Quality Specialist; 1st Shift

The Quality Specialist provides quality oversight, GMP guidance and support and makes 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 Specialist is responsible for supporting, design 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. Scope of the position includes Allentown, Macungie and/or Conshohocken. The impact of decisions relating to customer interface, quality inspections, and documentation requirements could expose the company to significant risk or economic loss.

• 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 can 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
• Support DEA requirements and DEA Compliance
• Verify Major/Minor cleans when required
• Proactive review of new quality inspection 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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Indirectly provides guidance to the Quality Line Associates role on the shop floor.

Bachelor’s degree is preferred with one to three years related experience or Associates Degree with three to five 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.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel and talk or hear.

The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.…