Manager, Quality Assurance - Facilities Maintenance

QuVa Pharma; Bloomsbury (NJ); Sur place; USD 114 000 - 156 000; Plein temps

Avantages offerts par ce poste

Health, dental & vision benefits

401k with company match

22 paid days off + 8 holidays

Career advancement opportunities

Résumé du poste

Quva Pharma in New Jersey seeks a Manager of Quality Assurance - Facilities Maintenance to lead QA facility programs and oversee maintenance projects at our manufacturing site. The role emphasizes compliance, precision, and strong documentation practices to ensure safety, efficacy and quality in pharmaceutical operations.

You will guide a technical team, ensure cleanroom and regulatory standards, review investigations, and drive CAPAs while maintaining QA records and coordinating with

Qualifications

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

Responsabilités

• Lead QA Facility/Maintenance staff and oversee site work orders.
• Ensure cleanroom compliance during projects.
• Oversee investigations of deviations and equipment malfunctions.
• Develop and implement corrective and preventive actions.
• Monitor environmental monitoring data for facilities/maintenance.
• Maintain FDA 503B and cGMP compliance records.
• Maintain testing equipment records, calibration and certification.
• Contribute to QA policies for facility/maintenance.
• Communicate discrepancies to relevant departments.
• Enforce applicable personnel policies.

Connaissances

Supervision

QA

cGMP

FDA regs

Documentation

Cleanroom ISO7

Formation

Bachelor's in Life Science

Description du poste

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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