GMP Operational Quality Senior Specialist
Boston, MA (Onsite 3x per week)
Schedule:
Standard Office Hours
Duration:
24-Month Contract
Pay Range:$65-70/hr
Our client is a global biopharmaceutical leader dedicated to developing innovative therapies. This position provides an opportunity to play a key role in supporting quality and compliance activities across multiple programs in a collaborative, fast-paced environment.
Key Responsibilities
- Provide quality oversight for root-cause analysis and product impact assessments related to deviations, OOS, and OOT investigations, ensuring appropriate CAPA actions are implemented.
- Support change control assessments, implementation, and closure.
- Draft and revise Quality Agreements with external partners and suppliers.
- Represent Quality on cross-functional teams, applying strong communication and collaboration skills.
- Review executed batch documentation and testing data to support disposition of drug substance, intermediates, and finished products.
- Ensure compliance through GMP document review, including certificates of analysis and specifications.
- Contribute to continuous improvement projects and compliance optimization across functions.
Preferred Qualifications
- Experience supporting multiple projects and cross-functional teams within defined objectives and timelines.
- Strong written and verbal communication skills, with ability to present complex information effectively.
- Ability to collaborate across groups, departments, and project teams.
- Demonstrated capability to evaluate quality matters and solve problems using precedent and technical judgment.
- Expanded conceptual knowledge of cGMPs in a pharmaceutical setting.
- Proficiency in Root Cause Analysis (RCA), CAPA, and event investigations.
- Operational QA experience in analytical or manufacturing settings (small molecule preferred; biologics, devices, and gene therapy experience a plus).
- Practical GxP knowledge across the product lifecycle, including:
- GMP regulations and application to manufacturing
- Root Cause Analysis methodologies and tools
- Analytical techniques and data review
- Strong decision-making skills using risk-based approaches.
- Effective communication across diverse audiences with strong relationship management skills.
Required Qualifications
- Bachelor’s degree in a scientific or allied health field (or equivalent).
- 2 years of relevant work experience, or an equivalent combination of education and experience.
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