Quality Technician

Quality Technician

Wooster, OH (1st Shift - Monday through Friday)

$25-$27/HR + benefits

Type: 6-month contract with potential to hire

Quality Technician contributes to and influences organizational regulatory compliance and ensures product quality and suitability through execution of the nonconformances processes.

Quality Technician Responsibilities

Executes and monitors nonconformances to ensure accurate deviation descriptions, implementation of immediate corrective actions, and resolution activities to comply with regulations and industry standards.

Executes preliminary assessment of product suitability and scope determination.

Determines, assigns, and monitors tasks necessary to resolve the nonconformance, including product correction and CAPA.

Ensures documentation is maintained to support investigation activities, product disposition, and nonconformance resolution.

Provides direct compliance and investigative guidance to areas of the organization which are impacted by regulations and guidelines.

Creates, reviews, and approves procedures, work instructions, and batching instructions.

Approves rework instructions.

Maintains and coordinates storage and retrieval of supporting documents.

Provides independent assessments of nonconforming events, relevant systems, controls, and compliance programs and collaborative assessments of risk for specific nonconformance events and products.

Follows and supports current Good X (Manufacturing, Laboratory, Documentation) Practices for vendor nonconformances, including disposition approvals.

Communicates complex issues and inventory concerns to Quality Leadership and Supply Chain Management.

Provides direct support to Specialists in mentoring, coaching, and training and evaluation of assessments and investigations.

Acts as manager designee and performs critical managerial functions in absence of manager.

Participates or leads multidisciplinary teams.

Quality Technician Qualifications:

Bachelor’s in a technical field highly preferred with two (2) to five (5) years Quality or Regulatory experience in a cGMP environment.

Combination of education and experience will be considered

Prior experience in quality, regulatory and/or regulated manufacturing environment highly preferred

Moderate to advanced computer skills and experience with word processing, spreadsheets, and databases.

Demonstrated job record of success and increasing responsibilities.