Chemistry Technical Manager

2 months ago

Melville, United States Food Safety Net Services Full time
Job DescriptionJob Description

Develop, apply and maintain quality standards for sample testing process, documents, methods and procedures that comply with cGMPs, GLP, 21 CFR, ICH, Monograph, ISO and FDA regulations and guidelines. Schedule frequent meetings with top management to deliver presentations, protocols, reports, and all other data to keep them current on all projects and equipment schedules.

ESSENTIAL RESPONSIBILITIES

 

  • Follow and implement all management related activities within the internal SOPs (QSD, GEN and COP) as they pertain to the laboratory and R&D/Validation tests. 
  • This position requires the capability of working in cross-functional teams and to achieve departmental goals. 
  • Ensure processes related to the department are being followed by laboratory personnel. (e.g. Good documentation practices, Good Laboratory Practices, internal SOPs as they apply to the lab).
  • Provides technical expertise for customer inquiries. 
  • Act with impartiality and work in accordance with the Chemistry Laboratory and management. 
  • Act in a way to not be influenced by particular perspectives, value judgments, community bias, or personal interests that could compromise impartiality.   
  • Communicate possible impartiality risks to management from the Chemistry Laboratory operations to Quality Assurance and/or Management.  
  • Assist in writing, revising, and approving standard operating policies and procedures for the laboratory.  
  • Assist in writing, revising, and approving all method and form updates including associated documents including forms. 
  • Participate in maintenance and improvement of training modules for operation of instrumentation, performing testing, recording, evaluating, and reporting quality data.  
  • Participate in the maintenance of the training program and help to ensure results in effective and efficient training.  
  • Participate in maintaining and establishing organizational policies and operating procedures for the laboratory in a technical capacity. 
  • Manage Department PT program and results as per SOP. 
  • Keep abreast of all regulatory procedures and changes that pertain to the laboratory. 
  • Manage prevention or mitigation of issues in new and/or existing methods. 
  • Manage R&D, Validation, and optimization laboratory testing services. Ensure customer satisfaction, by laboratory communication to customers providing clear testing TAT’s when available and timely updates when schedule for testing is not certain.  
  • Ensure adherence to method validation, verification and transfer processes are followed as pe the SOPs. 
  • Manage the dashboard for overall quantity and quality of testing services provided and performed by the laboratory and interact with your direct management to ensure facility they are aware of requested resources required to support testing needs.  
  • Participate in external and internal, regulatory, and other audits when needed.   
  • Recommend response to laboratory related complaints, considering test reports and records, legal standards, and complaint validity.  
  • Must be able to operate/maintain equipment, including preventive maintenance of laboratory instruments and safety equipment.  
  • Maintain a high degree of technical competence, may attend professional conferences and seminars for information on techniques and instrumentation. 
  • Responsible for working alongside the Safety officer/committee to ensure employees are following safe work practices in the laboratory.

 

MINIMUM QUALIFICATIONS

  • Minimum of a Baccalaureate Degree is required; concentration in Biological or Chemical Science and a Masters or higher degree is preferred. 
  • A minimum of ten (10) years in the cosmetic, pharmaceutical, or related field, and four (4) years of regulatory, quality control, or quality assurance experience or equivalent is preferred. 
  • Must have a general working knowledge of 21 CFR, USP/NF, EP, JP, AOAC, ICH, GxP, cGMP, cGLP and/or ISO standards and guidelines. 
  • Must have the ability to communicate clearly in English, both orally and in writing, with scientific and non-scientific personnel is required. 
  • Must have the ability to communicate effectively and solve complex problems.  
  • Must have the ability to communicate clearly in English, both orally and in writing, with scientific and non-scientific personnel is required. 
  • Must be proficient in using Windows programs, Access, Acrobat, Chromeleon, Qtegra, Omnic, ValPro, Data Logger Software, Sievers DataPro2, and Insight with the ability to access, input, and retrieve information using a computer. 
  • Must be able to lift and move heavy items in the laboratory (glassware, solvent bottles, equipment, etc.). 
  • Must be able to work efficiently under pressure and successfully function in a fast-paced environment. 

PHYSICAL DEMANDS

  • Dexterity of hands and fingers to operate a computer keyboard, mouse and to handle other communications/computer components
  • Potential exposure to odors, fumes, airborne particles, hazardous chemicals, and microbiological pathogens
  • Noise level varies from quiet to loud
  • Temperature varies from hot to cold
  • Interactive and fast-paced team-oriented tasks
  • Overnight Travel is required at the discretion of management
  • Occasionally lift and/or move up to 25 pounds.
  • Color vision and depth perception

BENEFITS: 

  • Progressive 401k Retirement Savings Plan
  • Employer Paid Short- Term and Long-Term Disability, and Life Insurance
  • Group Medical
  • Tuition Reimbursement
  • Flexible Spending Accounts
  • Dental
  • Paid Holidays and Time Off

Certified Group values diversity in its workforce. The company is firmly committed to a policy of Equal Opportunity and will administer its policies in a manner that treats each employee and applicant for employment on the basis of merit. Certified Group will take affirmative action to seek out qualified applicants without regard to race, color, religion, sex, national origin, age, handicap, or veteran status.

Company DescriptionCertified Group is committed to delivering expert solutions and quality testing our customers can feel confident in – on time, every time – so the world can trust in what it consumes. As a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group includes Food Safety Net Services (FSNS), FSNS Certification & Audit, Certified Laboratories, EAS Consulting Group, and Labstat International Inc. Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries.Company DescriptionCertified Group is committed to delivering expert solutions and quality testing our customers can feel confident in – on time, every time – so the world can trust in what it consumes. As a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group includes Food Safety Net Services (FSNS), FSNS Certification & Audit, Certified Laboratories, EAS Consulting Group, and Labstat International Inc. Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries.

  • Chemistry Technical Manager

    2 weeks ago

    Melville, NY, United States Food Safety Net Services Full time

    Certified Group is committed to delivering expert solutions and quality testing our customers can feel confident in - on time, every time - so the world can trust in what it consumes. As a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group includes Food Safety Net Services (FSNS),...

  • Technical Operations Manager

    2 days ago

    Melville, New York, United States Kedrion Biopharma Inc. Full time

    Key ResponsibilitiesThe IT System Administrator role at Kedrion Biopharma Inc. requires an individual who can work autonomously in a fast-paced environment, providing technical support to end-users and ensuring corporate infrastructure and security standards are maintained.Main Responsibilities:Support day-to-day helpdesk operations, managing and resolving...

  • Technical Operations Manager

    3 weeks ago

    Melville, New York, United States Canon Solutions America, Inc. Full time

    As a leader in technology, solutions, and services, Canon Solutions America, Inc. is looking for a Technical Operations Manager to oversee a talented team of select technicians who service and support Canon's hardware and software technology-based solutions.The ideal candidate will have 5 years of related experience, including management of two or more...

  • Technical Support Specialist

    3 weeks ago

    Melville, New York, United States HBK CPAs & Consultants Full time

    Job SummaryThe Support Technician role at Vertilocity is a dynamic opportunity for individuals with a passion for technical problem-solving and customer service. As a Support Technician, you will provide fast and effective technical assistance to our clients, utilizing your solid technical knowledge and excellent communication skills to understand and...

  • Architect - Technical Lead

    4 weeks ago

    Melville, United States nextSource Full time

    Contract Duration: 2 Months with potential to extend Pay Range: $90 - $95/hour depending on experience. Ensures data and data integrity in enterprise systems. Envision, design, ideation and deliver solutions. plans and coordinates project activities to ensure goals and objectives of multiple and large projects are accomplished within prescribed timeframes...

  • Architect - Technical Lead

    1 month ago

    Melville, United States nextSource Full time

    Contract Duration: 2 Months with potential to extend Pay Range: $90 - $95/hour depending on experience. Ensures data and data integrity in enterprise systems. Envision, design, ideation and deliver solutions. plans and coordinates project activities to ensure goals and objectives of multiple and large projects are accomplished within prescribed timeframes...

  • Architect - Technical Lead

    3 weeks ago

    Melville, United States nextSource Full time

    Contract Duration: 2 Months with potential to extend Pay Range: $90 - $95/hour depending on experience. Ensures data and data integrity in enterprise systems. Envision, design, ideation and deliver solutions. plans and coordinates project activities to ensure goals and objectives of multiple and large projects are accomplished within prescribed timeframes...

  • Technical Solutions Architect

    19 hours ago

    Melville, New York, United States KPMG Full time

    Job OverviewWe are looking for a highly skilled Technical Lead I, Data Engineering to join our team at KPMG. As a key member of our Digital Nexus technology organization, you will play a crucial role in driving innovation and excellence in data management and analytics.This is a remote work opportunity that offers flexibility and autonomy. However, it...

  • Technical Lead

    7 days ago

    Melville, New York, United States nextSource Full time

    OverviewNexSource is seeking an experienced Technical Lead - Solutions Architect to lead technical solutions around healthcare standards. As a key member of our team, you will be responsible for envisioning, designing, and delivering solutions that ensure data integrity in enterprise systems.Salary$90-$95/hour depending on experience.Job DescriptionWe are...

  • Lab Analyst

    3 weeks ago

    Melville, United States Manpower Full time

    Job DescriptionJob DescriptionOur client, a global consumer goods company, is seeking a Lab Analyst (level 1) to join their team. As a Lab Analyst, you will be part of the Quality Control department supporting the analytical chemistry laboratory. The ideal candidate will have experience in a Quality Control laboratory for a global consumer goods or pharma...

  • Laboratory Technical Director

    3 weeks ago

    Melville, New York, United States Certified Laboratories Full time

    Certified Laboratories is a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services. We are committed to delivering expert solutions and quality testing that our customers can feel confident in – on time, every time – so the world can trust in what it consumes.As a certified Laboratory Technical...

  • STEM Research and Development Internship Opportunity

    3 weeks ago

    Melville, New York, United States The Estee Lauder Companies Full time

    About UsThe Estee Lauder Companies is a global leader in the prestige beauty industry, recognized for its commitment to innovation, creativity, and excellence. Our company culture values diversity, inclusivity, and employee development, providing opportunities for growth and advancement.Job SummaryWe are seeking a highly motivated and talented STEM research...

  • Technical Salesforce Manager

    2 days ago

    Melville, New York, United States Marsh LLC Full time

    About UsMarsh McLennan Agency (MMA) is a leading provider of business insurance and employee health & benefits solutions.Our team uses Sales Cloud, Experience Cloud, and AppExchange products to deliver purposeful work and meaningful impact every day.

  • Salesforce Development Lead

    2 days ago

    Melville, New York, United States Marsh LLC Full time

    About UsAt Marsh McLennan Agency (MMA), we're a leading provider of business insurance, employee health & benefits, retirement, and private client insurance solutions. Our team of over 11,000 talented professionals works together to deliver purposeful work and meaningful impact every day.We offer a unique combination of personalized service and global...

  • Cloud Architecture Engineer

    1 week ago

    Melville, New York, United States nextSource Full time

    Job SummaryNexSource is seeking a highly skilled Cloud Architecture Engineer - Project Manager to lead technical solutions around healthcare standards. As a key member of our team, you will be responsible for envisioning, designing, and delivering solutions that ensure data integrity in enterprise systems.Duties and ResponsibilitiesYour primary...

  • Senior IT Audit and Risk Management Professional

    2 days ago

    Melville, New York, United States EisnerAmper Full time

    Work You Will Do:As a Senior IT Audit and Risk Management Professional, you will play a key role in delivering IT-oriented risk advisory solutions rooted in risk management standards and technical expertise. Your responsibilities will include overseeing IT SOX internal audit and risk management engagements, leading consulting projects, and maintaining client...

  • Data Center Operations Manager

    2 days ago

    Melville, New York, United States Amadan Recruitment Full time

    Job DescriptionWe are seeking a highly skilled Data Center Operations Manager to join our team at Amadan Recruitment. This is a fantastic opportunity for a talented professional to take on a challenging role and contribute to the success of our organization.About the JobThe ideal candidate will have 7+ years' experience in an Enterprise Level Distributed...

  • Field Service Operations Manager

    3 weeks ago

    Melville, New York, United States Canon Solutions America, Inc. Full time

    Job OverviewThe Field Service Operations Manager - Technology Solutions will oversee a team of skilled technicians who provide top-notch service and support for Canon's hardware and software solutions. This role requires strong leadership skills, excellent communication abilities, and a deep understanding of the latest technology trends.About the JobWe are...

  • Enterprise Architecture Manager

    7 days ago

    Melville, New York, United States HRM INFO LLC Full time

    Job OverviewHRM INFO LLC is seeking a seasoned Senior IT Systems Architect to join our team in Melville, NY. This full-time position offers a hybrid work schedule, allowing you to balance your time between the office and remote work.Key Responsibilities:Develop and maintain technical architecture, ensuring alignment with business goals and objectives.Lead...

  • Senior Salesforce Development Manager

    18 hours ago

    Melville, New York, United States Marsh LLC Full time

    We are excited to offer a unique opportunity for an experienced Senior Salesforce Development Manager to join our team at Marsh McLennan Agency. In this role, you will be responsible for leading the development of Salesforce customizations and integrations, and mentoring junior developers to ensure the success of our projects.The ideal candidate will have a...