Senior Specialist, GMP Operational Quality

GMP, Quality Assurance, Batch Record Review, Batch Disposition, Product Release, Deviations, CAPA, Root Cause Analysis, Change Control, Equipment Qualification, Veeva, Oracle, eDMS. Master's degree in a relevant field with 2 3 years of relevant experience; or a bachelor's degree in a scientific or allied health field with at least 5 years of relevant experience; or a comparable background.

Job Title: Senior Specialist, GMP Operational Quality
Company: Intellectt Inc.
Location: Boston, MA
Employment Type: W2 Contract
Pay Rate: $45-$50/hour
Work Arrangement: Onsite
Shift: Second Shift

Job Description:

Intellectt Inc. is seeking a Senior Specialist, GMP Operational Quality to provide Quality Assurance oversight for clinical and commercial drug product manufacturing. This role supports manufacturing floor operations, batch record review, product disposition, investigations, GMP compliance, and inspection readiness.

Responsibilities:

• Review batch records, deviations, in-process results, environmental monitoring data, and QC release testing.
• Support product disposition and release decisions, including resolution of quality issues affecting shipment.
• Approve Certificates of Analysis (CoAs), generate BSE/TSE statements, and support product labeling.
• Archive batch records and supporting documentation in the electronic Document Management System (eDMS).
• Provide manufacturing floor QA support and guidance on GMP compliance.
• Review and approve manufacturing documents.
• Perform raw material release, area and line clearance, and equipment release activities.
• Provide QA oversight for change controls, investigations, root cause analysis, and CAPAs.
• Support equipment, utility, and facility qualification activities.
• Participate in QA walkthroughs, inspection readiness, and closure of audit observations.
• Identify quality risks and process gaps and coordinate timely resolution.
• Lead cross-functional quality initiatives and support continuous improvement.
  

Required Qualifications:

• Master's degree in a relevant field with 2 3 years of relevant experience; or a bachelor's degree in a scientific or allied health field with at least 5 years of relevant experience; or a comparable background.
• Experience providing QA oversight of GMP manufacturing, batch release, and equipment, facility, or utility qualification.
• Experience leading investigations, root cause analysis, and CAPA activities.
• Ability to independently lead cross-functional teams and resolve quality issues.
• Experience with systems such as Oracle and Veeva.
• Strong knowledge of GMP, quality systems, and documentation practices.
• Strong communication, organizational, and problem-solving skills.
• Availability to work second shift onsite in Boston, five days per week.
  

Key Skills:

GMP, Quality Assurance, Batch Record Review, Batch Disposition, Product Release, Deviations, CAPA, Root Cause Analysis, Change Control, Equipment Qualification, Veeva, Oracle, eDMS.

Recruiter Contact:

Rudra Prasad Kunnath
Email:

prasad.kunnath@intellectt.com

Phone: 732-200-2726

Benefits:

Employees hired into this position are eligible for benefits subject to applicable plan terms and eligibility requirements.

• Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for the full cost of insurance premiums.
• Retirement: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
• Paid Time Off: No PTO is provided beyond what is required by applicable state and local laws.
  

Equal Employment Opportunity:

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.