Quality Assurance Specialist

Title: Quality Assurance Specialist
Location: Devens, MA 01434
Pay: $26/HR
Duration: 5 months (possible extension/conversion!)
Shift: Second shift Monday - Thursday 3:45pm - 2:15am.

Summary:

• Executes day-to-day quality assurance objectives following a varied set of procedures ensuring adherence to company standards and regulatory requirements.
• Conducts inspections drafts and reviews quality related documentation and monitors production processes to maintain product quality and regulatory compliance.
• Refines testing protocols to accommodate new product designs troubleshoots unexpected deviations in quality metrics or adjusts compliance procedures in response to regulatory updates.
• Communicates with internal and/or external contacts in- and outside of the quality function on matters that involve obtaining or providing information requiring explanation such as coordinating corrective actions with manufacturing teams interpreting compliance guidelines for suppliers and assisting auditors with documentation reviews during inspections.

Job Duties and Responsibilities:

• Supports generation of job packets for Production
• Supports batch record review process.
• Assist in Label generation
• Supports certification requests
• Complies with company policies procedures work instructions and training requirements focusing on customer service production and quality.
• Ensures documentation and physical product segregation and containment of non-conforming material.
• Reviews production documentation for accuracy completeness and GDP compliance.
• Communicates issues / concerns to area owner and direct supervisor or manager.
• Assist with ensuring a state of audit readiness at all times.
• Follows applicable safety procedures
• Document any deviations or non-conformances following procedures and Work Instructions encountered during routine activities
• Assist in resolving basic quality issues under supervision.
• Collect data for quality reports.
• Order supplies for the quality department when needed.
• Ensures cleanliness of work areas.Performs other duties as assigned.

Skills:

• Good communication written skills and interpersonal skills
• Good attention to detailAbility to read understand and follow procedures
• Ability to escalate issues according to established procedures
• Familiarity with Quality Management SystemsGMP knowledge is preferred
• Self-motivated and ability to work independently and with a team
• Knowledge and experience utilizing Microsoft Outlook Word Excel and Access or equivalent software packages
• Good mathematics skillsBasic understanding of quality standards such as ISO 9001.
• Documentation skills to accurately record test results and quality issues.

Education/Training Experienceand Certifications

• High School completion or equivalent GED required.Bachelors degree is preferred.
• A minimum of 1-year related experience and/or training in a regulated industry is preferred.
• Experience in a Quality role within the medical device biotech or pharmaceutical industry is preferred.

Skills:

• BioTech pharma GMP regulations or ISO requirements experience - preferred
• Must be comfortable with Word and Excel - used heavily in the role.

Six Sigma certification is a plus but not required.
Power Automate or Power BI programs is a plus but not required.

A global defense and aerospace leader delivering advanced technologies that support national security, strengthen critical infrastructure, and protect those who serve.