QA Analyst II

Title: Quality Assurance Analyst II 

Location: Rockville, MD 20850

Schedule: Normal business hours

Type: 6 month Contract-possibility of extension or conversion based on continued business need and performance

Payrate $30-$36 an hr

Start date: Immediate

Responsibilities:

• QA on the floor for Manufacturing and QC, providing quality oversight of production and QC inspection/testing processes.
• Critically reviews executed GMP documents such as batch records, logbooks, EM data, and cycle reports.
• Writes / revises Standard Operating Procedures (SOPs) in the document management system.
• Reviews and approves GMP documents such as SOPs, master production batch records, forms, and logbooks in the document management system.
• Actively involved in daily operations to meet schedules or to resolve problems.
• Demonstrates strong organization skills related to priorities and workload. Ability to solve problems independently and within a team environment.
• Identifies opportunities for improvement within scope of work.
• Supports Operational Excellence initiatives related to the QA team.
• Participates in inspections/audits by providing documentation to fulfill requests for information and contributing in the inspection/audit as needed

Requirements:

• BS or BA degree preferred with 3 years of GMP experience in QA/QC role
• Minimum of one year in a FDA regulated industry.
• Must pay strong attention to detail.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Excellent written and verbal skills.
• Ability to exercise judgment to determine appropriate corrective actions.
• Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.
• Ability to use computer programs such as Veeva and SAP.
• Ability to work in a team environment.
• Proficient knowledge of cGMP.
• Coordinate multiple tasks simultaneously.
• Understands and responds to a diverse population.
• Ability to make sound decisions regarding compliance-related issues with moderate supervision.
• Strong leadership skills; high level of personal/departmental accountability and responsibility.

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services.  For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.