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.