At MannKind, our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.
Job Summary
Develops, implements and maintains the activities of quality control systems. Oversees development and implementation of standards, 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 key job responsibilities and essential functions.
- 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 to data integrity, SOPs, specifications, methods, USP, and cGMP through real time verifications of records, logbook, chromatograms, sequences, etc.
- 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
As a member of the Quality organization at MannKind Corp. the incumbent is also expected to use quantitative reasoning; and to be professional, committed to excellence, customer focused, detail oriented, a communicator, and a team player.
(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA, ISO 13485/9001, European requirements, etc.)
Section III: Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties; physical requirements for job if any.
- BS degree in a scientific discipline with 5+ years' experience or MS with 3+ years of experience or a combination of experience and training
- Proficiency in MS Word, Excel, and PowerPoint
- Strong interpersonal and organizational skills
- Supervisory experience
As a member of the Quality organization at MannKind Corp. the incumbent is also expected to use quantitative reasoning; and to be professional, committed to excellence, customer focused, detail oriented, a communicator, and a team player.