Job description

Job Description:

• This individual will execute routine QA responsibilities to support daily Operations / business targets by releasing products and resolving quality issues to ensure product quality, patient safety, site safety and site compliance.
• The individual will actively develop and improve quality system processes, and quality performance at the local, regional, and global level.
• Ensuring site operations, equipment, processes and product comply with local, regional, and corporate procedures.
• Collecting, analyzing and reporting site Quality System metrics for the site leadership team to ensure effective Quality System monitoring.
• Confirming technical quality and compliance for Validation, Facilities, Change Control, Investigations, Operations to ensure technically- and scientifically-sound, and GMP-compliant technical decisions and documentation.

Minimum Requirements:

• BS Degree in Chemistry-, Microbiology-, or Engineering- or Science/Pharmaceutical field.
• 10 years’ experience in pharmaceutical GMP commercial operations
• 5+ years direct experience in implementing or managing pharmaceutical / biologics GMP commercial quality management systems and processes
• Solid and broad understanding of key pharmaceutical GMP Quality Systems (e.g. Risk management, change control, facilities/equipment)
• Professional Certifications in Compliance, Quality Management, Quality Engineering, or Lean Six Sigma.

Job Type: Contract

Salary: $45.00 - $50.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Shepherdsville, KY 40165: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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