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Quva · 2 weeks ago

Director, Quality Control Lab

Bloomsbury, NJ

Full-time

Onsite

Director/Executive

$164K/yr - $225K/yr

10+ years exp

Quva is a leading provider of health-system pharmacy services and solutions. The Director, Quality Control Lab is responsible for overseeing the day-to-day operations of the Quality Control testing laboratories, ensuring compliance with cGMPs, and managing the department's short and long-term goals while leading and developing teams.

Health CareManufacturingMedicalMedical DevicePharmaceutical

Comp. & Benefits

No H1B

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

Qualification

Analytical ChemistryPharmaceutical manufacturingQuality Control testingManagement experienceMicrobiologyRegulatory requirementsCustomer supportCommunication skillsOrganizational skillsTeamwork

Required

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

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

Preferred

Has experience with manufacturing parenteral products

Has experience in QA/QC

Benefits

Comprehensive health and wellness benefits including medical, dental and vision

401k retirement program with company match

25 paid days off plus 8 paid holidays per year

Occasional weekend and overtime opportunities with advance notice

Company

Quva

Quva is a national, industry-leading provider of health-system pharmacy services and solutions, including 503B sterile injectable outsourcing and data software solutions that generate insights to help power the business of pharmacy.

Founded in 2015

Sugar Land, Texas, USA

1001-5000 employees