QC Microbiology Lab Consultant

Job Title: QC Microbiology Lab Consultant Job Function: Quality Consultant Location: Lexington, MA - Hybrid Compensation: 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 candidate's qualifications, skills, competencies, and proficiency for the role.
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.
For more details about our benefits, visit us here: www.USDM.com/careers Min Pay Rate: USD 82.00 Max Pay Rate: USD 89.00

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 sets 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

USDM is looking for a strong Microbiology Lab Consultant who will support our client. This person will qualify lab equipment and provide technical writing expertise by functioning as the QC SME on new QC equipment documentation. This consists of facilitating and authoring document revisions, technical protocols, and change controls.

Primary Responsibilities

Qualification of lab equipment.

Perform technical writing, specifically authoring document revisions, technical protocols and change controls.

Work alongside QC, QA and other applicable departments to drive work to completion.

Manage tasks based on aggressive timelines.

Interact in team environment.

Qualifications

5+ years of related experience, writing quality documents in pharmaceutical biologics and equipment qualifications.

Knowledge of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices.

Strong technical background.

Strong communication and interpersonal skills ensuring the ability to interact with the business, peers and vendors in a professional manner.

Ability to work independently with minimal supervision and adhere to timelines.

Quick learner.

Education & Certifications

Bachelor's degree in technical or scientific discipline.

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.