Job description

Position: Quality Assurance Specialist

Location: Devens, MA 01434

Contract: Long Term Contract

Job Description:

• 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:

• High School Degree required

• Relevant college or university degree preferred.

• Minimum 2 years relevant work experience, with experience in a Quality Assurance role.

QUALIFICATIONS REQUIRED:

• 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.

Job Type: Contract

Pay: $40.00 - $46.00 per hour

Experience level:

• 1 year
• 2 years

Schedule:

• 8 hour shift

Application Question(s):

• Must be fully covid-19 vaccinated?

Experience:

• Manufacturing: 5 years (Required)
• CGMP: 5 years (Required)
• FDA regulations: 3 years (Required)
• Batch Records: 4 years (Required)

Work Location: In person

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