Manager, Quality Control Lab

RXinsider LTD.; New Jersey; Hybrid; USD 99,000 - 136,000; Full time

Benefits offered by this job

Health benefits

401k plan

Paid time off

Paid holidays

Job summary

Quva is seeking a Manager Quality Control - Lab to lead daily QC activities, coach staff, and ensure analytical methods are validated and compliant. After training, you will oversee testing, method transfers, stability testing, and release testing for commercial lots while aligning with cGMP standards and regulatory requirements.

This role emphasizes attention to detail, strong communication, and budget management within a mission-driven pharmaceutical data and healthcare improvement environment

Qualifications

• BS or MS in chemistry, biology, or related field.
• 5 years' experience in Quality Assurance/Laboratory/cGMP/FDA-regulated industry.
• 3 years' supervisory or management experience.

Responsibilities

• Test and release finished product for potency, endotoxin, and sterility.
• Maintain notebooks for method validation and investigational studies per SOPs, cGMP, and GDP.
• Implement improvements to analytical test methods or instrumentation.
• Write investigation reports for OOS Sterility results.
• Provide quality oversight of the Laboratory and supervise testing end-to-end.

Education

BS/MS in chemistry or biology or related field

Job description

Our Manager Quality Control- Lab plays a vital role within our organization. Once you complete our training, your responsibilities will include managing daily activities, performance, and coaching and developing staff. Coordinate analytical activities including method transfers and stability testing. Perform release testing for analytical studies. At Quva, you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement 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 The Manager Quality Control -Lab Does Each Day

• Test and Release Finished Product routinely for Commercial lots for Potency, Endotoxin, and Sterility
• Maintain accurate and complete notebook records for all method validation and investigational studies in accordance with SOPs, cGMP, and current GdP
• Implement improvements to analytical test methods or to instrumentation
• Write investigation report for OOS for Sterility results
• Provide quality oversight of Laboratory
• Responsible for assigned testing and work from beginning to end with minimal supervision
• Write SOPs and follow policy, procedure and applicable government regulations, such as current Good Manufacturing Practices (cGMP), DEA compliance, quality standards and safety requirements
• Communicate with Operation for Scheduling the QC Samples
• Ensure that analytical methods are validated as efficiently as possible to ensure business milestones are met
• Provide technical support on an as-needed basis as directed by Director of the Laboratories
• Manage the budget for the Labs
• Ensure testing is conducted in a safe manner including but not limited to the proper PPE and ventilation; Any safety issue must be brought to the attention of the Director immediately

Our Most Successful Manager Quality Control- Lab

• Has a sense of urgency, accountability and resourcefulness (e.g., work in changing environment)
• Is a self-starter and independent learner
• Promotes active listening with team members; Contributes appropriately to conversations; Has strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organization
• Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform

Minimum Requirements For This Role

• BS. or M.S. degree in chemistry, biology or related field required
• 5 years prior experience in Quality Assurance /Laboratory/ cGMP / FDA regulated industry
• 3 years of supervisory or management experience required
• 18+ years of age
• Able to successfully complete a drug and background check
• 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

• Prior experience in Quality Assurance /Laboratory/ cGMP / FDA regulated industry

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
• 5 paid PLP and 17 PTO days off plus 8 paid holidays per year
• Occasional weekend and overtime opportunities with advance notice
• 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: $98,891 - $135,975 Annually
• This role is also eligible for an annual incentive bonus, subject to program terms and guidelines

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.” California Consumer Privacy Act (CCPA) Notice for Applicants and Employees