QA Specialist II - Shift is 12pm - 10:30pm, Wed - Sat

Charles River Laboratories; Rockville (MD); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a QA Specialist II to enhance their Quality Assurance processes. This role involves supporting quality systems, managing investigations, and ensuring compliance with regulatory standards. The ideal candidate will have a strong background in GMP and quality systems, with the ability to collaborate across departments to drive improvements. You'll be responsible for tracking quality metrics, conducting audits, and training personnel on best practices. Join this innovative firm and contribute to the quality assurance of biological products in a dynamic and supportive environment.

Qualifications

• 5+ years of GMP experience in pharmaceutical or bio-pharmaceutical fields.
• Strong knowledge of GMP, SOPs, and quality systems.

Responsibilities

• Support quality systems including investigation and deviation management.
• Compile and report monthly quality metrics and support audits.

Skills

GMP Experience

Quality Systems Knowledge

Organizational Skills

MS Office Proficiency

Technical Document Drafting

Training Skills

Education

Bachelor's Degree in Scientific/Technical Discipline

Master's Degree in Scientific/Technical Discipline

Tools

TrackWise

Pilgrim

Electronic Quality Management Systems

Job description

QA Specialist II - Shift is 12pm - 10:30pm, Wed - Sat

Join to apply for the QA Specialist II - Shift is 12pm - 10:30pm, Wed - Sat role at Charles River Laboratories.

Job Summary

The Quality Assurance Specialist II is responsible for supporting Quality Systems, including investigation/deviation management, CAPA tracking, Effectiveness Verification, change control, internal and external audits. This position will facilitate the compiling, trending (as required), and reporting key quality metrics for management, and other quality system functions, as needed. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.

Key Responsibilities and Duties

• Establishes and maintains Investigation, Deviation, CAPA, EV systems, and internal and external audit. Collaborates with cross-functional departments to ensure timely implementation and closure of quality records.
• Provides guidance and advice on methods, procedures, standardization, and requirements associated with these systems.
• Tracks and trends aspects of the Quality System and reports risks and trends to management.
• Performs CAPA effectiveness evaluation based on measurements.
• Administers Change Control process and verifies effectiveness of changes.
• Maintains tracking mechanisms for Quality Systems elements and ensures visibility.
• Monitors and reviews systems for compliance, quality improvements, and industry best practices. Supports QA compliance.
• Compiles and reports monthly quality metrics.
• Supports audits and prepares related reports, ensuring CAPA monitoring for compliance.
• Supports Deviation, CAPA, EV, and Change Control systems, ensuring proper investigations, root cause analysis, and effective corrective actions.
• Develops and delivers training on relevant processes and procedures.
• Reviews and updates procedures, ensuring personnel training and compliance.
• Identifies and escalates compliance gaps.
• Maintains customer complaint and sample management systems.
• Performs additional duties as assigned.

Job Qualifications

• BS required; MS preferred in scientific/technical discipline.
• 5+ years GMP experience.
• Strong knowledge of GMP, SOPs, and quality systems.
• Excellent organizational and review skills.
• Proficient in MS Office and electronic quality management systems; experience with TrackWise, Pilgrim preferred.
• Quality audit certification from ASQ is a plus.
• Experience in pharmaceutical or bio-pharmaceutical fields.
• Training in cell culture and gene therapy manufacturing is a plus.
• Proficient in drafting technical documents and presentations.
• Knowledge of document management and regulatory requirements.
• Ability to manage multiple assignments and collaborate across departments.
• Understanding of pharmaceutical manufacturing, quality assurance, aseptic processes, and product transfer.
• Strong presentation and training skills.