Quality assurance manager jobs in Lakewood, NJ - 211 jobs

Job Title: Microbiology, Manager The Microbiology Manager is responsible for overseeing the daily operations of the Microbiology laboratory and leading strategic planning for the lab and its staff. This individual serves as the subject matter expert on contamination control and microbiological testing of parenteral drug products. The role involves significant participation in customer and regulatory audits, client interactions, site metrics meetings, site-wide improvement projects, budgeting, and data review and interpretation, including protocols, investigations, and laboratory documentation. The manager is accountable for the entire laboratory team and handles staff management duties such as performance reviews, disciplinary actions, and ensuring proper training. Operating with limited supervision, this position requires the ability to work independently as well as collaboratively on cross-functional teams. Essential Duties and Responsibilities: Develop and maintain leader standard work in the laboratory Align and maintain staff shift schedules with required manufacturing support functions Demonstrate expertise in CGMP guidelines, ISO 17025, and USP microbiological testing, especially USP , , , , , and Maintain laboratory policy and procedure manuals; assist in developing and validating procedures and document preparation Ensure timely completion of projects, CAPAs, and investigations Manage, conduct, and/or delegate the final review and approval of environmental and microbiological test results, including those from contract labs, to support lot disposition and deliverables as prioritized by site leadership Oversee compliance guideline reviews, industry trend assessments, customer projects (method transfer, development, etc.), validation efforts, expansion projects, and continuous improvement initiatives Act as SME to lead collaboration between departments to trend and continuously improve site Contamination Control Strategy and Environmental Monitoring Program Represent the department during regulatory, customer, and internal audits; ensure timely response to audit observations and execution of related CAPAs Develop and execute training on laboratory methods, instrumentation, and aseptic technique Build and evolve the department Training Matrix to align with industry standards and best practices Write and revise Microbiology and other relevant SOPs as required Provide technical input on product testing issues and instrumentation/equipment Ensure laboratory compliance with cGMP through inspections of monitoring systems and equipment Ensure proper recording and review of data Test the integrity of raw materials or finished products Conduct and document failure and complaint investigations Serve as liaison to service, calibration, and technical representatives Facilitate revision and release of controlled documents Facilitate mandatory reviews of SOPs and month-end reports Provide oversight for projects to update/maintain official document templates Direct and manage the Change Control System Read and interpret SOPs to ensure compliance Maintain up-to-date training records Perform other duties as assigned Education and/or Experience: Bachelor's Degree in Microbiology or related field Minimum of five (5) years of experience in microbiology or related field within a GMP-regulated environment Minimum of two (2) years of experience in a microbiology leadership role Previous experience with pharmaceutical cleanroom environments Knowledge of 21 CFR 211 and EU Annex 1 cGMP requirements Preferred Experience: Five (5) years of experience in a microbiology leadership role Five (5) years of microbiology laboratory experience within a GMP-regulated setting Supervisory Responsibilities: This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. It also involves fostering a positive work environment, providing guidance and support to team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives. Language Skills: The ideal candidate should have the ability to read and interpret various documents, including safety instructions, standard operating procedures, technical procedures, and governmental regulations. Strong written and verbal communication skills are essential, along with effective presentation skills to successfully present information and respond to questions from managers, clients, customers, and the general public.

As the Manager - Quality, you will manage the inspection and testing of materials, parts, and products to ensure adherence to quality standards. You will propose corrective actions to improve compliance with quality specifications and recommend new or improved quality control methods, procedures, and standards. You will direct the activity of the quality department to ensure all customer requirements, product specifications, and process outputs will support current business plans. You will direct improvements in the quality management system to meet customer expectations and grow the business model. **Responsibilities:** + Manage and execute the Quality Management System + Direct the activities of the quality department + Manage a corrective action process to address quality issues + Lead communication with customers to resolve questions and define corrective actions + Develop plans for the Quality Management System to expand and support business growth + Report the performance of the operation using statistical processes + Devise ways to continually improve the quality control process to ensure higher-quality goods + Keep accurate documentation and performing statistical analysis + Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures **Qualifications:** + Bachelor's Degree + 5 - 8 years related work experience + 5 - 8 years supervisory experience + In-depth knowledge of quality control procedures and legal standards + Strong attention to detail, observation, organizational and leadership skills + Knowledge of mathematics, data analysis and statistical methods + Ability to travel up to 50%, including domestic and international travel **Working Environment:** + General Office - Work is generally performed within an office environment, with standard office equipment. Lighting and temperature are adequate and there are no hazardous or unpleasant conditions caused by noise, dust, etc. + Driver - Work is generally performed in moving vehicle. Driving required for an extended period of time with frequent stops and starts. Can be exposed to outdoor weather conditions. **Physical Requirements:** + Work is physically strenuous and workers are required to lift heavy packages up to 50 pounds + Work may require excessive bending or stooping + Employee required to walk long distances repeatedly throughout the day + Employee required to climb ladders + Employee required to use hand tools\#LI-CP1 At Wesco, we build, connect, power and protect the world. As a leading provider of business-to-business distribution, logistics services and supply chain solutions, we create a world that you can depend on. Our Company's greatest asset is our people. Wesco is committed to fostering a workplace where every individual is respected, valued, and empowered to succeed. We promote a culture that is grounded in teamwork and respect. With a workforce of over 20,000 people worldwide, we embrace the unique perspectives each person brings. Through comprehensive benefits (**************************************************************************** and active community engagement, we create an environment where every team member has the opportunity to thrive. Learn more about Working at Wesco here (******************************************************************* and apply online today! Founded in 1922 and headquartered in Pittsburgh, Wesco is a publicly traded (NYSE: WCC) FORTUNE 500 company. _Wesco International, Inc., including its subsidiaries and affiliates ("Wesco") provides equal employment opportunities to all employees and applicants for employment. Employment decisions are made without regard to race, religion, color, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, or other characteristics protected by law. US applicants only, we are an Equal Opportunity Employer. _ _Los Angeles Unincorporated County Candidates Only: Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act._

The Director, Quality & Compliance Training, is a senior leader within the Learning Center of Excellence under Global Quality. This role is responsible for developing and executing global training strategies for various functions (e.g., Commercial, Finance, HR, Legal, and other General & Administrative areas). The position ensures that learning programs drive business performance, compliance with corporate standards, and foster a culture of continuous development across the organization. **Key Responsibilities:** **Strategic Leadership & Governance** + Define and lead the global training strategy aligned with corporate objectives and quality principles. + Establish governance frameworks for training compliance and operational excellence, including policies and SOPs. + Serve as a key advisor to senior leadership on learning trends, capability-building strategies, and risk mitigation. **Program Development & Delivery** + Design and oversee training programs for Commercial and G&A functions, ensuring relevance and scalability. + Implement innovative learning solutions leveraging adult learning principles, digital platforms, and blended learning approaches. + Ensure training content aligns with corporate standards and supports organizational priorities. **Stakeholder Engagement & Collaboration** + Partner with functional leaders, HR, and Quality to identify learning needs and align initiatives with business goals. + Act as a trusted advisor to senior leadership on training effectiveness and workforce capability development. **Continuous Improvement & Analytics** + Define KPIs and leverage data analytics to measure training impact and drive enhancements. + Stay current with industry best practices, emerging technologies, and evolving business needs to continuously improve learning programs. **Operational Oversight** + Collaborate with training operations teams to ensure efficient delivery and compliance tracking. + Oversee vendor relationships for training services and technology solutions **Qualifications:** + Bachelor's degree required; advanced degree in Life Sciences, Education, Organizational Development, or related field preferred. + 10+ years in pharmaceutical or life sciences industry with significant experience designing and implementing global training programs. + Proven track record in designing and implementing global training programs and managing cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA, EMA, etc.). + Proven ability to design and deliver impactful learning programs using adult learning principles. + Experience with learning technologies (e.g., LMS, virtual learning platforms) and data-driven training strategies. + Excellent communication, collaboration, and stakeholder engagement skills. **Preferred Attributes:** + Strategic thinker with a passion for scientific learning and development. + Agile and adaptable in a fast-paced, matrixed environment. + Strong project management and organizational skills. + Committed to fostering innovation, compliance, and continuous improvement through learning. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Job Description About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit's team is inspired to touch and help change lives through Summit's clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: The Manager, Clinical QA will collaborate closely with Regulatory Affairs, QA, R&D and other cross functional teams within the Company to provide GCP/GLP/GPV and compliance-related advice to internal clinical study teams. This will be accomplished through ensuring tactical support is provided to assignments and wherever necessary, taking the lead in ensuring project related procedural documents, comply to relevant GxP's and regulatory requirements and guidelines. Role and Responsibilities: Partnering and collaborating with key stakeholders (R&D teams) to ensure that appropriate Quality support is provided to Summit Clinical and pre-clinical programs Ensuring end-to-end quality management through proactive compliance based on Clinical Development Plan (CDP) Liaising with the Global Audits and Compliance function to provide lessons learned from audits and inspections to program teams and support implementation of corrective actions Supporting CRO-relevant meetings, when necessary, to provide quality overview/ training to relevant stakeholders Providing support during the development and execution of Corrective and Preventive Actions (CAPAs). Coordinating and reviewing CAPAs to ensure adequate CAPAs are defined, implemented, and closed. Support formal investigations of issues as they arise, ensuring timely escalation to line management if critical incidents are not resolved in due course Identifying areas of continuous process improvement and engaging QA and key stakeholders as necessary QA support in interactions with internal and external contacts and Health Authorities (HA), as appropriate. In collaboration with the Global QA team, ensure inspection management by assisting in preparing program teams for FDA, EU, and key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspections. Support in providing interpretation of regulations and company process standards, guidelines, policies, and procedures to personnel for assigned programs or for continuous improvement projects Supporting or leading development and driving the implementation of study/program-specific quality plans to ensure proactive management of quality Supporting rectifying any necessary vendor-relevant issues identified for the assigned program Ensuring that protocols for assigned programs can be operationalized and address potential risks with key stakeholders Perform internal audits as applicable All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Bachelor's Degree in Life Sciences, Pharmacy, or Nursing required Master's Degree or other advanced degree preferred Minimum of 5+ or more years Quality Assurance experience and or Clinical Operations involvement in regulated activities or equivalent experience required Broad understanding of global expectations of Health Authorities in the management of clinical trials preferred Thorough understanding of international GCP/GLP regulations including FDA/EU GCP, ICH, pharmacovigilance, new drug regulations, other key HA guidance's, and current industry practice preferred Ability to travel up to 20% Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable Strong computer and database skills Attention to detail, accuracy and confidentiality Clear and concise oral and written communication skills Excellent organizational skills Critical thinking, problem solving, ability to work independently Must be able to effectively multi-task and manage time-sensitive and highly confidential documents Communicate effectively and articulate complex ideas in an easily understandable way Prioritize conflicting demands Work in a fast-paced, demanding and collaborative environment The pay range for this role is $139,000-$163,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's Talent Acquisition team at ********************* to obtain prior written authorization before referring any candidates to Summit.

Apply now " Job Type: Long-term / Regular At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients. Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis. Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging. For more information on Guerbet, go to *************** and follow Guerbet on Linkedin, Twitter, Instagram and Youtube WHAT WE ARE LOOKING FOR Guerbet is looking for a qualified, dynamic QA Manager to enhance our quality management system through comprehensive SOP development, review, and revision, ensuring compliance with FDA regulations including CFR (Code of Federal Regulations), ISO standards, industry best practices, as well as all applicable legislative requirements for the company's product portfolio. Working with cross-functional teams, you will have to be an excellent communicator and will be responsible for ensuring that all projects have the appropriate local quality and safety input and guidance. Implementation and maintenance of an audit and quality assurance system at the local level aligned with the Policies of the Group. YOUR ROLE General * Ensure good relations and communications with all members of the team and responding respectfully and in a timely fashion to internal and external customers. * Interact influentially with all members of staff to maintain and develop a positive progressive Quality culture throughout the organization. * Perform other duties as assigned by management. Quality Assurance * Ensure compliance with the legislative requirements as set out by FDA (21 CFR 314, 21 CFR 820, 21 CFR 822) and PIC/S PE 011-1, as well as all applicable legislative requirements for the company's product portfolio. * Ensure that all third-party contractors are legally approved, and the applicable Technical Quality Agreements (TQA) are in place. * Prepare and act as signatory in quality agreements (intercompany and external). * Ensure the implementation of ISO 13485:2016 requirements for a quality management system where the organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. * Ensure that the business complies with cGxP requirements. * Be able to retrieve product traceability and ensure recall readiness * Responsible to attend and support regulatory body inspections (For example-FDA, state agencies or any other health authority) at Guerbet LLC level. * Ensure of the conformity of fully finished imported pharmaceutical product and release for the US market. * Perform the Product Quality Review system by reviewing PQRs and engaging with relevant departments to address recommendations and outstanding information. * Oversee the Customer Complaints system and facilitate investigations to establish root cause and work with cross functional teams to facilitate the resolution of the customer complaints. * Administration and monitor the QMS, including SOPs, quality management meetings, change controls, deviations, quality risk assessments, customer complaints, recalls, adulteration or counterfeiting investigations, periodic reviews, self-inspection and external audit reports. * Facilitate follow-up meetings to discuss the audit findings, clarify questions, and agree on timelines for implementing of the corrective action plans. * Ensure any updates and reviews of SOPs are documented and stored in a controlled system and ensure compliance with Global SOPs and with regulatory standards across various operations within the organization. * Cooperate with Training Responsible to ensure the appropriate training of the staff. * Provide quality support for assistance with Request For Quotation (RFQ) documents and processes. * Supervise supply chain activities pertaining to Guerbet pharmaceuticals and medical devices performed by the third-party logistics. Ensure that these activities are performed in compliance with the local legislation and regulations. * Ensure Guerbet products are only supplied to persons who are authorised or entitled to supply medicinal products to the public, through the customer qualification process. Inspection & audits * Implement all necessary tools to evaluate the quality of the local processes and activities. * Conduct/assist with internal self-inspection audits and complete response report. * Coordinate, evaluate and follow up on CAPAs related to audit and inspection findings until implementation of CAPA supported by acceptable evidence for critical and major findings. * Analyze audit findings, identify areas for improvement and communicate trends to senior management. * Maintain high level of awareness and expertise in international regulations so as to ensure appropriate regulatory surveillance YOUR BACKGROUND * Minimum of 8 years of QA experience in the pharmaceutical/medical device industry * Advanced degree in a relevant field (Chemistry, Engineering, Life Sciences) * Demonstrated expertise in FDA regulations and ISO standards * Experience with electronic quality management systems * Strong technical writing and process development skills * Previous consulting experience in SOP development * Proven experience in audit management and non-conformity resolution. * Knowledge of document management/quality systems * Experience with FDA inspections * Knowledge of radiology environment (preferred) Soft Skills/Qualifications * Excellent communication and project management skills. * Ability to work independently and as part of a team. * Interviewing and presentation skills * Strong and effective communication and interpersonal skills * Excellent analytical, problem solving and decision-making skills * Attention to detail, initiative, confidentiality, customer focused, logical thinking, information seeking and sense of urgency * Supervisory skills * Excellent computer skills We offer continued personal development. When you join Guerbet, you : * Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, * Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world, * Are joining a company where we value diversity of talents coming from various horizon. We # Innovate # Cooperate # Care #Achieve at Guerbet. Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion. Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to ******************* or you can also call this number ************

About Us QISG leverages Quanta's comprehensive resources to deliver collaborative solutions for our partners' energy infrastructure needs. We use in-house talent, expertise and resources to plan, design, engineer, manage, conduct maintenance on and construct projects. Our turnkey service capabilities provide our customers with efficiency, consistency, attention to detail and safe execution. The QISG team brings together Engineering, Safety, Quality, Material Procurement, QA/QC, Right-of-Way Acquisition, Scheduling, Environmental Planning, Permitting, Title and Land Management expertise that ensure outstanding results for our clients. About this Role The Field Quality Manger at Quanta Infrastructure Solutions Group (QISG) will be responsible for monitoring and auditing a project's quality management requirements and executing the Project Quality Management Plan. This position collaborates closely with Project Managers and other stakeholders to oversee project quality objectives and activities. The QA Manager leads the planning and surveillance of procured equipment and materials, assisting the Director of Quality in measuring Quality Management System processes. This is a full-time, on-site role based in Linden, New Jersey. What You'll Do TYPICAL RESPONSIBILITIES Develop and review planning for quality requirements of projects, including identifying the appropriate standards, guidelines, and checklists for the project Develop and/or update project-specific audit plans, including schedule, documentation, and resource requirements Monitor the performance of the Sub-contractor for compliance with quality requirements. Assist Business Development and Marketing leads in developing quality-related deliverables for pursuits and new opportunities Create project-specific quality management plans during the planning stage of a project Provide guidance in the execution of the Quality Management System Lead changes and improvements in performance and process plans Offer leadership, support, and guidance for project-specific quality management activities Interact with Quanta Operating Units to provide guidance on contract-required quality obligations, requirements, and documentation Lead the project team in quality-related training and awareness regarding planned activities Monitor the alignment of project procedures and processes with the Quality Management System and project contract requirements Verify that lessons learned, corrective action items, and improvement measures for project requirements are completed Recommend procedural improvements and best practices based on audit results/experiences and lessons learned Plan and execute systematic and independent examinations/audits of project quality requirements, objectives, and documentation Identify and document issues that may cause or contribute to deviations from planned/expected outcomes and develop corrective action plans to address these issues Assist the Directors of Operations with maintaining the overall Quality Management System for activities specific to procedures, processes, and training Regularly interact with field operations and project management teams, corporate Operations Support, Project Controls teams, and clients regarding quality-related matters Perform detailed inspection/audit reviews of each feature of work within the definable features of work Perform random inspections of work performed by Quanta Operating Units and subcontractors; review QA documents as they are issued Review Quanta Operating Units or subcontractor procedures and quality records to verify compliance Manage document control as it relates to quality; verify that project documents used at the job site are updated, maintained, and stored in accordance with project procedures. This includes design drawings, supplier and subcontractor drawings, test records, etc. Manage Non-Conformance Control; verify that non-conformances are identified, documented, tracked, and resolved by the PM and the Site CM acceptably Adhere to internal standards, policies, and procedures Perform special projects and complete other duties as assigned or requested What You'll Bring REQUIRED EXPERIENCE AND EDUCATION Bachelor's degree in a relevant field, or an equivalent combination of education, training, and experience 30-hour OSHA certification CIA - Certified Internal Auditor CQA - Certified Professional Auditor Certifications involving inspection, testing, welding inspection, structural bolting, testing, and commissioning Minimum of ten (10) years' experience in various aspects of design, surveillance monitoring, and Project Management, including: Experienced in electrical and substation, mechanical, and piping construction, as well as facility startup and operations Must have heavy mechanical process piping background Full understanding of ASME codes Full understanding of Hydrotesting, pneumatic testing and mechanical startup process Quality Inspections/Audits of Engineering and/or other Projects Successful development and implementation of a Quality program, including all necessary processes and procedures Experience as a Manager, Superintendent, Project Manager, or Quality Manager/Auditor on projects Experience working in multiple states and understanding state and local codes relating to quality Experience meeting Local AHJ requirements Strong background or familiarity with safety requirements on projects Strong understanding of environmental considerations Leadership and inspection experience in surveillance oversight programs Developing inspection test plans for monitoring/observation programs for surveillance of project or program specified manufacturer's equipment and materials Technical expertise related to design and related requirements Testing, standards compliance, etc. Thorough understanding of equipment and material specifications and testing requirements employed at manufacturer facilities Technical expertise in implementing Inspection and Testing programs Solid understanding of critical path scheduling Excellent problem-solving skills Strong attention to detail Strong organizational and planning skills Excellent communication skills with strong interpersonal skills Ability to work alone as well as in a team environment TRAVEL REQUIREMENTS Travel: Yes Percent of Time: 100% What You'll Get Competitive Compensation 401(k) Retirement Plan Holiday Pay Paid Time Off (PTO) Comprehensive Health Coverage Pet Insurance Employee Assistance Program (EAP) Professional Development Tuition Assistance Employee Discount Program Compensation Range The anticipated compensation for this position is USD $140,000.00/Yr. - USD $160,000.00/Yr. depending on experience and qualifications. Equal Opportunity Employer All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, national origin or ancestry, sex (including gender, pregnancy, sexual orientation, and/or gender identity), age, disability, genetic information, veteran status, and/or any other basis protected by applicable federal, state or local law. We are an Equal Opportunity Employer, including disability and protected veteran status. We prohibit all types of discrimination and are committed to providing access and equal opportunity for individuals with disabilities. For additional information or if reasonable accommodation is needed to participate in the job application, interview, or hiring processes or to perform the essential functions of a position, please contact us the Company's Human Resources department.

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.

Full-time Description SS White Burs is a leading dental device manufacturer that strives to bring high quality dental products to market, enabling practitioners to work more efficiently and to maximize patient comfort and quality. The creation of unique and differentiated products is the cornerstone of SS White Dental. Our footprint has been around for 170 years and makes us one of the most well recognized and trusted names in the industry today. Requirements Manages Customer complaints (RMA: Return Material Authorization): · Receive and organize return product for RMA process · RMA processing which involves receipt/system transaction and proper disposition of material in Epicor as per Procedure PROSP9 · Perform needed testing of product according to complaint and as per Work Instruction WISP901. · Recording of evaluation results for quality complaints · Physical movement/disposition of product · Proper closeout of customer complaints in Epicor · Closeout DMRs generated for quality related complaints Calibration: · Manage calibration program which includes monthly calibration schedule, maintaining calibration records, calibration results entry in GageTrak and conduct calibration inspection when needed as per procedure PROSP5. · Schedule calibration for outsourced calibration equipment which includes obtaining quotes from vendor, completing internal purchase requisition to get Purchase Order from Purchasing Department. Other responsibilities and functions: · Generate and issue COC (Certificate of Compliance) and COA (Certificate of Analysis) as requested by Customer and according to Shipping Pick list · Assist with File Heat Treating as needed · Manage set-up bin (in Epicor and physical inventory) Qualifications: · High school diploma or equivalent · Proficiency using Microsoft Office and other Windows based applications · Demonstrated ability to read, write legibly, and understand English · Highly organized & detail orientated · Ability to communicate and work with all departments and all levels of management

Safety is a core value at Voyant Beauty. We prioritize the well-being of our team members, ensuring a safe and secure environment where everyone can thrive and excel. If you're seeking to be part of a team where your talents are valued, your safety is paramount, and your efforts contribute to meaningful change, then Voyant Beauty is the place for you. Come join us and be a part of our journey. A Brief OverviewThe Plant Quality Manager provides strategic and operational leadership for all quality functions at a high-volume OTC manufacturing facility. This role ensures GMP compliance, drives a quality culture, and leads quality system improvements to enhance overall site performance. As a critical leader, the Plant Quality Manager will strengthen the Quality organization, foster quality culture transformation, and optimize operational excellence across the facility. The ideal candidate is a hands-on, technically proficient leader with cGMP knowledge (21 CFR 210/211) and the ability to align cross-functional teams to elevate the site's quality systems and compliance.What you will do Lead QA, QC Labs, Document Control, Validation, and Complaint Management operations. Oversee implementation and improvement of site QMS in line with FDA and corporate standards. Serve as quality site lead for FDA and customer inspections. Ensures inspection readiness at all times. Address compliance issues and manage CAPAs effectively. Promote accountability, data integrity, and a right-first-time mindset. Collaborate with Ops, Eng, R&D, etc., on investigations, change management, validations, and continuous improvement. Supervise review of batch records, product release, deviations, and investigations. Work with customers, and other stakeholders to meet compliance expectations. Analyze metrics to drive performance and quality improvement. Coach and develop a High Performing Team. Ensure effective resourcing of quality teams. Represent site quality leadership in executive meetings. Contribute to corporate quality strategy alignment. Participate in strategic planning and facility expansion discussions. Some duties may vary slightly by location. Education Qualifications Bachelor's Degree in Chemistry, Pharmacy, Microbiology, Chemical Engineering, or similar. (Preferred) advanced degree (Preferred) Experience Qualifications 10+ years in FDA-regulated OTC, pharmaceutical, or personal care environments. (Preferred) 10+ years managing FDA inspections and remediation efforts. (Preferred) 10+ years background in aerosol manufacturing and topical formulations is a plus. (Preferred) Skills and Abilities Expertise in cGMPs, 21 CFR 210/211, ICH, USP (High proficiency) Leading FDA/customer audits and inspection readiness (High proficiency) Remediation planning and effectiveness verification (High proficiency) Working with Ops, Eng, and R&D on QMS topics (High proficiency) Team coaching, mentoring, and resourcing (High proficiency) Effective internal/external stakeholder communication (High proficiency) ERP (e.g., SAP), LIMS (e.g., MasterControl), TrackWise (High proficiency) Driving transformation in quality mindset and execution (High proficiency) Licenses and Certifications ASQ Certification (Preferred) Lean Six Sigma or OpEx training (Preferred) To Staffing and Recruiting Agencies: Our company does not accept unsolicited curriculum vitae's or applications from agencies. We are not responsible for any fees related to unsolicited curriculum vitae's or applications and explicitly reserve its right to contact candidates presented in such unsolicited curriculum vitae's or application. Our company provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, color, national origin, sexual orientation, age, disability or veteran status. Voyant Beauty will consider requests for accommodations due to a disability impacting a qualified employee's ability to perform the essential functions of their position consistent with applicable laws. In addition to federal law requirements, Voyant Beauty complies with applicable provincial and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

OPEN JOB: Quality Manager - Manufacturing / EHS / 3 rd Party Agency Audits SALARY: $100,000 to $150,000 INDUSTRY: Manufacturing & Production JOB CATEGORY: Manufacturing - Quality IDEAL CANDIDATE Experience Managing 3rd party external agency audits EHS experience Our client's Light Safety division is currently seeking a Quality Manager. This role is located out of Long Branch NJ. The Quality Manager will be responsible to formulate, implement and administer Quality Management System (EQMS) and strategic initiatives to achieve short and long range quality improvement objectives. Driving focus will be on the reduction of warranty and customer concerns along with improving internal quality performance and driving continuous improvement. In Additions to Quality Manager responsibilities the incumbent will have EHS function responsibilities. What you'll do: Manage the quality function and direct reports to meet plant quality objectives and drive the quality culture with the leadership team Lead the timely response to customer concerns Deploy “I own Quality” culture to reduce internal and external DPPM Lead cross-functional teams to effectively introduce New Products to full production. Understand and adhere to EQMS to ensure compliance with ISO 9001, customer specific requirements, and all regulatory requirements Review daily in-process metrics to determine team priorities Deploy 5S and foster/expand 5S culture Interact with divisional resources to improve product quality Develop internal product validation methods to ensure process quality consistency Drive employee engagement in continuous improvement and lean manufacturing practices Lead the quality team utilizing the Leadership Model to effectively communicate requirements and expectations Leads and supports team to facilitate risk assessments to identify critical EHS hazards. Works with leadership team to create targets and objectives based on key EHS risks Determines appropriate leading and lagging indicators to track performance against targets and objectives Supports EHS goals to drive EHS culture, compliance, and results Assigns MESH element champions and facilitates their ownership of and development in the MESH elements Facilitates annual MESH self-assessments and corporate MESH assessments every three years Drives and promotes zero incident EHS culture throughout site Creates EHS engagement through employee involvement in EHS teams (Safety, Ergonomic, First Aid, etc.) Works with leadership team and MESH champions to complete regular compliance evaluations and checks of federal, state, and local regulations Uses established EHS data processes such as MESH PRISM and Benchmark to manage data such as injuries and illnesses, environmental metrics, risk assessments, EHS actions and other pertinent information Creates training matrices to ensure that all training is defined and tracked to completion Ensures that all key EHS operational controls are in place, on a PM program, and that EHS action items are resolved on a timely basis Leads monthly divisional report outs on EHS related goals, actions and culture development Basic Qualifications: Bachelor's degree in Engineering from an accredited institution required Minimum of 3 years of combined experience in manufacturing or quality Thorough experience with ISO9001 Must be legally authorized to work in the United States without company sponsorship No relocation benefit is offered. Candidates must reside within 50 miles of Long Branch, NJ. Preferred Qualifications: Experience and knowledge of ERP systems (preferably SAP) Experience with Lean Six Sigma Certification by the American Society for Quality as Six Sigma Black Belt or Certified Quality Engineer EHS Experience If you are interested in pursuing this opportunity, please respond back and include the following: MS WORD Resume required compensation. Contact information. Availability Upon receipt, one of our managers will contact you to discuss the position in full detail. STEPHEN FLEISCHNER Recruiting Manager INTERMEDIA GROUP, INC. EMAIL: *******************************

Job DescriptionQuality Manager (Manufacturing | Quality & EHS) Industry: Manufacturing & Production Function: Quality Management / EHS Employment Type: Full-Time Compensation: $120,000 - $140,000 base (dependent on experience) Travel: Occasional Relocation: Not available (candidates must be local) About the Role: We are seeking a Quality Manager to lead plant-level Quality Management Systems (QMS) while also owning key Environmental, Health & Safety (EHS) responsibilities. This role is responsible for driving a strong quality ownership culture, reducing customer and warranty concerns, improving internal quality performance, and embedding continuous improvement across operations. This is a hands-on leadership role within a safety-critical manufacturing environment. The Quality Manager partners closely with site leadership, operations, and cross-functional teams to ensure quality and EHS systems are effective, compliant, and fully integrated into daily operations. Key Responsibilities: Quality Leadership Lead and manage the quality function and direct reports to meet plant quality objectives Implement and administer a plant-level Quality Management System aligned with ISO 9001 Lead timely investigation and response to customer concerns and quality escapes Drive reduction in internal and external defects (DPPM) through root cause and corrective actions Support New Product Introduction (NPI) through cross-functional quality readiness Review daily quality metrics and set priorities for the quality team Develop and improve internal validation and inspection methods Deploy and sustain 5S and continuous improvement practices Lead third-party, customer, and regulatory audits EHS Leadership Own and support site EHS programs, risk assessments, and compliance activities Promote a strong zero-incident safety culture through employee engagement Identify leading and lagging EHS indicators and track performance against goals Support regulatory compliance with federal, state, and local EHS requirements Ensure training matrices are defined, tracked, and completed Lead EHS reporting, assessments, and continuous improvement initiatives What We're Looking For: Required Qualifications Bachelor's degree in Engineering or related technical discipline 3+ years of combined experience in manufacturing and/or quality Strong working knowledge of ISO 9001 quality systems Experience managing third-party or external audits Hands-on experience in a manufacturing plant environment Authorization to work in the U.S. (no sponsorship available) Ability to work on-site; candidates must live within commuting distance Preferred Qualifications Experience with ERP systems (SAP preferred) Lean Six Sigma experience or certification ASQ certification (Six Sigma Black Belt, CQE, or similar) Prior Quality Engineer or Quality Manager experience Practical EHS leadership experience What This Role Is (and Is Not) This role is: Plant-based and operations-focused Leadership-oriented with hands-on execution Focused on quality culture, metrics, and continuous improvement Integrated with EHS and safety accountability This role is not: A documentation-only or audit-only quality role A remote or hybrid position Limited to inspection or customer complaints alone What Success Looks Like: Reduced customer complaints, warranty issues, and internal defects Strong audit performance and sustained ISO compliance Engaged employees who take ownership of quality and safety Clear quality and EHS metrics tied to plant performance Visible leadership presence on the floor If you are a manufacturing quality leader who thrives in plant environments, values safety, and enjoys driving real operational improvement, we encourage you to apply. Equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.

Our client is a fast-growing personal care and cosmetics manufacturer known for innovation, high standards of product excellence, and a passionate consumer base. They are now looking for a Quality Control Manager. Salary/Hourly Rate: $90k - $115k The Quality Control Manager will lead product-focused quality control operations to ensure all finished goods meet established specifications, regulatory requirements, and internal quality standards. This role is integral in overseeing product release, managing QC laboratory functions, supporting investigations, and driving continuous improvement initiatives. The Quality Control Manager will supervise a team of 2-3 specialists and serve as a key partner to the Quality Director in strengthening quality systems, documentation, and operational readiness. Expected travel is approximately 30% to contract manufacturers nationwide. Responsibilities of the Quality Control Manager: * Oversee the complete product release process, including incoming inspection, analytical testing, disposition, and management of nonconformances. * Review and approve deviations, investigations, and CAPA documentation to ensure effective root-cause analysis and corrective actions. * Collaborate cross-functionally to support new formulation launches and ensure quality requirements, inspection criteria, and testing protocols are implemented. * Manage QC laboratory operations, including equipment oversight, instrument calibration, cleanliness, and safety compliance. * Supervise the retain program and maintain product master standards. * Evaluate consumer complaint samples and support quality trend analysis. * Administer and enhance the Quality Management System (QMS), including SOPs, CAPAs, audits, inspections, and documentation. * Develop and deliver training related to cGMP, quality systems, and technical processes. * Provide leadership, coaching, and performance feedback to QC Specialists. * Monitor, analyze, and report quality KPIs to drive continuous improvement. Required Experience/Skills for the Quality Control Manager: * 5+ years of QC or quality-related experience in personal care, cosmetics, or fragrance manufacturing (required). * Prior supervisory experience with the ability to lead and develop laboratory personnel. * Strong background in nonconformance management, analytical testing, and product release processes. * Experience working within cGMP and ISO 22716 environments. Education Requirements: * Bachelor's degree in a Scientific or Engineering discipline, or equivalent experience. Benefits: * Comprehensive medical, dental, and vision coverage (including HSA with employer contribution). * Paid time off and paid holidays. * 401(k) retirement plan. * Additional competitive benefits.

Job SummaryDirect, lead and supervise the development of a total quality environment with an emphasis on unexcelled customer satisfaction and continual quality improvement. Accomplish quality-related objectives using quality meetings, planning, training, statistics, and internal/external audits. Ensure that processes and products are in compliance with the current Quality Management System requirements and applicable regulatory obligations. Serve as the designated authority for regulatory programs (e.g., ODA), maintaining compliance with external agency expectations while aligning with company quality standards.Job Description Key Accountabilities: •Direct and coordinate all aspects of Quality Management, including ISO/AS/TS compliance, quality improvement initiatives (CQIB), and customer satisfaction strategies to support company goals and objectives. •Report on the suitability and effectiveness of the Quality Assurance System while fostering a strong quality culture across all branches through leadership collaboration and communication. •Partner with department managers to establish goals, assess competencies, and guide quality outputs in alignment with corporate Quality Objectives. •Maintain frequent communication with site Quality Assurance Representatives to ensure consistency, effectiveness, and alignment across regions. •Lead and oversee quality assurance functions, including planning, statistical process controls, corrective/preventive action systems (CPAR), customer/vendor claims, trend analysis, and documentation of customer quality requirements. •Direct internal and external audits, provide technical assistance, root cause/corrective action process, manage quality non-conformance and drive employee training and development in quality, regulatory compliance, LEAN, and safety. •Support overall ODA program activities as required, including maintaining Unit Member records, coordinating application reviews and evaluation panels, tracking required FAA training, and assisting with annual evaluations and related correspondence. •Assist in developing, revising, and maintaining ODA quality manuals and procedures in collaboration with ODA representatives and stakeholders, ensuring alignment with FAA policies and identifying process or training impacts from regulatory updates. •Contribute to planning and execution of ODA and FAA audits, including preparing audit materials and reports, coordinating timely closure of corrective actions, and ensuring accurate tracking and reporting of ODA/FAA-required metrics and quarterly submissions. •Provide leadership and direct supervision to quality department teams across multiple functions, ensuring alignment with organizational goals. •Report directly to the Plant Manager and indirectly to Corporate Regulatory/Trade Compliance leadership to drive corporate quality, standardization, and safety initiatives. •Participate, support, and comply with all health, safety, quality, ISO and 6S Initiatives, compliance and Lean initiatives, requirements, and/or trainings. •Ability to access and work in SAP or other Warehouse Management System •Provide leadership and direct supervision to quality department teams across multiple functions, ensuring alignment with organizational goals. •Report directly to the Plant Manager and indirectly to Corporate Regulatory/Trade Compliance leadership to drive corporate quality, standardization, and safety initiatives. •Participate, support, and comply with all health, safety, quality, ISO and 6S Initiatives, compliance and Lean initiatives, requirements, and/or trainings. •Ability to access and work in SAP or other Warehouse Management System The above is intended to describe the general content of and requirement for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements. Meet all other TKMNA employee attributes and competencies Qualifications: Minimum Requirements: This position requires access to export-controlled technical data or technology. Employment is contingent upon obtaining any required export authorization from the appropriate government agency or agencies. When export authorization is necessary, the length of time to obtain the authorization by the government is outside of the Company's control. •Bachelor's degree/ 3+ years management experience/ leadership/team building/training in Quality Assurance/Control. •ODA Certification/industry credential & knowledge of ODA programs, FAA regulations, or aerospace regulatory compliance. •3+ years relevant experience working as a supplier ODA Focal or Unit Member in an aerospace or any equivalent industry. •Experience in TQM, ISO/QS 9000 ISO Assessor Certification, SPC. •Demonstrated proficiency in Microsoft Word, Excel, and PowerPoint, with strong verbal, written, and interpersonal communication skills. •Demonstrates dedication to delivering high-quality customer service while being positive, detail-oriented, organized, team-oriented, and a proactive problem-solver capable of multitasking and prioritizing in a fast-paced, deadline-driven environment. Preferred Requirements: •ASQ certification •ISO Lead Assessor Certification •5 years plus Quality Assurance/Control •3+ years of experience as an FAA ODA Unit Member or Supplier ODA Focal, with working knowledge of FAA rules, regulations, ODA programs, and aerospace regulatory compliance (or equivalent industry experience). •Training in strategic planning and motivation Benefits Overview We offer competitive company benefits to eligible positions, such as : Medical, Dental, Vision Insurance Life Insurance and Disability Voluntary Wellness Programs 401(k) and RRSP programs with Company Match Paid Vacation and Holidays Tuition Reimbursement And more! Benefits may vary based on job, country, union role, and/or company segment. Please work with your recruiter or tk representative for applicable benefits information. Disclaimer This is to notify the general public that some individuals/entities are using the thyssenkrupp (“TK”) name, trademark, domain name, and logo without authorization. They are posing as employees, representatives, or agents of TK and its associated/group companies. These individuals/entities are fraudulently offering jobs online through texts, websites, telephone calls, emails, or by issuing fake offer letters. They are also soliciting jobseekers to deposit money in certain bank accounts or providing jobseekers with fraudulent checks to obtain banking information. TK does not ask, solicit, or accept any monies in any form from candidates, job applicants, or potential jobseekers, who have applied to or wish to apply to TK, whether online or otherwise as a pre-employment requirement. TK bears no responsibility for money being deposited/withdrawn therefrom in response to such fake offers. TK does not: 1. Send job offers from free email services like Gmail, Rediffmail, Yahoo mail, etc.; 2. Request payment of any kind from prospective jobseekers or candidates for employment; 3. Authorize anyone to collect money or agree to any monetary arrangement in return for a job at TK; 4. Send checks to job seekers; or 5. Make job offers through third parties. In the event TK uses professional recruitment services through a third party, offers are always made directly by TK and not by any third parties. PLEASE NOTE: 1. TK strongly recommends that potential jobseekers do not respond to such fake solicitations, in any manner; 2. TK will not be responsible to anyone acting on an employment offer that is not directly made by TK; 3. Anyone making an employment offer in return for money is not authorized by TK; and 4. TK reserves the right to take legal action, including criminal action, against such individuals/entities. TK follows a formal recruitment process through its own HR department and applications are evaluated by its HR department through pre-defined processes. Please visit our official careers website at ******************************** to view authentic job openings at TK. If you receive any unauthorized, suspicious, or fraudulent offers or interview calls, please email us at **********************************************. We shall not accept any liability towards the representation made in any fraudulent communication or its consequences, and such fraudulent communication shall not be treated as any kind of offer or representation by TK or its group companies and affiliates.

**General Description:** Manages all Quality Control (QC) Physicochemistry laboratory activities to support GMP manufacturing, testing and release of materials, intermediates and finished products under FDA/EU regulations, applicable International Regulations, BeOne processes and procedures. Establishes and implements QC Physicochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Physicochemistry laboratory. This position reports to the Senior Manager QC and is located full time at the Hopewell, NJ site. **Essential Functions of the Job:** + Lead the QC Physicochemistry laboratory daily workflow. + Establish and maintain QC Physicochemistry laboratory related quality systems to ensure conformance with regulations and BeOne Global quality standards. + Manage QC Physicochemistry laboratory routine operations, including but not limited to validation, SOPs, specifications, testing records, personnel training and assessment, scheduling, etc. + Ensure Physicochemistry laboratory compliance with Environmental Health and Safety (EHS) standards. + Ensure timely completion of testing (e.g., In-process control, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations. + Review of laboratory test results, ensuring adherence to Good Documentation Practices. + 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. + Ensure that the QC Physicochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives. + Expertise in Quality Control (QC) within a Good Manufacturing Practice (GMP) environment, ensuring compliance with industry standards and regulations through hands-on laboratory experience. + Working knowledge and experience with physicochemistry analytical methods such as GC, HPLC, UPLC, IEF, TOC, UV, FTIR, etc. + Knowledgeable with USP/EP and cGMP/EU GMP regulations. + 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. + Strong leadership/team management skills and experience. + Manage, motivate, coach and mentor direct reports. + Credible and confident communicator (written and verbal) at all levels. + Strong analytical, problem-solving ability, with excellent attention to detail, with the ability to work accurately in a busy and demanding environment. + Excellent project management skills. + Hands-on approach, with a 'can do' attitude. + Ability to prioritize, demonstrating good time management skills. + Self-motivated, with the ability to work proactively using own initiative. + Committed to learning and development. + Interacts with all levels of BeOne employees + Undertake any other duties as required. **Supervisory Responsibilities:** + Manage direct reports from QC Physicochemistry laboratory. + 2+ years of managerial experience directly managing people required. + Leadership experience leading teams, projects, programs or directing the allocation of resources. **Computer Skills:** + Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). + Ability to work on a computer for extended periods of time **Travel:** Must be willing to travel approximately 10% **Education/Experience:** + Bachelor of Science degree and 5+ years of experience in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility required. + Bachelor's in Chemistry, Biology, Molecular Biology, Biotechnology, Biochemistry, or related scientific discipline preferred. + Master's degree and 4+ years of relative experience preferred. 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.

The Clinical Research Quality Control Manager is a senior leader responsible for the strategic oversight, planning, and execution of all quality control activities within the clinical research unit. This role ensures that clinical trial processes, documentation, and regulatory submissions consistently meet internal standards and external regulatory requirements. The manager leads QC reviews, identifies non-conformances, drives process improvements, and mentors QC staff. RESPONSIBILITIES Strategic Leadership & Oversight * Develop, implement, and maintain a comprehensive quality control program for clinical research activities. * Lead and mentor QC staff, providing guidance, training, and performance management. * Serve as the subject matter expert for QC processes, regulations, and best practices. Quality Control Operations * Oversee QC review of clinical documents (source documentation, regulatory binder, pharmacy binder, laboratory binder, presentation materials, and clinical sections of regulatory submissions). * Ensure all clinical processes comply with applicable regulations, SOPs, laboratory manuals, and study protocols. * Oversee alignment of processing forms and shipping manifests with SOPs and protocols. * Attend key study visits to ensure quality and compliance. * Follow up on outstanding source documentation review issues with designated staff. * Maintain and utilize QC tracking logs for live QC activities. Continuous Improvement & Risk Mitigation * Identify non-conformances during clinical trial conduct and lead root cause analyses. * Develop and implement risk mitigation strategies and corrective action plans. * Drive ongoing process improvement initiatives. Training & SOP Development * Lead the writing and review of clinical quality-related SOPs. Regulatory & Compliance * Ensure correct IRB-approved informed consent forms and subject source documents are used. * Communicate with operational departments regarding project status and issues. * Ensure compliance with current Good Clinical Practices (cGCPs) and corporate policies. Strategic Planning & Vision * Develop and execute the long-term vision and strategy for quality control across all clinical research programs. * Align QC objectives with organizational goals and regulatory trends. Organizational Leadership * Lead and manage multiple QC teams or units across sites, ensuring consistency and excellence in QC practices. * Oversee recruitment, development, and retention of QC staff; set performance standards and conduct evaluations. Cross-Functional Collaboration * Serve as the primary QC liaison to executive leadership, regulatory affairs, clinical operations, and external partners. * Lead cross-functional committees focused on quality, compliance, and process improvement. Other Duties * Perform other QC-related duties as assigned. TRAVELING Between Corporate New Jersey and New York locations, as needed. Salary Range: $85,000-$95,000 annually. Final compensation is based on skills, experience, location, and overall expertise. Requirements * Education: Bachelor's degree in a relevant field (e.g., Life Sciences, Chemistry, Biology, Nursing, or related discipline) required; advanced degree preferred. * Experience: Minimum 5 years of progressive experience in clinical research quality control or related field, with at least 2 years in a leadership or management role. * Deep knowledge of clinical research processes, regulatory requirements, and QC methodologies. * Proven leadership and team management abilities. * Excellent communication, analytical, and problem-solving skills. * Strong organizational and project management skills. * Ability to provide accurate documentation and drive process improvements.

Haddad is a privately held family business with 100 years' experience in the children's apparel & accessories industry. A leader in the children's wear industry, Haddad Brands is the exclusive global licensee for the most iconic brands in the world, which include Nike, Jordan, Converse, Hurley, Levi's, Polo, Abercrombie and Fitch, Lacoste, Tommy Hilfiger, Calvin Klein and Huggies. Supported by a team of professionals skilled in design, sourcing, production, sales, marketing & distribution of premium quality children's wear, Haddad distributes globally to 100+ countries and maintains sales and sourcing offices in 22 cities globally, including New York, Paris, Hilversum, Shanghai, Egypt, Bangkok, Vietnam, Sri Lanka, London and Montreal. Overview: The International Quality Manager supports global Quality Control operations by providing leadership, oversight, and coordination of product quality execution across all international regions. This role provides assistance with ensuring consistency of standards, alignment with customer requirements, and effective implementation of global QC initiatives. The manager works closely with director of quality control to strengthen overall product quality. Domestic and international travel is required. Key Accountabilities: Support global QC team initiatives by implementing company quality standards across all international regions Provide guidance to regional QC teams to ensure consistent inspector performance, inspection accuracy, and procedural compliance Partner with overseas managing offices and factory management to resolve quality issues, support corrective actions, and improve factory outgoing product quality Review and analyze global and domestic inspection reports, defect trends, and quality metrics to identify areas for improvement Visit factories as required to review production, evaluate quality risks, and verify corrective actions Communicate critical quality findings and risk assessments to the Director of Quality Control and other cross-functional leaders Support retailer chargeback prevention through compliance oversight and documentation accuracy Partner with the Director of Quality control to develop and refine global QC processes, manuals, and training materials Provide pre-production and inline quality support to factories to reduce final inspection failures Maintain consistent quality communication channels between domestic and international teams Recruit top talent, train and develop team members Special projects as assigned Requirements Required Skills/Abilities/Education: Bachelor's degree in Quality Management, Manufacturing, Engineering, or related field preferred 5-7 years of experience in Quality Control or Quality Assurance within apparel, or consumer products Strong knowledge of global manufacturing processes, inspection methods, and quality assurance systems Prior experience working with overseas factories and international QC teams Excellent communication, coaching, and cross-cultural collaboration skills Strong analytical and problem-solving abilities with attention to detail Ability to work independently across multiple regions and time zones Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook) Ability to travel domestically and internationally as required Consistent in-office presence is vital to the role as it is for all Haddad Brands team members, so that we all have a full appreciation, aesthetically and tactilely, of the qualities that define our brand partners' products and set them apart from their competitors. Salary Description $80,000 - $100,000 per year

Job Description Come work for a great company at APluscare! The Quality assurance Coordinator is responsible for preserving the standard of the services of the agency. Quality assurance personnel are accountable for assisting to create and execute quality control and management methods and systems. Personnel are accountable for monitoring that the services of the agency meet the standard and are error free. Job Duties: The principal responsibility of quality assurance personnel is to make sure quality of the services provided by APluscare is at the highest level. Quality assurance employees must review the business statistics and then determine areas requiring enhancement. A quality assurance employee should also inspect the samples and formulate policies concerning improvement of the present quality standards. Personnel should ensure that the services take place in accordance with the standards established. Additional responsibilities include all other duties as assigned by APluscare. The Quality Assurance Coordinator is required to: Oversee and ensure agency's compliance with DDD regulations at all levels of operations. Demonstrate broad knowledge of New Jersey Division of Developmental Disabilities (DDD) and Department of Human Services (DHS) licensing standards, regulations, and circulars. Maintain agency's residential/other programs compliance with DDD, DHS, Medicaid, and other applicable state and federal regulations. Cooperate and coordinate with state and other relevant officials during investigations of incidents that involve APluscare and/or its personnel. Ensure agency's compliance with applicable federal and state laws, regulations, and licensing requirements. Ensure agency's compliance with applicable accrediting bodies. Suggest and participate in policy and procedure development, modification, renewal, as well as adherence while maintaining compliance with applicable requirements. Provide weekly training and In-service to all staff involved in providing services and supports to clients of APluscare. Conduct weekly visits and audits of all DDD licensed programs in order to maintain continuous compliance with DDD licensing standards. Identify program deficiencies for all residential programs on a weekly basis and supervise program staff as needed to correct deficiencies. Maintain DDD licensure renewal for all agency programs that are licensed by the division. Maintains all company vehicles including registration, insurance, preventative maintenance, repairs, and equipment inventory according to APluscare policies and licensing standards. Maintains all licenses/certificates for each APluscare program and prepares homes on a regular basis and for licensing inspections. Prepare new programs for initial DDD licensing inspection and secure licensure. Maintain continuous program integrity for all agency programs through quality assurance surveys and reviews. Track and report on quality-related indicators, including areas of risk management and compliance. Conduct weekly quality assurance surveys for all DDD licensed programs Maintain agency compliance with all local, state, and federal regulations for all agency programs Conduct monthly visits and audits of all residential and other programs Prepare and submit program integrity and quality assurance weekly report to the Executive Director Identify program deficiencies for all residential and other programs on a monthly basis and supervise program staff as needed to correct deficiencies All other duties as assigned by APluscare Qualifications: The Quality Assurance Coordinator is expected to posse s excellent interpersonal skills, including the ability to communicate effectively with in individuals with intellectual and developmental disabilities and their families, colleagues, and other parties as necessary for employment with APluscare. Outstanding negotiation skills, customer-oriented approach, excellent analytical skills, effective leadership capability to lead projects, fundamental knowledge of operational software and understanding concerning concepts, equipment and various other quality management techniques. Employee must cooperate with the officer of licensing and/or any department of Human Service staff in any inspection or investigation Employee must successfully complete and demonstrate proficiency in all areas of required training. Valid Driver's License Must be at least 18 years of age Physical Demands/Working Conditions: Handles detailed, basic to complex, and specialized concepts and problems, balancing multiple tasks simultaneously. The ability to effectively communicate (orally and written) and interact with others, including diverse, interdisciplinary, cross-functional teams The ability to read, concentrate and learn Physical requirements include sitting, standing, walking, and computer work for long periods of time Pushing, pulling, and lifting up to 50lbs Driving and travel locally and between agency sites and other required locations Support and maintain all corporate policies, procedures, and quality and confidentiality standards Duties and responsibilities may be added, deleted or changed to meet the needs of the organization

Quality Manager (Manufacturing | Quality & EHS) Industry: Manufacturing & Production Function: Quality Management / EHS Employment Type: Full-Time Compensation: $120,000 - $140,000 base (dependent on experience) Travel: Occasional Relocation: Not available (candidates must be local) About the Role: We are seeking a Quality Manager to lead plant-level Quality Management Systems (QMS) while also owning key Environmental, Health & Safety (EHS) responsibilities. This role is responsible for driving a strong quality ownership culture, reducing customer and warranty concerns, improving internal quality performance, and embedding continuous improvement across operations. This is a hands-on leadership role within a safety-critical manufacturing environment. The Quality Manager partners closely with site leadership, operations, and cross-functional teams to ensure quality and EHS systems are effective, compliant, and fully integrated into daily operations. Key Responsibilities: Quality Leadership Lead and manage the quality function and direct reports to meet plant quality objectives Implement and administer a plant-level Quality Management System aligned with ISO 9001 Lead timely investigation and response to customer concerns and quality escapes Drive reduction in internal and external defects (DPPM) through root cause and corrective actions Support New Product Introduction (NPI) through cross-functional quality readiness Review daily quality metrics and set priorities for the quality team Develop and improve internal validation and inspection methods Deploy and sustain 5S and continuous improvement practices Lead third-party, customer, and regulatory audits EHS Leadership Own and support site EHS programs, risk assessments, and compliance activities Promote a strong zero-incident safety culture through employee engagement Identify leading and lagging EHS indicators and track performance against goals Support regulatory compliance with federal, state, and local EHS requirements Ensure training matrices are defined, tracked, and completed Lead EHS reporting, assessments, and continuous improvement initiatives What We're Looking For: Required Qualifications Bachelor's degree in Engineering or related technical discipline 3+ years of combined experience in manufacturing and/or quality Strong working knowledge of ISO 9001 quality systems Experience managing third-party or external audits Hands-on experience in a manufacturing plant environment Authorization to work in the U.S. (no sponsorship available) Ability to work on-site; candidates must live within commuting distance Preferred Qualifications Experience with ERP systems (SAP preferred) Lean Six Sigma experience or certification ASQ certification (Six Sigma Black Belt, CQE, or similar) Prior Quality Engineer or Quality Manager experience Practical EHS leadership experience What This Role Is (and Is Not) This role is: Plant-based and operations-focused Leadership-oriented with hands-on execution Focused on quality culture, metrics, and continuous improvement Integrated with EHS and safety accountability This role is not: A documentation-only or audit-only quality role A remote or hybrid position Limited to inspection or customer complaints alone What Success Looks Like: Reduced customer complaints, warranty issues, and internal defects Strong audit performance and sustained ISO compliance Engaged employees who take ownership of quality and safety Clear quality and EHS metrics tied to plant performance Visible leadership presence on the floor If you are a manufacturing quality leader who thrives in plant environments, values safety, and enjoys driving real operational improvement, we encourage you to apply. Equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.

**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.