Grifols Shared Services North America, Inc Manufacturing Assurance Specialist in los angeles, California
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals, pharmacies, and healthcare professionals with the tools, information and services they need to deliver expert medical care. Grifols’ three main divisions – Bioscience, Diagnostic & Hospital – develop, manufacture, and market innovative products and services available in more than 100 countries. At Grifols we are united around a strong sense of pride, operating under the highest standards for quality and safety.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. We would love for you to consider growing your career with us. If challenging and meaningful work excites you, make a difference and join us in this rewarding enterprise!
Investigate manufacturing / facilities / packaging deviations, environmental monitoring excursions, calibration investigations and summarize the information including determination of assignable cause and impact on the product and production.
Essential Job Duties:
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.
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.
Bachelor of Science degree in Engineering, Biology, Chemistry, Biochemistry or closely related scientific / technical discipline is required.
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 cGMPs, FDA regulations, and industry guidelines.
Direct hands on experience in manufacturing, maintenance, packaging, validation, and/or aseptic processing is preferred.
Experience in conducting investigations is preferred.
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.
This job description is accurate at the date of publication. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned and qualifications required may change over time.
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Learn more about Grifols
Req ID: 95310
Type: Regular Full-Time
Job Category: Manufacturing