Compliance Investigator III – cGMP (Onsite)

Catalent Pharma Solutions

Kansas City (KS)

On-site

USD 65,000 - 85,000

Full time

11 days ago
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Benefits offered by this job

Career growth
Paid time off
8 holidays
Benefits from day one

Job summary

Catalent is seeking a Compliance Specialist III for its Kansas City facility to lead investigations and ensure adherence to regulatory standards across cGMP operations. You will work with cross-functional teams to identify and resolve compliance gaps, maintaining high-quality documentation.

This full-time, onsite role runs Monday–Friday, 1pm–9pm in Kansas City, MO, with emphasis on deviation management, trend monitoring, and continuous improvement of manufacturing records and procedures.

Qualifications

  • Bachelor’s degree or equivalent in a regulated industry, or a high school diploma with 5+ years of related experience.
  • Proficiency in Microsoft Word and Excel with strong computer skills.
  • Well organized, capable of multitasking and meeting deadlines with attention to detail.

Responsibilities

  • Lead deviation and investigations using root cause analysis methods.
  • Lead cross-functional teams and meetings to address compliance gaps.
  • Monitor compliance trends and identify gaps in processes.
  • Assist with review of technical reports supporting cGMP operations.
  • Collaborate with cGMP units to resolve record inconsistencies.
  • Recommend batch record changes for continuous improvement per SOPs.
  • Assist in writing SOPs for equipment and instruments used in operations.
  • Maintain high-quality manufacturing documentation per regulatory guidance.
  • Participate in assigned improvement projects and training requirements.
  • Perform other duties and special projects as assigned.

Skills

Attention to detail
Strong computer skills
MS Word
MS Excel

Education

Bachelor’s Degree or equivalent in a regulated industry
High School diploma with 5+ years in a regulated industry

Job description

Catalent is seeking a Compliance Specialist III for its Kansas City facility to lead investigations and ensure adherence to regulatory standards across cGMP operations. You will work with cross-functional teams to identify and resolve compliance gaps, maintaining high-quality documentation.

This full-time, onsite role runs Monday–Friday, 1pm–9pm in Kansas City, MO, with emphasis on deviation management, trend monitoring, and continuous improvement of manufacturing records and procedures.

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