Senior QA Specialist

Proclinical is currently recruiting for a Senior QA Specialist for a busy, non-profit, biotechnology company located in Rockville, MD. The ideal candidate will be an organized, flexible, and competent professional who has a keen eye and solid experience in not only quality assurance, but quality control, with a goal to ensure the high quality of our operations and services aiming towards the long-term success of our business.

Job 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).

Skills and 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.
• 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.

COVID-19 considerations:

• Daily health screening required upon entry, face masks are worn in the office, sanitizing stations located throughout, social distancing measures in place, conference meetings via WebEx or Zoom.

If you are having difficulty in applying or if you have any questions, please contact Christian Delbaere at (+1) 347-227-1672 or c.delbaere@proclinical.com.

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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