Job Description

POSITION OVERVIEW:

The Quality Assurance Specialist provides daily on-the-floor support and oversight to all Manufacturing area(s). The oversight includes evaluation and review of ongoing manufacturing activities in real-time.

The on-the-floor quality team is responsible for making sure the process and documentation records are compliant with patient safety in mind, executing with efficiency always. Quality, safety and on-time delivery is a must to be successful in this role!

RESPONSIBILITIES MAY INCLUDE:

• Provide real-time oversight to the Manufacturing unit to ensure that all products produced meet formulation, compounding, labeling, and packaging requirements as defined by Standard Operating Procedures (SOP’s) and current Good Manufacturing Practices (cGMP)
• Provide QA support during aseptic processing
• Review batch records and related production documentation in real time, ensuring resolution of all identified issues prior to records leaving the shop floor for product disposition. Work with internal functions to address all identified good documentation issues in a timely manner
• Perform Environmental Monitoring within an aseptic environment
• Other duties as designated by Quality Management

QUALIFICATIONS:

• Legally authorized to work in the job posting country
• Bachelor of Science Degree in a scientific discipline (or 4 years of technical manufacturing experience in lieu of degree) required
• Minimum of 2 years related experience supporting compliance in regulated industry required or 3 years direct pharmaceutical experience in lieu of
• Good working knowledge of aseptic techniques and gowning requirements.
• Good understanding of Good Manufacturing Practices (GMPs)

Company Description

QuVa Pharma is a leader in 503B outsourced compounding, serving all 50 states with a full portfolio of sterile, ready-to-administer injectable products. QuVa was purpose-built to change the 503B industry for the better and is leading the way in making it more safe, efficient, and reliable. With unmatched expertise in cGMPs and sterile pharmaceutical manufacturing, we achieve higher than required quality and safety standards and maintain a leading FDA compliance record, so hospitals can more confidently and reliably focus on patient care. While our leading cGMP processes, sterile-to-sterile portfolio, and expansive capacity of 300,000 sq ft across four facilities are the foundation of success, it is our transparency, customer-focused service, and contracted supply arrangements that enable us to help hospitals and health systems better meet their patient care and operational needs. As FDA compliance becomes more stringent, QuVa's ability to reliably supply the highest-quality products is more valuable than ever and allows hospitals to spend more time on patient care and less time worried about beyond use dates, waste, workload inefficiencies, and compliance. That is why QuVa is proud to be recognized as the partner of choice for many of the nation’s leading health systems. So, whether you are calling for a response or being called on for a solution, know that QuVa is accountable, and in us, you always have an answer.