Manager, Quality Control Lab

About the role

The Manager Quality Control-Lab plays a vital role within our organization. After completing our training, your responsibilities will include managing daily activities, performance, and coaching and developing staff. You will coordinate analytical activities, including method transfers and stability testing, and perform release testing for analytical studies.

Responsibilities

• 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 reports for OOS 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 operations for scheduling 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 the Director of Laboratories
• Manage the budget for the labs
• Ensure testing is conducted in a safe manner including proper PPE and ventilation; any safety issue must be brought to the attention of the Director immediately

Requirements

• Bachelor's or Master'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
• Currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas

Qualifications

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

Skills

• Sense of urgency, accountability, and resourcefulness
• Self-starter and independent learner
• Active listener 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

Benefits

• Full-time, consistent work schedule
• Comprehensive health and wellness benefits including medical, dental, and vision
• 401(k) 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
• 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
• Rewarding 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.”