Chemistry Technical Manager

6 days 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.

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