Manufacturing QA Investigator

3 weeks ago

Baltimore, United States Compli Full time
Job DescriptionJob Description

Manufacturing Quality (QA) Investigator - Baltimore MD

(Pharmaceutical/Biotech)-Competitive Salary, Work/Life Balance

On-Site

Previous Pharmaceutical/Biotech/Medical Device industry experience is mandatory for these roles.

Are you looking to be a part of a close-knit work community? Do you have experience in the Life Science industry? Will you represent Compli, LLC as an experienced Manufacturing QA Investigator for our pharmaceutical manufacturing, biotech, and medical device client projects? Do you enjoy traveling the country and making a difference? If so, this could be the right opportunity for you

The investigator will work closely with the client to provide innovative solutions to our clients. We are experiencing growth as a firm and are seeking a qualified QA investigator with expertise in cell/gene therapy, biologics manufacturing. The ideal candidate will be a self-starter who takes pride in their work and actively pursues opportunities to learn and assist others when needed.

Job Responsibilities:

Lead a team of Manufacturing Quality Investigators performing the following activities:

Execute the initiation and/or evaluate deviation(s), interview personnel, analyze root cause, assess impact, identify corrective / preventive actions, present to management and close investigations in the Quality Management System (QMS).. The Investigators in this role will be responsible for executing root cause investigations, owning/authoring deviations, driving continuous improvement efforts, and overseeing CAPA's. They will also manage both minor and major investigations. Cell/Gene Therapy experience preferred.

The Lead Investigator will also be responsible for reporting to the client management on a weekly basis on investigative details, project progress and project metrics.

Our client is an equal opportunity employer, and we embrace the increasingly diverse world around us. Our client prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Compli, LLC was founded in 2001 to provide commissioning, validation, and regulatory support services, CQV, asset management, reliability engineering, and staff augmentation services to the life sciences industry. We serve pharmaceutical companies across the U.S. Regarding regulations and compliance, it has never been more important to understand the documentation and quality assurance activities as they relate to vendors, engineering, construction, and contractors, which is why clients trust the Compli team.

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