SUMMARY:

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 to support, design and implement 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.

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

• 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 to the organization when required

SUPERVISORY RESPONSIBILITIES:

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

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with minimal supervision. 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.

EDUCATION and/or EXPERIENCE:

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

MATHEMATICAL SKILLS:

Ability to apply moderately complex mathematical operations including an understanding of statistical skills. 

LANGUAGE SKILLS:

Ability to effectively communicate (written and verbally) with the following groups:

Internal Communication: Quality, Operations, Sales, Customer Service, Project Management, Validation, and Engineering teams.

External Communication: Represents Quality as the subject matter expert (SME) for customers and regulatory agencies on Quality Operations related processes and issues.

WRITTEN SKILLS:

Above average writing and verbal skills, ability to provide clear, concise and legible communication within written procedures, internal and external correspondence, such as memos to file, electronic mail and Non- Conformance and procedure writing. 

REASONING ABILITY:

Ability to make independent rational decisions pertaining to Quality and Compliance is required.  Ability to resolve problems effectively and efficiently.

COMPUTER SKILLS:

Intermediate Windows applications including the Microsoft Office Suite and electronic QMS.

PHYSICAL DEMANDS:

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.   Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing 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 normally required to sit at a desk or periodically go onto the shop floor.  The working environment is clean and not normally subject to hazardous environment or conditions.