Specialist I, QA Floor (2nd Shift, M-F) Contract to Hire

Position:Specialist I, QA Floor (2nd Shift, M-F) Contract to Hire

Location: Danbury, CT

Mann Kind 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.

Ensures processes and products conform to established company and regulatory standards. Reviews, analyzes 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.
This is a 2nd Shift position. Hours are from 2:00pm to 10:30pm.

• 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.
• Point of contact on the manufacturing floor as needed
• Review executed batch records – real time remediation to prevent deviation (e.g., GDP, settings, alarm response)
• Perform QA activities in the batch record.
• Verify entries occur real time in batch records
• Perform QC/Retain sampling for each batch
• General observations regarding procedural compliance of staff.
• Observe the gowning and flow of materials and people.
• Review all operations for the batch were performed accordance with  .
• Identify, communicate and escalate compliance issues, identify options for resolutions
• Perform data entry and execute records in electronic systems.
• 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.
• HS/GED with 2-3 years’ experience in a scientific or technical discipline or BA/BS degree in a scientific or technical discipline with 1-2 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).

With the spread of the coronavirus, many individuals are concerned about access to their medication supply. At this time, Mann Kind does not anticipate that the supply of its inhalable insulin Afrezza (insulin human) Inhalation Powder will be affected by the coronavirus.

We will continue to closely monitor our supply chain for potential impact to the supply of Afrezza. Mann Kind sources critical raw materials from suppliers in the United States and Europe and we remain in close communication with key suppliers to assure a reliable supply of insulin.

Our US manufacturing facility is fully operational and we are taking a number of steps to prevent any impact to our supplies. Afrezza is still readily available in U.S. pharmacies, and if needed, pharmacies can order additional supplies from wholesalers with expected delivery within 1-2 days. As the global situation evolves, we will continue to take the necessary steps to safeguard the reliable supply of Afrezza.