What Jobs are available for Quality Control in Las Vegas?

Job Description

JOB SUMMARY

The 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) 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

• Conducting comprehensive inspections and tests on incoming raw materials, in-process work, and finished products using various measurement instruments and testing equipment.
• Interpreting technical drawings, blueprints, and specifications to verify product conformity.
• Identifying, documenting, and segregating non-conforming materials or products.
• Performing root cause analysis for quality defects and collaborating with production and engineering to implement corrective and preventive actions.
• Maintaining accurate inspection records, test results, and quality documentation.
• Participating in internal quality audits and supporting external audit preparations.
• Calibrating and maintaining inspection and testing equipment.
• Ensuring adherence to quality control procedures, safety regulations, and industry standards.
• Providing feedback to production and engineering teams on quality issues and improvement opportunities.
• Mentoring and guiding junior quality inspectors as needed.

• High School Diploma or equivalent; Associate's degree or relevant technical certification preferred.
• Minimum of 5 years of experience in quality control inspection within a manufacturing environment.
• Proficiency in using various precision measurement tools (e.g., calipers, micrometers, CMM).
• Ability to read and interpret complex technical drawings, GD&T, and specifications.
• Strong understanding of quality management systems (e.g., ISO 9001).
• Excellent analytical and problem-solving skills.
• Meticulous attention to detail and accuracy.
• Good written and verbal communication skills.
• Ability to work independently and as part of a team in a production environment.
• Knowledge of statistical process control (SPC) is a plus.

• Lead and manage the daily operations of the Quality Control laboratory, including personnel management, workflow optimization, and resource allocation.
• Develop, validate, and implement analytical methods for raw materials, in-process samples, and finished products using techniques such as HPLC, GC, UV-Vis, ICP-MS, and Karl Fischer titration.
• Ensure all testing is performed in compliance with cGMP, FDA regulations, ICH guidelines, and other relevant regulatory requirements.
• Review and approve analytical test data, reports, and specifications, ensuring accuracy and completeness.
• Investigate out-of-specification (OOS) results and deviations, identifying root causes and implementing corrective and preventive actions (CAPAs).
• Collaborate with R&D, Manufacturing, and Regulatory Affairs departments to support product development, process validation, and lifecycle management.
• Manage the qualification and calibration of laboratory equipment and instrumentation.
• Train and mentor QC analysts, fostering a culture of scientific rigor and compliance.
• Contribute to the development and maintenance of the Quality Management System (QMS).
• Participate in internal and external audits as a subject matter expert.
• Stay current with scientific advancements and regulatory changes impacting pharmaceutical quality control.

• Master's or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a closely related scientific discipline.
• A minimum of 8 years of progressive experience in pharmaceutical quality control or analytical development.
• Demonstrated experience in leading and managing a team of scientists in a QC laboratory setting.
• Expertise in a wide range of analytical techniques relevant to pharmaceutical product testing, with a strong emphasis on chromatographic methods (HPLC, GC).
• Thorough understanding of cGMP, FDA 21 CFR Part 210/211, ICH guidelines (Q2, Q7, Q8), and USP/EP monographs.
• Proven experience with method validation and transfer.
• Strong knowledge of laboratory information management systems (LIMS).
• Excellent documentation, data review, and investigation skills.
• Exceptional problem-solving abilities and a meticulous attention to detail.
• Strong leadership, communication, and interpersonal skills.

Job Description

Position Summary

The Entry-Level Associate, Quality Assurance supports the Quality Management System (QMS) and documentation processes at the Chestnut Ridge site. This role is designed for individuals beginning their career in pharmaceutical quality assurance and provides hands-on experience in maintaining compliance and supporting documentation workflows in a regulated environment.

Roles and Responsibilities

• Assist in organizing and maintaining QMS documentation including SOPs, CAPAs, deviations, and complaints.
• Support the preparation and tracking of quality metrics and trending reports.
• Help coordinate internal audits and document audit responses.
• Participate in documenting product quality complaints and adverse event records.
• Aid in digitizing logbooks and checklists using electronic systems.
• Collaborate with cross-functional teams to ensure timely and accurate documentation updates.
• Provide administrative support for change control processes and quality-related meetings.
• Assist in preparing documentation for regulatory inspections and external audits.
• Maintain document control systems and ensure timely review and archival of QA records.
• Support training documentation and tracking for QA-related procedures.
• Help with data entry and analysis for quality reports using basic statistical tools.
• Monitor document lifecycle and ensure version control compliance.
• Participate in continuous improvement initiatives related to documentation and QMS processes.

Education & Experience

• Required Education: Bachelor’s degree in Pharmaceutical Sciences or a related field.
• Preferred Education: Master’s degree is a plus.
• Experience: 1–3 years in a pharmaceutical or regulated industry (internships or co-op experience acceptable).
• Tools/Technologies: Familiarity with QMS platforms and electronic documentation systems preferred.

Physical Requirements

• On-site role at Chestnut Ridge, NY.
• Standard work hours: 8 AM to 5 PM.
• No travel required.
• No lifting or driving responsibilities.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

• Design, develop, and execute detailed test plans, test cases, and test scripts for web and mobile applications.
• Identify, document, and track software defects using bug tracking systems (e.g., Jira).
• Perform various types of testing, including functional, regression, integration, performance, and user acceptance testing (UAT).
• Collaborate effectively with product managers, developers, and other stakeholders to understand requirements and define test strategies.
• Contribute to the continuous improvement of QA processes, tools, and methodologies.
• Automate test cases where possible to increase efficiency and coverage.
• Provide clear and concise status reports on testing progress and defect resolution.
• Participate in agile development ceremonies, including sprint planning, daily stand-ups, and retrospectives.
• Validate bug fixes and ensure that resolved issues do not introduce new problems.
• Mentor junior QA engineers and share best practices.
• Stay current with industry trends and emerging technologies in quality assurance.
• Ensure all testing activities align with project timelines and quality objectives.

• Bachelor's degree in Computer Science, Information Technology, or a related field.
• Minimum of 5 years of experience in software quality assurance and testing.
• Proven experience in designing and executing test plans and test cases.
• Proficiency with bug tracking and test management tools (e.g., Jira, TestRail).
• Experience with automated testing tools (e.g., Selenium, Cypress) is highly desirable.
• Strong understanding of SDLC (Software Development Life Cycle) and various testing methodologies.
• Excellent analytical, problem-solving, and debugging skills.
• Outstanding communication and collaboration skills, essential for a remote team environment.
• Ability to work independently, manage time effectively, and meet deadlines in a remote setting.
• Experience with API testing and SQL is a plus.
• Agile/Scrum certification is a plus.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field. Advanced degree preferred.
• Minimum of 7 years of progressive experience in pharmaceutical quality assurance or quality control.
• Extensive knowledge of cGMP, ICH guidelines, and other relevant regulatory requirements.
• Proven experience in leading internal/external audits and managing regulatory inspections.
• Demonstrated ability in deviation investigation, root cause analysis, and CAPA implementation.
• Strong leadership, team management, and decision-making skills.
• Excellent analytical, problem-solving, and documentation skills.
• Experience with validation processes for manufacturing equipment, processes, and analytical methods.
• Ability to work effectively in a hybrid environment, with some on-site presence required.

• Develop, implement, and manage comprehensive Quality Assurance systems in accordance with GMP, GCP, GLP, and relevant international regulatory guidelines.
• Oversee all aspects of batch record review, release, and deviation management processes.
• Lead and mentor a team of Quality Assurance specialists, providing guidance and professional development.
• Conduct internal audits and host external regulatory inspections (e.g., FDA, EMA), ensuring successful outcomes.
• Manage the CAPA (Corrective and Preventive Actions) system, investigating product quality complaints and implementing effective solutions.
• Review and approve validation protocols and reports for equipment, processes, and analytical methods.
• Ensure compliance with change control procedures and manage associated documentation.
• Develop and deliver quality training programs to relevant personnel across the organization.
• Monitor and analyze quality metrics, identifying trends and opportunities for process improvement.
• Collaborate with R&D, Manufacturing, and Regulatory Affairs departments to ensure seamless product lifecycle management and regulatory adherence.
• Stay current with evolving regulatory requirements and industry best practices.
• Contribute to the strategic direction of the Quality Unit and the overall organization.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 8 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
• Extensive knowledge of GMP regulations and guidelines (e.g., 21 CFR Parts 210/211).
• Proven experience in managing QA operations, including batch release, deviations, CAPA, and audits.
• Demonstrated leadership and team management experience.
• Strong understanding of validation principles and documentation requirements.
• Excellent analytical, problem-solving, and decision-making skills.
• Exceptional written and verbal communication skills, with the ability to interact effectively with regulatory agencies and internal stakeholders.
• Detail-oriented with a high degree of accuracy.
• Proficiency in using quality management software and standard office applications.
• Experience with aseptic processing and sterile drug product manufacturing is a significant advantage.