Deviation Management Specialist - I (Assistant)

TALENT Software Services; West Point (PA); On-site; USD 75,000 - 120,000; Full time

Job summary

TALENT Software Services is seeking a QA/Investigation Specialist in West Point, PA to support cGMP manufacturing operations. You will lead investigations, perform root cause analysis and CAPA development, and ensure effective corrective actions are implemented.

The role requires 1–3 years post‑Bachelor experience in pharm/biotech, strong technical writing and verbal communication, and the ability to work independently and with cross‑functional teams in a fast-paced environment.

Qualifications

• B.S./M.S. degree in engineering/science required.
• 1–3 years post‑Bachelor cGMP experience in pharma/biotech.
• Experience writing investigations with root cause analysis and CAPA.
• Familiar with Lean Six Sigma methodologies.
• Strong written/verbal communication and cross‑functional teamwork.

Responsibilities

• Resolution and reduction of process deviations, development and implementation of CAPA.
• Lead manufacturing and laboratory investigations on production floors.
• Provide on-floor technical/scientific support for manufacturing areas within TALENT Software Services’ Manufacturing Division (MMD).
• Develop working relationships with counterparts in aseptic manufacturing, testing, planning, release, and use sound science to investigate deviations.
• Troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events; design/execution of lab/pilot-scale experiments.

Skills

cGMP experience

Root cause analysis

CAPA development

Lean Six Sigma

Written & verbal communication

Education

B.S./M.S. degree in engineering/science

Job description

Qualifications

• B.S./M.S. degree in appropriate engineering/scientific field
• Minimum of 1-3 years post-Bachelor’s degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry; Academic/internship experience accepted
• Previous experience in writing investigations with root cause analysis and corrective and preventative action (CAPA) development for atypical events in a manufacturing environment
• Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities
• Demonstrated ability to work both independently and as a part of a cross-functional team
• Excellent technical/scientific writing and verbal communication skills

Responsibilities

• Primary responsibilities include resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory investigations
• This individual will be responsible for providing on production floor technical/scientific support for manufacturing areas within ***’s Manufacturing Division (MMD)
• This Individual will also develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release and is required to utilize sound scientific and engineering principles to investigate process deviations
• Troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events, development of corrective/preventative actions is required
• Analysis of complex problems through critical analytical thinking and the design/execution of laboratory/pilot scale experiments is required