Job Description

Job Description

Job Description

Position Title: Investigator (Cell & Gene Therapy/Biologics)

Location: Maryland

Opportunities: 10

100% Onsite work approximately four to five months

Summary

The Investigator will be responsible for executing root cause analyses, owning/authoring deviation investigations, non-conformances, and CAPA investigations. Immediate availability to start and relocate to Maryland, USA, is required. Experience with Cell & Gene Therapy or Biologics is essential, as manufacturing life-saving medicines with patient safety in mind is our priority. Ensuring quality, safety, and on-time delivery is crucial for success in this role. The candidate should be experienced in driving continuous improvement efforts, handling various quality report types, and revising GMP documents such as SOPs and manufacturing batch records to support assigned investigations.

The Role

• Initiates Quality Records and conducts deviation investigations that meet both industry and our client's expectations.
• Leads or manages investigations, including root cause analysis, and assesses product impact using input from various departments.
• Develops, executes, and oversees CAPAs.
• Provides technical leadership to ensure product and process understanding is sufficient for investigating deviations, ensuring investigations are technically sound, meet quality expectations, and corrective actions are effective.
• Works with the team to monitor critical process parameters.
• Revises and manages manufacturing documents such as Batch Records and SOPs.
• Leads or supports Continuous Improvement projects.
• Conducts data gathering, trending, and data presentation as needed to support investigations.
• Provides real-time, on-the-floor response in support of operational deviations by gathering information and completing an initial event report.
• Interviews personnel to obtain information required to close out assigned investigations during non-standard shifts and weekends.
• Must be immediately available to start if selected by our client.
• Performs other tasks as needed.

The Candidate

• Bachelors degree in a science or engineering field with 3 to 5+ years of demonstrated technical competency in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g., Production, Development, Process Engineering, Technical Services, or related field).
• Previous experience operating equipment such as incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers, and in-process testing equipment.
• 3 to 5+ years of experience in process deviation investigations and remediation.
• Ability to perform interviews and familiarity with root cause analysis.
• Previous experience authoring and/or revising technical documents.
• Ability to support and/or lead system troubleshooting efforts.

Ready to join our dynamic team? Send your updated resume to careers@proqualitynet.com with the subject line: Investigator - MD, USA. We look forward to hearing from you!

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