QA Specialist

Our client is a global pharmaceutical manufacturer seeking an experienced Quality Assurance (QA) Specialist to support quality operations within a regulated laboratory environment. This role will focus heavily on investigations, root cause analysis, and CAPA development while ensuring compliance with cGMP standards and internal procedures. Located in

Rensselaer, NY Contract Position Pay:

$40-60/hour

Key Responsibilities:

Collaborate with cross-functional teams to drive investigations to timely completion, identify root cause, and implement effective corrective and preventive actions (CAPA). Initiate and manage Quality Events, ensuring timely completion of initial impact assessments and QA approvals. Coordinate with QA leadership to manage investigation timelines, including requesting extensions when necessary. Conduct, document, and approve deviation investigations in accordance with internal procedures and regulatory requirements. Lead Out-of-Specification (OOS) investigations, including coordination with external customers as required. Apply structured root cause analysis tools (e.g., 5 Whys, Fishbone/6M) to support thorough investigations. Ensure all investigations are conducted in full compliance with cGMPs and internal quality standards. Track and maintain laboratory quality metrics to identify trends and opportunities for CAPA (e.g., analyst error, equipment issues, method performance). Partner with internal teams to develop investigation strategies aligned with customer and regulatory expectations. Provide regular updates on investigation status to cross-functional stakeholders and leadership. Identify training gaps and support updates to training programs to reduce recurring errors. Serve as a primary QA investigator and approver for quality events, working independently as needed.

Qualifications:

Bachelor's degree in Chemistry or a related scientific discipline. Minimum of 6 years of experience in a Quality Control laboratory or similar regulated environment, or an equivalent combination of education and experience. Strong experience with investigations, including root cause analysis, technical writing, and CAPA development. Working knowledge of cGMP regulations and quality systems. "This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!" #INDBH #LI-JR1