Quality Control Scientist

General Responsibilities:

Performs testing in support of product manufacturing, employing manual and automated analytical equipment for a variety of molecular, protein and cell based assays, such as PCR, ELISA, and flow cytometry.

Responsibilities:

Execute Analytical Test Methods for bulk intermediate testing and final product release testing.

Execute testing for raw materials.

Participate in authoring, reviewing and revising QC SOPs and other technical documents as necessary to maintain compliance.

Review of Quality Control raw data for accuracy, completeness, and compliance with effective SOPs to ensure the strength, identity, safety, purity and quality of the product.

Timely response to Out of Specification (OOS) results, including notification to area supervision.

Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule.

Maintain housekeeping in the laboratories.

Assist the Quality Control Supervisor in daily operations, as needed.

Perform Growth Promotion testing on prepared media.

Direct Sterile Media Fill Trials and perform support testing.

Authoring and/or executing protocols and generating technical reports.

Analytical method validation

Equipment qualification

Training of other employees

Completion of thorough Laboratory Investigation Reports (LIRs) to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered and implemented.

Computer Skills:

To perform this job successfully, an individual should have knowledge of Database software; Project Management software; Spreadsheet software and Word Processing software.

Education:

Bachelor of Science degree in a relevant scientific discipline, such as biochemistry, chemistry, molecular biology

Advanced degree (masters or doctorate) in a relevant scientific discipline, such as biochemistry, chemistry, molecular biology

Experience:

3-5 years Quality Control experience in a similar role in the biologics or pharmaceutical industry

2-3 years experience in mammalian cell culture in an academic or industrial laboratory

Knowledge of basic laboratory skills (including aseptic technique, etc.) are required

Knowledge of Current Good Manufacturing Practice and Industry standards

Experience with analytical technical transfer is preferred

Familiarity with analytical equipment including PCR, UV absorbance plate readers, Flow cytometers, microscopes and pH meters

Experience in aseptic processing and mammalian cell culture

Excellent verbal and written skills

Good interpersonal communication skills

Must be open to occasional off shift and weekend work