drjobs Associate II QA Manufacturing Support SunDay Shift Contract

Associate II QA Manufacturing Support SunDay Shift Contract

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1 Vacancy
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Job Location drjobs

Danbury, CT - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

MannKind
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 drypowder 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.
Job 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 workinprocess finished product as applicable.
The shift is Sun/Day: Sunday Monday Tuesday and Every Other Wednesday from 6am to 6:30pm. Plus enjoy a 5 Shift Differential!
**CONTRACT to HIRE!**
Essential Duties:
  • Identify communicate and escalate basic technical issues. Identify options for resolutions and lead implementation of corrective actions.
  • Prioritize own work and works independently on daytoday 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 BR.
  • 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.
Minimum qualifications:
  • HS/GED with 23 years experience in a scientific or technical discipline or BA/BS degree in a scientific or technical discipline with 12 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 problemsolve 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 degown (including the use of a decontamination fogging shower) in up to three layers of clean room and potent compound facility gowning (i.e. Tyvekjumpsuit).
  • THIS IS A CONTRACT TO HIRE ROLE!


Required Experience:

IC

Employment Type

Part-Time

Company Industry

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