Position Summary
This position is responsible for assuring overall cGMP compliance with all procedures affiliated with holding, staging, and distributing clinical supplies to sites. The primary focus of the role will be inspection and verification.
Position Reports to:
Distribution Warehouse Manager
Position Supervises:
Distribution Warehouse Associates
Essential Duties and Responsibilities
The essential functions include, but are not limited to the following:
- Supervise daily activities of Distribution Warehouse Associates, including work prioritization and task assignment
- Responsible for compliance with internal SOPs and cGMPs.
- Responsible for verifying compliance with shipping regulations relating to process documentation and handling of pharmaceutical products.
- Ensure all associates maintain current training records and compliance readiness
- Reinforce a culture of inspection readiness and audit preparedness
- Responsible for inspection of staged materials and verifying related documentation.
- Maintains inventory of finished product warehouse.
- Promote safe handling of materials, equipment, and environmental conditions
- Monitor employee performance and provide ongoing coaching, feedback, and developmen
- Maintains an inventory log of packing supplies and notifies key personnel when packing supplies need re-ordering
- Immediately notifies Operations and Quality management groups of any discrepancies related to shipment and/or status of drug product.
- Act as liaison with Distribution Warehouse Manager and Distribution Project Managers in determining and maintaining inventory levels and expiration dates of products including finished goods as well as components.
- Maintains warehouse storage of product according to cGMP compliance procedures.
- Collaborate with QA on root cause analysis and corrective actions (CAPA)
- Participate in continuous improvement initiatives
- Enters data into ICS system as it pertains to the shipment of clinical materials.
- Maintains work area and related warehouse and dock areas in a clean and orderly fashion and in accordance with SOPs and cGMPs.
- Responsible for daily operational reporting to the Distribution Warehouse Manager
- Other duties as assigned.
Minimum Qualifications (Knowledge, Skills, and Abilities)
- High school diploma or GED or equivalent work experience
- Must have working knowledge of department practices
- Excellent interpersonal skills
- Excellent reading and writing skills
- Excellent communication skills
- English literacy
- Excellent mathematical skills
- Computer literacy skills
- Attention to detail
- Knowledge of cGMPs
- Familiarity with the pharmaceutical industry
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 is required to sit; stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 15 pounds and occasionally lift and/or move up to 30 pounds. While performing the duties of this job, the employee is exposed to warehouse and operations (packaging) environments including regular 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.
Pay: $51,000.00 - $62,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Work Location: In person
