Work Schedule:
The work schedule follows a 2-week rotation as detailed below:
5:00 AM to 5:30 PM
2 days on (Tuesday, Wednesday)
2 days off (Thursday, Friday)
3 days on (Saturday, Sunday, Monday)
2 days off (Tuesday, Wednesday)
2 days on (Thursday, Friday)
3 days off (Saturday, Sunday, Monday)
Holidays are included as the needs of the business warrant.
Job Summary:
A Contractor Field QA Specialist is needed for the QA Operations organization at the LSCC in Devens, MA. This role is responsible for quality activities in accordance with company policies, standards, procedures, and Global cGMP guidelines.
Job Responsibilities:
- Perform QA on-the-floor activities.
- Ensure manufacturing compliance with applicable procedures and batch records.
- Perform real-time review of manufacturing batch records.
- Review manufacturing shop floor documentation.
Education Requirements:
- Relevant college or university degree required.
- Minimum 4 years of relevant work experience, with a focus on Quality Assurance.
- Equivalent combination of education and experience may be considered.
Qualifications Required:
- Must be action-oriented, with strong decision-making, relationship-building, problem-solving, conflict management, planning, organizing, resource allocation, coaching, and analytical skills.
- Knowledge of continuous improvement and efficiency/productivity enhancement within the team or project.
- Ability to build relationships both internally and with cross-functional teams.
- Strong knowledge of FDA-regulated cGMP warehousing, Quality, and compliance environments, with preference for familiarity with GMP Manufacturing operations and processes.
- Lead quality initiatives to promote continuous improvement and enhance site quality system efficiencies.
- Recognize and resolve Quality issues; communicate proposed solutions to management and seek guidance on complex issues.
- Identify conflict and notify management with proposed recommendations for resolution.
- Must be able to work independently and with minimal supervision for routine tasks.
- Confident in making decisions for non-routine issues and capable of developing and revising procedures.
- Intermediate to advanced ability to interpret results, identify issues, and provide recommendations for resolution.
- Ability to prepare clear, accurate written communications and effectively report problems to management.
- Must be able to manage multiple tasks effectively.
- Knowledge of US and global cGMP requirements, with a strong ability to critically review investigations, interpret results, and draw technical conclusions aligned with Quality Risk Management principles.
- Skilled in planning, organizing, decision-making, and relationship-building.
- Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
JOB ID: 81134