Their scientific, technical and professional skills to develop products designedto protect life Review all documentation generated as each step is completed for accuracy of calculations / data entry and completeness of process signature ,…
Full Description :
Those who join feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
I: Job Summary
This position is responsible for the inspection and packaging of product. Will perform all aspects of Inspection and Packaging with the ability to assist in day to day operations.
II: Essential Functions
Demonstrate competency on assigned qualification blocks: Job specific Standard Operating Procedures
New Inspector Qualification
Execute and document procedural steps in compliance with cGMP standards.
Adhere to the procedures and safe practices for movement of product and materials and accurately complete all applicable documentation. This applies to room temperature and cold storage loctions.
Perform room clearances in accordance with relevant Standard Operating Procedures
Perform 100% visual inspection of product and classify rejected materials utilizing approved categories within required timelines (Qualification)
Successfully complete annual inspector re-qualification requirements
Manually package product in final packaging components while verifying that lot information, including lot number and expiration date, are accurate
Load and unload product from vial labeling machine during labeling process
Package product in final packaging components while verifying that lot information, including lot number and expiration date, are accurate
Maintain state of facility environmental control including: preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly and annual cleaning of manufacturing surfaces and equipment per Standard Operating Procedures
Review all documentation generated as each step is completed for accuracy of calculations / data entry and completeness of process signature steps
Stock gowning and consumable supplies in the controlled areas maintaining Just-In-Time inventory (JIT) control of manufacturing materials
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
HS Diploma or equivalent
0-2 years of relevant experience
Knowledge of cGMP and CFR requirements
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.
The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ’ approved agency list. Unsolicited resumes or candidate information submitted to by search/recruiting agencies not already on ’ approved agency list shall become the property of and if the candidate is subsequently hired by , shall not owe any fee to the submitting agency.