Category

Description

ROLE RESPONSIBILITIES

• Perform necessary assessments of Aseptic and Terminal Sterilized SVP Filling operation and update necessary documents.
• Able to present sanitation programs to auditors.
• Accumulates key metrics for presentation to Management team, including gowning and aseptic technique observation.
• Responsible for maintaining working knowledge of Current Good Manufacturing Practices (cGMPs) and emerging regulatory and compliance concerns as related to aseptic manufacturing.
• Perform audits of sanitation, aseptic techniques, clean room behaviors, and gowning.
• Write investigations and implement Corrective Action/Preventative Action (CAPAs)
• Generate change controls for procedure updates.
• Perform daily room check inspections in the manufacturing areas.
• Provide support to aseptic process simulations (media fills).
• Supervise team of direct reports and conduct performance evaluations.

BASIC QUALIFICATIONS

• Requires Bachelor's Degree in a technical or science field.
• 2 years of supervisory experience preferred.
• Knowledge/experience in aseptic technique.
• Requires strong oral, written, communication, presentation and interpersonal skills.
• Requires thorough knowledge of GMP's and ability to handle multiple projects.
• Requires strong/effective leadership ability.

PREFERRED QUALIFICATIONS

• Pharmaceutical manufacturing experience

PHYSICAL/MENTAL REQUIREMENTS

Must be able to function in stressful situations while being able to remain focused on the necessary requirements. Must be able to appropriately identify and escalate issues in a timely manner.

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