Our Lead Incoming Quality Assurance plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include coordinating Incoming Quality Assurance (IQA) aspects of materials and supplies for compounding pharmaceuticals. This role requires critical thinking and authority to proactively address and/or escalate IQA issues. This role will report to the Manager Incoming Quality Assurance at the site. This group will provide visibility of leading indicators for concerns around IQA risks at the site. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.
What The Lead Incoming Quality Assurance Does Each Day
- Supports failure and discrepancy investigations and documenting investigations on incoming supply process deviations
- Executes timely and accurate release of incoming supplies to ensure the production schedule is not jeopardized
- Maintains IQA records associated with release of supplies
- Assists in developing policies and procedures related to IQA
- Promptly communicates with Operations regarding supply issues/variance
- Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation
- Processes waste including handling of rejected materials
- Supports department supervision in oversight and prioritization of day-to-day responsibilities
- Ensures all work is performed and documented in a timely manner and according to approved standard operating procedures and in general compliance with cGMP
- Demonstrates a high level of discretion in the timely identification, and resolution of events potentially impacting the Quality of products and processes
- Provides established technical expertise for current processes and oversees training of department personnel on new processes
- Own the creation, revisions, review, approval and implementation of procedures supporting IQA
- Develop and establish communication and meeting strategies supporting IQA including an escalation process when Quality risks have been identified
- Review applicable documents for compliance with company standards and create applicable GAP analysis as required
- Coordinate with document retrieval during audits and inspections
- Coordinate roles and responsibilities providing assignment of IQA activities to ensure completion on time
- Lead and participate in process improvements and projects within the company
Our Most Successful Lead Incoming Quality Assurance
- Understands updating Standard Operating Procedure, with documentation of summary of changes and version control
- Manages projects coordinating cross-departmental activities
- Is detail-oriented with strong verbal and written communications skills
Minimum Requirements For This Role
- High School diploma or general education degree (GED) required
- At least 2 years’ experience in FDA regulated Quality Assurance, Sterile Compounding and/or GMP production facility required
- At least 2 years’ experience in Incoming Quality Assurance
- Proficiency in Microsoft Office, Adobe, Word and Excel
- Must be currently authorized to work in the United States on a full-time basis; QuVa will not sponsor applicants for work visas
Any Of The Following Will Give You An Edge
- Bachelor’s Degree in life science or equivalent work experience
Benefits Of Working At QuVa
- Set, full-time, consistent work schedule
- Comprehensive health and wellness benefits including medical, dental and vision
- 401k retirement program with company match
- 17 paid days off plus 8 paid holidays per year
- Occasional weekend and overtime opportunities with advance notice
- National, industry-leading high growth company with future career advancement opportunities
About QuVa
QuVa is a national, industry-leading provider of pharmacy services, including ready-to-administer sterile outsourcing and advanced AI-generated insights providing clarity for revenue capture and inventory management. QuVa Pharma delivers essential medications in injectable formats critical for effective patient care. LogicStream, a QuVa company, partners with health systems to aggregate, normalize, and analyze large amounts of complex data through AI and machine learning tools that generate actionable insights supporting revenue optimization, inventory management, and inventory-related workflows. Through QuVa’s integrated solutions, health systems can transform pharmacy management to achieve greater value by operating more efficiently and effectively as they deliver high-quality patient care.
QuVa is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. QuVa's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with QuVa is “at will.”
