Quality Assurance Senior Specialist, Engineering/Validation (Contract) 858

Job Description

The Senior Quality Specialist will provide QA support for commissioning, Qualification and Validation (CQV), and project-related QA activities at Vertex Manufacturing Center (VMC), Boston, MA.

As a key member of our Quality Assurance team, this person will be responsible for ensuring the quality and compliance of our facilities, equipment, and utilities through meticulous review, guidance, and collaboration with stakeholders. This person will leverage their project management expertise and deep understanding of quality systems to facilitate successful CQV projects and maintain the integrity of our manufacturing processes. The Senior Quality Specialist supports or executes daily activities related to equipment or instrumentation supporting Facilities, Utilities, Manufacturing, and Labs.

The position will support multiple production functions (from Quality operations to Quality Engineering) to achieve site goals while providing Quality oversight and ensuring compliance. Supporting resolution of potential nonconformance events by applying the deviation and CAPA management procedure, in conjunction with other procedures as applicable, to facilitate decision-making with a cross-functional team, as needed. Advising Production on proper documentation as needed and performing other duties as assigned.

This role will require local presence at the VMC, Boston site.

Key Leadership Skills:

• Cross-functional collaborator
• Results Driver

Key Knowledge/ Skills and Competencies:

• Strong leadership skills with the ability to thrive in a high throughput environment
• Critical Thinking / Problem-Solving
  • Ability to evaluate quality matters and make decisions
• Strong oral and written communication skills required
• Good Interpersonal skills required
• Attention to detail
• Knowledge in the following areas:
  • Knowledge of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices
  • Ability to work under limited supervision

Oversight of Internal Operations – Quality Engineering:

• Provide QA oversight and support for Commissioning, Qualification, and Validation projects for facilities, equipment, and utilities, ensuring alignment with project timelines and quality standards.
• Review and approve comprehensive qualification and validation strategies and plans developed by stakeholders.
• Critically review and approve qualification protocols (IQ, OQ, PQ) and validation protocols (e.g., process validation) for accuracy, completeness, and compliance.
• Analyze qualification and validation data presented by stakeholders, review reports for accuracy and completeness, and provide QA input on findings.
• Independently author and manage quality system records, including deviations, change controls, and Corrective and Preventative Actions (CAPAs) related to qualification and validation activities, often initiated by or in collaboration with stakeholders.
• Provide expert QA guidance and support during the execution of qualification and validation protocols by cross-functional teams.
• Collaborate effectively with cross-functional teams, including Engineering, Manufacturing, and Quality Control, to ensure a productive and compliant approach to CQV.
• Participate in risk assessments related to facilities, equipment, and utilities, providing a QA perspective and critical evaluation.
• Contribute to the development and improvement of quality assurance procedures and policies related to validation, facility, and engineering standards through insightful review and recommendations.
• Critically review and assess CQV documentation and activities, providing constructive feedback and guidance to stakeholders.
• Provide Quality oversight and review of calibrations, PMs, eCRs, work orders and laboratory operations via instrument qualifications.
• Review and approval of qualification activities, and periodic assessments, and trending programs (equipment, facility, utilities, etc.)
• Support EM and UM programs and control programs (Veriteq, pest control)
• Provide support for facilities and engineering projects, including capital projects, annual plant shutdowns, and various improvement projects as assigned.
• Ensure that all CQV activities are performed in accordance with Good Manufacturing Practices (GMP) and other applicable regulatory requirements through effective review and guidance.
• Support regulatory inspections and internal audits related to qualification and validation by providing QA expertise and documentation.
• Maintain a strong understanding of current industry best practices and regulatory expectations for CQV to provide informed guidance and ensure compliance.
• Proactively work with stakeholders to ensure a quality-driven approach to all CQV activities.
• Facilitate productive discussions and collaborations with stakeholders to resolve quality-related issues and ensure project success.

Minimum Qualifications:

• M.S in life sciences (or equivalent degree) and 5-7 of relevant work experience, or
• B.S in life sciences (or equivalent degree) and 8-10 years of relevant work experience
• Experience providing QA support and oversight of GMP manufacturing operation
• Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:
  • cGMP’s and associated CMC regulatory considerations
  • experience with continuous manufacturing a plus
• Experience with equipment, facilities and utility system qualifications activities in a cGMP setting
• Experience successfully leading change control, event investigations, Root Cause Analysis (RCA), and CAPA
• Experience with network-based applications such as Oracle and Trackwise preferred.
• Ability to thrive in a high throughput environment.

Preferred Qualifications:

• Affinity with digital innovation, data sciences, and Quality engineering .
• Experience with Cleaning validation and practices.
• Experience with Temperature Control unit qualifications.
• Highly effective verbal and written communication skills, strong interpersonal skills
• Great attention to detail and high degree of accuracy in task execution and GMP documentation
• Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues
• Strong organizational skills, including ability to follow assignments through to completion
• Knowledge of ASTM E2500, CSV/GAMP, and other associated standards

Pay Range

$57-$65/hr

No C2C or Third-Party Vendors