About MannKind
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 a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life. Please visit mannkindcorp.com to learn more.
Position Summary:
Ensure processes and products conform to established company and regulatory standards. Review, analyze, and report on quality discrepancies related to manufacturing and testing of products and company systems. Investigate problems and recommend dispositions and corrective actions for recurring discrepancies. Use predetermined methods, operations, and procedures to inspect and test raw materials, work-in-process, and finished products as applicable.
Essential Duties and Job Functions:
- Work with minimal direction and be responsible for training junior associates.
- Provide solutions to relatively complex problems with significant independence.
- Identify, communicate, and escalate basic technical issues.
- Identify options for resolutions and lead implementation of corrective actions.
- Prioritize own work and work independently on day-to-day activities, with additional supervision for new assignments.
- Understand calibration requirements.
- Understand Fill/Pack, Bulk, and Kitting equipment/processes.
- Serve as a point of contact on the manufacturing floor as needed.
- Review Master Batch Records for compliance, identify issues, and suggest resolutions.
- Review executed batch records and perform real-time remediation to prevent deviations.
- Verify entries occur in real-time in batch records.
- Perform QA activities in the batch record.
- Perform QC/Retain sampling for each batch.
- Observe procedural compliance of staff and the flow of materials and personnel.
- Identify, communicate, and escalate compliance issues, and suggest resolutions.
- Review all operations for the batch to ensure they were performed according to the Batch Record.
- Participate in deviation events and investigations related to the batch.
- Author or revise controlled documents using the change management system.
- Perform data entry and record execution in electronic systems.
- Perform other duties as necessary.
- Observe all Company, Health, Safety, and Environmental guidelines.
- Maintain flexibility to cover different shifts as needed.
Knowledge, Experience, and Skills:
- HS/GED with 10-12 years experience in a scientific or technical discipline, or BA/BS degree with 4-6 years related experience, preferably in the pharmaceutical industry.
- Knowledge of GxP Compliance and ISO standards.
- Ability to work autonomously and demonstrate excellent analytical skills.
- Excellent written and verbal communication skills.
- Physical ability to perform required tasks.
- Willingness and ability to receive medical clearance to wear a respirator.
- Ability to gown and de-gown in clean room and potent compound facilities.
#J-18808-Ljbffr