QA Specialist I
Schedule M- F from 2:00 PM to 10:30 PM
Contract 6 Months
Onsite -Boston, MA 100 %
The Quality Assurance Specialist I position will support continuing cGMP training to keep all employees aware of their responsibilities and changing requirements for cGMP compliance. Works collaboratively with Manufacturing, Engineering, Quality Control, and other functional experts to support all daily operational activities. Functions as an information source to various company departments when special and critical quality issues occur. Functions in conjunction with manager and functional experts on special department projects. Works with internal departments to ensure implementation, maintenance, and improvement of the quality management system.
Performs the essential duties and responsibilities as listed in section below.
• Writes and revises operating procedures
• Conducts training for staff at all levels as it relates to quality systems
• Processes document change requests and training records
• Compiles quality metrics for daily/weekly/monthly reporting and reports metrics to site management
• Compiles information for Quality Management Review
• Conducts inspections of materials
• Reviews records for compliance such as inspection reports, test records, and Device History Records
• Updates component, product, and documentation databases
• Reviews validation/qualification reports for GMP and quality system compliance
• Conducts complaint investigations
• Conducts CAPA investigations, proposes corrective and preventative actions, and conducts verification and effectiveness reviews
• Investigates and reviews Nonconforming Material reports and presents reports/metrics during periodic meetings
• Evaluates supplier quality performance and conducts periodic evaluations of suppliers
• Conducts internal audits
• Participates in audits/inspections by customers and regulatory agencies and compiles corrective and preventative action responses
• Other duties may be assigned as necessary
Desired Minimum Qualifications:
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
• Ability to work on 2nd shift (2:00pm EST – 10:30pm EST).
• Associates Degree with related work experience is required. A Bachelor’s Degree is preferred.
• A minimum of 0-2 years’ experience in a Quality/Regulatory Compliance environment.
• Familiarity with application of FDA and/or ISO quality standards in a government regulated industry.
• Moderate computer competence, including experience with database and Microsoft Office.
• Knowledge of QA terms, tools, and methodologies.
SRG ED&I and EEO Statement
• ED&I: Impellam Group and its brands are equal opportunity employers committed to diversity and inclusion.
• EEO Statement: Impellam Group is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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