Chemist III, Quality Control

3 months ago


Spring Valley, United States Strides Pharma Inc Full time
Job DescriptionJob Description

JOB SUMMARY

The Chemist III, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation. Has demonstrated competence in conducting all types of physical and chemical analyses (including complex analyses) using all equipment. Detects, conducts, and reports on OOS/OOT/NOE and other investigations. Learns and stays current with regulatory guidance and compendia relevant to laboratories and pharmaceutical manufacturing. Participates in troubleshooting analyses and instrumentation. Trains less senior staff.

All incumbents are responsible for following applicable Division & Company policies and procedures.


KEY ACCOUNTABILITIES

Analysis & Testing

  • Conducts laboratory analyses according to approved test methods: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
  • Uses laboratory software for analyses
  • Reviews and approves laboratory test data and documentation for completeness and compliance
  • Is alert to and detects abnormalities during performances of tests and reviews. Elevates abnormalities to Supervisor
  • Performs lab methods transfer and participate in method validation/verification studies

Lab Equipment

  • Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping
  • Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals
  • Troubleshoots instrument/chromatography problems and identifies improvements/CAPAs

Investigations

  • Detects, conducts and reports on OOS/OOT/NOE and other investigations
  • Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action
  • Writes, edits and reviews SOPs and laboratory investigations

Training

  • Maintains assigned training records current and in-compliance
  • Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures

Compliance

  • Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting
  • Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs
  • Follows internal processes related to controlled substances

Safety

  • Follows EH&S procedures to ensure a safe work environment
  • Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS


QUALIFICATIONS

Education & Experience

  • Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years’ relevant analytical laboratory experience OR
  • Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experience

Knowledge

  • Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports
  • Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
  • Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS
  • Has demonstrated competence in conducting chemical analyses
  • Strong knowledge of wet chemistry techniques
  • Competency in Microsoft Office Suite

Skills & Abilities

  • Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management
  • Ability to display and analyze data in a logical manner
  • Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information
  • Ability to display and analyze data in a logical manner
  • Strong verbal and written communication skills as well as good computer skills
  • Strong attention to details and accurate record keeping
  • Establish and maintain cooperative working relationships with others
  • Solid organizational skills
  • Ability to coach less senior staff and develop laboratory skills and ability
  • Ability to take initiative, set priorities and follow through on assignments


  • Spring Valley, United States Strides Pharma Inc Full time

    Job DescriptionJob DescriptionJob SummaryOversee physical/chemical/microbiological testing and analyses of pharmaceutical raw materials, excipients and finished drug products, including release, stability testing, cleaning verification test, and in-process testing. Supervise daily work of Chemists, Microbiologists and Technicians; provide guidance and...


  • Silver Spring, United States WSSC Water Full time

    Essential FunctionsServes as a subject matter expert for Laboratory staff Conduct primary analyses and serve as alternate for other analyses Uses instrumentation such as GFAA , ICP , Hg Analyzers, Flow Injection Analyzers, BOD Analyzers, TOC Analyzers, Sulfate Analyzers, ICP -MS, UV VIS , COD Analyzers, FlowCAM, Microscopes, GC, or other technical equipment...


  • Central Valley, New York, United States G-III LEATHER FASHIONS Full time

    Position Overview:At G-III Leather Fashions, our inventory management team plays a crucial role in our operational success. We are currently seeking a Part-Time Inventory Control Supervisor to join our dynamic team.Key Responsibilities:Oversee the unloading of merchandise shipments.Ensure the stockroom is well-organized and efficient.Manage the receiving and...


  • Silver Spring, United States WSSC Water Full time

    Essential FunctionsServes as a subject matter expert for other employees in the laboratory Provides cross training and guidance on advanced technologies, instrumentation, and procedures to laboratory personnel to ensure continuous quality data Monitors, reviews, evaluates, and validates data to detect or assess problems and to determine compliance with...

  • Chemist II

    1 month ago


    Spring Valley, United States Strides Pharma Inc Full time

    Job DescriptionJob DescriptionJob SummaryThe Chemist II, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation. Has demonstrated competence in conducting all types of physical and chemical analyses (including complex analyses)...

  • Chemist II

    4 weeks ago


    Spring Valley, United States Strides Pharma Inc Full time $30 - $35

    Job DescriptionJob DescriptionJob SummaryThe Chemist II, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation. Has demonstrated competence in conducting all types of physical and chemical analyses (including complex analyses)...

  • Analytical Chemist

    1 month ago


    Golden Valley, United States Lube-Tech Full time

    Description With a purpose to make tomorrow a little bit better than today for each other, our customers, and our communities, Lube-Tech provides an environment where you can love what you do and be your best every day. What you will enjoy by being a part of a 2024 USA Great Place to Work certified company: A position that is: Full time - Salary With...


  • Spring, Texas, United States The Global Edge Consultants Full time

    Job Title: Geotechnical Quality Control SpecialistLocation: Offshore Georgetown GuyanaType of Role: ContractPOSITION OVERVIEW:The Geotechnical Quality Control Specialist serves as the client's representative, tasked with overseeing and advising on operational aspects, data collection, core sampling, storage, equipment management, recording, instrumentation,...


  • Spring, Texas, United States The Global Edge Consultants Full time

    Position Title: QC Geotechnical RepresentativeLocation: Offshore Georgetown GuyanaType of Role: Contract POSITION OVERVIEW:The QC Geotechnical Representative acts as the client's liaison, responsible for overseeing and providing guidance on operational activities. This role is crucial in ensuring that all geotechnical work adheres to the highest standards of...


  • Spring, United States Eldridge Roofing & Solar Full time

    Job DescriptionJob DescriptionSalary: 45k - 55k yearly !!Quality Control Supervisor!!This is not a "JOB" posting. It's the start of Something that will make you realize there is more to life than the 9-5 corporate American Hustle. Your wisdom and experience are as valuable as your education. We are searching for someone ready to invest their expertise...


  • Big Spring, United States Texas Department of Aging & Disability Services Full time

    Job Description: Warehouse Lead III Looking for a stable job with reliable weekday hours? We have a Warehouse Lead III opening at the Big Spring State Hospital. The Warehouse Lead III reports to the Warehouse Supervisor, Supply Services, and serves as the backup supervisor. Our team operates at each of our 23 facilities across the state, so come grow...


  • Spring, Texas, United States The Global Edge Consultants Full time

    Position Title: QC Geotechnical RepresentativeLocation: Offshore Georgetown GuyanaType of Role: Contract POSITION OVERVIEW:The QC Geotechnical Representative acts as the client's liaison, responsible for overseeing and providing guidance on operational activities. This role is crucial in ensuring that all geotechnical processes adhere to the highest...


  • Fountain Valley, California, United States TriCom Quest Full time

    Job SummaryWe are seeking a highly skilled Quality Control Specialist to join our team at TriCom Quest. As a Quality Control Specialist, you will be responsible for ensuring the quality of our products and services.Key ResponsibilitiesOversee laboratory analysis to ensure compliance with physical and chemical parameters.Prepare and submit quality control...

  • GCMS Chemist

    2 days ago


    Simi Valley, California, United States ALS Environmental Full time

    About the RoleThe primary objective of this position is to analyze samples using GC/MS methodologies, ensuring accuracy and precision in our laboratory results. Key responsibilities include:Analyzing air and vapor samples following EPA methodologies and laboratory SOPs.Documenting activities and reporting results in a concise and accurate manner.Analyzing...


  • Spring, Texas, United States The Global Edge Consultants Full time

    Position Title: QC Geotechnical RepresentativeLocation: Offshore Georgetown GuyanaType of Role: Contract POSITION OVERVIEW:The QC Geotechnical Representative acts as the client's liaison, providing oversight and guidance on operational activities. This role involves:1. **Monitoring**: Regularly observing and assessing geotechnical operations to ensure...


  • Scotts Valley, United States Select Staffing Full time

    Description Select is NOW HIRING for a Quality Control Inspector in Scott Valley CA for a vitamins and supplement company. Payrate: $18.50/Hr. Shifts Available: • 1st- 6AM-2:30 PM • 2nd- 2PM-10:30 PM • 3rd- 10PM-6:30 AM Quality Control Inspector Responsibilities: • Inspect, document and issue disposition instructions on production orders for tablets,...


  • Big Spring, United States Lightspeed Construction Group Full time

    QUALITY CONTROL INSPECTOR - OSP PROJECTSPosition OverviewReel Broadband is a subsidiary of Full Circle Fiber Partners. The Quality Control Inspector role is responsible for completing inspection and acceptance of fiber placement and associated construction activities for any assigned OSP project, both aerial and underground. This position is responsible for...


  • Silver Spring, Maryland, United States Blueprint Staffing Full time

    Job OverviewPosition Title:Quality Control Assistant Manager / Site Safety and Health Officer - Federal ConstructionCompany Overview:The Quality Control Assistant Manager / Site Safety and Health Officer plays a vital role in supporting the management and execution of daily quality control and safety tasks for various projects. This position is essential in...

  • Quality Specialist

    1 month ago


    Spring, United States Global Edge Group Full time

    Global Edge is an international staffing firm connecting projects worldwide with the industry’s most talented project professionals. We work with high level technical and commercial personnel across multiple industries including Oil and Gas, Energy, Renewables, Infrastructure, Automotive and Motorsports, IT, Marine, Mining, and more. With offices...


  • Silver Spring, United States eSimplicity Full time

    Job DescriptionJob DescriptionDescription:About Us:eSimplicity is a modern digital services company that delivers innovative federal and commercial IT solutions designed to improve the health and lives of millions of Americans while defending our national interests. Our solutions and services improve healthcare for millions of Americans, protect our borders,...