Supervisor, Sterility Assurance

Quva • Bethlehem Township, NJ

20h • Onsite

About The Position

Our Supervisor, Sterility 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 supervising Quality Assurance aspects of sterility assurance including environmental and personnel monitoring teams ensuring compliance within the facility. Operates within the legal and regulatory compliance, producing a quality product. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

Requirements

• Bachelor’s Degree in Microbiology, Life Science or another related field
• 2-3 years prior experience in Quality Assurance / cGMP / FDA regulated industry
• 1 year of supervisory or management experience
• Experience training personnel on aseptic techniques and appropriate gowning techniques
• Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP’s and have demonstrated strength in problem solving and resolution
• Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation
• Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas

Nice To Haves

• Understanding of process flows, gap assessments and analysis of data to drive improvement
• Proficiency with computerized tracking tools
• Comprehensive knowledge of Adult learning techniques

Responsibilities

• Supervises all environmental and personnel monitoring (EM/PM) staff providing learning and development where appropriate
• Ensures standardization of site Sterility Assurance program with respect to Corporate Policies
• Ability to escalate QA decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
• Responsible for timely and accurate in process review of EM/PM documents supporting lot release on time
• Provides SME support and review of Deviations / Investigations
• Maintains environmental monitoring program including environmental and personnel monitoring results that exceed alert or action limits and interpreting results
• Provides training support for personnel on appropriate aseptic techniques and gowning techniques
• Periodically review records to verify that quality standards for each drug product is met
• Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
• Responsible for maintaining EM/PM records
• Responsible for maintaining all testing equipment in compliance, calibration, and certification.
• Assists in developing policies and procedures related to Sterility Assurance
• Enforces applicable personnel policies and procedure

Benefits

• Set, full-time, consistent work schedule
• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 22 paid days off plus 8 paid holidays per year
• National, industry-leading high growth company with future career advancement opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees