to have 3-5 years in a manager role in a biotechnology/LifeScience industry or specifically in the Good Distribution Practice (GDP) of biopharmaceutical products.
- Strong knowledge of Quality Management Systems(QMS) for the Good Distribution Practice (GDP) of biopharmaceutical products
SKILLS AND SPECIFICATIONS
- Excellent oral and written communication skills
- Recognized as a great listener, learner, and strategic contributor
- Proven management skills including communicating with executive management
- Experienced in the management of a regulated medical products company
EDUCATION
Bachelor's degree or above.
CORE COMPETENCIES
Ethics and Values
Regulatory Knowledge
Conflict Management
Problem Solving
Personal Learning
Action Oriented
Timely Decision Making
Organizational Agility
Drive for Results
Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
#LI-DD
Quality Assurance Tester
Posted 1 day ago
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Job Description
Responsibilities:
- Collaborate with implementation partners to define test scopes and align them with project milestones and timelines.
- Oversee defect management, resolution tracking, and regression testing to maintain system integrity.
- Develop and co-manage comprehensive test strategies, including test case creation, roles, responsibilities, and tool usage.
- Provide timely reporting on test results to consultants, workstream leads, and stakeholders, contributing to issue resolution.
- Maintain detailed records of test plans, issue logs, and resolutions using designated tools.
- Support data conversion, integration, and reporting teams by validating testing processes and outcomes.
- Coordinate and participate in core team and cross-functional meetings to communicate overall testing progress.
- Plan, schedule, and facilitate testing sessions while escalating critical issues to project leadership.
- Lead the development and prioritization of test cases, ensuring dependencies and outcomes are clearly defined.
- Collaborate with business users, workstream leads, and partners to ensure alignment across functional areas such as HR and Finance. Requirements - At least 6 years of experience with Workday HR and Finance, including 3 years as a testing lead.
- Hands-on expertise in testing Workday data conversions, integrations, reporting, and EIBs.
- Proven ability to lead testing efforts in higher education environments, including business processes, security, and automation.
- Familiarity with test management tools and methodologies, including end-to-end and cross-functional testing.
- Strong analytical, problem-solving, and communication skills.
- Experience in designing and executing test plans that ensure compliance with institutional security policies.
- Demonstrated ability to optimize test cases for reusability and efficiency.
- Knowledge of Workday functional areas such as Payroll and Financials, with a focus on testing methodologies. Technology Doesn't Change the World, People Do.®
Robert Half is the world's first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.
Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app ( and get 1-tap apply, notifications of AI-matched jobs, and much more.
All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.
© 2025 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking "Apply Now," you're agreeing to Robert Half's Terms of Use ( .
Quality Assurance Engineer
Posted 3 days ago
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Job Description
**Since 1989, SHI International Corp. has helped organizations change the world through technology. We've grown every year since, and today we're proud to be a $15 billion global provider of IT solutions and services.**
**Over 17,000 organizations worldwide rely on SHI's concierge approach to help them solve what's next.** **But the heartbeat of SHI is our employees - all 6,000 of them.** **If you join our team, you'll enjoy:**
+ **Our commitment to diversity, as the largest minority- and woman-owned enterprise in the U.S.**
+ **Continuous professional growth and leadership opportunities.**
+ **Health, wellness, and financial benefits to offer peace of mind to you and your family.**
+ **World-class facilities and the technology you need to thrive - in our offices or yours.**
**Job Summary**
The Quality Engineer is responsible for developing and implementing quality control processes to ensure product consistency and compliance, conducting audits, and collaborating with cross-functional teams to resolve quality issues. This role involves analyzing data to identify trends, leading root cause analysis, training employees, and driving continuous improvement initiatives to enhance product quality and operational efficiency.
**Role Description**
+ Develop and implement quality control processes to ensure product consistency and compliance.
+ Conduct regular audits and inspections of products and processes to identify areas for improvement.
+ Collaborate with cross-functional teams to address and resolve quality issues.
+ Analyze data from various sources to identify trends and recommend corrective actions.
+ Create and maintain documentation related to quality standards and procedures.
+ Train employees on quality control processes and best practices.
+ Lead root cause analysis and implement corrective actions for quality defects.
+ Monitor and report on key performance indicators related to product quality.
+ Ensure compliance with industry standards and regulations.
+ Drive continuous improvement initiatives to enhance product quality and operational efficiency.
**Behaviors and Competencies**
+ Adaptability: Can adjust to changes in the work environment, manage multiple tasks, and effectively handle uncertainty.
+ Analytical Thinking: Can apply critical thinking to analyze data, identify patterns, and make basic inferences.
+ Collaboration: Can actively participate in team discussions, respect differing opinions, and collaborate with others to achieve common goals.
+ Communication: Can effectively communicate complex ideas and information, and can adapt communication style to the audience.
+ Continuous Improvement: Can identify moderate areas for improvement and implement moderate changes.
+ Detail-Oriented: Can identify errors or inconsistencies in work and make necessary corrections.
+ Problem-Solving: Can identify problems, propose solutions, and take action to resolve them without explicit instructions.
+ Resilience: Can identify challenges, maintain a positive attitude, and take action to overcome them without explicit instructions.
+ Technical Expertise: Can apply technical knowledge and skills effectively in most situations, with occasional guidance.
+ Time Management: Can generally use time effectively and is working towards improving task prioritization and deadline management.
**Skill Level Requirements**
+ The ability to effectively utilize applications like Word, Excel, PowerPoint, and Outlook to enhance productivity and perform various tasks efficiently. - Basic
+ The capacity to manage, analyze, and draw insights from extensive and complex data collections. - Basic
+ Ability to oversee and direct projects to completion, ensuring goals are met, resources are utilized efficiently, and stakeholders are satisfied. - Basic
+ The capability to efficiently handle multiple tasks and adapt to rapid changes in a dynamic work environment. - Basic
+ Ability to read and interpret technical instructions/manuals, troubleshooting guides, and manufacturer specifications. - Basic
**Other Requirements**
+ Completed Bachelor's Degree or relevant work experience required
The estimated annual pay range for this position is $0,000 - 100,000 which includes a base salary. The compensation for this position is dependent on job-related knowledge, skills, experience, and market location and, therefore, will vary from individual to individual. Benefits may include, but are not limited to, medical, vision, dental, 401K, and flexible spending.
Equal Employment Opportunity - M/F/Disability/Protected Veteran Status
Quality Assurance Technician

Posted 16 days ago
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Job Description
Primo Brands is a leading branded beverage company in North America with a focus on healthy hydration. We are proud to offer an extensive and iconic portfolio of highly recognizable, sustainably sourced, and conveniently packaged branded beverages distributed across more than 150,000 retail outlets.
**If you are a current associate of Primo Brands, please apply via myADP or Success Factors.**
**Factory Location:** Jersey City, NJ
**Compensation:** $32.00/hour
**Shift differential:** 6%-8% of base hourly rate paid for applicable hours worked
**Schedule:** 12-hour shifts on a rotating schedule / 2,2,3
5:00am to 5:00pm, A Shift
Ability to work holidays and weekends per business needs
**Benefits:** Medical, prescription, dental, vision, life, and disability insurance, 401(k) with match, company discounts, paid vacation, and much more! Employees are eligible for benefit election on day 1 of employment
Responsibilities
**Key responsibilities include but are not limited to the following:**
-Accountable for Quality KPIs such as First Time Right, non-conforming product reduction, and consumer complaint reduction.
-Ensure compliance with Primo Brands quality policies and systems.
-Accountable for quality systems such as the Quality Monitoring Scheme, Food Safety Plan, FSSC 22000, Good Manufacturing Practices, Traceability, and Sensory.
-Key process management and maintenance as required but not limited to release of raw materials, process release, finished product release, Holds, investigation & troubleshooting, auditing, calibration & verification, training, record keeping, sample collection, and support of changeovers.
-Support manufacturing, warehouse, production sanitation, tanker, microbiology, chemistry, sensory, technical, and other areas as needed (not limited to shelf-life samples, COP for parts, communication, and troubleshooting, etc.)
-Work safely and is knowledgeable of the chemical hazards and SDSs.
-Onsite and offsite water chemistry testing.
-Basic water management including adjusting for monthly water usage, flushing boreholes, monitoring silo levels.
-Filter management including pressure differentials, change outs for sources and lines, and troubleshooting.
-CIPs/Sanitation of water process equipment and tankers.
-Maintains quality systems and documentation; develops/updates SOPs as needed.
-Other duties as required.
Qualifications
**Requirements/Qualifications:**
-College level education preferred or relevant experience.
-Prior experience performing basic laboratory procedures. Knowledge of microbiological techniques such as preparation of media, reading and interpreting microbial growth.
-Exposure to Quality Assurance or Production in a food or beverage processing facility.
-Solid communication and interpersonal skills with experience working in a team-based environment.
-Ability to interact with various internal contacts to manage the flow of work.
-Understanding of Good Manufacturing Practices and HACCP principles.
-Computer skills with knowledge of Microsoft applications, SAP experience is a plus.
-Focus on safe work practices and high quality while executing duties with a sense of urgency.
-Strong organizational, data analysis, and record keeping skills as well as acute attention to detail are necessary.
-Flexibility and the desire to work in a fast-paced factory environment are critical for success.
-Ability to work self-directed and with a team to support Quality goals.
-Auditing Skills.
-CIP and cleaning systems knowledge.
-Must be self-managed and efficient when performing work unsupervised.
-Be able to work flexible schedule as determined by business needs.
-Must be proactive in finding solutions to problems and issues as they arise.
-Communicate effectively with various support groups, supervisors, and team members.
-Able to read, interpret and analyze computer generated reports.
Director Quality Assurance Quality Control
Posted today
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Job Description
QA/QC Director – Fairfield, NJ
Summary:
The QA/QC Director is primarily responsible for the development and implementation of quality management systems. Establishing quality standards and procedures as well as monitor compliance and regulatory requirements.
Responsibilities
- To ensure that the production facility is operating at a high operational and compliance standard.
- Lead, coach and manage a team of chemists to ensure data integrity and performance to meet business objectives
- Monitor each department’s operations to ensure that all procedures are being adhered to and that only approved products or services are being delivered to the company’s clients.
- Oversee the entire department, ensuring that proper procedures are being followed when approving each product or service.
- Ensure that deadlines are met
- Train and develop colleagues
- Assist employees to solve problems, using quality management techniques
- Consult with the quality managers and other personnel to design quality strategies and goals for the department, which will be implemented by employees
- Help to promote the implementation of quality systems throughout the company
- Develop and implement policies relating to all operations in accordance with company objectives. Ensure these policies are adhered to by personnel under your supervision and that appropriate records are kept for future reference
- Keep management informed on product quality and any concerns that may influence this measure, such as complaints from customers or suppliers, etcetera
- Other duties assigned by Management
Education:
- Bachelor’s degree in a scientific discipline with a minimum of 10 years’ experience in quality management
Experience Requirements:
- Experienced with liquid manufacturing and packaging of Rx products.
- Experience with Empower 3
- Experience working in an FDA regulated environment
- Experience with ANDA and NDA submissions
- Experience with validations of processes, cleaning, analytical methods, facilities and equipment
- Knowledge of CFR & ICH Regulatory Guidelines
- Knowledge of cGMP processes and GDP.
Computer Skills:
- Microsoft Word
- Microsoft Excel
- Empower 3
Other Requirements:
- Has significant technical knowledge of quality management principles.
- In depth knowledge of all laboratory equipment, practices, and procedures
- Ability to think logically and independently
- Demonstrated managerial abilities
- Problem analysis, solving and resolution skills
- Has excellent oral and written skills
- Has excellent interpersonal skills
- Is self motivated
- Has a very high attention to detail
- Has a positive attitude
- Must speak, read, and write in English
Quality Assurance Engineer II

Posted 1 day ago
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Job Description
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The **Quality Assurance Engineer II** will provide Quality compliance support on all aspects of the Plainsboro, NJ CMC Quality System. The Quality Assurance Engineer II will monitor, prioritize and track the timely closure of NCs and CAPAs for the Plainsboro Plant facility, participate in problem solving teams, and participate from a Quality Engineering & Quality Systems and Plant perspective on the launching of new or improved products/processes. He or She will act as a Quality Reviewer for NCs and CAPAs, in addition to being responsible for the quality efforts in other areas of the NC/CAPA system, including Complaints. Monitor, prioritize and track the timely closure of NCs, CAPAs and Complaints for the Plainsboro Plant facility Facilitates the development, implementation and monitoring of quality programs and policies that ensure that the development, manufacture and distribution of medical products is in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 9001, ISO 13485, the Medical Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.
The QA Engineer II will collaborate with site NC investigators and CAPA owners from cross-functional areas to facilitate timely and effective closure of all Quality System records. The QA Engineer II will provide guidance to both technical and non-technical cross functional resources on how to conduct effective investigations and corrective actions, and will troubleshoot, escalate, to aid in resolving all product and/or process quality issues.
**ESSENTIAL DUTIES AND RESPONSIBILITIES**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to:
+ Performs Quality and technical review of Nonconformance investigations (NCs) and CAPAs within defined timeframes. Ensures investigations and root cause analysis are accurate and complete
+ Maintain an accurate log of Non-Conformances and CAPAs activities. Tracks, follows-up and assists in the timely closure of NCs/CAPAs.
+ Provides hands-on guidance and training to all personnel performing activities within the Quality system.
+ Ensure documentation is complete before closure.
+ Assist Quality Systems team as needed to investigate Nonconformances and ensure proper implementation of CAPAs.
+ Prepare monthly and quarterly metrics to present at Quality Review meetings.
+ Maintains a thorough understanding of the following regulations and guidelines: U.S. Food and Drug Administration (FDA) regulations, ISO 9001, ISO 13485, Medical Device Directive (MOD), the Canadian Medical Device Regulations (CMDR), Integra Corporation's policies and procedures, and other applicable regulatory agency requirements.
+ Interact and coordinate activities with other departments, external vendors and customers.
+ Perform other Quality Systems related duties as required.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill and/or ability required for his position.
+ Education: Bachelor's Degree in Science (Biology, Chemistry) or Engineering (Biomedical, Mechanical, Chemical, or Electrical)
+ Experience: 3 to 6 years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing.
+ Demonstrates knowledge of investigations, root cause analysis, quality systems, the CAPA system and technical writing.
+ Demonstrates excellent organizational and communication skills.
+ Proficient with the MS Office Suite, and statistical software.
+ Must be able to work independently with minimal supervision.
Salary Pay Range:
$71,300.00 - $97,750.00 USD Salary
Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training **.** In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation **.** Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law ( | EOE including Disability/Protected Veterans ( LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA ( . If you have difficulty using our online system due to a disability and need an accommodation, please email us at
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.
Integra - Employer Branding from Integra LifeSciences on Vimeo (
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Director, Quality Assurance Operations
Posted 8 days ago
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Job Description
Quality
**Job Sub** **Function:**
Quality Assurance
**Job Category:**
People Leader
**All Job Posting Locations:**
Raritan, New Jersey, United States of America
**Job Description:**
Johnson & Johnson Innovative Medicines is recruiting for the Director, Quality Assurance Operations- CAR-T Manufacturing. This position will be based in Raritan, NJ.
_At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Johnson & Johnson Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiopulmonary, and retina. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it._
Johnson & Johnson and Legend Biotech USA Inc, have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.
**Position Summary:**
The Director, Quality Assurance Operations, Raritan CAR-T leads and handles all aspects of Quality Operations in support of the Raritan CAR-T manufacturing site, in full compliance with established cGMP, J&J and JSC requirements. Functions and activities include Quality oversight of QA Incoming, QA Shop Floor, Batch Record Review, Drug Product Release, Cryopreservation, Lenti, and QCBB production facilities. Manages a team of people leaders and technical professionals within the QA based on assigned work, direction, mentoring and developing capabilities. Develops and implements long-term strategies, and execution of Quality programs.
We are seeking a dynamic and experienced Director, Quality Operations to join our team at Raritan CAR-T. In this pivotal role, you will be responsible for driving the Quality Operations strategy for our site, ensuring that all quality standards are met and maintained throughout our operations. The ideal candidate will possess strong leadership skills, a deep understanding of quality management systems, and a commitment to excellence in delivering safe and effective therapies to patients.
**Key Responsibilities:**
+ Develops, implements and drives a comprehensive Quality Operations strategy, aligned with site goals.
+ Leads the establishment and execution of quality objectives and key performance indicators (KPIs) that drive continuous improvement and operational excellence.
+ Proactively identifies recurring trends and implements a Right First Time program in collaboration with manufacturing and QC operations to reduce deviations and improve efficiency.
+ Ensure effective risk management practices are in place, including identification, assessment, and mitigation of quality-related risks. Provides leadership and direction to the Quality and Site Management Teams to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model.
+ Develops and champions an interpersonal culture that promotes behaviors that lead to outstanding business performance and organizational excellence.
+ Ensure effective risk management practices are in place, including identification, assessment, and mitigation of quality-related risks.
+ Responsible for appropriately staffing and developing the Quality Operations organization to meet budget and succession plans.
+ Leads launches of new products and technologies. Participates in product stage gate reviews representing Raritan site Quality Assurance.
+ Partners with the Compliance Team to prepare for and support Health Authority inspections at Raritan. Leads and hosts compliance audits. Serves as SME for QA operations to support all regulatory inspections.
+ Lead initiatives focused on process optimization, data-driven decision-making, and the application of quality improvement methodologies (e.g., Six Sigma, Lean).
+ Monitor industry trends and emerging best practices to innovate and enhance quality processes within the organization.
+ Ensures that all external customer complaints and internal complaints from affiliates are handled, evaluated and investigated in timely and effective manner, in conformance with cGMP's, Janssen Supply Chain Policies and Procedures.
**Qualifications - External**
**Education:**
A minimum of a bachelor's degree in Science is required, preferably in Biology, Microbiology, Chemistry, Pharmacy, Biochemistry, Chemical Engineering or related Science or Engineering.
**Required:**
+ Demonstrated experience building and leading exceptional Quality Assurance teams.
+ A minimum of 10 years relevant work experience, with 5 of those years managing a team of senior leaders and professionals within Quality Assurance.
+ Experience with implementing and coordinating GMP operations in a commercial manufacturing facility.
+ Experience leading process optimization initiatives, data-driven decision-making, and the application of quality improvement methodologies.
+ Monitor industry trends and emerging best practices to innovate and enhance quality processes within the organization.
+ Knowledgeable of Quality Risk Management concepts.
+ Experience in regulated environment (FDA, EMA) and other worldwide regulatory agencies and regulatory inspections.
+ Comfortable speaking and interacting with inspectors and senior leadership
+ Excellent communication, interpersonal relation, presentation, collaboration, and influencing skills.
**Preferred:**
+ Significant experience with Advanced Therapies is preferred.
**Other:**
+ This position may require up to 10% domestic travel
+ This position has an estimated annual salary of $146,000-$51,850 USD$< r>Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
_Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation,_ **_external applicants please contact us via_** **_ **_. internal employees contact AskGS to be directed to your accommodation resource._**
**The anticipated base pay range for this position is :**
146,000- 251,850 USD$< r>Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below.
Quality Assurance Engineering - Advisor

Posted 8 days ago
Job Viewed
Job Description
We're Fiserv, a global leader in Fintech and payments, and we move money and information in a way that moves the world. We connect financial institutions, corporations, merchants and consumers to one another millions of times a day - quickly, reliably, and securely. Any time you swipe your credit card, pay through a mobile app, or withdraw money from the bank, we're involved. If you want to make an impact on a global scale, come make a difference at Fiserv.
**Job Title**
Quality Assurance Engineering - Advisor
**About your role:**
As a Quality Assurance Engineering - Advisor I, you will play a critical role in ensuring the highest standards of quality and performance for our software products. Your in-depth expertise will help shape the quality assurance processes and frameworks, ensuring that our solutions are reliable and meet the needs of our clients. You will work closely with development and product teams, identifying issues and implementing best practices to drive continuous improvements in our QA operations. This role offers the opportunity to make a significant impact on the quality of our products and the overall user experience.
**What you'll do:**
+ Lead the execution of detailed quality assurance testing for complex software products.
+ Develop and implement comprehensive test strategies and plans.
+ Identify, report, and track software defects to resolution.
+ Collaborate with development and product teams to improve quality practices.
+ Mentor and guide junior QA team members to ensure adherence to best practices.
+ Participate in continuous improvement initiatives within the QA team.
+ Responsibilities listed are not intended to be all-inclusive and may be modified as necessary.
**Experience you'll need to have:**
+ 6+ years of experience in software quality assurance
+ 3+ years of experience in automation testing
+ 3+ years of experience in performance testing
+ 3+ years of experience in Agile methodologies
+ 6+ years of an equivalent combination of educational background, related experience, and/or military experience
**Experience that would be great to have:**
+ Experience with automated testing tools
+ Knowledge of continuous integration and continuous deployment (CI/CD) tools
+ Familiarity with security testing practices
+ Understanding of software development lifecycles
+ Certification in software testing methodologies
**Salary Range**
$100,000.00 - $165,600.00
_These pay ranges apply to employees in New Jersey and New York. Pay ranges for employees in other states may differ._
It is unlawful to discriminate against a prospective employee due to the individual's status as a veteran.
For incentive eligible associates, the successful candidate is eligible for an annual incentive opportunity which may be delivered as a mix of cash bonus and equity awards in the Company's sole discretion.
Thank you for considering employment with Fiserv. Please:
+ Apply using your legal name
+ Complete the step-by-step profile and attach your resume (either is acceptable, both are preferable).
**Our commitment to Equal Opportunity:**
Fiserv is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, gender, gender identity, sexual orientation, age, disability, protected veteran status, or any other category protected by law.
If you have a disability and require a reasonable accommodation in completing a job application or otherwise participating in the overall hiring process, please contact . Please note our AskHR representatives do not have visibility to your application status. Current associates who require a workplace accommodation should refer to Fiserv's Disability Accommodation Policy for additional information.
**Note to agencies:**
Fiserv does not accept resume submissions from agencies outside of existing agreements. Please do not send resumes to Fiserv associates. Fiserv is not responsible for any fees associated with unsolicited resume submissions.
**Warning about fake job posts:**
Please be aware of fraudulent job postings that are not affiliated with Fiserv. Fraudulent job postings may be used by cyber criminals to target your personally identifiable information and/or to steal money or financial information. Any communications from a Fiserv representative will come from a legitimate Fiserv email address.
Quality Assurance Field Engineer

Posted 16 days ago
Job Viewed
Job Description
The Field Quality Assurance Engineer will be directly responsible for the investigation and resolution of quality and wireless connectivity issues for Panasonic Connect North America (PCONA) Mobility customers, providing support at customer locations and remotely, achieving the PCONA Quality Assurance and Compliance Department established SLAs, and ensuring that all compliance regulations and policies established for PCONA products and 3rd party products supported by Panasonic are implemented.
**Responsibilities**
At Panasonic Connect, we connect the power of people and technology to change work, advance society and help connect to tomorrow. Empathy, results, relentlessness and teamwork are the foundations of the Panasonic Connect Culture. Our mission is to elevate the employee experience by empowering individuals to use their voice and have a positive impact on our business.
Watch this video ( to learn about Panasonic Connect and see how we connect talent to opportunity. Come join our journey!
**What You'll Get To Do:**
The Quality Assurance Field Engineer will be directly responsible for the investigation and resolution of quality issues for Panasonic Connect North America (PCONA) Mobility customers, providing support at customer locations and remotely, achieving the quality department established SLAs, and ensuring that all compliance regulations and policies established for PCONA products and 3rd party products supported by Panasonic are implemented.
The Quality Assurance Field Engineer will also be responsible for advising and communicating with customers on the technical aspects of their implementations as they interact with PCONA Mobility products, provide training and guidance to customers and authorized service providers, support quality investigations working as a team with other engineering groups, and act as a catalyst for change and improvement in performance and quality; with the objectives of maximizing Customer satisfaction and Company profitability.
**Key Accountabilities** **:**
**Execute on-site and remote investigation, testing, and resolution of quality and wireless issues reported by customers for PCONA Mobility products**
+ Investigate, evaluate, test countermeasures, and provide final closure and satisfaction follow-ups for quality and wireless issues by working on-site and remotely with customers
+ Work with PCONA and MSBD engineering managers to effectively communicate customers' status, needs, and requests for the agile and effective resolution of quality and wireless issues, maintaining the focus on customer satisfaction
**Support the creation of technical materials and training on the execution of technical processes and procedures for Customers and Partners**
+ Create technical documents, guides, manuals, and addendums that support the resolution of quality issues and the improvement of configuration and repair processes
+ Training of customers and partners on the execution of technical processes and procedures to assure compliance, performance, and quality
**Support the resolution of post-launch quality issues for all PCONA products/3** **rd** **Party solutions.**
+ Execute the processes required for the investigation, root cause analysis, and countermeasure actions for all Quality Issues
+ Manage the Quality Issues ticketing system to ensure all communications and activities are handled in a timely manner according to the established processes between PCONA and multiple factories
**What You'll Bring**
**Education & Experience** :
+ B.S. in Mechanical, Electrical, or Software Engineering required
+ Minimum 8 years of Engineering experience, preferably in Field Service and/or Product Engineering roles. 5+ years preferred
+ Demonstrated project management experience through the successful initiation, planning, execution, monitoring, and closing of projects. Experience with project management tools like Microsoft Project or Smartsheet is preferred. PMP or Six Sigma certifications are preferred.
+ Proven experience supporting the investigation and resolution of technical issues at Customers' locations through field engineering engagements.
+ Proven experience in the successful resolution of quality issues through technical information gathering, issue reproduction, root cause analysis, and development and acceptance of suitable countermeasures.
+ Proven ability to lead complex business Customer engagements, up to the determination and approval of customer satisfaction countermeasures. **Problem Solving** **:**
+ Strong analytical and problem-solving skills
+ Strong customer environment assessment capabilities
+ Ability to create, follow, and promote organized and thorough technical troubleshooting policies
+ Strong time management, priority allocation, and task management skills **Communication** **:**
+ Strong presentation skills focused on the explanation of complex technical processes and issues to both internal and external stakeholders
+ Strong written and oral communication skills, with the ability to interface effectively and professionally with all organizational levels and management, internally and externally, are required and essential to success in this position, and in PCONA activities, in general
+ Strong interpersonal skills to interact with customers and team members
+ Capability in effective communication with internal departments (Factories, Technical Support, PMO, Sales, Product Teams, Spare Parts, Engineering, Order Processing, Accounting, etc.) **Other Requirements** **:**
+ Ability to travel 70% of the time, domestically and internationally
+ Ability to work independently and as part of a team
**What We Offer:**
+ High Performance Culture
+ A focus on Diversity, Equity and Inclusion
+ Teamwork and Collaboration
+ Rewards and Recognition
+ Learning & Development Opportunities Across Multiple Business Units
+ Competitive compensation packages
+ Hybrid work model
+ Comprehensive benefits
+ Paid Parental Care Leave
+ Educational Assistance
+ Volunteer time off
+ Total Well Being Program
+ Employee Referral Program
_Panasonic is proud to be an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sex, sexual orientation, national origin, disability status, protected veteran status, and any other characteristic protected by law or company policy. All qualified individuals are required to perform the essential functions of the job with or without reasonable accommodation. Pre-employment drug testing is required for safety sensitive positions or as may otherwise be required by contract or law. Due to the high volume of responses, we will only be able to respond to candidates of interest. All candidates must have valid authorization to work in the U.S. Thank you for your interest in Panasonic Corporation of North America._
+ #LI-BP1
+ #LI-REMOTE
**The salary range below is just one component of Panasonic Connect's total package. Actual compensation varies depending on the individual's knowledge, skills, and experience. This role may be eligible for discretionary bonuses and incentives.**
**Salary Range**
85,000- 120,000 + Bonus REQ-