Director, Quality Control Lab
About The Position
Our Director, Quality Control Lab, plays a vital role within our organization. Once you complete our training, you will be responsible for day-to-day operations of the Quality Control testing laboratories supporting all Quva production sites. This position also coordinates, leads group activities, and develops and implements the department's short and long-term goals to assure compliance with cGMPs and agreement with Quva business initiatives. The Director, Quality Control Lab, manages and develops teams within the department to support Company activities. This role also serves as a technical expert for the site in the areas of chemistry, analytical methods, microbiology and test method transfer. 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
- A. /B.S. Degree in Chemistry, Biochemistry, Microbiology or related field with significant experience
- Ten years of analytical chemical/microbiology laboratory and 5 years of management experience
- Pharmaceutical laboratory experience in analytical methods development and validation area is expected
- 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
- Has experience with manufacturing parenteral products
- Has experience in QA/QC
Responsibilities
- Prepares resource analysis for the execution of projects; Prepares and manages the Department operational budget
- Establishes and maintains effective cross functional relationships; Provides necessary support to other Departments
- Provides leadership in the training program of laboratory staff; Evaluates subordinates through reviews and periodic discussions; Recommends future development objectives; Fosters teamwork, customer service and cross-functionality
- Prepares/reviews/approves departmental documentation (i.e. SOPs, Analytical Method Transfer protocols)
- Assures that departmental SOPs are followed and are compliant with current Good Manufacturing Practices (cGMP) and Company policies; Operates the laboratories in a safe and hazard-free manner
- Leads the routine Quality Control release testing laboratories to ensure testing is completed on time in a compliant manner
- Leads the corporate Stability laboratory to ensure products meet their BUD and with establishing BUD for new products
- Applies fundamental knowledge of Analytical Chemistry and advanced technologies in analysis, interpretation and understanding of test results, for both qualitative and quantitative analyses
- Provides expertise and assists in writing investigation reports for Laboratory investigation, Operations investigations, and Cross-functional investigations
- Recommends or makes changes to tests, assays and specifications to ensure reliability, accuracy and their adequacy for the monitoring of product quality
- Provides customer support as needed
Benefits
- Set, full-time, consistent work schedule
- Comprehensive health and wellness benefits including medical, dental and vision
- 401k retirement program with company match
- 20 + 5 PLP paid 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Associate degree
