Analyst, QC Bioassay

Fujifilm•Holly Springs, NC

2d•Onsite

About The Position

The QC Analyst, Bioassay, working with direction from a manager, performs routine quality control testing in support of manufacturing using cell- and plate-based analytical methods. Methods include protein binding assays, cell-based potency assays, cell culture maintenance, and residual testing for DNA, Host Cell Protein (HCP), and Protein A/G. The role operates in a GMP-compliant laboratory and generates analytical results while identifying laboratory exceptions, invalid assays, deviations, change controls, and corrective and preventative actions (CAPAs). It also supports analytical method transfers and validations as needed. The position tests in-process, drug substance, drug product, and stability samples in accordance with applicable GMP regulations, records data in LIMS, and maintains data integrity. It reports assay performance, contributes to improvements in quality and efficiency, supports laboratory activities, and assists with authoring and reviewing QC SOPs. The analyst works with QC departments, Manufacturing, Process Science, and Quality Assurance stakeholders. Flexibility to support a 24/7 manufacturing facility is required.

Requirements

Bachelor’s degree in life sciences, Virology, Biology, Chemistry, Biochemistry, or a related science field.
0–1 years of experience.
Basic understanding of GMP, GLP, and GDP requirements.
Experience with cellular and molecular analytical testing methods.
Experience performing QC testing involving cell culture, PCR, ELISA, Dot Blots, or similar methods.
Knowledge and experience growing and maintaining mammalian cell lines.
Knowledge of cGMPs, ICH, USP, EP, JP, and FDA requirements as they relate to Bioassay analytical methods.
Working knowledge and experience with Microsoft Office products, including Outlook, Word, Excel, and PowerPoint.
Ability to work with moderate supervision and function effectively in a fast-paced, highly technical environment.
Ability to work cross-functionally and develop and maintain strong business partner relationships.
Excellent verbal and written communication skills and attention to detail.
Thorough understanding of pharmaceutical/biotech testing.
Ability to assist with conducting investigations and writing deviations and CAPAs.
Basic technical writing and problem-solving skills.
Flexibility to support a 24/7 manufacturing facility.

Nice To Haves

Experience with LIMS software.

Responsibilities

Execute cell- and plate-based analytical methods, including protein binding assays such as ELISA and Dot Blot, cell-based potency assays, cell culture maintenance, and residual testing for DNA, HCP, and Protein A/G.
Perform analytical testing of in-process, drug substance, drug product, and stability samples in accordance with appropriate GMP regulations.
Capture analytical testing data in LIMS and maintain data integrity.
Report assay performance and assist with improvements to quality and efficiency within QC Bioassay.
Identify and follow up on excursions and deviations, and initiate CAPAs.
Coordinate and support QC Bioassay laboratory activities as needed.
Support laboratory execution of analytical method transfers and validations.
Assist with authoring and reviewing QC SOPs.
Work cross-functionally with QC departments, Manufacturing, Process Science, and Quality Assurance stakeholders.
Perform other duties as assigned.