QA Technician II

Please See Below for a Great Opportunity to start your career with one of the top Scientific companies in the Scarborough, ME area! This Opportunity allows for a lot of growth and ability to work with Quality Assurance practices!

If interested please reach out directly to Richard Saad 781-917-1013!

RESPONSIBILITIES:

• Conduct product testing to support complaint investigations and stability verification
• Generate, document and asses product testing results
• Perform troubleshooting activities
• Review production batch records (DHR's) for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records. Report all deviations in these records and assures these have been addressed and resolved prior to issuing approval.
• Collaborate with Manufacturing and QC groups to resolve issues in quality records
• Initiate and author Quality Incidents (QI)
• Participate in the internal audit program
• Conduct spot-check inspections/audits of production operations
• Write, review and approve Standard Operating Procedures (SOPs) as necessary
• Manage or assist in the management of the Calibration program
• Assist in supporting the Document Control program, record retention areas, and sample retention areas
• Communicate quality issues to QA Management in a timely manner
• Train new and current Quality Assurance technicians as needed
• Manage or assist in the management of the Stability Program
• Manage or assist in the management of the Retention Program

May support returned instrument processing which includes:

• Log returned instruments from the field.
• Decontaminate returned instruments in a Biohazard level II environment following standard operating procedure and documenting decontamination as required.
• Inspect returned instruments for damage and performing basic investigation and documenting results prior to second level processing.
• As necessary, process instrument documentation for return to repair facility, and pack instruments as required.

BASIC QUALIFICATIONS | EDUCATION

• Bachelor's Degree in Biology, Chemistry, Life Science, or related technical field or the equivalent combination of experience and education.
• 3 years in a Quality Assurance role within the medical device industry.

COMPETENCIES

• Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP)
• Ability to perform Immunological Assays and NEAR Molecular assays
• Knowledge of site software for inventory management, Document Control, Quality incident tracking and Customer Complaint tracking
• Good working knowledge of Excel and Microsoft Word software.
• Ability to follow procedures and accurately document results
• Understanding the manufacturing processes of Company products and ability to recognize deviations from approved documented procedures
• Ability to speak effectively before small groups of customers or employees of organization.
• Ability to use bleach for cleaning purposes is required
• Attention to detail

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.