Responsible for supporting all daily quality operations at Revelation
Maintain quality standards and procedures for quality systems, products, and services
Collaborate with management and staff to implement any regulatory changes effectively
Ensure QA/QC tasks are properly documented and maintained throughout pharmacy records for production, product testing and release validation
Participate in investigating deviations, failures, or errors and collaborate with management to identify root causes and implement developed corrective and preventive actions (CAPAs) as needed
Collect and analyze quality data to identify trends and areas for process improvement
Work with third-party laboratories to submit samples according to the established quality test(s) and criteria and follow up on outstanding results
Participate and support pharmacies with internal and external audits
Serve as an assigned trainer to provide training and guidance to pharmacy personnel on quality-related procedures and tasks
Assist management with recalls of medications when applicable
Assist pharmacies with board of pharmacy, FDA, and accreditation inspections and responses.

Bachelor’s degree in a related field preferred
Minimum of 3 years of experience in quality assurance or a related field
Strong understanding of quality management principles and procedures
Broad knowledge base of cGMP, FDA, USP, and other Healthcare compliance and applicable regulations
Experience with quality assurance systems and tools
Excellent written and verbal communication skills
Ability to work independently and as part of a team.
Physical Requirements: Proficient in using a computer and related equipment, including printers and fax machines.
Ability to sit or stand for extended periods.
Effective communication skills via telephone and email.
Capable of lifting up to 40 pounds as needed.
20/20 vision (with or without corrective aids) required for visual inspection of drug products, in accordance with legal requirements.

Quality Assurance Specialist

Key skills