Specialist, Clinical QC Compliance, Analytical Development and Quality Control

About the role

This is not a laboratory-based position. The specialist will provide compliance and documentation support to the Analytical Development and Quality Control (ADQC) and Clinical QC (GMP) laboratories, performing administrative tasks while maintaining the highest standard of quality and compliance.

Responsibilities

• Perform all job functions in compliance with cGXPs and maintain accurate and legible laboratory records.
• Generate, review, and provide assessments for Quality records for ADQC ensuring compliance with regulatory standards, data integrity, and system performance.
• Track and present schedules internally for compliance-related events in ADQC (Periodic reviews, system qualification and validation activities, guidance document updates, system obsolescence, and upgrade needs).
• Support compliance involvement for laboratory investigation reports, deviation reports, and CAPAs.
• Provide backroom assistance for Quality audits.
• Conduct reviews of new procedures and proposed changes to current procedures for compliance with regulatory and corporate requirements.
• Assist the compliance team with equipment maintenance and management, including the Clinical QC periodic review process, equipment qualification program, and EQV system.
• Create plans and present timelines to meet established targets, goals, and objectives.
• Strong verbal communication and presentation skills.

Requirements

• Minimum of BS/BA degree in a relevant field with 2-5 years of experience working in a cGMP setting.
• Knowledge of Pharmaceutical Quality Assurance, regulatory compliance, and/or quality control, including cGMP, FDA regulations, ICH guidelines, and EU regulations.
• Strong working knowledge of Microsoft suite programs.
• Excellent time and project management skills with the ability to multi-task and organize work responsibilities effectively.
• Strong proficiency in quality management systems and audit procedures.
• High attention to detail and ability to maintain accuracy in documentation and processes.
• Strong analytical and problem-solving skills with the ability to conduct risk assessments and root cause analysis.

Skills

• Strong and effective communication skills for interacting with cross-functional teams.
• Mental acuity: High attention to detail and ability to maintain accuracy in documentation and processes.

Physical Requirements

• Ability to bend, reach, and stand, with lifting up to 15 pounds and carrying over short distances.

Preferred Qualifications

• Working knowledge of validated documentation systems: Veeva Vault (EQV), LIMS, ValGenesis, Kneat, etc.
• Knowledge of pharmaceutical/biotechnology manufacturing processes.