Lead Quality Assurance Expert

2 weeks ago


Allentown, Pennsylvania, United States Germer International - Pharmaceutical Recruiting Full time

Overview

Germer International - Pharmaceutical Recruiting is seeking a highly skilled Senior Quality Assurance Specialist to enhance our client's established pharmaceutical operations. This role is pivotal in ensuring that quality standards are met, contributing significantly to the overall success of the organization.

Key Responsibilities

  • Oversee the assessment, approval, and final disposition of finished products, including the signature on Certificates of Analysis (CoA).
  • Manage client projects as necessary, ensuring that quality is delivered on time and in full.
  • Facilitate the investigation and resolution of non-conformances, ensuring that corrective and preventive actions (CAPA) and change controls are effectively initiated.
  • Lead or engage in cross-functional investigations and improvement initiatives related to deviations.
  • Review and approve laboratory investigations promptly, ensuring that root causes are accurately identified.
  • Support fellow QA team members and contribute to departmental training efforts.
  • Assist QA management during regulatory inspections and audits.
  • Examine Bills of Materials (BOMs), inspection protocols, pallet configurations, calibration documentation, and Standard Operating Procedures (SOPs).
  • Conduct internal audits and assist in drafting audit reports.
  • Maintain and update procedures associated with quality assurance functions. Support the Annual Product Review (APR) process by gathering batch record information and managing databases.
  • Oversee the vendor complaint management process.
  • Perform quality inspections on packaging lines as required.
  • Support and maintain the site’s Document Control System.
  • Review, authorize, and finalize Document Change Requests.

Qualifications

  • Bachelor's degree in a relevant scientific or technical field related to quality assurance.
  • A minimum of 5 years of relevant experience in the pharmaceutical industry.
  • In-depth knowledge of pharmaceutical cGMP, industry standards, and regulatory requirements.
  • Excellent verbal and written communication skills, with the ability to engage effectively across various functions and levels of seniority.
  • Proficient user of Quality Management Systems.
  • Familiarity with Microsoft Outlook, Excel, and Word, along with other web-based applications.
  • Comprehensive understanding of computer system validation and GAMP guidelines.


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