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SalaryAt 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
Executes quality and manufacturing procedures in order to meet production demands and regulatory requirements. Responsibilities include on-time manufacture of intermediate, semi-finished and finished pharmaceutical products that meet quality standards. Assists with establishing equipment operating specifications, standard operating procedures and improving manufacturing techniques. Assists with equipment maintenance, calibration and resolving technical issues. May review existing manufacturing operational processes and procedures and provide technical expertise in order to improve production efficiencies. This is evening shift, Monday - Friday from 2:30 pm – 11:00 pm and includes 10% shift differential.
Essential duties and key job responsibilities and essential functions.
- Works on assignments where considerable judgment and initiative are required in resolving problems and making recommendations. Exercises independent judgment evaluating criteria for obtaining results.
- May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
- Executes manufacturing operations as required by Manufacturing Records according to Current Good Manufacturing Practices and Standard Operating Procedures in a clean room environment
- Operates manufacturing production equipment, under little supervision as required by Manufacturing Records and Standard Operating Procedures
- Performs manufacturing area and equipment setup, cleanup, teardown and sanitization with little supervision
- Performs in-process inspection and testing, under little supervision, as required by Manufacturing Records and Standard Operating Procedures
- Accurately and completely documents manufacturing activities in appropriate Manufacturing Records, Controlled Forms, Product Container Labels and Logbooks
- Verifies and documents manufacturing steps performed by other Manufacturing Associates as correct in Manufacturing Records and / or Logbooks
- Responsible for observing all Company, Health, Safety and Environmental guidelines
- Fully qualified and able to operate approximately 75% of manufacturing area equipment.
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties; physical requirements for job if any.
- High School diploma/GED with minimum of 3 - 5 years related experience or the equivalent combination of experience and training.
- Experience writing and implementing SOPs in a GMP environment.
- Must be willing and able to receive medical clearance to wear a respirator (i.e., Powered Air Purifying Respirator) for entire working shift.
- Must be physically able to gown and de-gown (including the use of a decontamination fogging shower) in up to three layers of clean room and potent compound facility gowning (i.e., Tyvek® jumpsuit).
(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA, ISO 13485, European requirements, etc.)
