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  • Quality Management Specialist II

    Us Tech Solutions 4.4company rating

    Quality assurance manager job in Princeton, NJ

    Duration: 12 months The Quality Management Specialist II tasks include: CW shadows 3 ongoing studies and supports 7 ongoing studies (planning to reporting stage) to provide Quality oversight, to recommend best practices. Communicates and collaborates with the stakeholders (CM and FAs) partnering for cross-functional team support and attendance of project and study level meetings. With the assistance of Senior GCP Level 1 members, consults on major and critical quality issues, potential Serious Breaches, significant noncompliance, data integrity issues and protocol deviations, escalates to Senior Management, and performs periodic resolution checks for assigned studies. Supports risk assessments and risk-based approaches for the annual GQM Audit Plan, identifies the number of site audits and vendor audits based on risk-criteria with input from study teams. Provides study and site related information and documentation to the audit team, GCP Level 2 in preparation for audits. Participates in the risk assessment of preferred and active vendors utilizing risk assessment tools to prepare the annual GQM Vendor Audit Plan. Involved in CAPA review of Quality Issues, Audits, Inspections, eTMF audit responses. Participates and contributes to weekly, monthly, and quarterly GQM GCP meetings. Attends QA:QA and Quality Council meetings with CRO accompanied by a Senior Member from the GCP In-Line Quality (Level 1) Participates in the review and harmonization process of controlled documents such as protocols/ICF, CSRs, amendments, procedural documents & templates. Receives GCP training of ICH Guidelines E6 R3 and Modules from 21CFR and reads GCP Material. Team Members in training participate in weekly team support meetings. Involved in the Portfolio-wide proactive Inspection Readiness support (Sponsor, Site, CRO) - conducts Do & Don't training, participates in interview preparations/debriefs, assesses Inspection Readiness Visits and Pre-Inspection Visits outcomes. Reviews and assesses Pharmacovigilance System Master File (PSMF) and performs PV related activities as assigned. Qualifications: Bachelors Degree; preferably some Pharmaceutical background and GCP ICH E6 knowledge. About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ************************ US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Recruiter Details: Name: Vicky Email: ********************************** Internal Id: 25-54443
    $49k-76k yearly est. 4d ago
  • Quality Assurance Manager

    Hikma Pharmaceuticals 4.9company rating

    Quality assurance manager job in Cherry Hill, 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.
    $75k-105k yearly est. 5d ago
  • Manager, Microbiology

    EPM Scientific 3.9company rating

    Quality assurance manager job in Burlington, NJ

    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.
    $57k-85k yearly est. 3d ago
  • Quality Assurance & Control Manager (Electric Utility Construction)

    IB Abel Inc. 3.5company rating

    Quality assurance manager job in Philadelphia, PA

    If you need assistance with the application process, please notify IB Abel's Human Resources Department. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. About Us IB Abel's 110-year history is a testament to its adaptability, forward-thinking leadership, commitment to safety, and stellar service and project delivery process. Our core values-Responsible, Integrity, Results-Oriented, Ownership, and Professional-shape everything that we do at all levels of the company and are purposefully incorporated into all company communications, meetings, and strategic planning. Our use of the EOS model (Entrepreneurial Operating System) also provides structure and clarity among all levels of the company to maintain focus on our shared goals. IB Abel (IBA) is committed to providing ample learning and career development opportunities to its team members via our Associate's Program in Project Management, Estimating, and Accounting and our growing Learning Management System. The Opportunity We are seeking an experienced Quality Assurance Manager who is responsible for establishing, implementing, and maintaining the company's Quality Assurance and Quality Control program across all transmission, distribution, substation, and civil construction projects. This role ensures all work is performed to contract requirements, industry standards, and customer specifications. The QA/QC Manager partners closely with Safety, Operations, Project Management, and Field Leadership to drive consistency, reduce rework, promote right-first-time execution, and support a culture of continuous improvement. Key Responsibilities Quality Program Leadership - Develop, implement, and manage the company-wide QA/QC program tailored for utility construction (T&D, substation, and civil); establish quality standards, inspection processes, checklists, and documentation that align with utility customer requirements; and maintain quality manuals, procedures, and work instructions in alignment with industry best practices. Project Support & Field Oversight - Conduct field QA/QC audits, inspections, and work observations to verify compliance with engineered drawings, specifications, construction standards, and work methods; ensure crews understand and apply proper installation practices for poles, structures, conductors, and all related civil work; support project teams in interpreting drawings, standards, and technical requirements; and review and approve ITPs (Inspection & Test Plans), hold points, material submittals, and commissioning documentation. Documentation & Reporting - Maintain accurate QA/QC records, including inspection reports, NCRs (Non-Conformance Reports), corrective actions, testing results, photos, and QA/QC logs; prepare quality reports for leadership and customers, identifying trends, recurring deficiencies, and recommended improvements; and oversee turnover documentation and quality packages for customers. Non-Conformance & Corrective Action - Lead investigations into quality-related issues, rework events, or specification deviations; develop corrective and preventive action plans with field leadership and project teams; and track closure of NCRs to ensure accountability and lessons learned. Training & Continuous Improvement - Deliver training for foremen, line workers, operators, and civil crews on quality standards and proper installation techniques; support onboarding of new field leaders by reinforcing customer-specific construction standards; collaborate with Safety, Operations, and L&D to develop technical guidance, SOPs, and best practices; and lead quality-focused continuous improvement initiatives to reduce defects and rework. Customer & Regulatory Interface - Serve as the QA/QC point of contact for utility clients, inspectors, and third-party engineering firms; coordinate with customer QA reps, attend pre-construction meetings, and support project QC reviews; and ensure compliance with all customer requirements, environmental guidelines, and applicable regulatory standards. Who We're Looking For An acceptable combination of education and/or work experience including 7+ years of experience in electric utility construction (transmission, distribution, or substation) as well as 3+ years in a QA/QC, construction management, or field leadership role. Experience with civil construction related to utility infrastructure (foundations, excavation, concrete, site work). Familiarity with utility standards (e.g., IEEE, NESC, ASTM, utility-specific specifications). Proficient in quality documentation systems such as SiteDocs, Aclaimant, Procore, or similar. Local to Pennsylvania but with regular travel to other offices, customer facilities, jobsites and yard locations for offsite meetings (flexibility to work from home when appropriate). A “can-do” attitude, strong work ethic, excellent attention to detail, and ability to collaborate effectively with various teams. Why Choose IBA Culture of Growth: Many of our leaders started in entry-level field roles and advanced within the company. Flexibility & Autonomy: We empower our team to succeed without micromanagement. Competitive Compensation & Benefits: Includes competitive salary, vehicle allowance program, 401(k) with company matching, tuition reimbursement, and comprehensive benefits package including medical, dental, and vision. Stability & Variety: Work for multi-generational family-oriented business on diverse, fast-paced projects without the stress of a large corporate structure. Incentives: Performance-based bonuses/incentives and a progressive PTO programs that grows with your tenure! Collaboration: A team environment where we work together to solve challenges and celebrate wins. Step Into a Career That Powers the Future! IB Abel is an equal opportunity employer, all qualified applicants are encouraged to apply.
    $80k-108k yearly est. 21d ago
  • Food Safety Quality Assurance Manager Protein (2nd Shift)

    The Clemens Food Group 4.5company rating

    Quality assurance manager job in Hatfield, PA

    Step into a pivotal leadership role at Clemens Food Group, where your impact on food safety, people leadership, and product quality will be seen daily. Internally, this role is called a Superintendent, but externally we're seeking an Assistant FSQA Manager-a role often known in other organizations as a Food Safety Manager, Quality Assurance Manager, or FSQA Manager. In this role, you'll lead a team of QA supervisors and technicians in a USDA-regulated meat processing facility, ensuring compliance with HACCP, SSOPs, GMPs, and audit readiness. As the senior-most FSQA authority on second shift, you'll balance hands-on floor leadership with root cause analysis, corrective actions, and continuous improvement projects in one of our largest protein production plants. Shift Details Shift starts at 3:00 PM and runs for 9 hours As a management-level position, flexibility is expected-shifts may start or end an hour earlier or later based on operational needs On-call approximately one out of every four weekends The Impact You'll Make You'll own the shift. Literally. From running handoffs and leading root cause investigations to coaching your team and making critical decisions during audits or equipment failures-this role gives you end-to-end visibility and influence. Your leadership will drive our KPIs around safety, first pass quality, and regulatory compliance. What You'll Do Lead and develop a second-shift FSQA team (multiple supervisors and techs) Be the point of contact for USDA, customer complaints, and urgent investigations Review and act on trend data to improve quality and reduce CPMs Collaborate cross-functionally with Ops, R&D, and Sanitation Manage issue resolution, floor presence, audits, and on-call response (1 in 4 weekends) Prioritize food safety and people leadership at every turn What Makes This Role Exciting? You're the top FSQA decision-maker on your shift Gain experience in a high-capacity, 1.3M sq. ft. protein facility Every day brings new projects, challenges, and growth moments Room to grow-this role is a stepping stone to FSQA Manager What We're Looking For Proven FSQA leadership, meat/poultry/seafood industry required Proven ability to lead teams and manage performance Strong background in USDA, HACCP, audits, and corrective actions Comfortable with ambiguity, fast pace, and solving complex floor issues Skills & Mindset High initiative: confident in making decisions without constant direction Project-focused: can organize chaos into action plans and results People-first: builds trust, holds people accountable, and develops others Strong communicator: connects across functions, listens well, and presents data clearly Your Future at Clemens This isn't just a shift job-it's a career-building leadership role. We'll support your onboarding, help you get grounded in our culture, and give you visibility that sets the stage for broader advancement within FSQA. Application Note: Clemens Food Group is not accepting unsolicited resumes from search or staffing firms. All resumes submitted by search or staffing firms to any employee at Clemens Food Group via email, the Internet, or directly without a valid written search agreement for this role, and without having been asked to participate in this by Talent Acquisition, will be deemed the sole property of Clemens Food Group, and no fee will be paid in the event the candidate is hired. Firms not authorized to submit candidates will not be eligible for any fee or ownership claim. #LG-AG1 Keywords Food Safety, Quality Assurance, Food Safety Supervisor, FSQA Manager, Assistant Food Safety Manager, Meat Processing QA, USDA Compliance, HACCP, SQF, Food Manufacturing, Protein Industry, QA Team Leader, Quality Systems, Food Safety and Sanitation, Second Shift Food Safety, Regulatory Compliance, Food Plant QA, FSQA Superintendent, Assistant QA Manager. #LI-AG1
    $69k-100k yearly est. 60d+ ago
  • Quality Control Laboratory Manager

    Rocketpharma

    Quality assurance manager job in Cranbury, NJ

    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.
    $122k-144k yearly Auto-Apply 38d ago
  • Quality Control Manager

    Atrium Staffing

    Quality assurance manager job in Princeton, NJ

    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.
    $90k-115k yearly 1d ago
  • Manager, Quality Control Physicochemistry

    Beone Medicines

    Quality assurance manager job in Pennington, NJ

    **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.
    $69k-103k yearly est. 20d ago
  • Manager, Corporate Food Safety and Quality

    External

    Quality assurance manager job in Philadelphia, PA

    Manager, Corporate Food Safety and Quality Department: Corporate Food Safety & Quality Reports To: Director, Food Safety & Quality Salary Type: Exempt Make a greater impact at Bonduelle Americas! At Bonduelle Americas, we're on a mission to make plant-rich eating easy, accessible, and joyful for everyone. As a certified B Corp, we invite people to embrace a flexitarian lifestyle with an expanding portfolio of plant-rich products available in and beyond the produce aisle. With four facilities and nearly 3,000 Associates in the US, we're part of something bigger: a global movement rooted in over 170 years of family heritage. Our parent company, Groupe Bonduelle (BON.PA), brings plant-rich foods to tables in nearly 100 countries and partners with growers who cultivate more than 173,000 acres of fresh, nutritious produce each year. At Bonduelle-Americas, you'll find more than just a career, you'll find purpose with a team that puts people first, values sustainability, and believes in doing well by doing good. Together, we're inspiring the shift towards a plant-rich diet that nourishes both people and the plant. Position Summary: This job leads the overall food safety and quality programs within the manufacturing pillar of Bonduelle Americas. The Manager, Corporate Food Safety and Quality is responsible for the development, oversight, and execution of the Food Safety and Quality programs at all internal BA manufacturing facilities and internal warehouses/3PLs. This position effectively collaborates with facility operations leadership and cross-functional departments to drive the food safety and quality metrics, compliance and continuous improvement in products and processes to meet internal, customer and regulatory requirements. This role is a key part of BA's success by directing the development, implementation and continuous improvement of food safety and quality assurance systems, standards and programs to ensure the delivery of safe, wholesome, quality products to our customers nationally. The ideal candidate will demonstrate acute critical thinking skills and the ability to craft and execute solutions in a fast-changing environment. This candidate must be forward-thinking in their approach to maintaining the food safety and quality of our products, while modeling and acting in accordance with Bonduelle's mission, vision, and principles. What You'll Do Lead and Develop the Team: Directly supervise a team of Food Safety and Quality professionals, including Specialists, fostering a culture of accountability, collaboration, and continuous improvement. Oversee Food Safety & Quality Systems: Manage all food safety and quality programs across internal manufacturing and warehousing sites - from raw material receipt through finished product delivery. Establish and Maintain Programs: Develop, implement, and verify all produce-related food safety and quality policies, procedures, and records. Oversee programs related to training, change management, and document control (including version control, distribution, archival, retrieval, retention, and destruction). Benchmark and Align Programs: Ensure Bonduelle's food safety and quality standards are aligned with broader corporate initiatives and benchmarked against industry best practices. Audit Readiness & Leadership: Support facilities in maintaining audit readiness (SQF, Commercial Food Sanitation, customer, and regulatory audits) and serve as the Corporate lead during such audits. Ensure Hygienic Design & Sanitation: Oversee hygienic design, traffic flow, sanitation programs, and environmental monitoring across all sites in accordance with CFS and regulatory requirements. Drive Continuous Improvement: Lead initiatives to enhance process controls, performance metrics, and customer complaint resolution through a data-driven approach. Champion Digital Quality Systems: Act as a quality leader for digital food safety and quality applications, leveraging data analytics to track metrics, identify trends, and drive continuous improvement. Customer Support: Partner with Sales and Consumer Relations to address customer and consumer food safety or quality concerns, including communication, questionnaires, and portal management. Technical Expertise: Serve as a subject matter expert on food safety and quality for both internal stakeholders and external partners. Innovation Support: Collaborate with Product Development and cross-functional teams to ensure the safety and quality of new and existing products. Corporate Audit & Compliance: Manage the Corporate internal audit program to verify compliance with company and regulatory standards. Recall & Traceability: Support the execution of product recall and traceability exercises. Sustainability & ESG: Contribute to environmental and social initiatives, advancing progress toward Bonduelle's ESG and B Corp certification goals. Project Leadership: Lead and influence large-scale, cross-functional projects and initiatives to elevate organizational food safety and quality performance. Additional Duties: Perform other related responsibilities as assigned. What you'll bring: Experience & Education: 10+ years of supplier food safety experience within the food industry, or 5+ years with a master's degree in a related field. Minimum of 3 years in a supervisory or leadership capacity. Regulatory Expertise: Strong understanding of food safety regulations (USDA, FDA, etc.) and familiarity with fresh produce standards preferred. Audit Proficiency: Hands-on experience with Global Food Safety Initiative (GFSI) audit schemes-SQF certification preferred; exposure to other audit programs is a plus. Analytical Strength: Skilled in analyzing complex data, identifying root causes, and recommending effective, data-driven solutions. Quality Leadership: Knowledge of quality assurance methodologies within manufacturing environments; able to design, communicate, and champion continuous improvement initiatives. Technical Fluency: Proficient in Microsoft 365 (Excel, Word, PowerPoint) and comfortable with data analytics platforms such as Tableau, Power BI, or JDE. Exceptional Communicator: Excellent written and verbal communication skills; able to partner effectively across all levels and functions. Collaborative & Resilient: Thrives in fast-paced, changing environments; skilled in managing conflict, resolving issues, and leading through ambiguity. Project Management: Proven ability to manage multiple projects end-to-end and drive measurable outcomes. Flexibility: Willingness to travel up to 50%, with occasional night or weekend work as needed to support plant operations and audits. Compensation and Benefits: The base salary for this role typically ranges from $114,000 to $126,000 annually. Actual compensation will be determined based on a combination of factors, including skills, experience, expertise, and location. In addition to base pay, this position may be eligible for bonuses or other incentive programs as part of a comprehensive total rewards package, which includes: Medical, dental, and vision coverage with multiple plan options 401(k) retirement savings plan Generous paid time off and paid holidays Tuition reimbursement and professional development programs Employee discounts, wellness initiatives, and company-sponsored events Life at Bonduelle: Learn more by visiting: ***************************************
    $114k-126k yearly 60d+ ago
  • Manager, Corporate Food Safety and Quality

    Ba Candidate Gateway

    Quality assurance manager job in Philadelphia, PA

    Manager, Corporate Food Safety and Quality Department: Corporate Food Safety & Quality Reports To: Director, Food Safety & Quality Salary Type: Exempt Make a greater impact at Bonduelle Americas! At Bonduelle Americas, we're on a mission to make plant-rich eating easy, accessible, and joyful for everyone. As a certified B Corp, we invite people to embrace a flexitarian lifestyle with an expanding portfolio of plant-rich products available in and beyond the produce aisle. With four facilities and nearly 3,000 Associates in the US, we're part of something bigger: a global movement rooted in over 170 years of family heritage. Our parent company, Groupe Bonduelle (BON.PA), brings plant-rich foods to tables in nearly 100 countries and partners with growers who cultivate more than 173,000 acres of fresh, nutritious produce each year. At Bonduelle-Americas, you'll find more than just a career, you'll find purpose with a team that puts people first, values sustainability, and believes in doing well by doing good. Together, we're inspiring the shift towards a plant-rich diet that nourishes both people and the plant. Position Summary: This job leads the overall food safety and quality programs within the manufacturing pillar of Bonduelle Americas. The Manager, Corporate Food Safety and Quality is responsible for the development, oversight, and execution of the Food Safety and Quality programs at all internal BA manufacturing facilities and internal warehouses/3PLs. This position effectively collaborates with facility operations leadership and cross-functional departments to drive the food safety and quality metrics, compliance and continuous improvement in products and processes to meet internal, customer and regulatory requirements. This role is a key part of BA's success by directing the development, implementation and continuous improvement of food safety and quality assurance systems, standards and programs to ensure the delivery of safe, wholesome, quality products to our customers nationally. The ideal candidate will demonstrate acute critical thinking skills and the ability to craft and execute solutions in a fast-changing environment. This candidate must be forward-thinking in their approach to maintaining the food safety and quality of our products, while modeling and acting in accordance with Bonduelle's mission, vision, and principles. What You'll Do Lead and Develop the Team: Directly supervise a team of Food Safety and Quality professionals, including Specialists, fostering a culture of accountability, collaboration, and continuous improvement. Oversee Food Safety & Quality Systems: Manage all food safety and quality programs across internal manufacturing and warehousing sites - from raw material receipt through finished product delivery. Establish and Maintain Programs: Develop, implement, and verify all produce-related food safety and quality policies, procedures, and records. Oversee programs related to training, change management, and document control (including version control, distribution, archival, retrieval, retention, and destruction). Benchmark and Align Programs: Ensure Bonduelle's food safety and quality standards are aligned with broader corporate initiatives and benchmarked against industry best practices. Audit Readiness & Leadership: Support facilities in maintaining audit readiness (SQF, Commercial Food Sanitation, customer, and regulatory audits) and serve as the Corporate lead during such audits. Ensure Hygienic Design & Sanitation: Oversee hygienic design, traffic flow, sanitation programs, and environmental monitoring across all sites in accordance with CFS and regulatory requirements. Drive Continuous Improvement: Lead initiatives to enhance process controls, performance metrics, and customer complaint resolution through a data-driven approach. Champion Digital Quality Systems: Act as a quality leader for digital food safety and quality applications, leveraging data analytics to track metrics, identify trends, and drive continuous improvement. Customer Support: Partner with Sales and Consumer Relations to address customer and consumer food safety or quality concerns, including communication, questionnaires, and portal management. Technical Expertise: Serve as a subject matter expert on food safety and quality for both internal stakeholders and external partners. Innovation Support: Collaborate with Product Development and cross-functional teams to ensure the safety and quality of new and existing products. Corporate Audit & Compliance: Manage the Corporate internal audit program to verify compliance with company and regulatory standards. Recall & Traceability: Support the execution of product recall and traceability exercises. Sustainability & ESG: Contribute to environmental and social initiatives, advancing progress toward Bonduelle's ESG and B Corp certification goals. Project Leadership: Lead and influence large-scale, cross-functional projects and initiatives to elevate organizational food safety and quality performance. Additional Duties: Perform other related responsibilities as assigned. What you'll bring: Experience & Education: 10+ years of supplier food safety experience within the food industry, or 5+ years with a master's degree in a related field. Minimum of 3 years in a supervisory or leadership capacity. Regulatory Expertise: Strong understanding of food safety regulations (USDA, FDA, etc.) and familiarity with fresh produce standards preferred. Audit Proficiency: Hands-on experience with Global Food Safety Initiative (GFSI) audit schemes-SQF certification preferred; exposure to other audit programs is a plus. Analytical Strength: Skilled in analyzing complex data, identifying root causes, and recommending effective, data-driven solutions. Quality Leadership: Knowledge of quality assurance methodologies within manufacturing environments; able to design, communicate, and champion continuous improvement initiatives. Technical Fluency: Proficient in Microsoft 365 (Excel, Word, PowerPoint) and comfortable with data analytics platforms such as Tableau, Power BI, or JDE. Exceptional Communicator: Excellent written and verbal communication skills; able to partner effectively across all levels and functions. Collaborative & Resilient: Thrives in fast-paced, changing environments; skilled in managing conflict, resolving issues, and leading through ambiguity. Project Management: Proven ability to manage multiple projects end-to-end and drive measurable outcomes. Flexibility: Willingness to travel up to 50%, with occasional night or weekend work as needed to support plant operations and audits. Compensation and Benefits: The base salary for this role typically ranges from $114,000 to $126,000 annually. Actual compensation will be determined based on a combination of factors, including skills, experience, expertise, and location. In addition to base pay, this position may be eligible for bonuses or other incentive programs as part of a comprehensive total rewards package, which includes: Medical, dental, and vision coverage with multiple plan options 401(k) retirement savings plan Generous paid time off and paid holidays Tuition reimbursement and professional development programs Employee discounts, wellness initiatives, and company-sponsored events Life at Bonduelle: Learn more by visiting: ***************************************
    $114k-126k yearly 60d+ ago
  • Compliance Quality Assurance Manager (US)

    TD Bank 4.5company rating

    Quality assurance manager job in Mount Laurel, NJ

    Hours: 40 Pay Details: $86,840 - $139,360 USD TD is committed to providing fair and equitable compensation opportunities to all colleagues. Growth opportunities and skill development are defining features of the colleague experience at TD. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The base pay actually offered may vary based upon the candidate's skills and experience, job-related knowledge, geographic location, and other specific business and organizational needs. As a candidate, you are encouraged to ask compensation related questions and have an open dialogue with your recruiter who can provide you more specific details for this role. Line of Business: Compliance : Why Work with Us? At TD Bank US Compliance, we're on a mission to build a more resilient and scalable compliance risk management function. As part of our team, you'll play a key role in reshaping compliance structures and processes, driving innovation at every level. Here, each team member has a chance to make a tangible impact - both in day-to-day operations and in the design of a future-focused compliance program. This not just about implementing a new program - it's about creating a culture of compliance that will cascade throughout the organization. Department Overview The Compliance Quality Assurance (US) team is responsible for providing independent quality assurance of compliance risk through the execution of reviews. These reviews assess whether Risk Owners and Oversight functions are complying with established policies, standards and procedures. The Compliance Quality Assurance Manager (US) will execute these reviews and/or perform peer reviews. This role will play a key role in providing strategic guidance that reshapes Compliance's structures and processes. We're counted on to provide recommendations to enhance operational performance, foster meaningful process improvements and ensure adherence to internal policies, standards and procedures. Here, each team member has a chance to make a tangible impact - both in day-to-day operations and in the design of a future-focused Compliance Quality Assurance function. This is not just about implementing a new program - it's about creating a culture of compliance that will cascade throughout the organization. The above details are specific to the role which is outlined in the general description below. Please review Desired Skills & Experience below as you consider this opportunity. Our team currently operates under a hybrid work model, with employees expected to work in the office two days per week. Starting in November 2025, this expectation will increase to four days per week. Please note that, due to limited office space, the exact timing of this transition may vary depending on availability and individual circumstances Job Description Summary: The Compliance Testing Manager is responsible for planning and overseeing independent Compliance testing completed by specialists. May execute some independent testing as applicable. This role provides subject matter expertise on Compliance controls/processes and is responsible for leading all phases of the assigned testing engagement. Depth & Scope: * Works independently and be accountable for acting as a lead in executing engagements and provides work direction to others on those engagements * Considered subject matter expert in Compliance testing methodologies * Provides subject matter expertise and/or guidance to various stakeholders and team members * Advanced knowledge of external competition, industry and/or market trends in relation to own function/business * Scope of role may have enterprise impact * Undertakes and completes a variety of complex projects and initiatives requiring specialist knowledge and/or the integration of cross functional processes within own area of expertise * Independently performs concurrent multiple reviews and related tasks from end to end * May act as highest point of team escalation for resolution and provides direction to resolve issues or escalates Education & Experience: * Undergraduate degree or equivalent work experience * 7+ years of experience Desired Skills & Experience: * CPA, CIA, CFE, CRCM or equivalent a plus * 8+ years of internal audit, testing and/or quality assurance experience * Knowledge of financial institution laws/regulations, strategies and risk management/compliance programs * Possesses and demonstrates expertise in the advisory of policy, change management, project management and operations * Skilled in using computer applications including MS Office suite, with a focus on Excel and PowerPoint * High personal and professional integrity and standards to advance TD's vision and protect the brand * Strategic critical thinker: has excellent judgment, achieves the right risk/reward balance * Delivers on objectives, focuses on what matters and can work across silos to build effective working relationships * Clear and concise verbal and written communication skills Customer Accountabilities: * Executes and manages testing activities in accordance with established standards and strategic direction to achieve completion within target timelines * Executes follow-up on findings raised from testing engagements in accordance with established standards * Conducts skilled analytical research and analysis as part of testing engagement and initiatives * Understands risk identification, risk analysis, and risk mitigation according to regulatory requirements and best business practices * Develops strong relationships and works collaboratively with key partners * Oversees/leads the testing engagement, including communications and the reporting processes * Provides subject matter expertise and/or input to projects/initiatives as a representative for area of specialization * Proactively identifies matters which require additional attention, further escalation, or review, and liaises with the appropriate staff to resolve Shareholder Accountabilities: * Prioritizes and manages workload to deliver quality results and meet testing timelines * Contributes to the review of internal processes and activities and assists in identifying potential opportunities to improve operational efficiencies for area of responsibility * Adheres to internal policies/procedures, enterprise frameworks and methodologies and applicable regulatory guidelines * Clearly and concisely documents research as required to understand requirements specific to an engagement * Protects the interests of the organization - identifies and manages risks, and escalates non-standard, high risk transactions/activities as necessary * Applies subject matter expertise in the discipline, provides guidance, assistance, and direction to others * Actively manages relationships within and across various business lines, corporate and/or control functions, and drives alignment with enterprise and/or regulatory requirements * Assesses/identifies key issues and escalates to appropriate levels and relevant stakeholders where required * Participates in cross-functional/enterprise initiatives as a subject matter expert helping to identify risk/provide guidance for complex situations * Keeps abreast of emerging issues, trends, and evolving regulatory requirements and assesses potential impacts to the Bank * Maintains a culture of risk management and control, supported by effective processes in alignment with risk appetite Employee/Team Accountabilities: * Participates fully as a member of the team, supports a positive work environment that promotes service to the business, quality, innovation and teamwork and promotes timely communication of issues/points of interest * Provides thought leadership and/or industry knowledge for own area of expertise in own area and participates in knowledge transfer within the team and business unit * Keeps current on emerging trends/developments and grows knowledge of the business, related tools and techniques * Participates in personal performance management and development activities, including cross training within own team * Keeps others informed and up-to-date about the status/progress of projects and/or all relevant or useful information related to day-to-day activities * Contributes to team development of skills and capabilities through mentorship of others, by sharing knowledge and experiences and leveraging best practices * Leads, motivates and develops relationships with internal and external business partners/stakeholders to develop productive working relationships * Contributes to a fair, positive and equitable environment that supports a diverse workforce * Acts as a brand ambassador for your business area/function and the bank, both internally and/or externally Physical Requirements: Never: 0%; Occasional: 1-33%; Frequent: 34-66%; Continuous: 67-100% * Domestic Travel - Occasional * International Travel - Never * Performing sedentary work - Continuous * Performing multiple tasks - Continuous * Operating standard office equipment - Continuous * Responding quickly to sounds - Occasional * Sitting - Continuous * Standing - Occasional * Walking - Occasional * Moving safely in confined spaces - Occasional * Lifting/Carrying (under 25 lbs.) - Occasional * Lifting/Carrying (over 25 lbs.) - Never * Squatting - Occasional * Bending - Occasional * Kneeling - Never * Crawling - Never * Climbing - Never * Reaching overhead - Never * Reaching forward - Occasional * Pushing - Never * Pulling - Never * Twisting - Never * Concentrating for long periods of time - Continuous * Applying common sense to deal with problems involving standardized situations - Continuous * Reading, writing and comprehending instructions - Continuous * Adding, subtracting, multiplying and dividing - Continuous 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 responsibilities, duties and skills required. The listed or specified responsibilities & duties are considered essential functions for ADA purposes. #LI-AMCBCorporate Who We Are: TD is one of the world's leading global financial institutions and is the fifth largest bank in North America by branches/stores. Every day, we deliver legendary customer experiences to over 27 million households and businesses in Canada, the United States and around the world. More than 95,000 TD colleagues bring their skills, talent, and creativity to the Bank, those we serve, and the economies we support. We are guided by our vision to Be the Better Bank and our purpose to enrich the lives of our customers, communities and colleagues. TD is deeply committed to being a leader in customer experience, that is why we believe that all colleagues, no matter where they work, are customer facing. As we build our business and deliver on our strategy, we are innovating to enhance the customer experience and build capabilities to shape the future of banking. Whether you've got years of banking experience or are just starting your career in financial services, we can help you realize your potential. Through regular leadership and development conversations to mentorship and training programs, we're here to support you towards your goals. As an organization, we keep growing - and so will you. Our Total Rewards Package Our Total Rewards package reflects the investments we make in our colleagues to help them and their families achieve their financial, physical and mental well-being goals. Total Rewards at TD includes base salary and variable compensation/incentive awards (e.g., eligibility for cash and/or equity incentive awards, generally through participation in an incentive plan) and several other key plans such as health and well-being benefits, savings and retirement programs, paid time off (including Vacation PTO, Flex PTO, and Holiday PTO), banking benefits and discounts, career development, and reward and recognition. Learn more Additional Information: We're delighted that you're considering building a career with TD. Through regular development conversations, training programs, and a competitive benefits plan, we're committed to providing the support our colleagues need to thrive both at work and at home. Colleague Development If you're interested in a specific career path or are looking to build certain skills, we want to help you succeed. You'll have regular career, development, and performance conversations with your manager, as well as access to an online learning platform and a variety of mentoring programs to help you unlock future opportunities. Whether you have a passion for helping customers and want to expand your experience, or you want to coach and inspire your colleagues, there are many different career paths within our organization at TD - and we're committed to helping you identify opportunities that support your goals. Training & Onboarding We will provide training and onboarding sessions to ensure that you've got everything you need to succeed in your new role. Interview Process We'll reach out to candidates of interest to schedule an interview. We do our best to communicate outcomes to all applicants by email or phone call. Accommodation TD Bank is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or any other characteristic protected under applicable federal, state, or local law. If you are an applicant with a disability and need accommodations to complete the application process, please email TD Bank US Workplace Accommodations Program at ***************. Include your full name, best way to reach you and the accommodation needed to assist you with the applicant process.
    $86.8k-139.4k yearly Auto-Apply 4d ago
  • Quality Manager - Supplier ODA Focal

    Thyssenkrupp Materials

    Quality assurance manager job in Plainfield, NJ

    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.
    $87k-120k yearly est. Auto-Apply 60d+ ago
  • Quality Control Manager - QCM

    Bristol Bay Construction Holdings

    Quality assurance manager job in Philadelphia, PA

    Bristol Bay Construction Holdings LLC (BBCH) is seeking an experienced dual hat Quality Control Manager & Site Safety Officer to join our SES Civil and Environmental team, a subsidiary of BBCH. The primary responsibilities of this position are to coordinate, plan, and supervise subcontractors and/or craft activities to ensure adherence to plans and specifications; enforce site safety and provide contractor quality control. Candidates must have strong organizational and communication skills. This position is based in Folsom, Pennsylvania. Project Scope of Work: Interior and exterior renovation of MCRC Folsom PA, including site work, roofing, finishes, MEPs, and roofing. We are an equal-opportunity employer. All applicants will receive consideration for employment, without regard to race, color, religion, creed, national origin, gender, or gender identity, age, marital status, sexual orientation, veteran status, disability, pregnancy or parental status, or any other basis prohibited by law. We participate in the E-Verify Employment Verification Program. We are a drug-free workplace. Submittal coordination and review Updating submittal register Inspections of materials and workmanship Army Corps RMS system management and input Safety meetings AHA development and review Review material and safety submittals for compliance Supervise special inspections Verify qualifications Maintain rework/deficiency logs 3 phases of inspection Hold preparatory meetings with the team USACE Quality Control Management EM385 1-1 40hr OSHA 30hr 10 years' experience in construction Experience managing Government projects Proficient in RMS, proficient with Word, Excel, and PDF Experience with Procore Familiar with P6 or Microsoft Project scheduling tools Strong safety background and certs in Fall Protection, confined space, etc. Can pass a background check As a condition of employment, you may be required to pass a pre-employment drug screening and have acceptable references and background check results
    $68k-102k yearly est. 47d ago
  • Quality Control Senior Manager

    I.Rice & Company

    Quality assurance manager job in Philadelphia, PA

    This permanent, full-time position supports the Quality Assurance department. The Quality Control Senior Manager plays a critical role in maintaining and enhancing our commitment to food safety and quality. This hands-on position combines leadership with technical expertise, supporting the Director of Quality Control with administering department operations, validating program CCPs, and participating in audits, while also performing daily functions in the lab. Knowledge of laboratory principles is required. Product testing includes brix, pH, water activity, titrations, viscosities and organoleptic evaluations. Environment is a clean and modern lab working with terrific people. Essential Job and Duties - Develop, implement, and manage quality systems, food safety programs, and regulatory compliance standards (HACCP, GMP, FSMA, SQF, etc.) - Coordinate with the Director of Quality Control to lead internal and external audits, including customer, third-party, and regulatory inspections - Manage record-keeping and reporting systems related to production metrics and regulatory requirements. - Assist with monitoring sanitation programs and environmental testing, ensuring compliance with microbiological and allergen control standards. Promote a clean and safe working environment where respect for coworkers and the consumer is reflected in every procedure. - Maintain and update Operations documents and SOPs - Perform analytical tests on raw materials and finished products - Calibrate laboratory equipment - Work with production to make adjustments to batches in order to adhere to product specifications - Respond to customer questions or concerns in a professional and appropriate manner - Maintain the finished goods retention library - Sample finished product for microbial analysis - Maintain raw material specification documentation and product specification documentation - Maintain finished product specification documentation Requirements - Bachelor's Degree in Food Science, R&D, or related course of study preferred - 10+ years of related quality assurance or lab experience - Strong knowledge of HACCP, SQF, FDA, USDA, GFSI, SQF, FSMA, GMP, GLP, required - Food industry experience required - Ability to prioritize and organize ones work load - Ability to work in a team environment as well as individually in an environment with changing priorities - Comfortable working on an active busy production floor among batching and packaging equipment. - Ability to manage time effectively - Maintain proper lab conditions and equipment maintenance - Maintain proper record keeping and perform data entry - Be capable of working in various work settings of the facility including laboratory, office and plant areas - Perform basic math skills - Proficient computer skills, including above average knowledge of MS Excel - Understand and perform scaling/measuring in standard and metric formats - Lifting and carrying up to 50 pounds - Being able to withstand extended periods of time on one's feet - Working and walking in a wet environment
    $68k-102k yearly est. Auto-Apply 60d+ ago
  • Quality Assurance Coordinator

    S S White Burs 4.0company rating

    Quality assurance manager job in Lakewood, NJ

    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
    $52k-78k yearly est. 60d+ ago
  • International QC Manager

    Haddad Brands 4.0company rating

    Quality assurance manager job in Dayton, NJ

    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
    $80k-100k yearly 11d ago
  • Supplier Quality Manager

    Lancesoft 4.5company rating

    Quality assurance manager job in Raritan, NJ

    OVERALL RESPONSIBILITIES: Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts. DUTIES: • Responsible and accountable for on-time submission and accuracy of regulatory reports • Review and complete determination associated Medical Device Report and/or Vigilance Report • Knowledge of and familiarity with global regulations for reporting • Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events • Interact positively with internal, external business partners and colleagues • Adhere and comply to work instructions, standard operating procedures, and regulations • Expedite investigations by collaborating with internal/external business partners • Achieve productivity targets • Fully trained within three months of hire • Achieve accuracy targets for complaint documentations • Participate in projects and events • Complaint determination • Reportability assessments • Conduct follow-ups with complainant, reporters • Checking your own work • Updating SharePoint • Tracking complaints in the process for closure • All other duties as assigned Qualifications • Bachelor's Degree or equivalent experience • Generally requires 2-4 years of related work experience • RAC or ASQ certifications a plus Additional Information All your information will be kept confidential according to EEO guidelines.
    $88k-111k yearly est. 7h ago
  • Quality Assurance Coordinator - (DDD Experience Needed)

    Apluscare LLC

    Quality assurance manager job in East Brunswick, NJ

    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
    $51k-76k yearly est. 8d ago
  • Nursing Quality Assurance Coordinator

    Kabafusion

    Quality assurance manager job in Edison, NJ

    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.
    $51k-76k yearly est. 8d ago
  • Quality Assurance Coordinator

    Eurofins USA Clinical Diagnostics

    Quality assurance manager job in Philadelphia, PA

    Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description The Laboratory Quality Assurance (QA) Coordinator is responsible for ensuring that DPT's quality system is well-documented, traceable, and compliant. This role focuses specifically on regulatory readiness documentation and inspection support. Role is critical in tracking, organizing, and executing the administrative an procedural backbone of the laboratories' quality program.. This position ensures compliance with federal, state, and local regulations (e.g., CLIA, CAP, ISO, FDA) and drives continuous quality improvement initiatives. The QA Coordinator develops and maintains policies, conducts audits, manages documentation, and trains staff on quality procedures. Key Responsibilities: Quality Management System (QMS) Oversight: Develops, implements, and maintains the laboratory's comprehensive quality management system, including the Quality Manual, policies, and procedures. Regulatory Compliance: Monitor and ensure continuous compliance with all applicable accreditation and regulatory standards (e.g., CAP, CLIA, ISO 15189, GxP, FDA). Audits and Inspections: Coordinate and participate in internal and external audits/inspections, manage the response to findings, and implement corrective and preventive actions (CAPAs). Assist in preparing audit schedules and checklists. Track corrective actions and verify closures. Organize and maintain documentation needed for audits and inspections. Assist in preparing materials and responses for regulatory and accrediting inspections and client audits. Documentation and Record Control: Oversees the documentation control system.. Logs and tracks nonconformances, deviations and incident reports. Ensures completeness and accuracy of quality records. Change Management Support: Log and monitor change requests. Track approval workflows and implementation timelines. Assist in collecting / reminding of required objective evidence for activity / file closure. Ensure related documentation is complete before closure. Training and Education: Develop and conduct training sessions for staff on quality standards, new procedures, and best practices to promote a quality culture. Send reminders for upcoming and overdue training, as applicable. Event and Risk Management: Assist in investigation of non-conformances, errors, and incidents; perform root cause analysis; and determine corrective actions to mitigate future risks. Ensure timeliness of all activities to meet regulatory expectations. Develop tools to assist with tracking activities / actions. Communication and Coordination: Schedule QA Meetings and take meeting minutes. Communicate deadlines, updates and quality-related notifications. Serve as liaison between QA and other departments. Supplier Qualification Program: Develop schedule to ensure Approved Supplier List (ASL) is kept up-to-date. Ensure qualification / re-qualification documentation is current and filed appropriately. Participate in vendor-related SCAR issuance, receipt of responses and assuring documentation meets DPT's requirements. Qualifications Required Qualifications and Skills: Education: Bachelor's degree, preferably in a chemical, physical, biological science, or Medical Laboratory Science (MLS/MT) from an accredited institution. Experience: Minimum of 5-7 years of experience in a clinical or analytical laboratory environment, with demonstrated experience in quality assurance or quality control. Knowledge: Strong knowledge of quality management systems (e.g., ISO, CLIA, CAP) and relevant federal/state regulations. Skills: Excellent attention to detail and strong organizational skills. Strong analytical and problem-solving abilities, with an aptitude for data interpretation and statistical analysis. Excellent written and verbal communication skills, with the ability to effectively communicate with diverse staff and management. Proficiency with laboratory information management systems (LIMS) and Microsoft Office Suite. Ability to work both independently and collaboratively in a fast-paced environment. Preferred Qualifications: Certification in quality management (e.g., Certified Quality Auditor (CQA) or Six Sigma certification). Experience with specific laboratory certifications/standards relevant to the lab's specialty (e.g., ASHI, CAP, CLIA,) Additional Information Schedule: Monday - Friday 8:00am-4:30pm What we offer: Excellent full time benefits including comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holidays Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.
    $55k-82k yearly est. 42d ago

Learn more about quality assurance manager jobs

How much does a quality assurance manager earn in Mercerville, NJ?

The average quality assurance manager in Mercerville, NJ earns between $68,000 and $142,000 annually. This compares to the national average quality assurance manager range of $70,000 to $140,000.

Average quality assurance manager salary in Mercerville, NJ

$98,000

What are the biggest employers of Quality Assurance Managers in Mercerville, NJ?

The biggest employers of Quality Assurance Managers in Mercerville, NJ are:
  1. Integrated Resources
  2. DSM Services USA Inc
  3. Public Consulting Group
  4. Hilton
  5. Dsm-Firmenich
  6. Summit Therapeutics Sub, Inc.
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