Job Title: ChemistJob DescriptionWe are seeking a skilled and experienced Lab Analyst to join our analytical team. This role specializes in High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and Flame Atomic Absorption (Flame AA) instrumentation. The ideal candidate will have hands-on experience in method validation for various Active Pharmaceutical Ingredients (APIs), in-depth knowledge of analytical lab practices, and a strong understanding of FDA regulations specific to OTC manufacturing.Responsibilities
Perform routine and non-routine analytical testing using HPLC, GC, and Flame AA, ensuring accuracy and compliance with industry standards.
Maintain, calibrate, and troubleshoot analytical instruments, ensuring peak performance and reliability.
Develop, optimize, and validate analytical methods for various APIs to meet regulatory standards and support quality control requirements.
Document and execute method validation protocols and prepare detailed validation reports.
Ensure all laboratory procedures and records comply with FDA regulations, specifically for OTC manufacturing environments.
Conduct lab operations in alignment with cGMP and GLP guidelines, contributing to the development and maintenance of SOPs.
Accurately document all test results, observations, and deviations in laboratory notebooks and electronic systems.
Identify and investigate out-of-specification (OOS) results, performing root cause analysis and corrective action as necessary.
Prepare reports and provide data analysis for internal review, contributing to product release and quality assurance activities.
Collaborate with R&D, Quality Assurance, and Manufacturing teams to support new product development and continuous improvement projects.
Train and guide other lab personnel on analytical techniques and regulatory requirements.
Essential Skills
Expertise in method development and validation for APIs, specifically within the OTC sector.
Strong knowledge of FDA regulatory standards and compliance for analytical laboratories.
Proficient in cGMP, GLP, and ICH guidelines.
Additional Skills & Qualifications
Excellent analytical skills with strong attention to detail.
Effective communication skills for report writing and cross-functional collaboration.
Ability to work independently, manage time efficiently, and adapt to changing priorities.
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.