What are the responsibilities and job description for the Senior Specialist, Quality Assurance for Quality Control position at Global Applications Solution?
Senior Specialist, Quality Assurance for Quality Control
Location: Norwood, MA
Department: Global Drug Substance QA
Reports To: Director, Quality Assurance for Quality Control
Regulatory Environment: GxP / cGMP
Job Type: Contract
Position Overview
We are seeking a Senior Specialist, Quality Assurance for Quality Control to provide vital quality oversight, guidance, and decision-making for Quality Control (QC) equipment moves, qualification activities, and decommissioning across our Norwood sites.
As a key member of the QA for QC team, you will help build and sustain a robust culture of quality within our GxP and GMP laboratories. In this role, you will ensure that all laboratory instruments and associated data meet the highest standards of compliance, data integrity, and regulatory readiness.
Key Responsibilities
- Documentation & Protocol Oversight: Review and approve documentation associated with QC laboratory equipment, including qualification and validation protocols/reports, periodic reviews, method Standard Operating Procedures (SOPs), forms, and data tables to ensure data integrity and cGMP compliance.
- Compliance & Auditing: Review QC logbooks and ensure all laboratory personnel strictly adhere to Good Documentation Practices (GDP), Data Integrity requirements, and internal/external GxP regulations.
- Quality Systems Management: Identify, assess, classify, review, and approve deviations, change controls, work orders, SOPs, Corrective and Preventive Actions (CAPAs), and other documentation related to QC equipment and instrument activities.
- Independent Decision-Making: Make critical quality decisions to guarantee alignment with internal quality procedures and global regulatory standards.
- Execution & Audit Readiness: Execute tasks precisely per internal SOPs and work instructions, complete all required learning plans on schedule, and ensure documentation is audit-ready for regulatory inspections at all times.
Required Qualifications & Experience
- Education: Bachelor’s Degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or a related scientific/technical discipline.
- Professional Experience: 3 to 8 years of experience in Commissioning, Qualification, and Validation (CQV) activities within the biotechnology, biopharmaceutical, or heavily regulated GMP industry (preferably within Quality Assurance and/or Quality Control).
- Regulatory Knowledge: Sound working knowledge of FDA, EU, and ICH guidelines, alongside general GxP/cGMP regulations.
- Technical Expertise:
- Demonstrated familiarity with equipment qualification and CQV life cycles.
- Experience in analytical or microbiological general QC testing, analytical techniques, method validation, and method transfer.
- Hands-on experience with deviation management, change control, risk management, and digital Quality Management Systems (eQMS).
- Software Proficiency: Experience using Kneat (or equivalent paperless validation software), Microsoft Office Suite, and statistical software programs.
- Core Competencies: Exceptional attention to detail, proactive problem-solving capabilities, strong written/verbal communication skills, and a proven ability to quickly learn and navigate complex GxP regulatory frameworks.
Chandan Singh
Talent Acquisition Specialist
chandan.s@globalapplications.com
1 201-499-7364