Manager, Quality Control Lab

Quva • Bloomsbury, NJ

5d • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

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

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 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager