Quality Assurance Specialist Corporate in at Revelation Pharma LLC

The Quality Assurance Specialist is responsible for supporting all daily quality operations at Revelation, including maintaining quality standards and procedures for quality systems, products, and services. This role works with pharmacies and quality management in investigating deviations, resolving quality issues, and participates in continuous improvement initiatives to support optimal quality and regulatory outcomes at Revelation.

Responsibilities

• Maintain proficiency in pharmacy Standard Operating Procedures, USP 795, 797, 800 and all applicable chapters.
• Stay updated on state, federal, and industry laws and regulations relevant to our operations.
• 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.
• Work alongside management to support the corporate goal of instilling a Culture of Excellence, Financial Performance, and Focus on Quality with all pharmacy employees.
• Assist management with recalls of medications when applicable.
• Assist pharmacies with board of pharmacy, FDA, and accreditation inspections and responses.
• Other duties as determined by QA leadership.

• 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 and industry standards regarding regulation of compounded preparations
• 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.

Benefits:

• Health care insurance (medical, dental, vision)
• Life Insurance
• Supplemental Insurance
• PTO
• 401K matching
• Sick leave