Senior QC Scientist - Exton, United States - Beacon Hill

Description

eneral 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:

• 8-10 years Quality Control experience in a similar role in the biologics or pharmaceutical industry
• 6-8 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