Location: Boston, MA/Hybrid
Schedule: Standard Office Hours
Duration: 24-Month Contract
Pay Rate Range: $43.00/ph - $48.00/ph
The GMP Operational Quality Specialist operates independently to provide QA Analytical support for commercial product stability programs and performs routine QA Analytical tasks.
Key Responsibilities:
- Conduct QA reviews of GMP data for commercial product stability.
- Collaborate with internal and external partners to resolve quality issues.
- Act as a Quality technical resource on cross-functional teams.
- Oversee Root Cause Analysis (RCA), product impact assessments, and ensure appropriate corrective/preventive actions (CAPAs).
- Support stability-related change control activities, including assessment, implementation, and closure.
- Perform GMP document reviews (procedures, work instructions, specifications, methods, etc.).
- Manage external stability program activities, including protocol and data review and study initiation.
- Enforce Quality Agreements with external partners related to stability studies and data management.
- Identify and implement continuous improvement efforts.
- Assess risks and assist with risk mitigation plans.
Knowledge and Skills:
- Strong understanding of cGMPs and global GMP requirements.
- Familiarity with analytical techniques (e.g., HPLC, dissolution, GC, KF).
- Experience working with Contract Manufacturing/Testing Organizations.
- Ability to manage multiple projects in a fast-paced environment while ensuring quality and timeliness.
- Excellent communication skills for cross-functional collaboration.
- Competence in evaluating quality issues and making decisions based on technical expertise.
- Knowledge of quality event investigations, RCA, and CAPA implementation.
- Experience with change control assessment and electronic document management systems (e.g., LIMS, Veeva).
Preferred Qualifications:
- Bachelor's degree in a scientific discipline (or equivalent) with 3-4 years of relevant experience.
- Advanced knowledge of GMP regulations and guidelines (ICH, USP, etc.).
- Background in analytical or manufacturing QA operations.
- Proficiency in Root Cause Analysis tools, technical writing, and facilitation/problem-solving in regulated environments.
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