Manufacturing Assurance Specialist

GRIFOLS, S.A.

20h•Onsite

About The Position

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Requirements

Bachelor of Science degree in Engineering, Biology, Chemistry, Biochemistry or closely related scientific / technical discipline is required.
Equivalency: 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 typically requires an Associate's degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree.
Minimum of 2 years of experience in a pharmaceutical, GMP, or FDA regulated environment is required.
Requires an intermediate understanding of pharmaceutical manufacturing and laboratory processes/ equipment (ultrafiltration, CIP, chromatography, reactor tanks, centrifuges, filter presses, etc.)
Comprehensive knowledge and understanding of camp’s, FDA regulations, and industry guidelines.
Must have strong technical writing skills.
Ability to work independently with minimum supervision.
Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
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.
Excellent verbal and written communication skills in the English language.
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.

Nice To Haves

Direct hands on experience in manufacturing, maintenance, packaging, validation, and/or aseptic processing is preferred.
Experience in conducting investigations is preferred.

Responsibilities

Work closely with the Manufacturing, Maintenance, Packaging, Quality Operations Environmental Monitoring and Quality Assurance departments to ensure prompt closure of Deviation, Out of Tolerance and Environmental Monitoring reports.
Perform thorough investigations, identify root causes, and determine corrective actions.
Work closely with Manufacturing, Maintenance, and Packaging on the development and implementation of appropriate Corrective and Preventative Actions (CAPAs).
Identify areas where deviation/corrective maintenance / environmental monitoring excursion reoccurrence could be avoided.
Review manufacturing, packaging, facilities, environmental monitoring documentation and other documentation, as required, to generate an investigation report.
Document completed investigations by generating formal written reports that summarize findings and corrective actions to be implemented.
Maintain current knowledge of regulatory and industry standards.
Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.
Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.
Strict adherence to procedures and practices according to FDA regulations.
Strong emphasis on documentation according to FDA regulations.
Adhere to departmental corporate safety policies.