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Manufacturing Assurance Specialist
3 months ago
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 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. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us
*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.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with arrests or conviction records, in a manner consistent with the requirements of applicable state and local laws, including the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
Location: NORTH AMERICA : USA : CA-Los Angeles:USVALLEY - Valley - Valley Blvd - LA, CA
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