Supervisor Quality Assurance Lead

3 weeks ago

Pennsylvania USA, United States WuXi AppTec Full time

Job Summary:

The Supervisor Quality Assurance Lead will oversee the day-to-day activities of the Quality Assurance team, ensuring compliance with regulatory requirements and internal SOPs. This role will drive continuous quality improvement through communication, training, and process optimization.

Key Responsibilities:

  • Coordinate and monitor QA staff activities, including training and development.
  • Maintain compliance with current regulatory requirements (cGMP, GLP, GTP, CFR, PTC, and ICH) and internal SOPs.
  • Drive continuous quality improvement through communication, training, waste reduction, and mistake-proofing.
  • Solicit and implement industry best practices.
  • Keep team current with changes to GXP, including FDA and EU regulatory bodies and guidance documents.
  • Audit raw data in accordance with Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Code of Federal Regulations (CFR) guidelines.
  • Monitor and maintain quality systems and procedures (SOPs) for adherence to regulatory compliance requirements.
  • Perform trend analysis, report results, and coordinate corrective and preventative actions (CAPA) to drive compliance and quality initiatives.
  • Lead and/or participate on cross-functional teams and projects representing quality in a positive and compliant manner.
  • Conduct documentation review and approval, including testing and manufacturing batch records, cleaning records, client protocols, training records, qualification/validation documents.
  • Review, approve, and perform investigations, as needed, and provide guidance for CAPA related to non-compliance situations using creative problem-solving skills.
  • Support QA aspects of the change control processes (equipment, facilities, utilities, and documents) and ensure they are handled in a compliant manner.
  • Support and actively participate in client and regulatory audits/inspections.
  • Work on routine assignments per written procedures, where the ability to recognize deviation from accepted practice is required.
  • Accomplish staff results by communicating updated organizational information, job expectations, and supporting their work.
  • Plan, monitor, and appraise direct reports, including performance competencies, goals, and job results.
  • Coach, counsel, and conduct disciplinary actions.
  • Develop, coordinate, and follow organizational systems, policies, procedures, and labor and capacity standards.

Requirements:

  • High School Diploma or equivalent required.
  • 5+ years of relevant technical experience and at least 2 years in a Lead/Leadership/Supervisory Role.
  • BS/BA in a Science-related field preferred or a combination of relevant experience and education.

Knowledge/Skills/Abilities:

  • Proficient in oral and written communication skills.
  • Ability to read, write, and understand English.
  • Proficient in Microsoft (Excel, Word, Outlook).

Our Values:

Integrity and Dedication, Working Together and Sharing Success, Do the Right Thing and Do it Right.

About WuXi AppTec:

WuXi AppTec is a leading global contract research organization (CRO) and contract manufacturing organization (CMO) that provides a broad range of services to support the discovery, development, and manufacture of small molecule and biologic drugs. Our company is dedicated to providing opportunities for internal growth and development, with direct access to a dedicated and accessible Human Resources team.

Equal Employment Opportunity:

WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

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