Supervisor, Sterility Assurance 2nd Shift

QuVa Pharma; Sugar Land (TX); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Set, full-time, consistent schedule

Comprehensive health and wellness

401k retirement program with company 


22 paid days off + 8 paid holidays

Career advancement opportunities

Job summary

Quva in Sugar Land, TX is seeking a Supervisor, Sterility Assurance to lead environmental and personnel monitoring, ensure aseptic conditions, and support lot release. This full-time, on-site role operates on 2nd shift, Mon-Fri 2:00 PM–10:30 PM.

You will hold a Bachelor’s in Microbiology or Life Science, 2–3 years QA in a regulated environment, and 1 year supervisory experience while ensuring CGMP adherence and 503B compliance. Training and policy development are key parts of the job.

Qualifications

• BS in Microbiology or Life Science required (or related field).
• 2–3 years of QA / cGMP / FDA-regulated industry experience.
• 1 year of supervisory or management experience.
• Experience training personnel on aseptic techniques and gowning.
• Familiarity with 503B pharmaceutical industry CGMPs and quality requirements.
• Able to lift up to 50 lbs and perform physical tasks as needed.
• Must be authorized to work in the United States without sponsorship.

Responsibilities

• Supervises environmental and personnel monitoring staff and provides learning and development.
• Ensures Sterility Assurance program standardization with corporate policies.
• Elevates QA decisions related to aseptic conditions during manufacturing.
• Performs timely in-process review of EM/PM documents for lot release.
• Provides SME support and review of Deviations / Investigations.
• Maintains EM/PM records and interprets monitoring results.
• Delivers training on aseptic techniques and gowning.
• Reviews records to ensure drug product quality standards are met.
• Maintains compliance with FDA 503B and CGMP guidelines.
• Maintains testing equipment calibration and certification.
• Assists in developing Sterility Assurance policies and procedures.
• Enforces personnel policies and procedures.

Skills

Supervisory experience

Quality Assurance

Sterility Assurance

Environmental monitoring

cGMP compliance

FDA regulations

Training personnel

Gowning techniques

Education

Bachelor's Degree in Microbiology or Life Science

Tools

Computerized tracking tools

Job description

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.

This is a full-time role for our 2nd shift, working Monday through Friday from 2:00 PM to 10:30 PM. This is a set, consistent schedule with minimum overtime requirements and based on site in our Sugar Land, TX location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws.

What the Supervisor, Sterility Assurance Does Each Day:

• 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 elevate 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

Our Most Successful Sterility Assurance Supervisors:

• Work to create an environment of open communication, participation, and information-sharing within and between teams within Quality Assurance and throughout facility
• Are detail-oriented with strong verbal and written communications skills
• Support the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards
• Act decisively with purposeful pursuit of goals or objectives, and thinks strategically in terms of solutions
• Drive achievement, expresses energy, shows accountability, ability to multi-task and work in a fast-paced, quality-rich environment
• Motivate others, share knowledge, build high performing teams, show respect towards others, and give constructive feedback

Minimum Requirements for this Role:

• 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

Any of the Following Will Give You an Edge:

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

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
• 22 paid days off plus 8 paid holidays per year
• National, industry-leading high growth company with future career advancement opportunities

About Quva:

Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma's multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva's overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-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."

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