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

Lensa; Rockville (MD); On-site; USD 87,000 - 117,000; Full time

Job summary

A leading company is seeking a QA Specialist II to support quality systems in Rockville, MD. The role involves managing investigations, audits, and quality improvement processes in a GMP environment. Ideal candidates will have a scientific degree and extensive experience in quality assurance or the pharmaceutical industry.

Benefits

401K

Paid time off

Health coverage

Bonuses

Flexible work arrangements

Qualifications

• 5+ years of experience in a GMP environment.
• Certification from the American Society for Quality in quality auditing is a plus.
• Experience in pharmaceutical or bio-pharmaceutical fields.

Responsibilities

• Supports Quality Systems including investigation and deviation management.
• Tracks and trends aspects of the Quality System and reports to management.
• Conducts audits and prepares annual audit plans.

Skills

Strong knowledge of GMP

Excellent organizational skills

Knowledge of quality systems

Proficient in drafting technical documents

Strong presentation skills

Education

BS in a scientific/technical discipline

MS preferred

Tools

MS Word

Excel

PowerPoint

Adobe Pro

TrackWise

Job description

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

Be among the first 25 applicants one week ago.

Lensa is the leading career site for job seekers at every stage of their career. Our client, Charles River Laboratories, is seeking professionals in Rockville, MD. Apply via Lensa today!

For 75 years, Charles River employees have worked together to assist in the discovery, development, and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales, or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.

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 of 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 processes, collaborating with cross-functional departments to ensure timely implementation and closure of quality records.
• Provides guidance on methods, procedures, standardization, and requirements associated with these systems.
• Tracks and trends aspects of the Quality System and provides reports to management identifying risks and trends regularly.
• Performs CAPA effectiveness evaluations based on quantitative and qualitative measurements.
• Administers the Change Control process for the site and conducts effectiveness verification for changes implemented.
• Maintains tracking mechanisms to support various Quality Systems elements and ensures visibility throughout the organization.
• Continuously reviews systems and procedures for compliance, quality improvements, and efficiency, providing compliance support and expertise for QA.
• Compiles and reports site monthly corporate Quality metrics.
• Supports the Quarterly Management Review (QMR).
• Supports audits (internal, external) to verify regulatory compliance, internal and CRL procedures, and quality requirements. Prepares annual audit plans, conducts audits, writes reports, and monitors CAPA to ensure compliance.
• Supports Deviation, CAPA, EV, and Change Control systems to ensure proper investigations, root cause analysis, and implementation of corrective actions.
• Develops, implements, and delivers training on Deviation, CAPA, EV, and Change Control processes and procedures.
• Reviews procedures and facilitates updates for these systems.
• Ensures personnel are trained in the principles, policies, and procedures of these systems.
• Identifies and escalates compliance gaps across quality systems.
• Maintains customer complaint and suspect sample management systems.
• Performs additional duties as assigned.

Job Qualifications

• BS required; MS preferred in a scientific/technical discipline.
• 5+ years of experience in a GMP environment.
• Strong knowledge of GMP, SOPs, and quality system processes.
• Excellent organizational skills and ability to review and update processes or procedures.
• Proficient in MS Word, Excel, PowerPoint, Adobe Pro, and electronic quality management systems (TrackWise, Pilgrim experience preferred).
• Certification from the American Society for Quality in quality auditing is a plus.
• Experience in pharmaceutical or bio-pharmaceutical fields.
• Training or education in cell culture and gene therapy manufacturing is a plus.
• Proficient in drafting technical documents and presentations.
• Knowledge of document management processes.
• Ability to work on multiple assignments collaboratively.
• Knowledge of quality systems such as Deviation, CAPA, EV, and Change Control management.
• Working knowledge of regulatory requirements (21 CFR Part 11/210/211/600/820, ICH, EMA).
• Basic understanding of training, instructional design, communication, and education.
• Understanding of pharmaceutical manufacturing, quality assurance, aseptic and packaging processes, and product transfer.
• Strong presentation skills for conducting training sessions.

Compensation Data

The pay range for this position is $87,733 - $116,978 annually, with salaries varying based on experience, skills, education, certifications, and location.

About Biologics Testing Solutions

With over 50 years of experience, Charles River's Biologics group offers services including contamination testing, protein characterization, bioassays, viral clearance, and stability programs, supporting clients throughout biologic development.

About Charles River

Charles River is a global CRO supporting clients from target identification through preclinical development, with over 20,000 employees across 110 facilities worldwide. We are dedicated to improving health and well-being globally, contributing to 80% of FDA drug approvals in the past five years.

Benefits

Benefits may include bonuses, 401K, paid time off, stock purchase programs, health coverage, wellbeing programs, and flexible work arrangements.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer. We provide accommodations for applicants with disabilities. For assistance, contact [e-mail].

For more information, visit www.criver.com.