Come work for a company that is diverse, a WNY Best Place to Work, and is recognized for excellence in manufacturing!

The Quality Systems Engineer is responsible for supporting and leading Quality System activities for new product development and commercial finished goods, including validations, resolution of non-conformances (root cause and corrective actions), CAPA, Quality System, and process improvement activities. This position ensures that systems, processes, and products meet regulatory, quality, and performance standards through rigorous testing and documentation.

 Responsibilities

• Ensure Quality System Maintenance by developing and deploying quality procedures and documentation (including quality policies, standard operating procedures (SOPs), test methods, etc.), statistical sampling plans, and process capability studies.
• Support process improvements by utilizing lean methods, Kaizen, and Process Failure Mode and Effects Analysis (PFMEAs) to reduce product defects
• Support the calibration and maintenance scheduled for testing instrumentation to ensure all remains in a qualified state
• Develop and author validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for manufacturing equipment and processes
• Analyze statistical data from validation testing to identify deviations, determine root cause of failures and implement corrective actions
• Prepare comprehensive final validation reports summarizing test results and provide a clear conclusion on the qualification status
• Collaborate with cross-functional teams to ensure that validation activities are aligned with production schedules and project timelines
• Stay current with industry trends and regulatory requirements related to validation and quality assurance

 Required Skills

• Five plus years of experience in a manufacturing environment performing validation activities
• Hands-on experience with equipment validation, software testing, or process control
• Familiarity with regulatory standards for OTC, Cosmetics, and or Medical Devices
• Bachelor’s degree in Engineering or a scientific field
• Analytical and problem-solving skills to interpret test data and identify issues
• Attention to detail for accurate documentation and compliance
• Communication and teamwork skills to collaborate with cross-functional teams

Come work for a company that is diverse, a WNY Best Place to Work, and is recognized for excellence in manufacturing!

If you have the ambition and drive to take on new challenges, apply today!

Role Overview

The Chemist I is an entry-level professional responsible for performing routine analytical testing in support of OTC manufacturing operations. This role works under direct supervision and follows established procedures to ensure laboratory testing is conducted in compliance with cGMP, USP, FDA, and company quality standards.

Responsibilities

• Perform routine analytical testing of raw materials, in-process samples, stability samples, and finished OTC products according to approved methods
• The testing may include, but is not limited to: HPLC/GC, IR, UV, wet chemistry, Auto-titrator, etc., for raw materials, bulk liquids, and finished products
• Accurately document test results  in appropriate laboratory notebooks, worksheets, logs, or other designated forms in compliance with cGMP requirements
• Operate basic laboratory instrumentation, including pH meters, balances, pipettes, UV-Vis, FTIR, and titration equipment
• Follow approved SOPs, test methods, compendial testing, and safety procedures at all times.
• Notify supervisor of atypical results or laboratory issues
• Participate in training to develop proficiency in chromatographic techniques (HPLC and/or GC)
• Perform testing and review of raw materials, in-process samples, and finished products to adhere to required timeframes

 Requirements

• Associate or bachelor’s degree in chemistry, Analytical Chemistry, or other related field
• 1-2 years of laboratory experience (GMP experience preferred but not required)
• Basic understanding of chemistry principles and analytical techniques
• Familiarity with GMP concepts preferred
• Strong attention to detail and documentation accuracy
• Ability to follow detailed written procedures
• Good organizational and time management skills
• Basic proficiency with the Microsoft Suite
• Good interpersonal skills that support working in a team environment

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

 This job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the position.