What are the responsibilities and job description for the Operational Quality Specialist position at GROVE TECHNICAL RESOURCES, INC?
Job Title : Operational Quality Specialist / Senior Specialist (QA Analytical)
Location : Boston, Massachusetts (Hybrid 2-3 days per week onsite)
Type : W2 Contract
Duration : 6 Months (with possibility of extension)
Key Responsibilities
Conduct QA review of GMP data to support commercial product release.
Collaborate with internal and external stakeholders to resolve quality issues in QA Analytical processes.
Provide quality oversight for root cause analysis (RCA), deviation investigations, and CAPA implementation.
Support and approve change control assessments, implementation, and closure.
Review and approve GMP documentation, including procedures, specifications, protocols, and reports.
Facilitate analytical method validation and transfer for commercial and clinical products.
Draft and maintain Quality Agreements with CMOs / Suppliers.
Contribute to quality metrics and continuous improvement initiatives.
Participate in internal and external audits, supporting audit responses and compliance measures.
Required Skills and Qualifications
GMP Expertise : Comprehensive knowledge of cGMPs, global GMP regulations, and their application in pharmaceutical settings.
Analytical Techniques : Proficiency in QC analytical methods such as HPLC, dissolution, GC, and Karl Fischer.
Deviation Management : Hands-on experience with Quality Event Investigations, RCA, and CAPA processes.
Change Control : Proficiency in assessing and managing change control processes.
Documentation Systems : Experience with electronic systems like QDoccs, Trackwise, or Veeva.
Communication : Strong verbal and written communication skills with cross-functional team interaction.
Problem Solving : Demonstrated ability to independently address quality issues using RCA tools and methodologies.
Audit Support : Familiarity with audit preparation, response, and compliance processes.
Preferred Education and Experience
Education : Bachelors degree in a scientific or allied health field.
Experience : Minimum of 3 years in a QA analytical or manufacturing environment.
Technical Writing : Proficiency in technical writing and documentation review.
Operational QA : Strong operational QA experience, including interpretation and application of ICH, USP, and other relevant guidelines.
Key Attributes
Detail-oriented with the ability to manage multiple projects in a fast-paced environment.
Strong organizational, facilitation, and problem-solving skills.
Ability to identify risks and develop effective mitigation plans.
This position focuses on QA Analytical support, including data review, deviation handling, and CAPA implementation for GMP-compliant manufacturing and testing processes.
