Quality Assurance System Specialist

4 weeks ago

Allentown, Pennsylvania, United States Sharp Corporation Full time
Job Summary:

The Quality Assurance System Specialist provides quality oversight, guidance, and support to designated functional areas within Sharp Commercial sites. This role involves working closely with internal teams daily and representing Sharp Quality Systems in customer interactions. The Quality Assurance System Specialist is responsible for supporting, designing, and implementing GMP initiatives and continuous improvement opportunities within the Quality Systems through data analysis, training, motivation, and coaching in collaboration with internal and external stakeholders. A working knowledge of FDA regulations pertaining to Pharmaceutical/Pharmaceutical Packaging Operations is essential.

Key Responsibilities:

The Quality Assurance System Specialist will be responsible for the following key duties:

  • Participating in non-conformance investigations to identify robust root causes and effective CAPA and Continuous Improvement planning.
  • Reviewing and approving quality documentation, such as Investigations, Change Controls, CAPA Verification, and Quality System Record closure approvals, to ensure compliance with Sharp's approach, procedures, and regulatory standards.
  • Verifying Quality System Records (Change Controls, NCR, CAPA, Complaints, etc.) for accuracy, completeness, criticality, and utilizing good judgment and rationale to determine the appropriate content and criticality.
  • Reviewing completed action items for accuracy and compliance to the specific Change Control or CAPA plan and having the independent knowledge and expertise to accept or reject the completed action item based on the associated parent record.
  • Providing direction for change control requests using experience, regulatory guidance, and procedures to make independent decisions, recommendations, and modifications to the record and/or provide clear direction to Change Control Owners on changes or necessary changes.
  • Supporting customer-provided feedback and offering independent recommendations to internal stakeholders on how to proceed.
  • Completing QMS actions related to change controls, non-conformances, complaints, and CAPAs.
  • Supporting customer relationships related to Quality as needed.
  • Proactively identifying and facilitating resolution of potential risks.
  • Identifying issues and independently assessing the need for non-conformance and formulating recommended containment actions in conjunction with Quality leadership.
  • Implementing methods for process control and process improvement as it pertains to the Quality Management System.
  • Auditing Quality System records and processes for consistency while supporting internal stakeholders (operations, sales, customer service, project management, validation, and engineering) to ensure compliance of processes.
  • Reviewing the Quality System for trends and patterns from NCR and Complaint Investigations.
  • Generating, distributing, and participating in Quality system reporting (NCR, CAPA, Change Control, Complaint) while also participating in customer relations.
  • Responsible to monitor, review, analyze, and report on Quality Management System data to Management and Customers.
  • Supporting and leading (as needed) the Change Control Board and Material Review Board for Commercial US sites.
  • Providing Regulatory and Customer Audit Support/assist in providing observation response.
  • Collecting and distributing internal and Customer KPIs as required.
  • Supporting the training department to implement new opportunities for training programs.
  • Ability to simultaneously manage multiple tasks.
  • Must be flexible to meet the needs of the organization when required.
  • Responsible to build the team up by supporting positive teamwork within the department, company, and mentoring others in a positive manner.
Qualifications:

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.

Supervisory Responsibilities:

No direct supervision. Candidate's personal decisions can result in compliance decisions that may have regulatory and financial impact on the company.

Preferred/Required Education and/or Experience:

Bachelor's degree is preferred with three to five years related experience or Associates Degree with five to seven years of related experience. Experience in Pharmaceutical or related industry is required. Strong critical thinking, written, organization, and time management skills required. Prior experience in an electronic Quality Management System required. Outside certification of quality skills and practices (i.e., ASQ, CQIA, CQI, CQT, Lean Six Sigma, etc.) is highly desired.

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.

Disclaimer:

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

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