Quality Testing Specialist

The Quality Testing Specialist supports manufacturing by performing functional Quality Control testing against product specifications. They provide quality oversight, GMP guidance, and make quality-related decisions for the designated functional areas within Sharp Commercial sites. They work closely with internal teams daily and occasionally represent Sharp Quality in customer interactions. The Quality Testing Specialist is responsible for supporting, designing, and implementing GMP initiatives and continuous improvement opportunities within the Quality Operations organization through data analysis, training, motivation and coaching in collaboration with internal and external stakeholders. Must possess a working knowledge of FDA regulations pertaining to Pharmaceutical /Pharmaceutical Packaging Operations.
The impact of decisions relating to customer interface, quality inspections, and documentation requirements could expose the company to significant risk or economic loss.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
The following is a list of minimum responsibilities related to the Quality Testing Specialist position. Other duties may also be assigned.

• Perform functional Quality Control testing ensuring products meet established quality standards. They inspect, test, and analyze products throughout the production process, identifying defects and ensuring compliance.
• Actively participate in non-conformance investigations that identify robust root cause and effective CAPA and Continuous Improvement planning.
• Review and approve quality documentation such as forms, work instructions, shipping requirements, specifications, etc.
• Complete QMS actions related to change controls, non-conformance, complaints and CAPAs
• Support customer relationships related to Quality as needed.
• Proactively identify and facilitate resolution of potential risks.
• Identifies issues and independently assess the need for non-conformance and formulate recommended containment actions in conjunction with operational leadership.
• Implement methods for process control, process improvement, testing and inspection.
• Ensure testing and inspection meet internal and external requirements.
• Audit internal processes on shop floor and warehouse and support internal stakeholders (operations, sales, customer service, project management, validation, and engineering) to ensure compliance of processes and product.
• Perform periodic review of room / equipment logbooks and Master Packaging Records for completeness and accuracy.
• Author, review and / or approve quality documentation including work instructions, SOPs, Quality Forms, etc.
• Provide Regulatory and Customer Audit Support /assist in providing observation response
• Collect and distribute internal and Customer KPIs as required
• Assist with testing equipment calibration to ensure timely calibration and repair
• Verify Major/Minor cleans when required
• Proactive review relevant quality processes/procedures with operations and technical operations
• Perform In process inspections and AQL sampling as needed
• Support training department to implement new opportunities for training program
• Ability to simultaneously manage multiple tasks
• Must be flexible to meet the needs of the organization when required

PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:
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 in inspection of Pharmaceutical or related industry is required.
Outside certification of quality skills and practices (i.e. ASQ, CQIA, CQI, CQT, Lean Six Sigma etc.) is highly desired.
Experience performing QC functional testing is highly desired.