Jobs
>
Saddle Brook

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

    Lynkx Staffing LLC
    Lynkx Staffing LLC Saddle Brook, United States

    4 weeks ago

    Default job background
    Description

    Job Description

    Job DescriptionQuality Assurance Manager - ValidationAllendale, 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 will report into the Associate Director of Quality Assurance responsible for the oversight and management of Quality Assurance Validation/Qualification activity. Responsible for managing the quality assurance validation activity such as development, implementation, and continuous improvement initiatives at two Allendale, NJ manufacturing sites. This role works to build, enhance, harmonize and manage quality assurance validation across sites and is responsible for finding solutions and coordinating change initiatives. Core responsibilities include, but not limited to, document management: review and approval of validation protocol, report, investigation report, assignment of CAPA, SOP development and revisions. Provides cross departmental support within Quality Assurance, as well as, collaborates with other Quality departments to support organizational and functional strategy. Develops and/or revises policies and procedures, as well as, supports operational excellence initiatives. Represents Quality Compliance in internal and external audits which may include interaction with regulatory health authorities and clients.
    • Functions as the sites Quality Assurance validation partner ensuring quality standards are enforced.
    • Partners closely with quality training staff in development of learning curriculum that drives compliance standards.
    • Oversees and manages the activities of validation team; provides leadership and direction to ensure that organizational and departmental goals are met.
    • Coordinates the investigation and closure of deviations with root cause analysis.
    • Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented.
    • Manages end-to-end delivery of quality document assuring compliance of company's quality standards.
    • Reviews and approves GMP documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc.
    • Reviews and proposes changes to quality agreements.
    • Participates in ongoing quality system improvement programs and initiatives. Establishes Quality Validation KPI Reporting and Continuous Improvement metrics.
    • Participates in internal audits, regulatory agencies, and client audits.
    • Provides technical information during tech transfer activities to ensure all quality requirements are met according to current industry standard.
    • Establishes departmental KPIs in alignment with organizational goals and objectives.
    • Plans and allocates resources to effectively staff and accomplish the work to meet departmental productivity and quality goals.
    • Plans, evaluates, and improves the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output.
    • Makes business decisions that are financially responsible, accountable, justifiable, and defensible in accordance with organization policies and procedures.
    • Establishes and maintains relevant controls and feedback systems to monitor the operation of the department.
    • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees.
    • Provides oversight and direction to the employees in accordance with the organization's policies and procedures.
    • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities.
    • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback.
    • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise.
    • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization.
    • Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment.
    • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning.
    • Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary.
    • Maintains employee work schedules including assignments, job rotation, training, vacations and paid time off, coverage for absenteeism, and overtime scheduling.
    • Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM), and regular interpersonal communication.
    • Supervise 1-2 Direct Reports
    • Other duties as assigned.
    REQUIRMENTS
    • Bachelor of Science in biological sciences or other relevant field of study.
    • 5-10 years' relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. 3+ years of recent supervisory experience required. Experience in both clinical and commercial manufacturing is preferred.
    • Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis.
    • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
    • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (investigation, validation/qualification reports, SOPs etc.)
    • Experience in organizing and leading teams.
    • Experience participating in health authority inspections and/or client audits.
    • 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 team is essential
    • Flexible and able to adapt to company growth and evolving responsibilities.
    • Training; GXP, SOP & WI training, Safety
    • Must be able adaptable, collaborative, accountable, and have a "can-do" pioneering spirit.
    • Must be able to foster and work in a team-oriented environment.
    • Must be able to work infrequently on weekends, nights, and/or holidays as required/necessary.
    • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.
    • Must be able to handle the standard moderate noise of the manufacturing facility.
    • Must be able to work in open floor plan environment and may work in close proximity to others.
    • Wheel-O-Vator available for use.
    • Small breakroom available. No on-site cafeteria available.
    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.
  • Lynkx Staffing LLC

    Quality Assurance Manager

    2 days ago

    Lynkx Staffing LLC Saddle Brook, United States

    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 ...

  • Astrix

    Quality Assurance Manager

    1 day ago

    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 ...

  • Fullsteam Operations LLC

    Quality Assurance Manager

    20 hours ago

    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

    Quality Assurance Manager

    20 hours ago

    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

    Quality Assurance Manager

    4 weeks ago

    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

    Sr. Manager IT Quality Assurance Validation Computerization Systems

    6 days ago

    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

    Food Safety Quality Assurance Manager

    1 day ago

    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

    Food Safety Quality Assurance Manager

    4 days ago

    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

    Food Safety Quality Assurance Manager

    2 days ago

    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

    Quality Assurance Manager

    2 weeks ago

    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.

    Quality Assurance Manager

    6 days ago

    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

    Quality Assurance Manager

    1 week ago

    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

    Quality Assurance Manager

    3 weeks ago

    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

    Quality Assurance Manager

    6 days ago

    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 ...