A.B.S. Degree in Chemistry, Biochemistry, Microbiology, or related field with significant experience
Ten years of analytical chemical/microbiology laboratory experience
Five years of management experience
Pharmaceutical laboratory experience in analytical methods development and validation
Must be authorized to work in the U.S. on a full-time basis
Responsibilities
Manage day-to-day operations of Quality Control testing laboratories
Prepare and manage the departmental operational budget
Establish and maintain effective cross-functional relationships
Lead training programs for laboratory staff and evaluate their performance
Ensure compliance with cGMPs and company policies in laboratory operations
Oversee routine Quality Control release testing and corporate Stability laboratory
Provide technical expertise in analytical chemistry and assist in writing investigation reports
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
Career advancement opportunities in a national, high-growth company
Full Job Description
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.
This is an on-site role located in Bloomsbury, NJ with travel to Sugar Land, Texas.
What the Director, Quality Control Lab Does Each Day:
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
Our Most Successful Director, Quality Control Lab:
Has outstanding written and oral communication skills
Is excellent at organization of large volumes of data
Has experience in pharmaceutical manufacturing preferably sterile injectable
Manages multiple, parallel projects
Has Expert knowledge of regulatory requirements as they pertain to Human Drug Compounding and Pharmaceutical manufacturing
Minimum Requirements for this Role:
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
Any of the Following Will Give You an Edge:
Has experience with manufacturing parenteral products
Has experience in QA/QC
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
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
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: $163,764 - $255,881 Annually
This role is also eligible for an annual incentive bonus, subject to program terms and guidelines
About QuVa Pharma
QuVa Pharma is a pharmaceutical company that specializes in the production and distribution of sterile injectable drugs. The company's products are used in hospitals, clinics, and other healthcare facilities to treat a variety of conditions, including pain, infections, and cancer. QuVa Pharma's facilities are located in Texas and North Carolina, and the company has distribution centers throughout the United States. The company was founded in 2015 and is headquartered in Sugar Land, Texas.
