II.            STATEMENT OF PURPOSE

Responsible for performance of Batch Record Review and Disposition function for LCI.  Within that function, assure compliance with laws and regulations and in a manner consistent with best practices and applicable guidance.

Responsible for performing and managing activities related to GMP document review and disposition of commercial products. This includes related activities at third-party contractors including the oversight of validation, change control, investigations and CAPA activities related to LCI products.

III.            RESPONSIBILITY FOR WORK OF OTHERS

Yes.

IV.            BUSINESS COMMUNICATION

Excellent communication skills required and must be computer literate. Ability to effectively communicate with all levels of employees and external business associates, comfortable creating and delivering presentations.

V.            SUPERVISION REQUIRED

Limited supervision.

VI.            EDUCATION REQUIRED

Bachelor’s Degree in a life science-related discipline or equivalent work experience.

VII.            TRAINING AND SPECIALIZED KNOWLEDGE REQUIRED

• Knowledge of pharmaceutical industry regulatory requirements.
• High level of familiarity with practices needed to maintain compliance in the areas of batch record review, disposition, and validation and an ability to assess risk and develop solutions.
• Ability to exercise strong risk-based business judgment.
• Ability to collaboratively with a high sense of teamwork across diverse functions, operate independently and build strong networks throughout the corporate organization.
• Demonstrated ability to work with high integrity and an unwavering commitment to our corporate value of Quality.
• Works in a transparent and open manner in all aspects of the role and in all aspects of managing partnerships and relationships both internally and externally
• Good investigation and monitoring skills.
• Current knowledge of QC testing methods.
• Attention to detail and implementation of good documentation and GMP processes is essential.

VIII.            EXPERIENCE REQUIRED

Minimum of 3 years of GMP quality assurance experience, including hands-on experience in Quality Operations, batch record review, disposition, and/or validation. Experience in working with third-party contract manufacturers, laboratories, and packagers.

 IX.            TRAVEL REQUIRED

Minimal.

X.            SPECIFIC DUTIES AND RESPONSIBILITIES

• Batch Review and disposition:
  • Act as primary point of contact with third-party contract manufacturers, laboratories, suppliers, etc. to coordinate completion of all third-party records (deviations, CAPA, Change Controls, Complaints, Validation, QC test results, etc.) associated with release of LCI batches.
  • Review and approve Master Batch Records.
  • Perform the review of records and determine disposition of:
    • Bulk Drug Substance and related materials.
    • Bulk Drug Product and related materials.
    • Packaged/Labeled Drug Product.
    • Clinical Product
    • Investigations and CAPAs.
  • Perform the review of Testing Specifications.
• Validation
  • Coordinate and monitor validation activities.
• Provide support during regulatory inspections of GMP Contractors and LCI facilities.
• Assist in performing inspection readiness activities.
• Review Quality Agreements.
• Maintain current understanding of laws & regulations applicable to the pharmaceutical/biotechnology industry.
• Provide updates to Manager, BioMed Operations.

XI.            PHYSICAL DEMANDS

While performing the duties of this job, the employee is in a moderate office environment. The employee is regularly required to sit; stand; walk and use hands.

XII.            WORK ENVIRONMENT

The noise level in the work environment is usually moderate. When in the Manufacturing area, hearing protection may be required depending on the department.

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.