Quality Analyst Lead

JOB SUMMARY The Quality Analyst Lead serves as a senior member and day‑to‑day leader within the Quality Unit, providing oversight, technical direction, and workflow coordination across Quality Operations and Analytical Testing. This role ensures compliance with cGMP, USP, FDA, and internal Quality System requirements while guiding the performance and development of Quality Analysts. The Lead acts as the primary escalation point for analytical issues, quality events, and operational decision‑making, and drives continuous improvement across quality processes and laboratory operations.

KEY RESPONSIBILITIES Leadership & Oversight Provides daily leadership, guidance, and mentorship to Quality Analysts I & II. Oversees workload distribution, prioritization, and resource planning for the Quality Unit. Serves as the primary decision‑maker for quality‑related questions during manufacturing and laboratory activities. Train new and existing staff on cGMP practices, analytical methods, and QA workflows. Technical Expertise Functions as the senior Subject Matter Expert (SME) for analytical testing instruments, calibration processes, and technical troubleshooting.

Leads the evaluation, validation, and implementation of new analytical tools, technology, and systems. Provides advanced technical support during investigations, method issues, out‑of‑specification (OOS) events, and CAPA execution. Quality Systems & Process Ownership Acts as Process Owner for one or more major quality systems (e.g., Deviation Management, Change Control, CAPA, Document Control, Training). Leads process improvements and harmonization to strengthen compliance and reduce operational risk.

Reviews and approves complex documentation including deviations, change controls, technical protocols, and risk assessments. Testing & Operations Support Oversees incoming, in‑process, and finished‑product testing to ensure timely and accurate results. Provides final Quality approval for raw materials, components, analytical results, and finished goods before release. Ensures effective line clearance, production oversight, and adherence to aseptic and sterile compounding requirements. Environmental Monitoring & Compliance Supervises Environmental Monitoring (EM) activities and interprets EM trends to identify risks and preventive measures.

Ensures all testing, sampling, and documentation activities meet USP, FDA, and internal regulatory standards. Data Review & Continuous Improvement Reviews analytical and process data to identify trends, quality signals, and areas for efficiency improvement. Leads root‑cause investigations and develops corrective and preventive actions (CAPAs). Partners with cross‑functional groups (Manufacturing, Engineering, Supply Chain) to enhance operational performance and reduce quality events.

General Responsibilities Maintains audit readiness and supports internal and external audits. Supports Quality leadership with reporting, metrics, and special projects as needed. Performs all other duties as assigned in alignment with departmental goals. EDUCATION / TRAINING Bachelor’s degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or related discipline. Advanced training in laboratory instrumentation, method execution, and cGMP quality systems. Strong knowledge of: USP Sterile & Non‑Sterile Compounding FDA 21 CFR Part 211 Quality Risk Management principles Laboratory analytical instrumentation (HPLC, GC, FTIR, etc.)

WORK EXPERIENCE 5–7+ years of pharmaceutical, compounding, or related Quality experience. 2+ years of leadership experience (formal or informal) preferred. Demonstrated success in training staff, overseeing workflows, or leading complex technical initiatives. CORE COMPETENCIES Strong leadership, coaching, and communication skills. High decision‑making aptitude and risk‑based thinking. Proficient in data trending, problem‑solving, and scientific writing. Exceptional organization, prioritization, and follow‑through. Ability to operate independently with minimal supervision.

Strong competency with Microsoft Office and electronic quality systems.