Quality Assurance Specialist

Job Title: QASF (Quality Assurance Specialist, Floor)

Job Location: Devens, MA 01434 (On-site)

Day shift

Role Overview:

Client is seeking a Contractor Field QA Specialist for the QA Operations organization at the Cell Therapy Facility (CTF) in Devens, MA.

The Contractor Field QA Specialist is responsible for quality activities for the Cell Therapy Facility in accordance with the company's policies, standards, procedures, and Global cGMP.

Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues.

JOB RESPONSIBILITIES:

• Perform QA shop floor activities.
• Ensure manufacturing compliance with applicable procedures and batch records.
• Perform real time review of manufacturing batch records.
• Review manufacturing shop floor documentation.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

QUALIFICATIONS AND EDUCATION REQUIREMENTS:

• High School Degree required
• Relevant college or university degree preferred.
• Minimum 2 years relevant work experience, with experience in a Quality Assurance role.
• Equivalent combination of education and experience acceptable.
• Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross functional teams.
• Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Must possess an independent mindset. Work is self-directed.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Confident in making decisions for non-routine issues.
• Develops and revises procedures.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to effectively multi-task.
• Knowledge of US and global cGMP requirements.
• 2-3+ years of MFG experience (mgrs are looking for someone with experience)
• Experience with label control, MES (Manufacturing Execution Systems), and SAP is NOT Required but would be gladly welcomed.
• Prior GMP gowning experience (Grade 8 gowning minimum requirement).
• Digital Proficiency :
• Syncade, SAP, Veeva, Trackwise, electronic batch records, DeltaV, LIMS, Lab Notebooks are all pluses.

PHYSICAL REQUIREMENTS:

• Able to lift up-to 25 pounds several times a day.
• Able to stand and walk for several hours at a time in a 12-hour shift.
• Able to move between rooms in a timely manner.
• Able to work near strong magnetic fields.
• Able to gown for ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, coveralls, booties, etc.).