Packaging Label Control Specialist (Day Shift)
Grifols Shared Services North America, Inc
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
**1st Shift Monday-Friday 7am-3:30pm**
**Position Overview:**
The Label Control Coordinator maintains and issues controlled labeling components, prints internal controlled labeling and provides controlled labeling standards for incoming inspections to use for each controlled component received.
**Responsibilities include, but are not limited to the following:**
● Receives, issues and maintains inventory of controlled product labeling using SAP
● Creates and verifies internal controlled components (e.g., hot stamp, shipper labels, pallet labels, export/intermediate labels), includes batch-specific variable information (e.g.,
Lot, Expiration Date, Date of Manufacture, Potency) using various software (i.e. EasyLabel, etc.)
● Establishes controlled label copy, master files (Label Verification Sheets) and verifies printed controlled labeling against approved artwork using proofreading skills
● Interacts with Quality Operations Incoming Inspection, QO Release, Biochemistry and Packaging to provide controlled components in a timely manner to meet the Packaging schedule
● Provides Filling sample labels per the Fill schedule
● Performs and verifies cycle counts of controlled component inventory. Provides Filling sample labels per the Fill schedule
● Provides 1st Batch Notice to Regulatory Affairs for controlled components
● Issues and verifies stickered cartons to Packaging to meet international customer requirements
● Qualifies vendor counts annually utilizing initial and verification quantities
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
**Skills/Qualifications/Education Requirements:** (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).
+ Minimum of a high school diploma or GED along with the below referenced requirements. Associate's Degree in Life Sciences, Business or related field is preferred
+ 4 years of related manufacturing labeling experience is also required
+ Strong knowledge of compliance standards with the Food Drug Administration (FDA), international governing entities and Good Manufacturing Practices (GMPs)
+ Excellent oral and written communication skills
+ Excellent analytical and proofreading/editing skills
+ Strong MS Office and SAP skills
+ Ability to operate forklift truck and pallet jack
+ Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires an Associate’s degree plus 2 years of experience, an equivalency cold include 4 years of experience or a Bachelor’s degree
Work is performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals, electrical manufacturing equipment, hand tools and moving machinery. Exposure to high levels of noise and to extreme cold below 32*. Exposure to office electrical equipment. Personal protective equipment required such as protective eyewear, safety shoes, gloves and garments. Occasionally enters into confined spaces requiring squatting, kneeling or climbing. Work is performed standing for 6-8 hours per day with frequent walking. Frequent hand movement of 4-6 hours at one time of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light lifting and carrying of 15lbs. for 6-8 hours per day. Moderate lifting and carrying of 15-44lbs for 4-6 hours per day with a maximum lift of 45lbs. Occasionally bends and twists neck and waist. Occasionally reaches above and below shoulder height. Frequent foot movements. Hearing acuity essential. Color perception/discrimination, near and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs routine tasks that vary little each day by following a set of written or oral instructions/procedures.
EEO Females/Minorities/Veterans/Minorities
Learn more about Grifols (http://www.grifols.com/es/web/international/home)
**Req ID:** 530036
**Type:** Regular Full-Time
**Job Category:** Manufacturing
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