QAS: Sterility Assurance

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)

To be considered:

In order to be considered for this position you must complete the entire application process, which includes answering all prescreening questions and providing your eSignature on or before the requisition closing date.

Candidates for regular U.S. positions must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire.

It is the policy of QuVa Pharma to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.