Randstad Quality Assurance in Newark, Delaware

Quality Assurance

job details:

  • location:Newark, DE

  • salary:$24 - $28 per hour

  • date posted:Thursday, May 17, 2018

  • job type:Contract

  • reference:25056

job description

Job Title: Quality Assurance Auditor II - GMP

Job Responsibilities :

Ensures that quality standards are compliant for products and services according to Standard Operating Procedure and applicable regulations. Responsible for the review and approvals of documents in support of the manufacturing systems (e.g. production procedures, equipment procedures, facilities, training records).

Responsibilities and Duties:

  1. Review and approve SOPs, RMSR, customer specifications to ensure compliance with applicable ISO 13485 Standards and FDA Part 820, as applicable. Helps maintain the document management system (i.e. Intelex).

  2. Responsible for reviewing batch record to ensure that the quality of finished products are manufactured, labeled, tested and packaged in compliance with industry regulatory standards, customer specifications and policies. Review QC data and Certificate of Analysis, as applicable.

  • Periodically conduct visual inspections of processed finished product, shipping labels, shipping area and records.

  • Conduct internal audits according to Master Audit Plan, report findings to Head of Quality and Management. Ensure corrective actions are addressed to improve compliance and ensure product quality.

  • Promote Quality mindset and positive communication at all levels within the aspects of a growth organization.

  • Helps prepare the organization for ISO 13485, FDA Part 820 and routine audits.

  • Adheres to safety and security standards.

  • Performs other duties as assigned.

Qualifications : (Knowledge, Skills and Abilities: Education, Experience, Job Skills, Equipment Skills, and Certifications)

  • BS in biology, chemistry or related life sciences field.

  • Minimum of 5 years of experience in medical device / biotech field.

  • Working knowledge of cGMP, ISO 13485 and demonstrated ability to interpret and apply these guidelines and company policy into current practices and procedures.

  • Working knowledge of quality system operation in a GMP and/or ISO environment.

  • Computer literacy to include Office products and Intelex.