Location: Boston, MA/Hybrid
Schedule: Standard Office Hours
Duration: 12-Month Contract
Pay Rate Range: $50 - $60/ph
The GMP Operational Quality Specialist works with a high degree of independence to provide QA Analytical support for release and stability program for commercial products. The GMP Operational Quality Specialist executes routine tasks and activities in support of QA Analytical function.
KEY DUTIES AND RESPONSIBILITIES:
- Provides QA review of the GMP data in support of release of commercial product as required.
- Collaborates with internal and external business partners to resolve quality issues to ensure compliant solutions in support of QA Analytical function.
- Represents QA Analytical on cross-functional teams as an experienced Quality technical resource as needed.
- Supports quality oversite of root-cause analysis and product impact assessment for deviation and OOS/OOT investigations. Ensure that appropriate CAPA actions are identified. May approve investigations/CAPAs.
- Supports change control assessment, implementation, and closure as needed.
- Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and reports.
- Supports analytical method validation and transfer activities for commercial and clinical products as needed.
- Drafts and enforces Quality Agreements between CMOs/Suppliers as needed
- Identifies and facilitates continuous improvement efforts
- Supports generations and maintenance of Quality Metrics to support process improvement activities as necessary.
- Identify and communicate risks and assist with risk mitigation plans as necessary
KNOWLEDGE AND SKILLS:
- Knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing and testing.
- Strong knowledge of basic analytical techniques in a QC/commercial setting (e.g., HPLC, dissolution, GC, KF, etc.)
- Experience working with CMO/CTO's.
- Experience supporting multiple projects/teams, ability to work in a fast-paced environment and meet quality, accuracy and timeliness objectives
- Good communication skills (written and verbal) and the ability to communicate cross-functionally to a wide variety of audiences.
- Demonstrated ability to work independently to provide QA advice for large, multifaceted projects
- Demonstrated ability to evaluate quality matters and make decisions leveraging technical experience and judgement.
- Experience in supporting Quality Event Investigations, Root Cause Analysis (RCA) and CAPA implementation.
- Experience in assessing Change Controls
- Experience with electronic document management systems (e.g., Trackwise, Veeva).
PREFFERED EDUCATION AND EXPERIENCE:
- Bachelor's degree in a scientific or allied health field (or equivalent degree) and 3-4 years of experience, or the equivalent combination of education and experience.
- Advance knowledge of GMP regulations and applicability to duties.
- Operational QA experience in analytical or manufacturing setting, interpretation, and application of GMPs and applicable guidelines/guidance's ex. ICH, USP, etc.
- RCA tools/methodology/ technical writing
- Facilitation/ problem solving /organizational, planning, etc