Quality assurance manager jobs in Toms River, NJ

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

The QA Specialist will play a key role in ensuring the quality, safety, and compliance of raw materials and related processes in support of biotechnology manufacturing operations. This position is responsible for reviewing raw material documentation, coordinating and reviewing raw material sampling and release, verifying QC data, and supporting the review of stability reports to ensure adherence to internal procedures, regulatory guidelines, and cGMP standards. Key Responsibilities: Review and approve raw material documentation (e.g., Certificates of Analysis, specifications, vendor documents) for accuracy and compliance. Perform raw material release activities in accordance with established SOPs and GMP requirements. Coordinate and/or review raw material sampling to ensure proper identification, handling, and chain of custody. Review QC laboratory documentation and analytical data for accuracy, completeness, and compliance with applicable procedures and specifications. Review and track stability reports, ensuring timely completion, accuracy, and adherence to protocols. Support investigations, deviations, CAPAs, and change controls related to raw materials and QC data. Collaborate cross-functionally with Quality Control, Supply Chain, and Manufacturing to ensure smooth flow of materials and documentation. Participate in internal and external audits, as needed. Identify and support opportunities for continuous improvement in quality systems and documentation processes. Qualifications: Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field) required. 2-5 years of experience in Quality Assurance within the biotechnology, biopharmaceutical, or pharmaceutical industry. Strong knowledge of GMP regulations (21 CFR Part 210/211) and quality system principles. Experience reviewing QC data, raw material documentation, and stability reports. Detail-oriented with strong organizational and documentation skills. Excellent communication and teamwork abilities. Proficiency with Microsoft Office and familiarity with quality management systems (QMS) or LIMS preferred.

Preferred Experience: Experience with testing and testing tools. Drupal 10/11 Experience with writing automated tests Experience with Playwright Troubleshooting and debugging skills Manual testing Drupal Site Building Experience with version control and package management tools. Experience with PHP, HTMLS, CSS3, SASS, Twig GitHub Repo/Projects Code review and deployment Demonstrated understanding of accessibility standards and best practices for inclusive ---web development. Ability to write secure code and tests following Drupal coding standards and security guidelines. Example of Duties: Develop, apply, and implement tests and automated testing. Troubleshoot issues and provide insights on how to solve. Keeping tests up to date with latest code changes and deployments. Collaborate with other team members and teams on projects to plan, develop, test, deploy, support, and enhance Drupal websites. Work independently and efficiently as required. Communicate and meet with management and stake holders to get a better understanding of business requirements. Implement best practices and standards for website accessibility according to the latest published guidelines. Participate in code quality checks and deployment processes. Work directly with cloud platform vendors and infrastructure support teams to create and manage cloud-hosted website environments and code repositories. Perform code updates to ensure websites remain stable and secure. Stay up to date with the latest in Drupal developments and trends. Provide guidance and mentorship to team members regarding best practices and efficient use of Drupal. Ensure all websites meet Judiciary standards for information security. Required Skills Experience in Drupal site building, features, and theming - 4 Years Working experience with Drupal 10/11 ecosystem (Git, Composer, TWIG) and Playwright - 4 Years Understanding of Drupal architecture and ability to develop site testing strategy - 4 Years Experience with Drupal UI development, UX, theme development, and community theme customization - 4 Years Ability to code/debug in PHP, HTML, CSS, JavaScript/jQuery - 4 Years Experience working in iterative development (Jira, GitHub Projects, Agile, SCRUM) - 4 Years Keeping tests updated with latest code changes - 6 Years Experience with advanced PHP frameworks/workflows (Symfony, Composer) - 6 Years Bachelor's Degree - Required Desired Skills Acquia Drupal Developer Certification - 4 Years Familiarity with Acquia tools (Cloud IDE, Acquia Pipelines, BLT, DDEV, Acquia Cloud) - 5 Years

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

Sr. Quality Systems Engineering opp. w/ manufacturer of aero evacuation systems for aircraft e.g. safety slides, life rafts, vests. Maintain/Improve AS9100 Sys. PoC w/ 3rd Party Registrar & regulators i.e. FAA. Includes: Presentations to customers, regulators about the QMS; SIPOC documentation & PEAR diagrams; meeting KPIs; developing maintaining compliance matrices for regulator, cert & customer reqs; determining training needs; develop/ coordinate internal audits for all facilities; manage CAR process; present internal audit results at 1/4 Mgmt. review meetings; support QMS activities all facilities. Maintain quality sys. docs. e.g. QSP, SQD, GIP, SIP & others. Maintain Service Centers/Satellite Repair Stations/Quality Control Manuals & EU Aviation Safety Agency Supps. Member of Warranty Review Board, contribute to continuous improvement processes, e.g. warranty team, lean initiatives, developing PFMEA all facilities. Biz travel to facilities in MX, & MS, 2 wks./quarter or less, for meetings Considering applying for this job Do not delay, scroll down and make your application as soon as possible to avoid missing out. & Quality Audits. Min. Qual. BSIE or foreign equiv. degree plus 2-yrs. relevant exp. $110,311.00/yr. Email Safran Aerosystems Evac. Wall Township NJ. We prohibit discrimination in staffing practices, because of race, color, religion, sex, age, veteran status, marital status, disability, sexual orientation, or national origin. xevrcyc JobiqoTJN. , Location: TINTON FALLS, NJ - 07727

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

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

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

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

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

**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.

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 looking to add a Quality Control (QC) Manager to their team. Salary/Hourly Rate: $90k - $115k Annually Position Overview: The Quality Control (QC) Manager will lead product-focused quality control operations to ensure that 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 (QC) 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: 30% to contract manufacturers nationwide Responsibilities of the Quality Control (QC) 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 thorough root-cause analysis and effective corrective actions. * Collaborate cross-functionally to support new formulation launches and ensure quality requirements, inspection criteria, and testing protocols are clearly defined and implemented. * Manage the QC laboratory, including equipment oversight, instrument calibration, cleanliness, and adherence to safety practices. * Supervise the retention program and maintain product master standards. * Evaluate consumer complaint samples and support trend analysis. * Administer and enhance the Quality Management System (QMS) for documents, SOPs, CAPAs, audit records, and inspections. * Develop and deliver training on cGMP, quality systems, and technical processes. * Provide leadership, coaching, and performance feedback to QC Specialists. * Monitor, analyze, and report on quality KPIs to drive improvements across QC operations. Required Experience/Skills for the Quality Control (QC) Manager: * 5+ years of QC or quality-related experience in personal care, cosmetics, or fragrance manufacturing (required). * Prior supervisory experience. Ability to lead and develop laboratory personnel. * Strong background in nonconformance management, analytical testing, and release processes. * Experience operating in cGMP/ISO 22716 environments. Education Requirements: * Bachelor's degree in a scientific or engineering discipline (or equivalent experience) is required. Benefits: * Comprehensive medical, dental, and vision (including HSA with employer contribution). * PTO. * Paid holidays. * 401(K) and many more!

The Senior QA Coordinator plays a key role in supporting the Quality Assurance department by ensuring compliance to SOPs, batch records, master manufacturing records, GMP documentation and to 21 CFR Part 111 and 117 and other relevant quality standards in the nutraceutical manufacturing environment. This position will be responsible for coordinating quality assurance programs designed to ensure continuous production of products and includes tracking products, materials, status, and location. Involved in the issuance /review of batch records, on floor collection of samples , preparation of Master compliance documents and participating in audit preparations . Areas of Responsibility Oversee and maintain GMP documentation systems, including SOPs, batch records, deviations, CAPAs, change controls, and training records. Issuance of Manufacturing / Coating / Packaging Batch Cards Collects samples from on floor production for further testing and retention Distributes testing samples to Inhouse testing Analytical , Elemental and Microbiology Lab Preparation of different types of In process Labels for production , QA samples to be provided along with the Batch Records Scanning , photocopy, filing of GMP documents per Batch Product requirements Coordinate Finished Product release in Syspro Performs Sampling of materials / products per procedures as needed Reads and understands approved specifications/standards assigned to the project Keeps up to date with the regulatory requirements around documentation and implements changes if necessary. Work with internal teams to obtain an in-depth understanding of the processes and documentation requirements. Collaborate with Manufacturing, R&D, QC, and Regulatory teams to ensure seamless execution of quality processes. Play an active role on quality management team within the organization Any other duties which may be assigned from time to time Other Responsibilities Including Safety: Works in a safe and responsible manner to create an injury-free and incident-free workplace. Complies with all job-related safety and other training requirements. Keeps management informed of area activities and of any significant problems. Requirements Education & Qualification: Bachelor's degree in Life Sciences, Chemistry, Biology, or a related field. Minimum 3-5 years of QA experience in a nutraceutical, dietary supplement, or pharmaceutical manufacturing environment. Strong knowledge of GMP, 21 CFR Part 111,117 and other relevant quality standards. Detail-oriented with strong organizational and documentation skills. Proficient in Microsoft Office; experience with electronic Quality Management Systems (eQMS) preferred. Excellent communication and problem-solving skills. Certifications, Licenses, Credentials: N/A Skills & Ability In-depth understanding of nutraceutical manufacturing processes and regulatory compliance. Proficient in QA documentation, process audits, and deviation handling. Strong analytical and decision-making skills. Familiar with QMS tools, GMP documentation, and data integrity principles. Working knowledge of SOP writing, change control, and risk assessment. Physical Requirements (lifting, etc.): Ability to lift up to 35 lbs.; occasionally lift and move up to 50 pounds. Must stand and walk on production floor a minimum of 6 hours per shift Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances. Occasionally works from a rolling ladder or step stool. Must be able to wear all PPE including lab coat, face mask, booties, gloves, safety glasses. Work Environment (Office, Warehouse, temperature extremes, etc.): Work is regularly performed inside a manufacturing and packaging environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment. shift schedule :- General Shift 8.30am - 5.00 pm or extended

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.

Job Description Come join an exciting and innovative company that puts the “care” back in healthcare! Why do nurses want to work here? The reason people love working for KabaFusion is because of the impact we have on our patients. Here, it doesn't matter what your role is, you will be part of a team that works collaboratively to change lives. You will go home knowing you've made a difference and improved someone's life. About Us: What started as a single pharmacy in 2010 has grown into KabaFusion becoming the largest privately held home infusion company in the country. We have a national network of pharmacies and nursing offices strategically placed to service 40+ states. Couple that with over 30 years of combined experience and it's no wonder why KabaFusion is the industry leader in home infusion. About the role: At KabaFusion, providing exceptional patient care is our first priority. The Quality Assurance Coordinator plays a vital role in the patient care processes ensuring that our patients receive the level of care that KabaFusion is known for. You'll oversee medical records audits, oversee performance improvement, create plans of treatment, and assist with accreditation and licensing. Essential Duties & Responsibilities: Discharges patients in Computer System as needed and verifies census every week. Performs chart audits for active and discharges patients each quarter. Serves as a resource to all staff regarding quality improvement and documentation. As a Quality Assurance Coordinator, you bring: Current and unrestricted Registered Nurse license in the state of employment Minimum of 2 years' experience working in a position performing clinical record audits, developing plan of cares, or performing a QI audit function. Our Benefits: Benefits start on your 1st day of employment. 401k w 4% match - no waiting or vesting period PTO / Floating Holidays / Paid Holidays Company paid life insurance and short-term disability Reimbursement for certifications/ongoing certification renewal Free CEUs and reimbursement for approved CEUs Employee Assistance programs to help with mental health / wellness Learning & Development Programs Perks… includes discounts on travel, cell phone, clothing and more… Generous employee referral program KabaFusion is a mission driven company with a focus on innovation and patient care so, as a Nursing Quality Assurance Coordinator, if that sounds like something you want to be a part of, then look no further.

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Ensure that highest standards of data quality and study participant safety are maintained, as well as adherence to study protocols, CenExel SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines. Compensation: $27.15 - $35.50/h depending on education, experience, and skillset. Essential Responsibilities and Duties: Assists the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines Reviews follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis. Performs ongoing review of a percentage sampling of study inclusion/exclusion, study procedure records, and laboratory reports to ensure that they are conducted according to the protocol, applicable SOPs, ICH/GCP guidelines and federal regulations. Performs quality review of initially created source documentation, including amendments, to ensure all protocol required procedures are present. Provides training and education on SOPs, GCP, and federal regulations as appropriate. Prepares for internal and external audits and FDA inspections. Attends staff meetings. Attends site initiation visits, as needed. Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Must be able to effectively communicate verbally and in writing. Must have proper experience and demonstrate mastery of Quality Assurance Coordinator I position. Minimum 2 years quality assurance experience. Knowledge/Skills/Abilities: Must be self-directed and able to work with minimal supervision; Must have in depth knowledge of FDA regulations. GCP, and ICH guidelines; Able to take a flexible approach to shifting priorities; Able to manage multiple projects and responsibilities; Motivated to work consistently in a fast paced and rapidly changing environment; Must be detail oriented and have exceptional computer, organizational, and communication skills - both written and oral. Must reflect the professional image of the company, upholding the company vision in actions, demeanor, and appearance. Must be able to clearly communicate through written and verbal means with sponsors and staff. Working Conditions Indoor, Office environment. Essential physical requirements include sitting, typing, standing, walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. On site work arrangement. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

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

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

**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.