Manufacturing Assurance Specialist

Manufacturing Assurance Specialist

Location: CA-Los Angeles, US Contract Type: Regular Full-Time Area: MANUFACTURING

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.

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.

Job 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, 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 camp's, 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.

Occupational Demands:

Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement 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 to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex 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. Performs tasks by following a set of written or oral instructions/procedures.

The estimated pay scale for Manufacturing Assurance Specialist role based in California, is $73,000 - $90,000 per year. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression.