Primary responsibility is to perform routine to complex QC testing pertaining ELISA testing and Cell Based Assays in accordance with cGMP regulations and Thermo Fisher standards to meet departmental and organizational goals. This position entails testing for GMP release and stability along with support for the validation and qualification of ELISA and Cell Based Assays. Additional responsibilities include supporting the department to establish robust work processes and assess for continuous improvement opportunities.


What will you do?

Perform in-lab assay execution support for validation, qualification studies, and routine testing by ELISA and cell-based bioassays.

Revise/review specifications, SOPs, and other documents regarding QC-Analytical testing and assay execution.

Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.

Effectively communicate with peers, manufacturing, AD and QC staff, to resolve technical issues and direct activities.

Provide support to site Safety initiatives.

Perform any other tasks as requested by Senior Management to support Quality oversight activities.


Qualifications / Requirements:


Education

Bachelors Degree in a Biological Science or related field


Experience

2+ years of experience within the biopharmaceutical or pharmaceutical industry, preferably in ELISA or cell-based bioassay field.

Extensive knowledge of GMP regulations in a cGMP manufacturing environment.

Working Knowledge of scientific principles for wide range of analytical techniques strongly preferred. ELISA and Cell Based Assay experience with large molecules is strongly recommended.

Routine use of MS Excel, MS PowerPoint, and MS Word is essential


Knowledge, Skills, Abilities

Ability to understand customer requirements related to Quality control, including processes and equipment.

Outstanding technical writing skills.

Highly organized with attention to detail

Ability to communicate clearly and professionally in writing and verbally

Flexibility in problem solving, providing direction and work hours to meet business objectives

Working knowledge in 5S, SAP, and Trackwise preferred


Additional Detail:


Position hours? M-F, 8:30-5:00


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)