Allentown, Pennsylvania, United States · On-site
SUMMARY: The Sr. Data Integrity Specialist will concentrate on delivering subject matter expertise in GxP (GMP and GDP) to ensure compliance with data integrity standards. The position will support the Data Integrity Gov…
Skills: Data Integrity, GxP, GMP, GDP, Quality Risk Management
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The Senior Data Integrity Specialist provides subject matter expertise in GxP to ensure compliance with data integrity standards across Sharp US Commercial sites. They are responsible for managing governance programs, overseeing remediation efforts, and coordinating activities between Quality, IT, and other departments.
Candidates must have at least four years of direct data integrity experience and a strong understanding of pharmaceutical regulatory requirements. An associate or bachelor's degree is preferred, along with excellent documentation, interpersonal, and project management skills.
SUMMARY:
The Sr. Data Integrity Specialist will concentrate on delivering subject matter expertise in GxP (GMP and GDP) to ensure compliance with data integrity standards. The position will support the Data Integrity Governance program through assessment/remediation activities and is responsible for maintaining the Sharp US Commercial-wide Data Integrity governance system, ensuring that all regulatory and Sharp requirements are met comprehensively and promptly. Additionally, the role involves communicating data integrity principles and training individuals at all levels within the organization.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The following is a list of minimum responsibilities related to the Senior Data Integrity Specialist position. Other duties may also be assigned.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
SUPERVISORY RESPONSIBILITIES:
Moderate, including scheduling, oversight of assigned projects, and supporting Data Integrity Director as requested.
PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:
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 accommodation may be made to enable individuals with disabilities to perform the essential functions.
Essential skills include:
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 accommodation may be made to enable individuals with disabilities to perform the essential functions.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation 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.
A specialist CDMO delivering commercial packaging, clinical trial and sterile manufacturing services
Sharp helps pharmaceutical and biotech companies bring therapies to patients worldwide. As a specialist CDMO, we provide commercial packaging, clinical trial, and sterile manufacturing services. For more than 70 years, we have helped clients navigate complexity across the product lifecycle—from pre-clinical development through commercial launch and beyond. With facilities in the United States, United Kingdom, Belgium, and the Netherlands, and a global network of more than 30 clinical depots, we support our clients with the precision, quality and reliability they can lean on. We’re a team of 2,500+ united by our common purpose which is to help make lives better. Sharp consistently invests in the global capacity our clients need to innovate, evolve, and deliver. So, their therapies reach the patients who need them.
Offices: 7451 Keebler Way, Allentown, PA 18106, US · Unit 28, Heol Klockner, Heads of the Valleys Ind Est, Rhymney, Wales NP225RL , GB · 23 Carland Rd, Conshohocken, Pennsylvania 19428, US · 2400 Baglyos Circle, Bethlehem Township, Pennsylvania 18020, US · Klöcknerstraat 1 b, Hamont, Flemish Region 3930, BE
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