QUALITY CONTROL ANALYST (QC-004)

General Job Description/Team Overview:

As part of a talented and multi-disciplinary team advancing an exciting new approach to gene therapy drug discovery, development, and manufacturing, the successful candidate will support the QC operations and work in a laboratory environment under the direction of the QC Manager. This is an entry-level position and superb opportunity for candidates considering a quality control career in FDA regulated biotechnology and pharmaceutical industry. The level will be determined based upon the candidate’s education, skills, and/or related experience. 

Primary Duties and Responsibilities (include but are not limited to):

· Perform routine release testing of raw material, in-process intermediate, drug substance, and final drug product.

· Conduct routine laboratory instrument preventative maintenance, calibration, and cleaning.

· Sample cGMP raw material for release testing.

· Maintain and organize an inventory of laboratory chemicals, reagents, and consumables.

· Perform stability, reference, and reagent qualification, participate in analytical method development and qualification under supervision, and other non-routine testing as needed.

· Review testing raw data, prepare a testing summary report and maintain laboratory notebooks and tracking logs.

· Revise and draft Standard Operating Procedures (SOPs) and Standard Test Methods (STMs) as necessary.

· Assist in tracking and trending of laboratory test results, and investigation of laboratory non-conforming results.

· Dispose of laboratory-generated hazardous waste per approved company procedures.

· Assist in general upkeep of laboratory and maintain a clean work environment.

· Perform other duties as assigned.

Required Qualifications:

· Bachelor’s degree in Chemistry, Biochemistry, Biological Sciences, or related field.

· Experience in FDA regulated cGMP industry is preferred, but not required.

· Working knowledge of cell culture and aseptic techniques, PCR, cell-based assay, ELISA, gel electrophoresis, spectroscopy, chromatography, and wet chemistry is highly desired.

· Ability to read and follow SOPs and STMs.

· Individual must be a self-motivated and detail-oriented team player, who is energetic and eager to learn.

· Able to stand a prolonged time and lift 30 lbs.

· General knowledge of Federal and State regulatory requirements in a GxP environment.

· Proficient in computer skills including Microsoft Office (Word, Excel, PowerPoint) and others as applicable.

· Excellent organization skills with attention to detail and accurate record keeping.

· General knowledge of Federal and State regulatory requirements in a GxP environment.

· High degree of discretion dealing with confidential information.

· Ability and willingness to work flexible hours when needed.

· Demonstrated ability to work independently and in a team environment.

· Excellent written, verbal and interpersonal communication skills.

· Eligible to work in the U.S.

Job Type: Full-time