The Supervisor – Manages activities to ensure that the company’s labeling process remains in compliance with FDA, other regulatory and customer requirements. Label Control will manage the receiving, inspection, releasing, storage, inventory, and issuance of labeling in accordance with Current Good Manufacturing Practices (GMPs).
- Oversee the Label Control function and staff to ensure the labeling requirements for Packaging are met in a timely and efficient manner
- Manage, plan, release and issue orders for the Labeling Administrators
- Review labeling release documents for accuracy
- QA release labeling utilizing the electronic inventory management system.
- Review change controls for new and revised Labeling.
- Maintain Standard Operating Procedures
- Approve Labeling Master Files
- Plan labeling shipments to affiliates
- Order labeling from suppliers (blank labels) to maintain inventory levels for use in production
- Prepare Labeling Investigation Reports
- Provide labeling to the Packaging Department and meet packaging scheduling requirements.
- Maintain databases for label printing equipment
- Approve labeling master files; acquire applicable signatures.
- Maintain Labeling Master Files (i.e., retire labeling master files when no longer approved for use).
- Maintain daily employee attendance and time keeping records utilizing timekeeping system.
- Prepare labeling investigation reports utilizing the electronic system.
- Manage Label Control personnel to ensure all tasks are completed accurately, timely and in compliance with procedures and GMPs.
- Develop staff to meet their personal objectives and the business needs of the company.
- Assists Compliance Auditors in the inspections of Labeling Suppliers for adherence to GMP production of printed materials.
- Evaluates equipment and processes to support GMP compliance within the department.
- Must participate and successfully complete all training as required by the company.
- Other duties may be assigned.
Bachelor’s degree and 4+ years related supervisory experience or equivalent combination of education, training, and experience.
Knowledge and Skills
Thorough knowledge of cGMP’s and SOPs. Must possess excellent communication, time management, organizational, and interpersonal skills. Proficient in Microsoft Office applications (Word, Excel, Outlook) and business related application packages highly desired, plus the ability to learn company used applications.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to handle or feel; reach with hands and arms and talk or hear. The employee is occasionally required to stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job manufacturing environment.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.