Quality Assurance Specialist in Cicero, New York

Quality Assurance Specialist I - AVT-3752

Important Details:

•

Employment Type:

4+ Months (High possibility of extension or conversion to fulltime based on individual performance and business needs)

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Location:

Devens, MA 01434

• Pay Rate: $26/Hr on W2

• Benefits:
Health Benefits, PTO, 401(k)

• Shift: 2nd shift:
Monday - Thursday 3:45pm - 2:15am

Description:

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 Avantor 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.

Knowledge, Skills and Abilities:

• Good communication, written skills, and interpersonal skills
• Good attention to detail
• Ability to read, understand, and follow procedures
• Ability to escalate issues according to established procedures
• Familiarity with Quality Management Systems
• GMP 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 skills
• Basic understanding of quality standards such as ISO 9001.
• Documentation skills to accurately record test results and quality issues.

Qualifications (Education/Training, Experience and 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/

Experience:

• Bio Tech pharma, GMP regulations, or ISO requirements experience - preferred

Required Skills:

• Must be comfortable with Word and Excel - used heavily in the role.

Desired

Skills:

• The ideal candidate is self-driven - 2nd shift is less supervised than 1st shift.
• Will check behind each other's work. Should have a strong attention to detail as there is a lot of record keeping.
• Should have the ability to stay on task with routine tasks.

Certification Requirements:

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