Jobs
>
Saddle Brook

    Quality Assurance Manager - Saddle Brook, United States - Lynkx Staffing LLC

    Lynkx Staffing LLC
    Lynkx Staffing LLC Saddle Brook, United States

    2 days ago

    Default job background
    Description

    Job Description

    Job DescriptionQuality Assurance ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs. The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.
    • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements.
    • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs
    • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues.
    • Establish and maintain policy for documentation of all products and perform internal documentation audits.
    • Author and review relevant SOPs, validation and other documents.
    • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports.
    • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review.
    • Control Master Batch Records, distribution and label verification.
    • Perform line clearance activities as required.
    • Assign and maintain product lot numbers as applicable.
    • Ensure materials management nonconformance disposition and release activity as applicable.
    • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures
    • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions.
    • Provide Quality Assurance related support to various departments.
    • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.
    • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks.
    • Provide support to manufacturing for investigations of deviations, validations, and development of specifications
    • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements.
    • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted.
    • Perform employee training on QSR and ISO requirements and company quality systems
    • Perform document control activities as assigned.
    • Mentor/train/develop and manage Quality Assurance team.
    • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements
    • Travel may be required
    REQUIREMENTS
    • BS Degree in biological sciences or equivalent.
    • Minimum 5-10 years related experience in the pharmaceutical or biologics industry.
    • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).
    • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc.
    • Sound knowledge of aseptic processing and supporting technologies.
    • Analytical and technical troubleshooting skills are a plus.
    • Proficient with Microsoft Office Suite.
    • Excellent organizational skills and attention to detail.
    • Good verbal and written communication skills.
    • Strong team-oriented interpersonal skills are essential.
    • Strong business acumen
    • Relevant IT skills (able to work with Visio, Microsoft Project and Excel)
    • Ability to think strategically and tactically (detail-oriented)
    • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
    • Analytical and problem-solving skills
    • Strong written and oral communication skills
    • Meeting management/facilitation skills/teamwork
    • Ability to multi-task is essential
    • Flexible and able to adapt to company growth and evolving responsibilities
    Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.


  • Astrix Fair Lawn, United States

    Responsibilities: · Lead the development and implementation of the SQF Certified System · Ensure the effectiveness of the system through verification, validation, and ongoing maintenance. · Maintain the integrity and development of the HACCP facility · Ensure Good Manufacturing ...


  • Astrix Inc Fair Lawn, United States

    Responsibilities: · Lead the development and implementation of the SQF Certified System · Ensure the effectiveness of the system through verification, validation, and ongoing maintenance. · Maintain the integrity and development of the HACCP facility · Ensure Good Manufacturi ...


  • Fullsteam Operations LLC Little Ferry, United States

    A company is looking for a Quality Assurance Manager. · Key Responsibilities: · Assist product managers with acceptance testing and create a library of detailed test videos · Lead and coordinate testing strategies with an offshore QA team · Develop and maintain testing framew ...


  • Covetrus Little Ferry, United States

    SUMMARY · The Software · QA Manager drives vision and consistency across the QA Engineering organization along with the other QA Management team as well as across the Programs that they are accountable for. This individual will be responsible for growing, evolving, and executing ...


  • Lynkx Staffing LLC Saddle Brook, United States

    Job Description · Job Description · Quality Assurance Manager - Validation Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. This position wil ...

  • Stryker

    Manager, Assurance

    3 weeks ago


    Stryker Mahwah, United States Full time

    Why finance at Stryker? · Are you looking for a profitable and growing company with a great culture and reputation? Stryker was recently named one of the Best Workplace in the WORLD by Fortune Here, you will have many opportunities to learn and grow as we offer development opport ...


  • Lynkx Staffing LLC Saddle Brook, United States

    Job Description · Job Description · Senior Manager IT Quality Assurance Validation Computerization Systems · Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines ...


  • Woodland Foods Hawthorne, United States

    Job Description · Job DescriptionJob Summary: The Food Safety Quality Assurance Manager is responsible for leading the development, implementation, and maintenance of food safety and people safety systems at Idan Foods. This role involves overseeing the SQF Certified System, HACC ...


  • Woodland Foods Hawthorne, United States

    Job Summary: The Food Safety Quality Assurance Manager is responsible for leading the development, implementation, and maintenance of food safety and people safety systems at Idan Foods. This role involves overseeing the SQF Certified System, HACCP plans, and other certifications ...


  • Woodland Foods Hawthorne, United States

    Job Summary: The Food Safety Quality Assurance Manager is responsible for leading the development, implementation, and maintenance of food safety and people safety systems at Idan Foods. This role involves overseeing the SQF Certified System, HACCP plans, and other certifications ...

  • CohnReznick LLP

    Assurance Manager

    3 days ago


    CohnReznick LLP New York, United States

    As CohnReznick grows, so do our career opportunities. As one of the nation's top Professional Services and Business Advisory firms, we foster teams in Advisory, Assurance, and Tax services that value innovation and collaboration in everything they do · We currently have an excit ...

  • Career Developers

    Assurance Manager

    2 weeks ago


    Career Developers Parsippany, United States

    Refer a friend: · Referral fee program · Career Developers Inc , a well-established staffing agency/consulting firm, celebrating 29 years in operation. Headquartered in West Palm Beach, FL, we offer comprehensive staffing services nationwide. With a portfolio of carefully chose ...

  • Marcum LLP

    Assurance Manager

    2 weeks ago


    Marcum LLP East Hanover, United States

    Marcum LLP offers a great career with exceptional benefits. · There's a lot to think about when it comes to launching your career. At Marcum, we offer you a world of opportunity, a highly competitive salary, exceptional benefits, flexible work options, and industry-leading techno ...

  • Marcum LLP

    Assurance Manager

    2 weeks ago


    Marcum LLP East Hanover, United States

    Marcum LLP offers a great career with exceptional benefits. · There's a lot to think about when it comes to launching your career. At Marcum, we offer you a world of opportunity, a highly competitive salary, exceptional benefits, flexible work options, and industry-leading techn ...

  • CohnReznick

    Assurance Manager

    6 days ago


    CohnReznick Parsippany, United States

    Opportunity ID · 7148 · Department(s) · Assurance · Location(s) · Parsippany · Function · Audit · Job description · As CohnReznick grows, so do our career opportunities. As one of the nation's top Professional Services and Business Advisory firms, we foster teams in Advisory, Ass ...


  • Judge Direct Placement Orangeburg, United States

    Judge Direct Placement is seeking a Quality Assurance & Safety Manager in Orangeburg, NY area The qualified individual will ensure consistent production of quality, safe product by following government and corporate guidelines. They will supervise all Quality Assurance associates ...


  • Golden Platter Foods, Inc. Newark, United States

    Golden Platter Foods, a leader in the frozen food sector, is expanding its operations. We are seeking a fully onsite Quality Assurance Manager to oversee our new plant opening and to assist in setting up the processes and procedures required for this USDA/FDA operation. · Job Ov ...


  • Schreiner Group Blauvelt, United States

    Schreiner Group LP has a full-time regular position for a Quality Assurance Manager. · RESPONSIBILITIES: · Coaches, mentors, and leads all employees in the Quality Assurance Manager's areas of responsibility to achieve goals and objectives related to quality control, quality ass ...


  • Garonit Pharmaceutical Fairfield, United States

    Summary: · This role will focus on Pharmaceutical Manufacturing, so a background in this area is required. The ideal candidate will manage the development, establishment, and maintenance of Quality Systems, policies, procedures and controls ensuring that performance and quality o ...


  • JLB New York, United States

    JLB are delighted to be supporting the Major League Baseball Players Association, in their search for a Quality Assurance Manager. · The successful candidate will oversee the Quality Assurance team, being responsible for reviewing MLB Players Inc. and MLBPA-licensed products for ...