Job Details
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