Grifols Shared Services North America, Inc Manufacturing Specialist - (Albumin 315 Bulk) in Los Angeles, California
Grifols is a global healthcare company whose mission is to improve the health and well-being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
In general, the Manufacturing Specialist is responsible for performing the essential administrative functions that support the manufacturing operations. The Manufacturing Specialist will work in conjunction with the Manager, Manufacturing to coordinate all logistics pertaining to manufacturing operations. Furthermore, this position will be responsible for assisting in document review and process trending.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Perform daily data entry functions within the SAP system.
Request and maintain all documents relating to manufacturing, i.e. MWOs (Manufacturing Work Order), MSOs (Manufacturing Support Order) and other appropriate logs.
Works with the department manager to maintain the production schedule.
Request and coordinate all materials required for the manufacturing operations.
Request and maintain all administrative and safety supplies for the department.
Document, trend and report the department KPI’s (Key Performance Indicators) within the appropriate databases.
Organize and maintain the department document archives.
Assist the department manager with various administrative tasks.
Strict adherence to procedures and practices according to FDA regulations.
Strong emphasis on documentation according to FDA regulations.
Adhere to departmental corporate safety policies.
REQUIRED EXPERIENCE/SKILLS & EDUCATIONAL QUALIFICATIONS
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, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
High school diploma or GED required. Associate’s degree, applicable certification, and/or military veterans preferred.
Minimum of 2 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required.
Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
Ability to work independently with minimum supervision.
Must be proactive, results oriented, and have strong attention to detail.
Self-starter with strong work ethic and the ability to exercise good judgment.
Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
Must be able to read, write, and speak English.
Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation.
Specific experience with SAP or other inventory management systems is preferred.
Manual dexterity to perform all job functions.
Ability to lift /move up to 25 pounds.
Ability to sit for extended periods - up to four (4) hours at a time.
Ability to gown and work in an aseptic/clean room environment.
Exposure to toxic/caustic chemicals and biological hazards.
*This job description is accurate at the date of publication and may change over time. It is not intended as an exhaustive description of the job. Other duties may be assigned and qualifications required may change.
Learn more about Grifols at http://www.grifols.com/es/web/international/home