What are the responsibilities and job description for the Supervisor, Quality Control position at MannKind Corporation?
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. With the recent acquisition of ScPharmaceuticals, MannKind has expanded into the cardiometabolic space, adding FUROSCIX® to its portfolio and reinforcing its commitment to innovative, patient-centric solutions across chronic and complex conditions.
Job Summary
Develops, implements and maintains the activities of quality control systems. Oversees methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products. Contributes information to help develop budgets. Makes recommendations for corrective action necessary to assure conformity with quality specifications. Assures finished products conform to government and company standards and satisfies GMP regulations.
Essential Duties And Responsibilities
Job Summary
Develops, implements and maintains the activities of quality control systems. Oversees methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products. Contributes information to help develop budgets. Makes recommendations for corrective action necessary to assure conformity with quality specifications. Assures finished products conform to government and company standards and satisfies GMP regulations.
Essential Duties And Responsibilities
- Provide general or direct supervision to exempt employees and/or skilled nonexempt employees
- Act as advisor to unit or sub-units, becomes actively involved as required to meet schedules or resolve problems
- Provides supervision on the floor enforcing compliance data integrity, SOPs, specifications, methods, USP, and cGMP through real time verifications of records, logbook, chromatograms, sequences, etc.
- In-depth experience with OOS/OOT investigations, root cause analysis, and CAPA implementation.
- Comprehensive understanding of 21 CFR Parts 210 & 211 and their application in a GMP-regulated environment.
- Advanced troubleshooting skills for HPLC, GC, PSD, and other chemical analysis techniques.
- Knowledge of USP General Chapters, system suitability, and instrument qualification.
- Experience with method validations, verifications, and transfers in compliance with USP and ICH guidelines.
- Ability to critically review analytical data for anomalies and trends, ensuring compliance with SOPs, specifications, and cGMP requirements.
- Helps analysts by trouble shooting methods, instrumentation and execution of the tests.
- Schedules testing/review of raw materials, in-process, finished product, and stability samples, complaint samples, samples from process and cleaning validation activities
- Exercise judgment within defined procedures and policies to determine appropriate action. Critically review data for anomalies or trends and approve data
- Lead and approve investigations of suspect or out of specification results. Ensures implementation of CAPA.
- May perform bench analysis, as needed
- Frequently interacts with subordinates, outside customers, and functional peer groups at various management levels
- Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects/schedules, etc. Contributes to cross functional projects with significant impact to company
- Responsible for observing all Company, Health, Safety and Environmental guidelines
- Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary
- BS degree in a scientific discipline with 5 years’ experience or MS with 3 years of experience or a combination of experience and training
- Experience with HPLC is required
- Empower software experience is required
- Proficiency in MS Word, Excel, and PowerPoint
- Strong interpersonal and organizational skills
- Supervisory experience
Salary : $77,600 - $116,400