Senior Specialist, Manufacturing Technical Operations (Contract) 23842
Job Description:
The Senior Specialist will play a key role in our growing event investigations team and will be responsible for conducting root cause analysis (RCA), assessing impacts, and developing corrective actions and preventive measures to ensure the effectiveness of our processes.Reporting to the Technical Services Manager or designee, this is an exciting opportunity to work in a fast-paced environment and make a real impact.
KEY RESPONSIBILITIES:
- Lead, write and review deviations and investigations for Vertex Cell and Genetic Therapies (VCGT). Including the manufacturing, facilities, supply chain/materials management and support QC deviations.
- Identify and assemble proper SMEs for triage, determine immediate actions taken, document impact assessments, lead RCA, develop appropriate CAPAs.
- Coordinate meetings with SMEs for triage, determine immediate actions taken, document impact assessments, perform RCA, develop appropriate CAPAs.
- Own deviation, CAPA and Effectiveness Check (EC) records in electronic Quality Management System (eQMS) and drive to completion by record due dates.
- Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across VCGT.
- Collaborates with subject matter experts to develop controlled documentation, ensuring accuracy and completeness, and provides ongoing support to facilitate effective implementation.
- Demonstrate Vertex behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.
- Other duties and projects as assigned to meet departmental requirements.
REQUIRED KNOWLEDGE AND SKILLS:
- Knowledge of cGMP requirements.
- Strong organizational skills.
- Adept in managing multiple regulated records in parallel.
- Strong interpersonal skills, including the demonstrated ability to manage through influence and lead dynamic teams.
- Experience with technical writing including the creation of procedures, reports, and training materials.
- Experience using quality management software to manage quality documentation and records in a regulated environment.
- Minimum 5 years working experience in relevant field (may be reduced based on education level).
- Proven ability to develop and implement new functions within a matrix organization.
- Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI.
- Experience in developing and implementing written procedures in a GMP-compliant environment.
- Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.
Pay Range:
$45-$60/hr
Requisition Disclaimer:
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law.
In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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