Apply on Employer Site

Leiters Health · 6 hours ago

Quality Control Manager

Denver Metropolitan Area

Full-time

Onsite

Senior Level

5+ years exp

Leiters Health is a pioneering pharmaceutical company dedicated to delivering high-quality compounded sterile products. The Quality Control Manager is responsible for ensuring the safety, identity, strength, quality, and purity of medications produced, while managing QC activities and collaborating with various teams to maintain compliance with cGMP regulations.

Health CarePharmaceutical

H1B Sponsor Likely

Responsibilities

Lead and manage employees who are responsible for all quality control activities in a 503B facility, ensuring the required initial and continuing training of personnel is accurate or adapted according to need

Develop and maintain and ensure adherence to an appropriate staffing model to ensure that the QC unit is appropriately staffed to meet the demands of the business in an efficient and comprehensive manner based on the Company’s strategy, goals and objectives

Evaluate completed formulation records and other relevant information to ensure procedures were followed, product tests performed appropriately, and acceptance criteria met

Review sampling instructions, specifications, test methods, quality control procedures, and standard operating procedures for intended use

Approve and monitor analyses carried out under contract through 3 rd party private laboratories

Monitor the maintenance of the department(s) premises, processes and equipment

Ensure that the appropriate validations, including those of analytical procedures, and calibration of control equipment are completed and current

Investigate reprocessing/rework of products, complaints, analytical failures, deviations and OOS

Achieves quality operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change

Meets quality financial objectives by estimating requirements; assisting in the preparation of an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions

Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality control procedures

Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations

Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations

Interact effectively with the Leadership Team and contribute to the continued growth and success of the Company through innovative thinking, planning, and implementation of new concepts, products and services

Professionally represent Company, including all relevant conferences and new customer segments

Work with a team to ensure that the systems involved in a 503B outsourcing facility are in a state of control

Other duties as assigned

Responsible for managing and leading all Quality Control Associates, providing direction, support, and developmental opportunities while ensuring compliance with cGMP requirements

Conduct regular performance reviews, provide constructive feedback, and implement performance improvement plans as needed

Provide a positive and collaborative work environment, addressing and resolving conflict promptly and fairly

Qualification

CGMP regulationsQuality assurance/controlFDA-regulated environmentAnalytical skillsCompounding techniquesMicrosoft WordMicrosoft ExcelCommunication skillsProblem solvingTeam playerAttention to detail

Required

Minimum of 5 years of experience working in an FDA-regulated environment, minimum of 3 years of management experience

Strategic and analytical thinker, with the ability to examine details and interpret the impact of key business drivers or potential adverse issues

Demonstrated knowledge and experience with US FDA cGMP, preferably in a commercial compounding outsourcing facility

Superior problem solving and decision-making skills

Team player with the ability to build relationships and work collaboratively across lines of senior leadership and other team members as appropriate

Knowledge of compounding techniques, controlled environments, and appropriate materials and conditions

Highest level of integrity and good judgement, with the ability to effectively deal with highly sensitive, confidential information

Demonstrated commitment to sound business ethics and corporate responsibility

Excellent organization as well as oral and written communication and documentation skills

Detail oriented

BS or BA degree required (in a scientific discipline desired)

Experience in a cGMP environment in manufacturing/laboratories with a preference for sterile compounding

Computer skills, including Microsoft Word and Excel

Able to lift up to 20 lbs and stand for up to two hours when required

Benefits

Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)

Flexible Spending & Health Savings Accounts (FSA & HSA) available

Dental & Vision insurance

Employer Paid Life Insurance & Employee Assistance Program

Short Term & Long-Term Disability Insurance

Up to 4% 401K Matching (100% vested on day one!)

Generous Paid Time Off Options – vacation, sick , paid leave and holidays!

$5,250 Annual Tuition Reimbursement after 6 months

$1,000 Referral Bonus Program with no limit

Eligible for annual bonus program

Company

Leiters Health

Leiters Health is a trusted FDA-registered 503B outsourcing provider of high-quality compounded sterile preparations and pharmacy services.

Founded in 1926

Englewood, Colorado, USA

201-500 employees

https://leiters.com/

H1B Sponsorship

Leiters Health has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2024 (1)