Quality Assurance Specialist Jobs

Job Title: QA Shop Floor Specialist

Job Duration: 6 Months

Job Location: Devens,MA 01434

Morning Shift: 6 AM- 6 PM - they will join the Panama Schedule.

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JOB SUMMARY:

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 client 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. The Contractor Field QA Specialist role is stationed in Devens, MA and reports to the Head of QA Field for the Devens CTF.

JOB RESPONSIBILITIES:

• Perform real time review of manufacturing batch records.
• 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.
• Ensure manufacturing compliance with applicable procedures and batch records.
• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
• Perform QA shop floor activities.
• Review manufacturing shop floor documentation.

QUALIFICATIONS AND EDUCATION REQUIREMENTS:

• Develops and revises procedures.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Knowledge of US and global cGMP requirements.
• Minimum 2 years relevant work experience, with experience in a Quality Assurance role.
• 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.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• High School Degree required
• 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.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
• Equivalent combination of education and experience acceptable.
• Relevant college or university degree preferred.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Able to effectively multi-task.
• Builds relationships internally within and with cross functional teams.
• Confident in making decisions for non-routine issues.
• Must possess an independent mindset. Work is self-directed.

PHYSICAL REQUIREMENTS:

• Able to move between rooms in a timely manner.
• Able to gown for ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, coveralls, booties, etc.).
• Able to work near strong magnetic fields.
• 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.