Quality manager jobs in Trenton, NJ

This position will lead and participate in projects for the integration of new products into systems that impact the US Pharm Local Operating Company (LOC) and Deliver organizations. Open to candidates located in Horsham PA or Titusville NJ. Responsibilities: Key responsibilities include, but are not limited to: Projects (100%) Provide project leadership and support related to quality systems for US Pharm CQ and US Deliver initiatives. Complete GMP documentation to ensure compliance. Track completion of project deliverables. Coordinate and collaborate with project team members. Propose process improvements. Provide routine project updates. Perform additional tasks as needed to support project deliverables. Others: Execute compliance activities on behalf of team leadership, including but not limited to the creation and revision of regional and local procedures and/or work instructions. Escalate appropriate issues to management. Make quality decisions based on assessments of compliance risks, balanced with overall business needs. Drive strategic initiatives for both CQ and distribution centers. Ensure strategies are implemented and closed out in a compliant and timely manner. Experience: Minimum of 3 years' experience in the Medical Device, Pharmaceutical, or Consumer Products industry. Experience working in a highly regulated industry. Proven experience leading projects and influencing team members to achieve results without direct supervision. Strong written and verbal communication skills, with the ability to take initiative independently as well as collaborate as part of a team. Demonstrated problem-solving, decision-making, data analysis, inductive reasoning, critical thinking, and root cause analysis skills. Excellent communication and presentation skills. Strong change management, collaboration, and influencing skills to effectively partner across functions. Ability to work under tight timelines and maintain customer focus. Must be able to manage and provide leadership across multiple sites. Advanced proficiency in PowerPoint and Microsoft Excel, including VLOOKUPs and pivot tables. Demonstrated flexibility to handle complexity and multiple initiatives. Proven ability to successfully partner and collaborate with business partners outside of Quality. Experience interpreting compliance requirements and regulations. Preferred Skills and Experience: Project Management certifications. Understanding of FDA 21 CFR Part 210, 211, ISO 9001 and/or ISO 13485. Understanding of Installation Qualification, Operational Qualification, Process Qualification (IQ, OQ, PQ), and associated report writing. Familiarity with Comet. Skills: Project Management Biomedical Industry Pharmaceutical Regulatory Compliance Education: Bachelor's/University degree. About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ************************ US Tech Solutions is 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, disability, or status as a protected veteran. Recruiter Details: Name: Azhar Email: **************************** Internal Id: 25-53768

JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Job Title: Sr Quality Specialist - Cell Therapy Mfg./Pharma Duration: 12 Months Pay Rate: Hourly on W2 ONLY - NO C2C 50% onsite required Work Schedule: Mon-Fri(normal business hours) Position Summary: This position is intended to increase compliance with data quality related activities associated with the addition of new fields in SQM and initial migration of data. In addition, ensure supplier records and associated record relationships are complete and accurate. Duties/Responsibilities The position holder is responsible and accountable for the tasks given below (non-exhaustive list): Request supplier objects and complete SQM records for vendors and materials supporting Cell Therapy manufacturing. Create and manage supplier-related change controls associated with supplier and material qualification, data governance and quality type changes, as needed. Evaluate Quality Agreements and audit documentation to ensure proper linkages to the appropriate supplier records within the SQM system and correct gaps/inaccuracies. Cleanse metadata in source documents (BMSDocs) for supplier related records (materials and service providers). Work with stakeholder groups to identify and populate teams, and the lead oversight groups for each GMP/GDP supplier object/profile in SQM to ensure accountability and compliance. Complete transition of material qualifications from heritage forms to current forms. Complete materials qualification transactions in SQM Module. Reporting Relationship Role is an individual contributor reporting to the project lead. Qualifications: Required Bachelor's degree in science, or a related field. 5+ years of experience in a GMP pharmaceutical, biopharmaceutical, or Advanced Therapeutic Modality Products (ATMP) environment including previous QA experience e.g., QA compliance role, Supplier Quality oversight. 2+ yrs experience with supplier management & oversight, material qualification, governance frameworks, and performance metrics. 3+yrs knowledge and experience with core quality processes - including change control, deviations/OOS, CAPA management, investigations. Thorough knowledge of cGMP in the pharma/Biotech industry as well as FDA, EU, and JP regulatory requirements, ICH guidelines. Knowledge of cell therapy manufacturing processes and testing is a plus. Skilled in planning and organizing, building relationships, innovation management and resource allocation. Ability to make independent and objective decisions and to work under minimal supervision with cross functional teams and partners worldwide. Team spirit. Action-oriented and customer-focused. Negotiation and persuasion skills. Good knowledge of common office software. Good verbal and written communication skills in English. Travel- 5% required to other NJ locations nearby

Traveling Energy Marshal - Mission Critical Construction The Traveling Energy Marshal is responsible for overseeing the safety and quality of electrical installations in mission critical construction projects. This role involves traveling to various job sites to ensure compliance with safety standards, quality control measures, and electrical regulations, ultimately ensuring that all work meets the rigorous demands of data center environments. Key Responsibilities Conduct on-site inspections of electrical installations to ensure adherence to NFPA 70E and other safety regulations. Implement quality control processes to monitor the standard of work on construction sites. Collaborate with project managers and construction teams to address safety and quality concerns. Provide training and guidance to site personnel on safety practices and quality standards. Review project plans and specifications to identify potential quality issues before they arise. Maintain accurate documentation of inspections, findings, and corrective actions taken on-site. Qualifications Proven experience in electrical work, particularly in mission critical environments such as data centers. Strong knowledge of safety regulations including NFPA 70E and construction safety practices. Experience with quality control processes and methodologies in construction. Ability to work independently and travel frequently to various job sites. Excellent communication and teamwork skills to effectively collaborate with diverse teams. Certifications in electrical safety and construction management are a plus. Email Your Resume In Word To Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also: alec.grice@cybercoders.com Please do NOT change the email subject line in any way. You must keep the JobID: linkedin : AG21-1854587 -- in the email subject line for your application to be considered.*** Alec Grice - Sr. Executive Recruiter For this position, you must be currently authorized to work in the United States without the need for sponsorship for a non-immigrant visa. This job was first posted by CyberCoders on 05/29/2025 and applications will be accepted on an ongoing basis until the position is filled or closed. CyberCoders is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable state and local law, including but not limited to the Los Angeles County Fair Chance Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act. CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. Individuals needing special assistance or an accommodation while seeking employment can contact a member of our Human Resources team at Benefits@CyberCoders.com to make arrangements.

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

Holtec Advanced Manufacturing Division in Camden, NJ is seeking a highly motivated and experienced Quality Manager to lead and oversee all aspects of quality assurance and control within our precision manufacturing operations. This role is critical to ensuring that all products meet internal standards and customer specifications, while driving continuous improvement across processes and systems. The Quality Manager will be responsible for developing and implementing quality strategies, managing inspection and testing activities, supporting regulatory compliance, and leading a team of inspectors and quality engineers. This position requires strong leadership, technical expertise in manufacturing quality systems, and the ability to work collaboratively across departments. This role is critical to ensuring that all products meet internal standards and customer specifications, while driving continuous improvement across processes and systems. Specific Areas of Responsibility: Lead the development, implementation, and maintenance of the division's Quality Management System (QMS). Oversee inspection and testing activities, including NDE, dimensional inspection, and final product verification. Ensure compliance with applicable industry standards (e.g., ASME, ISO 9001, NQA-1) and customer requirements. Manage internal and external audits, corrective actions, and continuous improvement initiatives. Collaborate with engineering, production, and supply chain teams to resolve quality issues and improve processes. Develop and monitor key quality metrics and provide regular reports to senior leadership. Supervise and mentor quality inspectors and engineers, fostering a culture of accountability and excellence. Support qualification and certification programs, including SNT-TC-1A for NDE personnel. Maintain documentation and records in accordance with regulatory and company standards. Represent the quality function in customer and regulatory audits and surveillance as needed. Work directly with Production to assure the highest quality product is provided. Manage the Quality Engineer personnel, including calibration, nonconformances, quality records, training, purchase order reviews, material receipt inspection and release, internal surveillances, and vendor surveillances. Manage the Quality Control personnel, ensuring training and qualifications are completed and up to date, and inspection support is provided for Production. Minimum Requirements: Bachelor's degree and three years of quality assurance related work; or high school diploma and seven years of quality assurance related work; or ten years of quality assurance related work. Experience and training in corrective action analysis including root cause and apparent cause investigations. Experience in the preparation of procedures. Strong management and supervisory skills. Knowledge of applicable codes including, but not limited to, 10CFR21; 10CFR50 Appendix B; NQA-1; ISO 9000 and ASME Section III & Section VIII. Minimum of three years of experience in a manufacturing environment. Optional Additional Qualifications: Demonstrated leadership skills with the ability to motivate and guide teams. Strong interpersonal and communication skills to interact effectively across departments. Proficiency in inspection techniques and quality tools. Knowledge of NDE methods and inspection equipment. Qualification requirements aligned with SNT-TC-1A standards for NDE personnel. Ability to coach and develop team members in quality and inspection practices. Salary Range: $90,000 - $115,000 Annually Holtec International offers a competitive benefits package to eligible associates, which includes: Medical, dental, and vision insurance 401(k) retirement plan with company match Paid time off and 11 Paid Holidays Company-paid life and AD&D insurance Employee Assistance Program Wellness resources and voluntary benefits Training and educational assistance As a technology trailblazer and a prominent innovator in clean energy (nuclear and solar) industry, Holtec strives to foster a meritocratic work environment conducive to continuous learning and professional growth of its associates. Holtec is an equal opportunity employer with a long-standing commitment to social equity and environmental justice. The company gives special preference to disabled veterans as a part of its recruitment policy. Detailed information on the Company can be obtained by consulting the website: holtecinternational.com.

The Director Quality Assurance is accountable for driving quality assurance activities and managing resources to ensure compliance with FDA and other applicable health authority and regulatory requirements. In addition, the Director Quality Assurance provides strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities. Finally, the Director, Quality Operations promotes a culture of quality and compliance through effective leadership and demonstrating Bora's core values. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Functional Leadership Provide leadership across Quality Assurance with the primary objective of ensuring the products manufactured at the site are safe and are manufactured in compliance with regulatory requirements. Functional areas of responsibility include: · Lot Release and Disposition · Deviation and CAPA Management · Non-Conformance Management · Regulatory Compliance · Inspection/Audit Management Facilitate the Quality Management System, including the Quality Manual, and provide an on-going assessment of QMS effectiveness via monthly Quality Management Review meetings with cross-collaboration from each function. Monitor programs / processes for efficacy and recommend improvements. In partnership with the Quality Site Head, recommend measures for the Cost of Quality / Cost of Poor Quality (COQ/COPQ) and provide routine status reports to management. Monitor and implement quality improvement efforts for greater efficiency and compliance with applicable cGMP regulations. This may include leading system / process engineering or redesign efforts. Provide direction to the Quality Management Review process, including analysis and reporting of Quality System performance metrics Identify potential compliance gaps and improvement opportunities to ensure effective Inspection Readiness. Facilitate the internal audit program, including oversight of audit schedules, plans, and follow-up according to internal procedures, regulatory guidance / expectations, and auditing best practices in alignment with compliance policies and standards. Partner with Project Management to strengthen the Client Quality Agreement (QTA) process to ensure consistency with expectations that enhance overall client relationships. Provide oversight to the GMP training team to assure direction to assure specific GMP job functions aligned to s for assigned training. Provide oversight to the regulatory inspection team who are responsible for coordination of activities for regulatory inspections (announced or unannounced), reviewing / preparing documentation demonstrating prior commitments were met, identifying areas of potential vulnerability and communicating / mitigating accordingly, and managing logistics for hosting an audit / inspection. Coordinate response activities following regulatory inspections including drafting responses, periodic updates (as required), and ensuring adequate follow-up on suggestions for improvement (e.g. FDA EIR notes, recommendations, etc.) within the site quality system. In partnership with the Director, Project Management, ensure the Client Audit Program schedules, audit activities and communications to audit response letters are complete. Provide input to regulatory inspection responses to ensure systemic, comprehensive solutions address root causes and prevent recurrence. Accountable to ensure that all products, services and validation activities comply with corporate quality standards and regulatory requirements; and are consistent with the overall business strategy of the company. Establish operational plans containing specific objectives that are fully aligned to Strategic and Divisional Operational Plan goals. Contribute to the development of quality strategic initiatives, and communicate quality strategies, key quality concepts and regulatory requirements effectively to all levels of the organization. Accountable for the implementation of quality standards through establishment of effective quality processes, Standard Operating Procedures, quality metrics and protocols for manufacturing operations. Accountable for the management and execution of quality and compliance systems (e.g. site compliance audit program, local execution and coordination of global SQM program; development and maintenance of CMO quality agreements; coordination of compliance programs with Global Quality and data integrity). Accountable for Quality Risk Management and stability programs. Responsible for ensuring completion of all GMP commitments to regulatory authorities. Responsible for the creation and management of the department's annual budget. Harmonizes key business processes. This includes developing global templates, work instructions, SOPs and/or standards whenever possible. Champion change to productively create continuous improvement opportunities to improve quality systems effectiveness and efficiency and reduce or prevent regulatory compliance risk. Partner with the manufacturing team on operational initiatives and development projects. Drive the investigation process and communicate with other departments during high-level crisis situations, applying strong problem-solving skills. Draws on technical expertise to judge impact on project quality and sets appropriate course of action such as setting priority and direction. Ensure a safe and productive workplace for team members, premises and equipment. People Leadership Develop, coach, and mentor team members to achieve organizational goals and business excellence. Optimize resources and build team effectiveness to create efficiencies and synergies. Demonstrate accountability and promote core values through leading the team by example in overcoming challenges to key deliverables. Lead the quality team through hiring, assessing, training and developing talent. Responsible for executing succession planning for the department. External Stakeholders Act as the negotiator with regulatory agencies on quality related matters, involving and coordinating with the business to maintain, resolve or improve company's compliance standing. Advocate for the customer and influence senior management on critical customer issues. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS Bachelor's degree in Science, Pharmacy, Engineering, or related field. A Master of Science Degree would be considered an asset. A minimum of ten (10) years in a senior management position in Quality or Regulatory. Proven ability to independently manage issues regarding regulatory compliance, product acceptability, risk assessment and functional operations. Ability to maintain an enterprise mindset and to apply an organizational lens to departmental decision making. Excellent communication, negotiation, interpersonal skills, management and organizational acumen. Demonstrate a strong commitment to teamwork, empowerment and innovation to drive performance. Ability to build, maintain and navigate relationships with stakeholders at all levels of the organization, such as negotiating with stakeholders and influence senior level leaders regarding matters of significance to the organization. Translate technical details, regulatory and quality standards and business judgment into concrete requirements and actionable priorities. Navigate decision making through the lens of cycles of cause and effect analysis, corrective actions and prevention. Compensation Range: $162,233.00 - $243,350.00 Bora Pharmaceuticals Injectables, Inc. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals Injectables, Inc. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions * Independently conduct audits * Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits * Facilitate Sponsor health authority inspections of global clinical facilities and study sites * Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs * Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. * May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements * Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. * 5+ years of experience in GCP auditing. * Substantial experience in inspection management. * Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. * Demonstrated ability to operate and influence decision-making processes * Effective communication skills * Successful track record of supervising employees and managing cross-cultural differences * Technical and administrative capabilities to independently carry out routine, complex and for-cause audits * Knowledge of data integrity controls and systems quality for clinical area * Strong analytical skills and report writing skills * Experience with GxP systems including computer system validation and associated regulations, recommended. * Ability to Travel (approximately 20%) * Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

Job Description Bridgeway is seeking a Director, Quality Assurance to join our Technology team. The Director, Quality Assurance leads the QA function to ensure delivery of high-quality software products that meet business, regulatory, and customer requirements. This role manages Automation Engineers and QA Analysts, develops scalable testing strategies, and drives continuous improvement across processes, tools, and methodologies. This role will work closely with Product, Engineering, and Operations to embed quality throughout the software development lifecycle (SDLC). This is a remote position, with occasional travel. East Coast candidates preferred. Key Responsibilities: Develop and implement QA strategy, standards, and best practices across manual and automated testing. Ensure test planning, execution, defect tracking, and reporting processes are effective and repeatable. Integrate QA practices within Scrum and DevOps workflows. Oversee design and execution of test plans, test cases, and regression suites. Drive automation initiatives to increase efficiency and coverage. Ensure comprehensive testing across functional, regression, integration, performance, and security dimensions. Build, lead, and mentor a high-performing QA team, fostering a culture of collaboration, accountability, and continuous improvement. This includes hiring, setting and monitoring individual performance objectives, career development, performance appraisals, and providing regular feedback and coaching. Set clear expectations and create a positive work environment based on accountability, in collaboration with the engineering and management teams. Build and maintain productive relationships across departments, navigating organizational complexity and silos. Lead and/or contribute to cross-functional initiatives and change efforts. Provide visibility into quality metrics, release readiness, and defect trends to leadership. Evaluate emerging QA tools and technologies, introducing improvements to enhance testing effectiveness. Promote a shift-left testing culture, emphasizing prevention of defects over detection. Identify and address process bottlenecks, inefficiencies, and risks. Prioritize initiatives and allocate resources effectively, monitoring progress and adjusting if necessary. Analyze data and insights to make informed decisions. Handle uncertainty and make timely, high-impact choices. Foster a culture of innovation and proactive problem solving. Communicate clearly, consistently and persuasively, adapting messaging to different stakeholders of various levels, both internally and externally. Requirements: 7+ years' experience in software quality assurance, with 3+ years' managing a team delivering commercial software products to market (SaaS, on-premise, mobile) Proficiency in test management and defect tracking tools Proficiency in Python and understanding of .NET Framework Experience with defining and implementing standard QA processes Solid understanding of the Software Development Life Cycle (SDLC) and Agile methodologies Experience working with Agile software development teams releasing new versions at least monthly Excellent leadership, communication, and problem-solving skills Highly collaborative and influential in acceptance and support of solutions aligned with strategic technology direction of the company Passion for modernizing a platform from IaaS to more PaaS cloud native services Hands on expertise with QA automation tools including Playwright, TestComplete/ReadyAPI (Smart Bear), Selenium WebDriver, TestNG, Cucumber, etc. Holds at least 1 advanced ISTQB certification such as CTAL-TTA, CTAL-TM, CTAL-ATT, CTAL-ATLaS, CTEL-TM, or CTEL-ITP Bachelor's degree in Computer Science, Software Engineering or related discipline Bridgeway is an equal opportunity employer.

We Are: Are you ready to step into the heart of digital transformation in one of the world's most critical - and most dynamic - industries? The Chemicals Industry is evolving at lightspeed: demand for sustainability-driven products is on the rise. At the same time, digital platforms, real-time analytics, AI, and SAP-enabled processes are no longer "nice to have" - they are foundational. As part of Accenture's SAP Chemical's Practice, you'll be delivering major SAP engagements (for example, Business Transformation Strategy & Roadmaps, migrations to SAP S/4HANA, process standardization, cloud-enablement) that help clients win in this new environment and guide major Chemical clients through the journey of business-model reinvention, process excellence and enterprise technology enablement You Are: Do you have a passion for storytelling and for originating, selling and delivering SAP-based Supply Chain Transformation projects that make a positive impact in your clients' business? Are you inspired by working with the best companies in their industries? Want a role that provides you with a sense of purpose and satisfaction? Then join Accenture and build a rewarding career improving the way the world works and lives, as you help clients innovate with leading-edge SAP and Accenture Supply Chain solutions and technologies on some of the most innovative projects in the world You will thrive in our highly collaborative, digitally-driven and innovation-led environment while nurturing your talent for thoughtful and game changing solutions in our inclusive culture that values diversity of ideas, experiences and backgrounds. Ultimately, you are a confident manager who spots and stays ahead of the SAP platform, industry and Supply Chain trends and knows how to translate client goals into clear and actionable outcomes that everyone can get behind. You know how to fully utilize the capabilities of various SAP platforms to drive business value, transform end-to-end functions and drive leading practices for your clients in markets all over the globe. The more complex their challenges, the more excited you are about leading the charge to solve them. The Work: Team with clients on their SAP functional transformation programs through your combined SAP application and functional process expertise which includes your ability to: * Engage with client executives on the business challenges/trends and the potential value of SAP solutions (current & future) * Lead customers in defining their SAP journey through the development of business cases & roadmaps including during sales origination, proposal development and client presentations * Architect E2E solutions that leverage SAP technologies, custom apps, & add on partner solutions * Advise, design and deliver solutions based on the latest industry and technology best practices leveraging a SAP solutions and embedded innovation. * Lead small teams - helping them achieve transformational roadmaps - onsite with clients or within Accenture * Become a trusted expert and advisor to your clients, team, and Accenture Leadership by staying current on regulations, trends, and innovations across your area of expertise * Be a thought leader, build assets and best practices and develop the next level of transformation experts Travel may be required for this role. The amount of travel will vary from 0 to 100% depending on business need and client requirements Qualification Here's what you need: * Minimum of 5 years of SAP functional and technical experience/expertise in Quality Management and/or Manufacturing. * Minimum 3 years of experience in SAP projects supporting Chemicals clients. (SAP support / managed services experience will not be considered for this requirement) * Minimum 2 end-to-end SAP S/4 implementations, including project planning, estimation and solution architecture for Chemicals clients * Experience managing SAP delivery teams, in a Global Delivery Model, including but not limited to the following responsibilities: driving complex workshops and leading design decisions, as well as leading the design and execution of system build, configuration, testing, cutover, and go-live in the SAP Transportation Management or Quality Management area * Prior experience in a Consulting and/or Advisory role * Bachelor's degree or equivalent (minimum 12 years' work experience). If Associate's Degree, must have equivalent minimum 6-year work experience Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired as set forth below. We accept applications on an on-going basis and there is no fixed deadline to apply. Information on benefits is here. Role Location Annual Salary Range California $94,400 to $293,800 Cleveland $87,400 to $235,000 Colorado $94,400 to $253,800 District of Columbia $100,500 to $270,300 Illinois $87,400 to $253,800 Maryland $94,400 to $253,800 Massachusetts $94,400 to $270,300 Minnesota $94,400 to $253,800 New York/New Jersey $87,400 to $293,800 Washington $100,500 to $270,300 Locations

AYR Global IT Solutions is a national staffing firm focused on cloud, cyber security, web application services, ERP, and BI implementations by providing proven and experienced consultants to our clients. Our competitive, transparent pricing model and industry experience make us a top choice of Global System Integrators and enterprise customers with federal and commercial projects supported nationwide. Subject: Quality Manager consultant Location: Cherry Hill, NJ Duration: 6+ months plus US Citizen, GC is preferred but will accept H1. Qualifications Job Description: Quality Manager consultant Responsible for leading testing and quality process for IT functions supporting car automation. Responsible for regression testing plan and execution. Work with business to ensure integration requirements for IT platforms are properly established and executed. Responsible for unit and integration test plans for IT applications. Ensure quality metrics are established and achieved in partnership with the business owners. High touch interaction between business and IT team members. Additional Information If anyone might be intersted please send resumes to kmarsh@ayrglobal (dot) com or you can reach me direct at **************

Create a future where DNA is no longer destiny. Join Rocket Pharma. Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits. Position Summary This Quality Control (QC) Laboratory Manager role is a scientific based position that involves reviewing and analyzing test results as well as overseeing daily lab operations. You will be a key team member responsible for keeping QC operations running in an efficient and productive state. This role interacts with the lab technicians, management, EHS, Facilities, and QA to ensure strict adherence to procedures with a continuous improvement mindset. The ideal candidate will be extremely organized, have a strong analytical operations background, and have a strong passion and curiosity for science and gene therapy. Responsibilities Managing Lab Technician(s) overseeing sample management (receipt, storage, distribution, and disposal) and stocking of lab consumables and reagents Scheduling assays through Electronic Scheduling System for QC and preparing all necessary materials and controlled worksheets and protocols/methods for the scientists to execute the assays Supporting Management by performing peer reviews of testing data Supporting Method Performance tracking and trending through data entry, verification, and record archival Establishing and maintaining training curriculum for the lab scientists and supporting scheduling for cross-training of analysts Maintaining control and inventory of critical reagents, Reference Standards, Retains/Reserves, etc. Operations tracking including Assay Results, Invalid Assays, and Equipment cleaning, maintenance, and calibration Tracking on time closure of QC Quality records including Deviations, Invalid Assays, OOS and CAPAs and reporting of Metrics upwards to QC/QA management Support revision of SOPs and forms to improve workflows in QC Overseeing Housekeeping activities of lab areas Verifying Logbooks are reviewed on time Tracking Lab Notebooks lifecycle Working with EHS to improve Safety Culture in QC Qualifications M.S. in Biology, Molecular biology, or Immunology with 4+ years of relevant experience or BS in Biology, Molecular Biology, or Immunology with 6+ years of relevant experience or equivalent experience in the biotechnology industry. Ability to be onsite 5 days per week Deep understanding and experience with working in a GMP environment Experience with dd PCR, ELISA, Flow-cytometry, UPLC and/or cell-based assays Ability to work independently and make decisions Leadership experience and project management skills to support a multi-project environment in small biotech. Physical Requirements: Constantly works in a GMP lab environment with analytical instruments, reagents and cleaning materials Cleaning with biohazard materials and chemical solutions including bleach and Spor-Klenz Constantly wears proper PPE including lab coat, safety glasses and chemical resistant gloves Must be able to remain in a stationary position for 50% of the time Must be able to detect and distinguish primary colors (red, yellow, and blue) and secondary colors (green, orange, and purple) as they appear on process equipment digital displays and computer screens Constantly communicates verbally with people to exchange information, and give and receive instructions Frequently positions self to set-up, operate, clean, and maintain process equipment and handle materials Compensation The expected salary range for this position is $122,000 to $144,000. At Rocket, our compensation philosophy and ranges are built upon data and insights collected from validated world-class providers. We are committed to compensating employees equitably based on several factors, including responsibilities and level of the position, depth and types of the employee's experience, location of the position and availability of similar talent in a competitive market. For U.S.-based candidates, this is an at-will position, and Rocket reserves the right to adjust the range at hire or during the year due to market shifts. In addition to base salary, Rocket offers a competitive total rewards package that may include bonuses (short-term incentives), medical, dental, and vision insurance, life insurance, 401(k) with company match and generous vesting, paid vacation and holidays, global shutdown days between Christmas and New Year's, and a variety of wellness resources and employee support programs. Also, certain positions are eligible for added forms of compensation, such equity awards (long-term incentives). EEO Statement A diverse workforce fosters innovation and strengthens Rocket's business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.

**General Description:** Supervises staff and executes QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, BeOne processes and procedures. Establishes and implements QC Biochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Biochemistry laboratory. **Essential Functions of the job:** + Lead the QC Biochemistry GMP laboratory through late phase activities. + Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and BeOne Global quality standards. + Supervise a highly efficient QC Biochemistry team. Identify and develop key talents. + Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and, scheduling, etc. + Execute laboratory bench work for analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as required. + Ensure Biochemistry laboratory compliance with Environmental Health and Safety (EHS) standards. + Ensure timely completion of testing (e.g., in-process, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results In support of manufacturing operations. + Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures. + Implementation of effective corrective actions and preventive actions (CAPAs). + Participate in internal and external GMP audits where possible. + Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports. + Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives. + Manage, motivate, coach and mentor direct reports. + Undertake any other duties as required. **Core** **Competencies** **, Knowledge, and Skill Requirements:** + Scientific degree (ideally in Biochemistry, molecular biology, biotechnology or related). + Minimum of 5-7 years working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required. + Working knowledge and experience with Biochemistry analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as well as instruments such Incubators, Biosafety Cabinets, Plate Washers, and Microplate Readers, etc. + Knowledgeable with USP/EP and cGMP/EU GMP regulations. + Direct experience in a GMP quality control lab is a must. + Familiar with instrument and equipment validation. + Expert knowledge of quality control principles, practices, and standards for the biopharmaceutical industry. + Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level. + Credible and confident communicator (written and verbal) at all levels. + Strong analytical and problem-solving ability. + Excellent project management skills. + Hands-on approach, with a 'can do' attitude. + Ability to prioritize, demonstrating good time management skills. + Excellent attention to detail, with the ability to work accurately in a busy and demanding environment. + Self-motivated, with the ability to work proactively using own initiative. + Committed to learning and development. **Supervisory Responsibilities:** + Supervise a highly efficient QC Biochemistry team. Identify and develop key talents. + Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and scheduling, etc. + Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports. + Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives. + Manage, motivate, coach and mentor direct reports. **Computer Skills:** + Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). + Ability to work on a computer for extended periods of time. **Education Required:** Bachelor's Degree required in Chemistry, Biochemistry, or Biotechnology related scientific discipline and 5-7 years of working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company are required. Master's degree in Chemistry, Biochemistry, or Biotechnology related scientific discipline and 4-5 years of working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company are preferred. **Travel:** + Must be willing to travel approximately 10%. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Bristol Bay Construction Holdings LLC (BBCH) is seeking an experienced dual hat Quality Control Manager & Site Safety Officer to join our SES Civil and Environmental team, a subsidiary of BBCH. The primary responsibilities of this position are to coordinate, plan, and supervise subcontractors and/or craft activities to ensure adherence to plans and specifications; enforce site safety and provide contractor quality control. Candidates must have strong organizational and communication skills. This position is based in Folsom, Pennsylvania. Project Scope of Work: Interior and exterior renovation of MCRC Folsom PA, including site work, roofing, finishes, MEPs, and roofing. We are an equal-opportunity employer. All applicants will receive consideration for employment, without regard to race, color, religion, creed, national origin, gender, or gender identity, age, marital status, sexual orientation, veteran status, disability, pregnancy or parental status, or any other basis prohibited by law. We participate in the E-Verify Employment Verification Program. We are a drug-free workplace. Submittal coordination and review Updating submittal register Inspections of materials and workmanship Army Corps RMS system management and input Safety meetings AHA development and review Review material and safety submittals for compliance Supervise special inspections Verify qualifications Maintain rework/deficiency logs 3 phases of inspection Hold preparatory meetings with the team USACE Quality Control Management EM385 1-1 40hr OSHA 30hr 10 years' experience in construction Experience managing Government projects Proficient in RMS, proficient with Word, Excel, and PDF Experience with Procore Familiar with P6 or Microsoft Project scheduling tools Strong safety background and certs in Fall Protection, confined space, etc. Can pass a background check As a condition of employment, you may be required to pass a pre-employment drug screening and have acceptable references and background check results

This permanent, full-time position supports the Quality Assurance department. The Quality Control Senior Manager plays a critical role in maintaining and enhancing our commitment to food safety and quality. This hands-on position combines leadership with technical expertise, supporting the Director of Quality Control with administering department operations, validating program CCPs, and participating in audits, while also performing daily functions in the lab. Knowledge of laboratory principles is required. Product testing includes brix, pH, water activity, titrations, viscosities and organoleptic evaluations. Environment is a clean and modern lab working with terrific people. Essential Job and Duties - Develop, implement, and manage quality systems, food safety programs, and regulatory compliance standards (HACCP, GMP, FSMA, SQF, etc.) - Coordinate with the Director of Quality Control to lead internal and external audits, including customer, third-party, and regulatory inspections - Manage record-keeping and reporting systems related to production metrics and regulatory requirements. - Assist with monitoring sanitation programs and environmental testing, ensuring compliance with microbiological and allergen control standards. Promote a clean and safe working environment where respect for coworkers and the consumer is reflected in every procedure. - Maintain and update Operations documents and SOPs - Perform analytical tests on raw materials and finished products - Calibrate laboratory equipment - Work with production to make adjustments to batches in order to adhere to product specifications - Respond to customer questions or concerns in a professional and appropriate manner - Maintain the finished goods retention library - Sample finished product for microbial analysis - Maintain raw material specification documentation and product specification documentation - Maintain finished product specification documentation Requirements - Bachelor's Degree in Food Science, R&D, or related course of study preferred - 10+ years of related quality assurance or lab experience - Strong knowledge of HACCP, SQF, FDA, USDA, GFSI, SQF, FSMA, GMP, GLP, required - Food industry experience required - Ability to prioritize and organize ones work load - Ability to work in a team environment as well as individually in an environment with changing priorities - Comfortable working on an active busy production floor among batching and packaging equipment. - Ability to manage time effectively - Maintain proper lab conditions and equipment maintenance - Maintain proper record keeping and perform data entry - Be capable of working in various work settings of the facility including laboratory, office and plant areas - Perform basic math skills - Proficient computer skills, including above average knowledge of MS Excel - Understand and perform scaling/measuring in standard and metric formats - Lifting and carrying up to 50 pounds - Being able to withstand extended periods of time on one's feet - Working and walking in a wet environment

Job Description With a projected 1,000 cafes in the United States by 2030, Paris Baguette is one of the fastest-growing neighborhood bakery cafés in the world. Our vision is to reestablish the neighborhood bakery café as the heart of the community around the world. Paris Baguette's mission is to bring expertly crafted baked and brewed goods through a warm and welcoming bakery café experience that delivers joy to everyone. If you are someone who has heart, wants to spread joy, nourish community and is ready to rise to the occasion, we are looking for you to join our growing team! WHAT WE ARE HUNGRY FOR The position of Quality Control Manager is responsible for auditing Paris Baguette's standards for all our food, baked products, and beverages while ensuring all-around quality assurance for such products across all of our cafes, with an emphasis on ensuring compliance to company policies and procedures, food safety standards, government regulations, and following up that we are using best practice standards and continually improving programs in place. KNOWLEDGE AND RESPONSIBILITIES Champion adherence of all elements of the food safety and quality roadmap to ensure integration in all cafes. Coach and advise the café teams to ensure an adherence to all Company standards regarding quality. Monitor progress on opportunities and follow up with café teams to ensure corrective actions are taken to address issues where needed. Partner with café production teams and district production managers to provide any necessary feedback to ensure consistency in production standards. Address non-compliance concerns by supporting district managers and district production managers with follow up suggestions for corrective actions needed in cafes based on assessments and visits. Support café production teams and District Production Managers by reinforcing updates and product specification changes as necessary. Audit external suppliers for food safety, food quality, and ingredient specification compliance. Inspect ingredients, packaging materials, and finished products for compliance with company standards and specifications. Help conduct studies to identify problems, potential problems, or continuous improvement opportunities relating to food quality and food safety. Utilize data collection, trend information, and analysis to drive continuous improvement Format and compose weekly, monthly and annual QC quality and food safety reports Performs other related duties and special projects as assigned WHAT YOU NEED TO HAVE Related bachelor's degree, preferably in Food Science, Engineering or Business Administration At least 1-2 years' relevant experience Knowledge of food production processes, sanitation, quality programs Knowledge of food production techniques, food microbiology and food sanitary safety practices and procedures Flexible, adaptive, upbeat, open and visible work style, with a successful track record of supporting operations leaders across a large geographically decentralized portfolio. Passion for people! Dynamic and engaged leader who has a passion for empowering, inspiring, motivating & developing team members and franchisee relationships. Exceptional organizational and communication skills with the ability to effectively balance priorities and deliver results in a fast-paced, ever-changing, and highly entrepreneurial environment. Feedback is a gift! Ability to provide constructive feedback and recognition to every member of the organization, along with Franchisees, to ensure we have an open and transparent culture of high-performance standards. High emotional intelligence with the ability to work with, and support diverse teams by being highly empathetic, intuitive, self-motivated and driven. Teams Win! Has to be a team player who fosters a collaborative and engaged teamwork environment. Being a Brand Ambassador, with an excellent knowledge of and commitment to Paris Baguette's Mission, Vision, Brand Values and Culture. Love of travel! Ability to commute to all current Corporate and Franchise locations, as well as proposed openings. SWEET BENEFITS Competitive compensation Free Cake for your Birthday Medical, Dental, Vision benefits 401K Retirement Plan Paid time off, paid Holidays High Performance Culture

We are working with a globally produced brand that brings premium specialty food to US consumers. Their diverse portfolio fits any table, in or out of the home. Their generations of craft, expertise, and passion enrich every meal. This company is seeking a Senior Quality Control Manager to supervise the QC and Sanitation departments. Reporting in to the QC Director, this individual will ensure HACCP, PCQI, SQF, and GMP standards are met. Location: Edison, NJ Job Responsibilities: Directly supervise a team of QC Technicians and Sanitation Team to ensure they understand and successfully perform job duties associated with the FSQA role. Train QC technicians to complete all required documentation relating to quality checks, sanitation, product holds and release, and any other function to maintain and improve quality and integrity of the products. Verify that all CCP's and quality checks are correctly carried out and completed. Completion of the all-around day finished product inspection to ensure the fitness of next-day shipping. Ensure all testing equipment is in good operating condition and calibrated according to the written procedure. Carry out environmental swabbing, ensure Swabs and finished product samples are sent to the lab. Helps QC Director to implement SQF requirements, company's GMP, Quality, and Food Safety policies and procedures. Able to communicate and provide guidelines (Hazzard Analysis and Risk-Based Preventive Controls) for any product and procedures to the Quality Team as well as Production Supervisor/Line Leads in the absence of the QC Director. Ability to perform Customer Complaints investigations and conduct Rot Cause Analysis. Help Director for updating and maintaining SQF compliance documentation for the 1 st and 2 nd shift. Work with Production Manager and QC Director for completing monthly food safety inspections, corrective actions, and risk assessments. Conduct internal GMP and Facility audits and monitor Sanitation activity to achieve objectives while fostering s a safe working environment. Keep inventory of all PPE and Sanitation supplies and communicate to QC Director for re-order as necessary. Required Skills/Qualifications: Bachelor's degree in Food Science or associate with a minimum of three years of Food Manufacturing Quality Assurance experience in place of degree required. Knowledge of the industry's best practices of GMP HACCP Certified PCQI Certified A bilingual (Spanish) communication skill is highly preferred to manage and train staff to maintain the high-quality standards in the facility. Previous dairy industry experience is a big plus. Ability to stand/walk for a minimum of 6 hours during shift. Ability to work occasional weekends and flexible schedules as business needs demand. Ability to work with or around a cold environment and confined spaces like spiral, freezer, etc. Must be able to wear/utilize personal protective equipment when and where needed.

OVERALL RESPONSIBILITIES: Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts. DUTIES: • Responsible and accountable for on-time submission and accuracy of regulatory reports • Review and complete determination associated Medical Device Report and/or Vigilance Report • Knowledge of and familiarity with global regulations for reporting • Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events • Interact positively with internal, external business partners and colleagues • Adhere and comply to work instructions, standard operating procedures, and regulations • Expedite investigations by collaborating with internal/external business partners • Achieve productivity targets • Fully trained within three months of hire • Achieve accuracy targets for complaint documentations • Participate in projects and events • Complaint determination • Reportability assessments • Conduct follow-ups with complainant, reporters • Checking your own work • Updating SharePoint • Tracking complaints in the process for closure • All other duties as assigned Qualifications • Bachelor's Degree or equivalent experience • Generally requires 2-4 years of related work experience • RAC or ASQ certifications a plus Additional Information All your information will be kept confidential according to EEO guidelines.

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