Position Description

Position Summary

This position is responsible for assuring the GMP compliance of the organization for clinical supplies preparation.  The primary focus of this position is pre-approval of batch records.

Position Reports to:

QA Manager, Documentation Control

Position Supervises:

None

Essential Duties and Responsibilities

The essential functions include, but are not limited to the following:

• Maintain work area in accordance with GMPs

• Approve proposal-related documentation created by Project Managers, including:

• unexecuted batch records
• packaging samples
• material specifications
• label print batch records
• batch record change controls
• and other documents, as needed
• Verify client approval of proposal-related documents that have been previously reviewed and approved
• Assure control of documentation
• May assist in the generation, revision or review of standard operating procedures, data collection forms and work instructions
• Enter and verify data in the Inventory Control System (ICS)
• Create and revise documents in ZenQMS
• Participate in client audits as necessary
• Serve as a backup for QA Associate, Batch Record Auditor
• Serve as a backup for QC Associate, Batch Record Inspector
• Perform other work-related duties as assigned

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor’s degree or equivalent work experience
• Excellent interpersonal skills

• Excellent reading and writing skills
• Excellent communication skills
• English literacy
• Excellent mathematical skills

• Excellent time management skills

• Computer literacy skills
• Attention to detail
• Familiarity with cGMPs
• Familiarity with the pharmaceutical industry

• Previous successful Packaging Room Supervisor experience

 Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.  Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.  While performing the duties of this job, the employee is regularly required to talk or hear.  The employee frequently is required to sit.  While performing the duties of this job, the employee is exposed to warehouse, operations and office environments including occasional exposure to elements such as odor, noise, dust, heat, cold or chemicals.  The noise level in the work environment is usually moderate.

Note

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position.  Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.  All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities.  To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently.  Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others.  The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.  This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.