Supervisor, Sterility Assurance 2nd Shift

RXinsider LTD.; Sugar Land (TX); On-site; USD 78,000 - 110,000; Full time

Benefits offered by this job

Set, full-time schedule

Health and wellness benefits

401k with company match

Paid time off

Job summary

Quva Supervisor, Sterility Assurance leads environmental and personnel monitoring, ensuring Sterility Assurance programs align with corporate policies and cGMP standards. Oversees QA decisions and maintains EM/PM records to support timely lot release.

You will train staff in aseptic techniques, review deviations, and help sustain a culture of quality across the manufacturing site in Sugar Land, TX. This is a full-time, safety-sensitive role requiring upholding FDA CGMP requirements.

Qualifications

• Bachelor's degree in Microbiology or Life Sciences required.
• 2-3 years in Quality Assurance / cGMP / FDA regulated industry.
• 1 year of supervisory experience preferred.
• Experience training personnel on aseptic techniques and gowning.
• Knowledge of 503B CGMP requirements and problem solving.

Responsibilities

• Supervises environmental and personnel monitoring (EM/PM) staff and provides development.
• Ensures standardization of Sterility Assurance programs with Corporate Policies.
• Escalates QA decisions related to aseptic conditions during manufacturing.
• Performs in-process review of EM/PM documents to support on-time lot release.
• Provides SME review of Deviations / Investigations and maintains EM/PM records.
• Trains personnel on aseptic techniques and gowning; ensures records accuracy.
• Reviews records to verify drug product quality standards are met.
• Maintains compliance with FDA 503B and CGMP regulations; protects safety and quality.

Skills

Quality Assurance

cGMP knowledge

Supervisory experience

Aseptic training

FDA regulations

Environmental monitoring

Education

Microbiology degree

Tools

LIMS software

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 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

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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