Sr. Quality Specialist/Manager - Boston MA - 17327
Boston, MA 02210 US
Title: Sr. Quality Specialist/Manager
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: Contract
- Job Location: Boston MA
- Pay rate: $70-80/hr
- Job#: bh15239
The Sr. Quality Specialist or Manager is recognized as an expert internally in the principles and application of quality assurance and compliance. The Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external Cell & Genetic Therapeutic programs. This role will review & support activities related to product disposition including review of batch data, batch records, deviations, in-process data, EM data, QC release testing and other quality systems documentation.
Key Duties and Responsibilities:
- Supports for quality oversight of Cell and Gene Therapy manufacturing operations across all phases of development and commercial
- Responsible for GMP batch disposition activities including review of batch records, deviations, in-process data, EM data, QC release testing, materials review board and other quality activities as applicable to determine acceptability of product disposition
- Support Cell & Genetic Program and Quality projects including Quality system, protocol and test data review and manufacturing process/SOP improvements
- Support QA execution of process and OOS investigations, and associated CAPAs
- Supports change control assessments, implementation, and closure
- Participates and supports in compliance activities and help drive the closure of any observations by partnering with Compliance and Quality Assurance for CDMO and CTO activities. Escalate critical and major finding to Quality management related to GXP Operational areas
- Supports drafting and revising Quality Agreements between CMOs/Suppliers, as needed Communicates proactively with internal and external partners and management
- Assists department mgmt. with monthly/quarterly Quality System data review metrics and reporting
- Expanded conceptual knowledge of cGMP's in a pharmaceutical setting
- Demonstrated experience providing QA support and oversight of GMP manufacturing operation in Cell & Gene manufacturing
- Helps represents Quality on cross-functional working teams, applying strong communication and collaboration skills
- Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
- Support continuous improvement projects Knowledge and Skills
- Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA Education and Strong communication and influencing skills
- Ability to evaluate quality matters and make decisions utilizing risk-based approach
- Proficiency in using Microsoft Office applications
- Some experience with quality metrics, dashboards, analysis, and improvement programs
- Some experience with network-based applications such as Oracle, Trackwise or Veeva
- Basic knowledge of current industry trends and could use the latest technologies
- Bachelor's degree in scientific or allied health field (or equivalent degree)
- Typically requires 3-4 years of Quality Assurance experience, or the equivalent combination of education and experience
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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