POSITION SUMMARY:  

Provide leadership, technical support and analysis to the manufacturing operation on FDA regulatory compliance and current Good Manufacturing Practices (cGMP).

ESSENTIAL DUTIES AND RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skills, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function in accordance with applicable law:

• Evaluate existing systems and controls against cGMP and other regulatory requirements.
• Prepare and execute technical support documents including standard operating procedures [SOP'S], change control documentation, evaluate validation protocols
• Maintain high level of regulatory awareness and compliance across manufacturing. Define and execute technical project plans.
• Analyze data from product requirements and processes
• Participate in presentations to internal & external audiences on assigned projects.
• Participate on continuous improvement, new product and task force teams.
• Write technical report summaries.
• Interpret regulatory and cGMP requirements and institute plans to comply with requirements.
• Interpret data to determine trends or shifts in compliance
• Execute and review audit reports and corrective action plans along with records and reports.
• Review protocols, SOPs & work instruction documents for compliance.
• Assess document change control programs.
• Maintain understanding of regulations & cGMP among CM operational areas.
• Work across organizations to gather and assess information
• Support FDA and Canada Health Audits.
• Other duties as assigned

REQUIRED EDUCATION/EXPERIENCE:

• Bachelor degree in technical field (i.e. Chemistry, Engineering, Biology preferred)
• At least 2 years’ experience in a quality and/or manufacturing environment
• Ability to self-manage work load and work on team projects
• Excellent organizational, analytical, and problem solving skills required
• Excellent oral, written and interpersonal skills necessary
• Experience in a GMP and FDA regulated environment is necessary
• Auditing experience a plus

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with applicable law:

The working environment includes both office and plant floor settings. Exposure to industrial noise, forklift traffic, noise, wet floors, odors, fumes, moving mechanical parts, and temperature fluctuations and extremes in operating areas of the plant. Specified PPE required in operational areas