Manager, Quality Assurance

Our Manager of Quality 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  managing all Quality Assurance aspects of compounding sterile pharmaceuticals for compliance within the facility. Operates within the legal and regulatory compliance, producing a quality product. Operates the area as the manager over the QA operations/staff, coordinating day to day functions. 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 Does Each Day: 

• Manages all Manufacturing QA staff providing learning and development where appropriate
• Ability to make 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 batch records and QA checks within the manufacturing process
• Provides review/approval of Deviations / Investigations, CAPAs, Change Controls
• Generates procedures related to Manufacturing QA functions / activities
• Designs and maintains the environmental monitoring program including environmental and personnel monitoring results that exceed alert or action limits and interpreting results
• Trains 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
• Prepares and submits weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities
• Responsible for maintaining QA records associated with internal and external testing
• Responsible to maintain all testing equipment in compliance, calibration, and certification
• Assists in developing policies and procedures related to QA
• Promptly communicates with Operations regarding complaints, product issues/variances
• Enforces applicable personnel policies and procedures

Our Most Successful Quality Assurance 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 other related field required
• 5 years prior experience in Quality Assurance /Laboratory/ cGMP / FDA regulated industry
• 3 years of supervisory or management experience required
• Experience training personnel on aseptic techniques and appropriate gowning techniques
• Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation
• Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP’s and have demonstrated strength in problem solving and resolution
• 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:

• 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
• The base compensation for this role is estimated to be within the range described below.  The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditions
• Range: $113,724 - $156,371 / Year

 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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