Manufacturing Assurance Specialist

Grifols

Manufacturing Assurance Specialist ensuring regulatory compliance and quality in pharmaceutical manufacturing. Collaborating across functions to close deviations and maintain industry standards in a healthcare organization.

Posted 5/6/2026full-timeLos Angeles • California • 🇺🇸 United StatesJuniorMid-Level💰 $73,000 - $90,000 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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).

Benefits

Comp & perks

Medical
Dental
Vision
Life insurance
PTO
Paid holidays
Up to 5% 401(K) match
Tuition reimbursement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

pharmaceutical manufacturinglaboratory processesultrafiltrationCIPchromatographyreactor tankscentrifugesfilter pressestechnical writinginvestigations

Soft Skills

organizational skillsanalytical skillsproblem-solving skillsattention to detailproactiveresults orientedself-startergood judgmentability to prioritizeinterpersonal skills