Under general direction of the Vice President, Operations, responsible for assisting in the management of the Operations and Distribution groups and assuring overall cGMP compliance. Oversees all procedures affiliated with receiving, storing, packaging, distributing, returns processing and disposition of clinical supplies.
This position is responsible for daily operational activities related to the execution of labeling and packaging batch records and the qualification and operation of packaging equipment.
Position Reports to:
Vice President of Operations
Packaging Room Supervisor
Packaging Room Associate
Essential Duties and Responsibilities
The essential functions include, but are not limited to the following:
Ensures that packaging room staff is properly trained in GMPs and Xerimis SOPs on an ongoing basis.
Ensures compliance with company standards and procedures.
Responsible for assignment of lab personnel to packaging rooms.
Oversees the staging and prioritizing of batch records into the labs.
Responsible for maintaining job flow within the labs and tracking job progress to assure priorities and timeline are met.
Collaborates with Project Management, Distribution, and Quality Assurance personnel to ensure packaging timelines are met.
Investigates Non-Compliant Events and completes reports.
Communication with Distribution to ensure supplies are packaged in the appropriate size containers for transport.
Provides support training in packaging rooms on an ongoing basis.
Develops and updates training courses in Zen QMS as required.
Resolves training deficiencies.
Re-trains all individuals that require re-training due to corrective action discrepancies.
Verifies the completion of performance qualifications performed on packaging equipment.
Performs performance qualifications where required.
Assists with the creation and revision of Standard Operating Procedures.
Facilitates the cycling of lab coats with approved cleaning vendor.
Responsible for maintaining adequate supply of packaging room materials (for gowning, cleaning, etc.) and ordering additional supplies when necessary.
Completes performance reviews.
Communicates packaging room status as well as personnel concerns with Vice President of Operations on a routine basis.
Other duties as assigned
Minimum Qualifications (Knowledge, Skills, and Abilities)
Bachelors degree or equivalent work experience
Successful training as a packaging room supervisor
Excellent interpersonal skills
Excellent reading and writing skills
Excellent communication skills
Familiarity with 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. 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.
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.
Job Type: Full-time
Employee assistance program
Health savings account
Paid time off
8 hour shift
Monday to Friday
Work Location: One location