Senior Quality Assurance Specialist

QUALITY ASSURANCE SPECIALIST / LEAD SPECIALIST

Gaithersburg, MD

Responsibilities:

• Monitoring of studies for assurance that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the GLP and CAP regulations. Performing phase inspections, reviewing maintenance records of equipment, and training records of laboratory staff.
• The Quality Assurance Specialist assures compliance with all CFR Part 58 maintenance of records and indexing of the records
• Maintains a copy of all study protocols and the Master Schedule of all nonclinical laboratory studies
• Inspects nonclinical laboratory studies at adequate intervals to assure the integrity of studies and maintains written records.
• Determines that no deviations from approved protocols or standard operating procedures are made without proper authorization and documentation.
• Review final study reports assuring that the reports accurately describe the methods used, the SOPs followed, and raw data.
• Prepares and signs the quality assurance statement included in the final study report.
• Provides staff annual GLP training
• Responsible for the review and revision process of Standard Operating Procedures (SOPs).

Qualifications:

• 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.
• Quality inspection, auditing, and/or testing experience, required. Trained in Good Laboratory Practice (GLP) procedures, required. SQA RQAP-GLP Certification, highly desired. Knowledge of College of Anatomic Pathology (CAP) credentialing requirements a plus.
• Knowledge of methodologies of quality assurance and standards.

Interacts with people well, has excellent communication and organizational skills. Confidence in communicating and interacting with others.