Gmp (Good Manufacturing Practice) Manager Sanford, Nc

TheGMP (Good Manufacturing Practice) Managerwill oversee contamination control and environmental cleaning compliance within ISO 8 and ISO 9 cleanrooms. Responsible for cleaning validation GMP documentation and comprehensive SOP reporting. Manage client relationships and ensure the delivery of high-quality clinical engineering services.

Key Responsibilities:

• Document contamination control workflows per GMP standards.
• Clean and disinfect cleanrooms labs controlled environments using validated methods
• Strictly follow Standard Operational Procedures (SOPs) Safety Rules (OSHA) and cGMP guidelines
• Log and signoff on all cleaning activities logs and checklists to satisfy audit and regulatory needs.
• Controls overhead expenses.
• Responsible for the attainment of financial goals.
• Reviews and analysis of financial statements with leadership weekly operating reports.
• Monitors future contract financial reviews and updates.
• Responsible for productivity and staffing that is appropriate to and divisional goals.
• Monitors period analysis and initiates action plans as necessary.
• Maintains and supports client satisfaction at a level that ensures account retention.
• Maintains an active stewardship program at multiple levels.
• Administers are required to conduct client/customer surveys (and other feedback instruments) and respond in a timely and effective manner.
• Promotes client awareness of program alternatives and the availability of corporate resources.
• Monitors and ensures compliance with the provisions of client contracts.
• Assists in customizing programs to meet account unique needs as required.
• Ensure accurate documentation compliance for cleanroom operations.

Preferred Qualifications:


Bachelors Degree or equivalent work experience required.
Minimum five years GMP environment experience in clinical high customer/client relationships.
Experience managing clinical engineering account.
Budgeting forecasting experience preferred.
Ability to communicate effectively in written format and oral presentations.
Ability to multitask and establish priorities.
Ability to maintain organization in a changing environment.
Exhibit initiative responsibility flexibility and leadership.
Possess a thorough knowledge of contract administration and office procedures.

Proficient in the use of Windows-based office software including but not limited to Microsoft Office Word Excel PowerPoint and Outlook