Associate Specialist, Quality Control

Responsibilities Essential functions include, but are not limited to: demonstrate competence in routine laboratory assignments, apply existing procedures for routine testing, interpret quality policies, guidelines, and regulatory requirements, use laboratory instrumentation, compile technical reports, and participate in root cause analysis and corrective actions. Employees should promote team effectiveness, respect diverse perspectives, seek continuous improvement, and communicate results clearly. Primary Activities Supports continuous improvement and sustainability of implemented changes. Ensures work is completed right the first time. Participates in and leads Tier I and Tier II activities. Demonstrates working knowledge of product performance and testing methodology. Promotes inclusive culture through 12 Inclusive Behaviors. Responds to and remediates audit observations. Ensures proper usage of equipment. Coordinates testing activities within the work team. Tests and interprets results for raw materials, active pharmaceutical ingredients, water, microbial limit testing, and finished pharmaceutical products. Maintains compliance by following corporate policies, guidelines, and SOPs. Interprets compendial and internal monographs, NDAs, and company Quality Standards. Provides analytical support for cleaning validations, laboratory support requests, equipment validations, method transfers, and API Stability Packaging Description (ASPD). Ensures laboratory compliance with cGMP, CFR, and other regulations. Revises laboratory procedures as required. Maintains a safe workplace and identifies actions to prevent safety incidents. Maintains 5S organization and identifies improvement opportunities. Participates in project activities to improve laboratory operations and compliance. Performs any other work as assigned by Manager. Education Requirements B.A./B.S. degree (preferably in Science or Engineering) Required Skills Knowledge of continuous improvement principles. Experience operating routine laboratory equipment (Karl Fisher, pH meter, conductivity meter, UV, etc.). Knowledge of regulatory and cGMP principles. Preferred Skills Experience operating laboratory equipment: HPLC, dissolution apparatus, FTIR, NIR, etc. Experience utilizing Empower. Experience utilizing GLIMS. Execution of root cause analysis. Background in technical writing (e.g., updating SOPs and writing quality notifications). Knowledge of Tier processes. Experience executing 5S principles. Salary & Benefits Salary range for this role is $65,100.00 - $102,500.00. The employee may be eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, 401(k), paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. Accommodation We are committed to inclusion and welcome accommodations during the application or hiring process. Job Posting End Date 07/01/2026 #J-18808-Ljbffr