Quality Control Manager
This description is intended to be illustrative of the major duties performed by the employee assigned to this position. Performs other duties as assigned.
This position reports to the Senior Director of Quality. The Quality Control (QC) Manager is responsible for the assurance that medications produced by Leiters Health has the safety, identity, strength, quality and purity represented. The candidate must possess a keen understanding of cGMP regulations and have experience managing personnel to these standards. The position evaluates, tracks, trends and monitors QC activities This role requires close collaboration with site teams, corporate leadership and external regulatory bodies to ensure adherence to cGMP. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality assurance/control, attention to detail, and excellent communication with other functional areas and sites.
Why Join Leiters Health?
Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team!
At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.
- Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
- Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.
- Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
- Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
- Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.
Who We're Looking For:
We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today!
Essential Functions:
Responsible for drug preparation and supporting activities including:
- 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 3rd 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.
Supervisory Responsibilities:
- 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.
Experience and Necessary Skills:
- 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:
- 100% employer paid medical plan.
- Dental & Vision insurance options including FSA & HSA
- 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
Timeline: We will be accepting applications on an ongoing basis until position is filled.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.
