Supervisor, Quality Assurance Floor
Supervisor, Quality Assurance Floor
Posted on :
22-06-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
22-06-2025
Job Description
AboutMannKind
MannKind Corporationfocuses 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 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 learn more.
Position Summary:
Ensure processes and products conform to established company and regulatory standards. Reviews analyze and reports on quality discrepancies related to manufacturing and testing of product and company systems. Investigates problems and recommends disposition and corrective actions for recurring discrepancies. Uses predetermined methods operations and procedures to inspect and test raw materials work-in-process finished product as applicable.
Essential Duties and Job Functions:
Works with minimal direction and is responsible for the training of junior associates. Provides solutions to relatively complex problems and exercises significant latitude and independence. Identify communicate and escalate basic technical issues. Identify options for resolutions and lead implementation of corrective actions.
- Prioritize own work and works independently on day-to-day activities additional supervision/guidance for new assignments
- Basic understanding of calibration requirements
- Basic understanding of Fill/Pack Bulk and Kitting equipment / Process
- Point of contact on the manufacturing floor as needed
- Review Master Batch Records for compliance identify issues and suggest possible resolutions.
- Review executed batch records real time remediation to prevent deviation (e.g. GDP settings alarm response)
- Verify entries occur real time in batch records
- Perform QA activities in the batch record.
- Perform QC/Retain sampling for each batch
- General observations regarding procedural compliance of staff.
- Observe the gowning and flow of materials and people.
- Identify communicate and escalate compliance issues identify options for resolutions
- Review all operations for the batch were performed accordance with BR
- Participate in deviation events and investigations as required related to the batch
- Author or revise controlled documents using the change management system
- Perform data entry and execute records in electronic systems
- Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary
- Responsible for observing all Company Health Safety and Environmental guidelines
- Flexibility to cover different shifts when needed
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Knowledge Experience and Skills:
- HS/GED with 10-12 years experience in a scientific or technical discipline or BA/BS degree in a scientific or technical discipline with 4-6 years related experience preferably in the pharmaceutical industry or the combination equivalent of training and experience
- Knowledge of GxP Compliance and ISO standards
- Ability to work autonomously to problem-solve demonstrating excellent analytical skills
- Excellent written and verbal communication skills
- Physical Required
- 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)
Required Experience:
Manager
Employment Type
Full Time
Key Skills
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