Manager, Quality Assurance - Facilities Maintenance

Quva; Bloomsbury (NJ); On-site; USD 114,000 - 156,000; Full time

Benefits offered by this job

Health and wellness benefits

401k retirement program with company해

Job summary

Quva is seeking a Manager of Quality Assurance – Facilities Maintenance to lead site QA for facility and maintenance activities in our US manufacturing facility. This role ensures compliance with FDA/cGMP, maintains documentation, and drives corrective actions across maintenance projects.

The position requires 5+ years in QA/facility environments, a life-science degree, and supervision experience. It offers comprehensive benefits, salary range based on experience, and a strong focus on quality

Qualifications

• Bachelor’s degree in Life Science or related field is required.
• 3+ years of supervisory or management experience in QA/facility settings.
• 5+ years in Quality Assurance / cGMP / FDA regulated industry.
• Understanding of Good Documentation Practices.
• Experience with Maintenance Safety practices and protocols.
• ISO 5/7 cleanroom gowning knowledge.
• Understanding manufacturing processes and facilities maintenance.
• Able to lift up to 50 lbs; physically capable for shift work.
• Authorized to work in the United States; no visa sponsorship.

Responsibilities

• Oversee QA – Facility / Maintenance staff daily operations.
• Review and approve facility-related work orders for the site.
• Ensure clean room standards during all projects.
• Investigate deviations, equipment malfunctions, and discrepancies.
• Identify and implement corrective and preventive actions.
• Monitor environmental data supporting maintenance work orders.
• Maintain QA records for facilities/maintenance.
• Maintain calibration and certification of testing equipment.
• Develop policies related to QA Facility / Maintenance.
• Communicate discrepancies to relevant departments.
• Enforce applicable personnel policies.

Skills

Supervisory experience

QA knowledge

cGMP familiarity

Good Documentation Practices

Maintenance safety practices

Cleanroom gowning ISO 5/7

Manufacturing process understanding

Education

Bachelor’s degree in Life Science

Job description

Our Manager, Quality Assurance – Facilities Maintenance 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 leading the oversight and compliance of all site-related facility maintenance and engineering projects, repairs, work orders and processes within the pharmaceutical manufacturing facility. This position operates within the legal and regulatory compliance, ensuring that any and all facilities related activities are documented when performed in accordance with site compliance while upholding quality standards. 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.

What Manager, Quality Assurance - Facilities Maintenance Does Each Day:

• Manages Quality Assurance – Facility / Maintenance staff
• Reviews, approves and ensures completion of all facility related work orders for the manufacturing site
• Ensures compliance with clean room standards during all facility related projects
• Oversees failure and discrepancy investigations and documenting investigations on process deviations or equipment malfunctions related to facility / maintenance work orders, processes and/or jobs performed
• Develops and provides oversight to identification and implementation of appropriate corrective actions and preventive actions
• Responsible for routine evaluation of environmental monitoring program data supporting facilities/maintenance work orders ensuring activities performed maintain compliance with site policies and procedures
• Maintains compliance with FDA 503B and cGMP guidelines / state and federal laws
• Responsible for maintaining Quality Assurance records associated with facilities or maintenance
• Responsible to maintain all testing equipment records in compliance, calibration, and certification
• Assists in developing policies and procedures related to QA Facility / Maintenance
• Promptly communicates with appropriate departments regarding discrepancies, variances, or issues
• Enforces applicable personnel policies and procedures

Our Most Successful Quality Assurance - Facilities Maintenance Managers

• Have strong technical writing and verbal/written communication skills
• Develop action plans to meet a specific objective including identification and methods of tasks, milestones, resources requirements and metrics
• Possess time management skills

Minimum Requirements For This Role

• Bachelor’s Degree in Life Science or another related field
• 3+ year' supervisory or management experience
• 5+ years' experience in Quality Assurance / cGMP / FDA regulated industry
• Understanding of Good Documentation Practices
• Experience with Maintenance Safety practices and protocols
• Knowledgeable in ISO 5/7 environment cleanroom gowning
• Knowledge of manufacturing processes, procedures and basic facilities maintenance functions
• 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

Benefits Of Working At Quva

• 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
• Salary range based on experience $113,724 - $156,371

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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