SUMMARY: The Quality System 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 Systems in customer interactions. The Quality System Specialist is responsible to support, design and implement GMP initiatives and continuous improvement opportunities within the Quality Systems 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 Conshohocken. The impact of decisions relating to customer interface, review and verification of Quality System records, 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 System Specialist position. 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 Investigations, Change Controls, CAPA Verification and Quality System Record closure approvals, etc. by making an independent assessment to ensure compliance with Sharp approach, procedures and regulatory standards.
- Verify Quality System Records (Change Controls, NCR, CAPA, Complaints, etc.) for accuracy, completeness, criticality and utilizes good judgement and rationale to determine the appropriate content is inputted and criticality is selected.
- Responsible to review completed action items for accuracy and compliance to the specific Change Control or CAPA plan. Have the independent knowledge and expertise to accept or reject the completed action item based on the associated parent record (i.e., Change Control, Non-Conformance Record, and CAPA Plan).
- Provides direction for change control requests by using experience, regulatory guidance and procedures in order to make independent decisions, recommendations, and modifications to the record and/or provide clear direction to Change Control Owners on changes or necessary changes.
- Support customer provided feedback and offer independent recommendations to the internal stakeholders on how to proceed.
- 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 Quality leadership.
- Implement methods for process control and process improvement as it pertains to the Quality Management System.
- Audit 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.
- Review the Quality System for trends and patterns from the NCR and Complaint Investigations.
- Generate, distribute and participate 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.
- Support and lead (as needed) the Change Control Board and Material Review Board for Commercial US sites.
- Provide Regulatory and Customer Audit Support /assist in providing observation response
- Collect and distribute internal and Customer KPIs as required
- 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
- 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.