At MannKind our employees are our number one asset and we continue becoming a tightknit community where each of us plays a critical role in our collective 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 family summary:
Executes quality and manufacturing procedures in order to meet production demands and regulatory requirements. Responsibilities include ontime manufacture of intermediate semifinished 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.Hours: Sunday Monday Tuesday and Every Other Wednesday 6:00 am to 6:30 pm. Essential duties and key job responsibilities and essential functions.
- Works on assignments that are semiroutine in nature where some judgment is required in resolving problems and making routine recommendations
- Exercises some judgment within defined practices and policies in evaluating criteria for obtaining results
- May provide guidance on assignments to other lowerlevel personnel
- Execute manufacturing operations as required by Manufacturing Records according to Current Good Manufacturing Practices and Standard Operating Procedures in a clean room environment
- Perform manufacturing equipment disassembly and cleaning with supervision
- Ability to assemble manufacturing production equipment maintaining high tolerances with supervision
- Perform clean room sanitization with supervision
- Operates manufacturing production equipment under supervision as required by Manufacturing Records and Standard Operating Procedures
- Performs inprocess inspection and testing under 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 50% of manufacturing equipment
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
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.
- High School/GED with minimum of 0 3 years related experience or the equivalent combination of experience and training.
- Must be willing and able to receive medical clearance to wear a respirator ( Air Purifying Respirator) for entire working shift.
- Must be physically able to gown and degown (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.)
| Required Experience:
IC