What are the responsibilities and job description for the Deviation Investigator Scientist (Hybrid - Devens, MA) position at Stage 4 Solutions?
Deviation Investigator Scientist – (Hybrid – Devens, MA)
We are seeking a Deviation Investigator Scientist for our global pharmaceutical client. The focus of the role is to conduct and manage the resolution of deviations, root cause investigations, impact assessments, and CAPAs.
This is a 40-hour per-week, 6-month contract (extensions possible), 50% onsite at the client’s office in Devens, MA. Hours: Monday- Friday (Normal Business Hours)
This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered.
Responsibilities
Please feel free to forward this project opening to others who may be interested.
Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.
Compensation: $50/hr. - $53.22/hr.
We are seeking a Deviation Investigator Scientist for our global pharmaceutical client. The focus of the role is to conduct and manage the resolution of deviations, root cause investigations, impact assessments, and CAPAs.
This is a 40-hour per-week, 6-month contract (extensions possible), 50% onsite at the client’s office in Devens, MA. Hours: Monday- Friday (Normal Business Hours)
This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered.
Responsibilities
- Conduct and manage the resolution of deviations, root cause investigations, impact assessments, and CAPAs.
- Liaise with multiple groups and organizations to ensure effective collaboration.
- Proactively manage the progression of investigations and CAPAs to achieve timely closure.
- Lead and participate in cross-functional investigation teams.
- Present investigation findings to key stakeholders and site management.
- Apply Quality Risk Management and Operational Excellence principles to enable risk-based decision-making, drive continuous improvement, and eliminate waste.
- Investigate Quality Control deviations, including Out-of-Specification (OOS) and Out-of-Trend (OOT) results.
- 2–4 years of relevant experience leading cGMP investigations using formal Root Cause Analysis tools required.
- Experience with conducting and managing the resolution of deviations, root cause investigations, impact assessments, and CAPAs.
- Familiarity with SOPs, cGMPs, and working within a regulatory environment preferred. Knowledge of cell culture, recovery, and/or purification biopharmaceutical manufacturing preferred.
- Strong project management skills, including organization, collaboration, multi-tasking, and communication.
- Required Bachelor’s degree in chemical/biochemical engineering, biological sciences,
Please feel free to forward this project opening to others who may be interested.
Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.
Compensation: $50/hr. - $53.22/hr.
Salary : $50 - $53