Quality Control Analyst II

USDM Life Sciences QC Analyst

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

The QC Analyst will support various activities within the QC department. Key responsibilities are to execute analytical method transfers, including raw materials, for use in a cGMP environment in Quality control. You will be responsible for conducting biological or chemical and physical analyses on raw materials, in-process samples, drug substance and final product samples and other samples collected from manufacturing areas.

Primary Responsibilities

• Conduct biological, chemical, and physical analyses on samples including raw materials, initial, in-process and final products, and samples collected from environmental monitoring according to SOP and pre-approved protocols.
• Drive implementation of new methodologies, or new sample types into existing methods in a QC laboratory
• Support Investigation of nonconformances and troubleshoot unexpected results.
• Handle multiple tasks concurrently including testing and inventory management in a timely and appropriate manner.
• Perform review of test data, which includes overall documentation practices (CGDP). May perform release functions in LIMS or other computerized systems.
• Support generation and documentation of validation protocol deliverables.
• Draft and update, as required, QC SOPs.
• Perform test equipment, equipment maintenance and calibrations as required.

Additional Responsibilities

• Performs other related duties and assignments as required

Qualifications

• General understanding & knowledge of the following areas:
• Laboratory functions, test methods, equipment (including but not limited to analytical equipment (e.g. HPLCs, plate readers, processes and applicable procedures.
• Laboratory safety including standard precautions and hazardous and biohazardous chemical handling.
• Wet and instrumental methods of analyses.
• Operating and troubleshooting procedures for lab equipment
• General knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices is preferred.
• Knowledge of quality and regulatory requirements pertinent to pharmaceutical manufacturing labs is a plus.
• Ability to write detailed investigation reports, knowledge of how to implement investigation strategies and apply root cause failure analysis is a plus.

Education & Certifications

• High School degree or equivalent required; Bachelor's Degree in Chemistry, Microbiology or Biological Sciences strongly preferred
• Minimum 2 years of related work experience
• Experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment is strongly preferred.

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.

Compensation

Salary/Hourly Rate Range (W2): USD 40.00 - 60.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM's compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate's qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.