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

Bpc-Jad Group; Boston (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Senior Quality Specialist to provide critical QA support for Commissioning, Qualification, and Validation (CQV) activities. The role focuses on ensuring compliance with GMP regulations and quality standards while collaborating with various teams to enhance operational efficiency.

Qualifications

• 5-7 years of experience with M.S., or 8-10 years with B.S.
• Hands-on experience in GMP environment.
• Ability to manage multiple priorities.

Responsibilities

• Provide QA oversight for CQV projects.
• Review and approve qualification documentation.
• Collaborate with cross-functional teams.

Skills

GMP regulations

Quality systems

Risk assessments

Change control

Communication skills

Education

M.S. in life sciences

B.S. in life sciences

Tools

Oracle

TrackWise

Job description

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