Lead GLP QA Specialist

Lead GLP QA Specialist - Permanent - Gaithersburg, MD

Proclinical is seeking a proactive, reliable, and experienced Quality Assurance Specialist with a strong background in Good Laboratory Practice (GLP). This is a permanent position based in Gaithersburg, MD.

Primary Responsibilities:

The successful candidate will play a crucial role in ensuring our operations and services meet the highest quality standards, contributing to the long-term success of our business. This role is perfect for an organized, flexible, and competent professional who excels in both quality assurance and quality control.

Skills & Requirements:

• Bachelor of Science degree in Quality Assurance, Business Administration, or another undergrad degree focusing on safety & reliability, manufacturing, technical communications, statistics, and engineering or equivalent experience.
• Experience in quality inspection, auditing, and/or testing.
• Trained in Good Laboratory Practice (GLP) procedures.
• SQA RQAP-GLP Certification is highly desirable.
• Knowledge of College of Anatomic Pathology (CAP) credentialing requirements is a plus.
• Knowledge of methodologies of quality assurance and standards.
• Excellent communication and organizational skills.

The Lead GLP QA Specialist will:

• Monitor studies to ensure facilities, equipment, personnel, methods, practices, records, and controls conform to GLP and CAP regulations.
• Perform phase inspections, review maintenance records of equipment, and training records of laboratory staff.
• Ensure compliance with all CFR Part 58 maintenance of records and indexing of the records.
• Maintain a copy of all study protocols and the Master Schedule of all nonclinical laboratory studies.
• Inspect nonclinical laboratory studies at adequate intervals to assure the integrity of studies and maintain written records.
• Ensure no deviations from approved protocols or standard operating procedures are made without proper authorization and documentation.
• Review final study reports to ensure they accurately describe the methods used, the SOPs followed, and raw data.
• Prepare and sign the quality assurance statement included in the final study report.
• Provide staff annual GLP training.
• Responsible for the review and revision process of Standard Operating Procedures (SOPs).

If you are having difficulty in applying or if you have any questions, please contact Christina Chung at (+1) or .

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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