Senior Quality Control Technician

The Sr. QC Technician is responsible for maintaining laboratory testing equipment to ensure testing is performed only using validated programs/processes and following Sharp’s standard operating procedures (SOPs), work instructions (WRKIs), and/or other relevant job-aids and standard requirements for data reliability, product safety, and efficacy. All duties and tasks will be performed under supervision and assigned by the Supervisor, Quality Testing.
This role must adhere to specific guidelines, rules, and regulations to ensure compliance with applicable standards and requirements for release testing finished products. It will interact with and communicate information to multiple departments. The candidate must possess a working knowledge of FDA regulations pertaining to pharmaceutical laboratory operations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities are listed below but other duties may be assigned.
• Operate, maintain, and troubleshoot functional testing equipment and analyze system generated data/results.
• Work with equipment vendors to ensure equipment is maintained in accordance with expectations, specifically preventative maintenance and calibration schedules are met.
• Act as system owner of laboratory equipment, responsible for data integrity compliance including execution and review of audit trails, ensuring ALCOA+ principles, managing user access, overseeing periodic backup/archival, and ensuring validated state of systems.
• Represents Quality on assigned project teams and leads projects relevant to the Functional testing laboratory.
• Complete documentation following the company's Quality Management System guidelines and all applicable regulatory requirements.

• Must be an effective team player who actively participates and cooperates with others to improve the overall quality of our processes.
• Actively participate in non-conformance investigations that identify robust root cause and effective CAPA and Continuous Improvement planning.
• Develop, review and approve quality documentation such as SOPs, forms, work instructions, shipping requirements, specifications, etc.
• Complete QMS actions related to change controls, non-conformance, complaints and CAPAs
• Proactively identify and facilitate improvement opportunities and reduce potential quality/compliance risks.
• Identify issues and independently assess the need for non-conformance and formulate recommended actions in conjunction with leadership.
• Implement methods for process control, process improvement, testing and inspection.
• Provide regulatory and customer audit support. Assist in writing observation responses as applicable.
• Collect and distribute internal and Customer KPIs as required
• Support training of QC Technicians on functional testing equipment

This position requires a Bachelor’s degree is preferred with a minimum of one (1) year related experience or associate’s degree with a minimum of (3) years of related experience or a minimum of five years of related experience. Experience working in a pharmaceutical laboratory is required.

• Technical certification(s) or laboratory equipment maintenance experience is highly desired.
• Thorough knowledge of quality control/assurance and/or operations is preferred
• Good written and oral communication skills are required
• Good organizational and planning skills are required
• Able to communicate and interact effectively with others