## Job Title: Electronic Batch Records Systems Analyst
**Location:** Washington, DC
**Position Type:** Full-time
### Responsibilities:
- Maintain and update completed Electronic Batch Records (EBR) as per defined protocols.
- Manage EBR design and configuration changes according to the standard change control procedure.
- Follow up with BT tickets and ensure resolution of EBR issues promptly.
- Identify deviations/exceptions in EBR management and escalate them to leadership as per appropriate procedures.
- Ensure compliance with safety procedures, Good Manufacturing Practices (GMP), and Good Distribution Practices (GDP) in all performed activities.
- Define and analyze business requirements through meetings with production units and develop detailed designs to meet those requirements.
- Collaborate with cross-functional teams to ensure alignment of EBR management with overall business objectives.
- Provide support and training to end-users on EBR systems and processes.
- Perform data analysis and reporting as required by regulatory authorities or internal stakeholders.
- Continuously improve EBR processes and systems to enhance efficiency and compliance.
### Skills:
- Proficiency in Rockwell Pharma Suite and preferably experience with AMPS.
- Strong understanding of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
- Experience with Electronic Batch Records (EBR) management and systems.
- Knowledge of Quality Tracking Systems and experience with system configuration and maintenance.
- Excellent analytical and problem-solving skills.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Attention to detail and ability to work under pressure in a fast-paced environment.
- Proficiency in the management of IDOCs (Intermediate Document) is crucial.
### Qualifications:
- Bachelor's degree in a relevant field such as Computer Science, Information Technology, Engineering, or related discipline.
- Previous experience in a Systems Analyst or Data Management role, preferably in a pharmaceutical or manufacturing environment.
- Proven experience in defining and analyzing business requirements and developing detailed designs to meet those requirements.
- Demonstrated proficiency in Rockwell Pharma Suite and AMPS (preferred).
- Familiarity with regulatory requirements related to electronic batch records management.
- Strong understanding of data management principles and practices.
- Ability to adapt to evolving technology and regulatory requirements in the pharmaceutical industry.
Job Types: Full-time, Contract, Temporary
Pay: $70,000.00 - $90,000.00 per year
Schedule:
Ability to Relocate:
- Washington, DC 20005: Relocate before starting work (Required)
Work Location: In person