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Job Location drjobs

Saint Louis - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Job Title: Quality Engineer Stability Program (Temporary)

Job Location: Saint Louis MO

Job Type: Contract (6months with chance of converting to fulltime)

Summary: We are looking for a temporary Quality Engineer focused on supporting the Stability Program. This role ensures the programs compliance with U.S. and international pharmaceutical manufacturing standards focusing on packaging storage and timely delivery of stability materials to prevent delays in testing processes. Additionally the position involves updating departmental procedures and developing solutions to enhance departmental efficiency.

Key Responsibilities:

  • Manage and maintain stability samples in accordance with ICH FDA DEA and cGMP guidelines.
  • Handle the packaging and delivery of stability samples at defined intervals and according to study requirements.
  • Maintain controlled substance inventory in line with DEA regulations.
  • Collaborate with the LIMS team to ensure functionality and accuracy of stability data in the system.
  • Oversee the packaging labeling and storage of stability samples to meet study requirements.

Additional Duties:

  • Assist with packaging and sample pulls as needed to support stability operations.

Minimum Qualifications:

  • Education: Some college or technical credits required.
  • Experience: At least 1 year in quality programs with familiarity in pharmaceutical regulations including GXP GLP or GMP.

Preferred Skills:

  • Strong communication skills and ability to work in a team environment.
  • Proficient in stability chamber and laboratory equipment use.
  • Basic understanding of statistics and data interpretation (graphs).
  • Knowledge of ELN LIMS Excel and MiniTab is advantageous.

Core Competencies:

  • Dealing with ambiguity decision quality technical skills integrity and customer focus.

Work Environment:

  • Split between laboratory exposure handling various products and chemicals and office work involving computer use.

This role involves close collaboration with internal departments such as QC QA Validation and APIDs to ensure efficient and compliant stability operations.

QA

Employment Type

Full Time

Company Industry

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