Chemist III - 2nd Shift

Essential Duties and Responsibilities

• Serve as a subject matter expert for analytical testing, instrumentation, and laboratory processes, independently performing and troubleshooting complex testing activities using equipment such as balances, pipettes, pH meters, UV/Visible spectrophotometers, TOC analyzers, IR, HPLC, and related laboratory instrumentation.
• Perform and review analytical testing of raw materials, in-process samples, finished products, stability samples, water, and particulates in accordance with approved methods, specifications, and regulatory requirements.
• Analyze, interpret, trend, and summarize analytical data; compile technical summaries and communicate findings, risks, and recommendations to management and cross-functional teams.
• Execute, author, review, and provide technical input for protocols, reports, investigations, change controls, data summaries, and laboratory documentation to ensure accuracy, compliance, and data integrity.
• Lead or support investigations involving deviations, problem reports, out-of-specification (OOS), and out-of-trend (OOT) results utilizing root cause analysis and risk assessment tools to identify corrective and preventive actions.
• Perform detailed data reviews and provide guidance and coaching on good documentation practices, error corrections, and compliance expectations.
• Provide technical training, mentorship, and cross-training to laboratory personnel on analytical methods, instrumentation, SOPs, aseptic practices, and regulatory requirements while maintaining accurate training records.
• Collaborate with Quality, Manufacturing, Validation, Engineering, external laboratories, and customers regarding testing schedules, technical updates, investigations, and project support activities.
• Coordinate testing activities performed by external laboratories and support raw material and customer-related testing requirements.
• Maintain, sanitize, troubleshoot, and support lifecycle activities for laboratory equipment and cleanroom areas while assisting with evaluation and implementation of new equipment, technologies, and procedures.
• Enter, review, track, and trend analytical data within applicable laboratory data management systems to support operational monitoring and continuous improvement initiatives.
• Lead departmental and cross-functional projects, including continuous improvement initiatives, new product onboarding activities, audit support, and customer-facing interactions.
• Maintain a thorough understanding of pharmaceutical regulatory and compliance requirements and support inspection readiness through adherence to GMP, GLP, safety, and aseptic gowning requirements.
• Adhere to all company, safety, quality, and regulatory policies while promoting a compliant, safe, and quality-focused laboratory environment.
• Read/interpret SOPs to ensure compliance.
• Maintain up to date trainings.
• Other duties as assigned.

Education and/or Experience

• Bachelor’s degree in Science, Chemistry, Biology or related field of study.
• Minimum of five (5) years experience in chemistry.
• Minimum of five (5) years experience in a pharmaceutical or aseptic/sterile related industry.

Supervisory Responsibilities

This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.

Language Skills

The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.

Mathematical Skills

Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills

The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.

Other Skills and Abilities

• Proficient in the use of operational theories of all common laboratory equipment.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to perform independent work related to projects and/or routine activities.
• Ability to meet deadlines and work under pressure with limited supervision.
• Ability to work effectively under pressure to meet deadlines.
• Be accessible to laboratory and plant area(s) and office staff.
• Able to use required office equipment.

Other Qualifications

• Must pass a background check.
• Must pass a drug screen.
• May be required to pass Occupational Health Screening.