Deviation Management Specialist – I (Assistant)

Spectraforce Technologies Inc; West Point (PA); On-site; USD 70,000 - 90,000; Full time

Job summary

Spectraforce Technologies Inc. is seeking a Deviations Management Specialist – I (Assistant) for our West Point, PA site. The role focuses on resolving process deviations, leading investigations, and driving CAPA programs to enhance manufacturing quality.

The position requires a background in engineering or science, 1–3 years in a cGMP setting, and strong writing and communication skills to collaborate across manufacturing and laboratory teams in aseptic environments.

Qualifications

• Bachelor’s or Master’s degree in engineering/science; required for the role.
• 1–3 years post‑Bachelor’s experience in a cGMP pharmaceutical/biotech setting; academics/internships accepted.
• Experience writing investigations with root cause analysis and CAPA for manufacturing deviations.
• Familiar with Lean Six Sigma and strong analytical/problem solving abilities.
• Ability to work independently and in cross‑functional teams; excellent writing and verbal skills.

Responsibilities

• Resolve deviations and develop/implement corrective/preventive actions; lead investigations.
• Provide on‑floor technical/scientific support for manufacturing areas.
• Develop working relationships with aseptic manufacturing, testing, planning and release teams; apply sound science/engineering principles.
• Troubleshoot and perform root cause analysis of lab test failures and atypical events; implement CAPAs.
• Analyze complex problems through critical thinking and design/execute lab or pilot scale experiments.

Skills

cGMP experience in pharma/biotech

Root cause analysis & CAPA development

Lean Six Sigma methodologies

Analytical/problem solving

Technical writing

Verbal communication skills

Cross-functional teamwork

Education

B.S./M.S. degree in appropriate engineering/scientific field

Job description

Deviation Management Specialist – I (Assistant)West Point, PA 1948612 months

Description:

Qualifications:

1. B.S./M.S. degree in appropriate engineering/scientific field
2. 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
3. Previous experience in writing investigations with root cause analysis and corrective and preventative action (CAPA) development for atypical events in a manufacturing environment
4. Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities
5. Demonstrated ability to work both independently and as a part of a cross-functional team
6. Excellent technical/scientific writing and verbal communication skills

Responsibilities:

1. Primary responsibilities include resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory investigations
2. This individual will be responsible for providing on production floor technical/scientific support for manufacturing areas within Manufacturing Division
3. 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
4. Troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events, development of corrective/preventative actions is required
5. Analysis of complex problems through critical analytical thinking and the design/execution of laboratory/pilot scale experiments is required.

SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at [e-mail] if you require reasonable accommodation.