Job Title: Senior QC Information Systems (QCIS) Analyst
Location: Frederick, MD - 100% onsite
Job Description:
As a Senior QC Information Systems (QCIS) Analyst, you will serve as a key liaison between laboratory groups and IT for enterprise projects like Empower, Biovia Laboratory Execution Systems (LES), Labware, LIMS, and other digital initiatives. Your primary responsibilities include administering computerized systems, supporting quality control (QC) lab functions, and ensuring compliance with GMP (Good Manufacturing Practices) in analytical laboratory information systems. You will manage day-to-day operations, troubleshoot technical issues, and participate in software validation activities. Additionally, you will facilitate training for local admins and contribute to the lifecycle management of QC information systems.
Key Responsibilities:
- Administer and maintain lab and manufacturing quality control computerized systems on a daily basis.
- Provide technical support to QC lab operations, resolving a variety of technical issues promptly.
- Participate in software and computer system validation processes, ensuring compliance with regulatory and security requirements.
- Coordinate and conduct training sessions for local administrators, preparing necessary training materials.
- Execute protocols, reports, investigations, and other documentation using Veeva and other QC systems.
- Support the entire lifecycle of QC information systems, from concept and development through validation, implementation, maintenance, and retirement phases.
- Interpret scientific documentation (e.g., quality assay SOPs, Master Specifications) to configure static data and generate reports in LIMS, Empower, and other data management systems.
Requirements:
- Bachelor’s Degree in Information Systems/Technology, Biotechnology, or a related field.
- 0-3+ years of experience in information management, preferably in a scientific laboratory setting.
- Familiarity with GMP and regulatory requirements for analytical laboratory systems is advantageous.
- Experience with software configuration, user management, and troubleshooting in IT environments.
- Strong analytical and problem-solving skills, with the ability to independently represent the team in site and global initiatives.
#IND2
Job Types: Contract, Temporary
Pay: $35.00 - $40.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Referral program
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Application Question(s):
- Are you an US Citizen or GC Holder? What is your work visa status?
- "Please Confirm your personal email address and contact number."
- What is your Expected Pay Range ?
- Are you ready for background check and drug screen in accordance with the local law and regulations?
- Can you describe your experience with configuring and administering software systems such as Empower, Biovia Laboratory Execution Systems (LES), Labware, or LIMS?
- What is your understanding of Good Manufacturing Practices (GMP) as they apply to analytical laboratory information systems?
- Can you share a challenging technical issue you encountered in a previous role related to QC information systems? How did you approach and resolve it?
- Describe your experience in preparing technical documentation, such as SOPs, validation protocols, or training materials for software applications.
- Give an example of a project you managed related to software/systems implementation or lifecycle management in a laboratory setting. What were the key challenges, and how did you overcome them?
Education:
Ability to Commute:
- Frederick, MD (Preferred)
Ability to Relocate:
- Frederick, MD: Relocate before starting work (Preferred)
Work Location: In person