Overview
QA Analyst III Jobs in United States at CentralSquare Technologies
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.
Summary:
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 called Sunday/Day shift: Every Sunday, Monday, Tuesday and every other Wednesday from 6am to 6:30pm. Add a 5% Shift Differential.
Job Responsibilities:
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
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Job Qualifications:
HS/GED with 6-8 years’ experience in a scientific or technical discipline or BA/BS degree in a scientific or technical discipline with 4-6 years or MS/MBA degree with 2-4 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).
(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA, ISO 13485, European requirements, etc.)
Title: QA Analyst III
Company: CentralSquare Technologies
Location: United States
