QA Shop Floor Specialist

Spectraforce Technologies; Harvard (MA); On-site; USD 55,104 - 82,656; Full time

Job summary

Spectraforce Technologies in Devens, MA is seeking a Contractor Field QA Specialist for the Cell Therapy Facility. You will ensure quality activities align with cGMP, perform real-time batch record reviews, and collaborate with operations to resolve manufacturing issues.

The role requires strong authorship, decision-making, organization, and the ability to navigate FDA regulated quality environments. 6-month contract with potential conversion based on performance.

Qualifications

• High School Degree required.
• Relevant college or university degree preferred.
• Minimum 2 years in a Quality Assurance role.
• FDA regulated cGMP warehousing/quality knowledge required.
• Independent, self-directed work style with strong decision-making.

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.
• Authorship capability to review investigations and produce technical conclusions aligned with Quality risk management.
• Plan, organize, and build relationships to support manufacturing quality.

Skills

QA shop floor

cGMP

Investigations & CAPA

Documentation review

Quality risk management

Problem solving

Planning & organizing

Cross-functional collaboration

Education

High School Degree

Relevant college or university degree preferred

Job description

Job Title: QA Shop Floor Specialist

Job Duration: 6 Months (potential for conversion based on performance)

Job Location: Devens, MA 01434

Morning Shift: 6 AM - 6 PM on the Panama Schedule.

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. Reports to the Head of QA Field for the Devens CTF.

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.

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.).