Manufacturing Assurance Specialist

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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.

Job Summary:

 

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.

 

 

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 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.

 

The estimated pay scale for the Manufacturing Assurance Specialist role based in Los Angeles, CA, is $67k - $75k 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, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on e