GMP operational Quality, Senior Specialist - Quality Engineer(contract) 25421

The Senior Quality Specialist will provide critical QA support for Commissioning, Qualification, and Validation (CQV) and project-related quality activities at a pharmaceutical manufacturing facility in Boston, MA. This role requires a strong understanding of GMP regulations and quality systems, and experience with facilities, equipment, and utilities qualification. The position supports daily operations across Quality Operations and Engineering functions, with a focus on maintaining compliance and quality standards across the site.

Key Responsibilities:

• Provide QA oversight for CQV projects related to facilities, utilities, and equipment.
• Review and approve qualification and validation documentation (IQ, OQ, PQ, and process validation protocols).
• Author and manage quality system records, including deviations, CAPAs, and change controls.
• Support execution and review of qualification and validation activities to ensure GMP compliance.
• Collaborate with cross-functional teams (Engineering, Manufacturing, Quality Control) on project execution and continuous improvement.
• Conduct risk assessments related to facility and equipment qualification, offering QA insights and mitigation strategies.
• Review and approve calibration records, PMs, change records (eCRs), and work orders.
• Participate in and support Environmental Monitoring (EM), Utilities Monitoring (UM), and pest control programs.
• Provide QA support for capital projects, shutdowns, and facility improvements.
• Support regulatory inspections and internal audits related to qualification and validation.
• Ensure accurate and compliant documentation of CQV activities in accordance with GMP and regulatory requirements.
• Review and contribute to SOPs, policies, and quality assurance procedures related to CQV.
• Maintain awareness of industry best practices and regulatory expectations for qualification and validation.

Qualifications:

• M.S. in life sciences or a related field with 5–7 years of relevant experience, or
• B.S. in life sciences or related field with 8–10 years of relevant experience.
• Strong knowledge of GMP regulations for drug product manufacturing (oral solid dosage preferred).
• Hands-on experience in equipment, facilities, and utility system qualification in a GMP environment.
• Demonstrated success in managing change control, CAPA, and event investigations using RCA.
• Proficiency with quality systems and applications (e.g., Oracle, TrackWise).
• Ability to work independently and thrive in a high-throughput, fast-paced environment.

Preferred Qualifications:

• Experience with continuous manufacturing.
• Familiarity with cleaning validation and temperature control unit qualifications.
• Understanding of digital innovation and data science in quality engineering.
• Knowledge of ASTM E2500, CSV/GAMP standards.
• Excellent verbal and written communication skills with attention to detail and accuracy.
• Ability to manage multiple priorities and communicate progress to stakeholders.

• Contract position