QC Scientist at USDM Life Sciences

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

Provide expertise and technical leadership in managing instrument/method validation, change requests, and improvement initiatives. Lead and manage assay qualification and validation activities for Quality Control (QC) by authoring/reviewing protocols, executing and coordinating testing with functional area managers, performing statistical data analysis, and compiling final summary reports per internal and regulatory guidelines.

Primary Responsibilities

• Collaborate with QC, QA, Supply Chain, Analytical Chemistry, Manufacturing, Manufacturing Technical Service, Regulatory Affairs, and Project Management, Lab Excellence, Compliance.
• Investigations and Compliance
• Author investigations by providing technical expertise, ensuring compliance with cGMPs, and exercising strong scientific judgment.
• Coordinate testing/sampling within QC to identify root causes.
• Microbiological Method Performance
• Provide technical expertise and support for microbiological method performance, troubleshooting, and assay remediation.
• Document Change Management
• Manage document change requests for method SOPs, risk assessments, corrective and preventive actions, and audit/inspection actions.
• Advisory and Regulatory Support
• Act as an advisor to subordinates to meet schedules and resolve technical problems.
• Support regulatory activities, including inspections and filings related to analytical methodologies.
• Oversee planning and execution of projects.
• Author and review protocols, reports, data summaries, and procedures.
• Lead, manage, and execute microbiological method qualification and validation studies.
• Support in training personnel as required.

Additional Responsibilities 

• Performs other related duties and assignments as required.

Qualifications

• 7-10 years of experience in the pharmaceutical industry, focusing on bioburden, endotoxin, sterility testing, final container testing, microbial identification, environmental monitoring, method verification/validation, and equipment onboarding.
• Team leadership experience.
• Direct experience with microbiological method validation and GMP investigations.
• Experience in Quality Control within GMP organizations preferred.

Education & Certifications 

• BS Degree in Biological Sciences, focusing on Microbiology Method Validation / Verification, Bioburden, Endotoxin, Sterility Testing, Environmental Monitoring, Contamination Control.

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.