Job Description
Work Type: Full Time Professional/Exempt Onsite Work Hours: 8:30AM - 5:00PM (may vary based on business needs) Experience Required: 4-8 years (minimum 3 years in analytical quality assurance) Reports To: Quality Assurance Manager Shifts: Must be willing to work first or second shift; weekends as required Relocation: Negotiable Location - Central Islip, New York, USA About the Company: Our client is a leading generic pharmaceutical company engaged in development, manufacture, marketing, and distribution of prescription medicines across therapeutic areas including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. This established organization, founded in 2003 and based in Central Islip and Hauppauge, NY, operates as part of a global pharmaceutical network. Job Overview Join the Analytical Quality Assurance (AQA) team as a QA Associate II responsible for ensuring compliance across all analytical operations. This role requires strong analytical chemistry background and experience in pharmaceutical quality assurance, focusing on raw materials, in-process, and finished product compliance in a cGMP environment. Key Responsibilities Review and confirm compliance of raw materials, in-process, and finished product analytical documents Monitor and ensure cGLP adherence by laboratory personnel during routine operations Validate and verify analytical methods, protocols, and study reports for regulatory compliance Prepare and review laboratory investigations (OOS/OOT/Deviation reports) ensuring regulatory compliance Verify laboratory chemicals/reagents and standards for completeness against SOPs Assess and implement Pharmacopoeia changes (USP, EP, JP) when new editions or supplements are effective Review laboratory audit trails during data review against standard operating procedures Coordinate with Analytical Teams to arrange required documents for cross-functional teams Maintain document control including tracking, recording, storage, and archival of analytical documents Identify system gaps during routine monitoring and recommend improvements to supervisors Support laboratory investigations and incidents ensuring proper compliance and documentation Must-Have Requirements Bachelor's degree in Chemistry, Pharmaceutical Sciences, or related field (Master's preferred) 4-8 years analytical experience with minimum 3 years in analytical quality assurance Strong computer skills including Microsoft Office and Quality applications/software Analytical laboratory expertise in API, drug products, analytical development, and QC Deep knowledge of cGLP/cGMP/GDP, USP monograph requirements, FDA & ICH guidelines Laboratory equipment proficiency including HPLC, UV-Vis, GC, pH meters, stability chambers Excellent communication skills across all organizational levels with strong English proficiency Strong documentation and technical writing capabilities Ability to work independently and in team environments under minimal supervision Nice-to-Have Skills Experience with inhalation products (DPI) is a plus Advanced degree in Chemistry, Pharmaceutical Sciences, or related field Validation experience with analytical methods and equipment qualification Regulatory audit experience with FDA, EMA, or other health authorities Work Environment & Requirements cGMP laboratory/manufacturing environment requiring personal protective equipment Shift flexibility - must be willing to work first or second shift (Monday-Friday or Tuesday-Saturday) Weekend work may be required based on business needs No remote work - onsite position only Professional competency in English as first or second language Self-motivated with ability to handle multiple tasks in fast-paced manufacturing environment