Quality Control Specialist [Temp to Perm]

Multiple positions available: Cell Culture, ELISA, EM/Micro, Flow Cytometry, PCR

General Responsibilities:

Perform testing in support of product manufacturing, employing manual and automated analytical equipment. Provide direct support of Quality Control analytical processes, test procedures, qualifications, validations, assay troubleshooting, equipment upkeep, logbook review, and inventory control.

Essential Requirements:

Must have direct subject matter expertise on the following techniques:

1. ELISA, Flow Cytometry, PCR or EM/Micro
2. Cell culture
3. Execution of sample and standard dilutions and volume calculations
4. Microliter volume pipetting and plating
5. Multi-Channel Repeater Micropipetting
6. Setup and Operation of plate washer and plate reader

Responsibilities:

• Execute Analytical Test Methods for in-process samples, bulk intermediate (drug substance), final drug product, and raw materials release, as well as stability testing.
• Primary testing responsibility will be conducting testing to support assays such as Residual p24, COL7/Lam332, BSA, and Trypsin assays. However, cross-training in cell culture and other analytical methods will be required (e.g. qPCR, flow cytometry platforms).
• Coordinate, schedule, and execute testing based on manufacturing schedules.
• Participate in the review process of SOPs and analytical test procedures as necessary to maintain compliance.
• Review Quality Control raw data for accuracy, completeness and compliance with effective SOPs to ensure the strength, identity, safety, purity and quality of the product.
• Troubleshoot and analyze nonconforming data.
• Perform timely response to Out of Specification (OOS) results, including notification to area management. Perform and document laboratory investigations to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered and implemented. Execute associated CAPA.
• Ensure data integrity is maintained for all applications, programs, and executed work. Ability to document all work using Good Documentation Practices and ALCOA principles.
• Maintain laboratory housekeeping including organization, cleanliness, and logbooks.
• Perform internal audits and GEMBA walk-throughs of laboratory areas to maintain compliance.
• Author and/or execute protocols and generate technical reports.
• Author and manage change controls.
• Perform equipment standardizations and qualification, as necessary.
• Perform training of other employees.
• Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule.

Computer Skills:

• To perform this job successfully, an individual should have knowledge of Microsoft Office software.

Education:

• Minimum Bachelor of Science degree in a biochemistry, chemistry, or similar scientific discipline

Essential Qualifications:

• 3-5 years Quality Control experience in GMP environment specifically in a similar role in the biologics industry
• 2-3 years’ experience in mammalian cell culture in an academic or industrial laboratory
• Knowledge of basic laboratory skills (including aseptic technique, pipetting, biohazard control)
• Knowledge of Current Good Manufacturing Practice, Good Documentation Practices, and Industry standards required
• Familiarity with analytical equipment such as UV absorbance plate readers, Flow cytometers, microscopes, and pH meters is recommended.
• Excellent verbal and written skills with good interpersonal communication skills
• Must be open to occasional off shift and weekend work