Job Description
A QA Specialist II role is required to perform quality assurance activities in a multinational research-based pharmaceutical company. The GSIUC QA Department, under the QA General Operations Support team, needs an individual with expertise in quality assurance systems, methods, and procedures.
Key Responsibilities:
* Reviews manufacturing and engineering records for compliance with regulatory requirements.
* Assists in customer complaint investigations and identifies deviations from accepted practices.
* Participates in authoring and reviewing Standard Operating Procedures (SOPs) and controlled documents.
* Reviews and approves GMP Deviation investigations and CAPAs.
* Identifies problems and generates alternatives and recommendations.
* Performs internal audits and walkthroughs to ensure site compliance with GMP.
* Participates in site Strategic, Technical, and Operational Excellence projects on behalf of QA.
Requirements:
* Prior experience in the pharmaceutical industry, preferably in a QA role.
* Working knowledge of current Good Manufacturing Practices (cGMPs).
* Demonstrated knowledge of quality assurance systems, methods, and procedures.
* Basic knowledge of OPEX Lean tools and root cause analysis techniques.
* Audit and investigation skills, as well as report writing skills.
* Excellent communication and interpersonal skills.
* Proficiency in Microsoft Office applications.
* 4+ years of relevant experience in a GMP environment related field and a Bachelor's degree.
* 3+ years of relevant experience and a Master's degree.