Job Description

Job Responsibilities:

• Develop/author/revise technical reports and laboratory procedures (SOPs, methods).
• Execute and troubleshoot raw material testing in support of production activities.
• Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures.
• Design and perform testing in support of method transfer/validation/qualification/verification.
• Review/authorize data and perform analysis and interpretation of test results and trends.
• Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations.
• Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration.
• Support and mentor junior team members.
• Collaborate with other network sites to share best practices.
• Other duties as required.

Skills:

• The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality.
• The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials.  This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Client Gene Therapies and the Client organization

Education/Experience:

• B.S. degree in chemistry, biological sciences or related field with 6+ years or M.S. degree with 4+ years of relevant experience in a GMP Quality Control role.
• Prior laboratory hands-on experience with a variety of techniques such as FTIR, Raman, Near-IR, HPLC analysis and other compendial assays.
• Technical knowledge and experience in relevant areas of 21CFR, ICH, USP, Ph. Eur. and FDA guidance documents as well as cGXPs in support of clinical and commercial manufacturing.
• Proven knowledge in cGMP raw material program (RM sampling plans and testing requirements).
• Ensures inspection, testing and release timelines are met.
• Strong understanding of data integrity requirements and regulatory requirements pertaining to biotechnology and pharmaceutical industries and proven experience analyzing experimental data.
• Experience using LIMS as an end user; Excellent technical writing and verbal communication skills.
• Must be capable of observing and adhering to lab safety standards and procedures.
• Successfully performs work independently with minimal instructions.
• Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment, strong knowledge of GMP, SOPs and quality control processes, and strong knowledge of quality systems and regulatory requirements.
• Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion.
• Highly self-motivated and goal oriented.
• Will support and demonstrate quality standards to ensure data of highest quality and works closely with team and other functional key stakeholders on the Client Operations team to execute work and will be expected to perform other duties and/or special projects as assigned.

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