Quality Assistant I

Title: Quality Assistant I

Location: Baltimore, MD

Start date: ASAP

Responsibilities:

• Quality Assistant I is responsible for the performance of a wide variety of activities that contribute to the production of pharmaceutical products that meet regulatory requirements.
• The Quality Assistant I is responsible for strictly following all standard operating procedures and company policies for accurately sampling materials, checking measurements, confirming Production results, creating / updating documents, and maintaining recordkeeping systems to ensure compliance with applicable regulatory requirements.
• This position takes appropriate measures to consistently produce error-free work.
• This position conducts certain QA inspections in a cleanroom environment. This position also contributes to projects and special assignments as assigned.
• The incumbent is assigned to duties based on demonstrated training and skill sets.
  The Quality Assistant I works on complex problems and issues with general management direction.
• Conduct tasks that provide the data required to demonstrate that pharmaceutical products meet regulatory requirements. The primary responsibilities for this position include, but are not limited to:
• Perform Quality Assurance inspections for operations within the Clean Room environment.
• Execute AQL Sampling and Inspection activities for raw materials, packaging components, and finished products.
• Perform Area Clearance, in-process inspections, and labeling material issuance.
• Execute and manage the Retains and Returned Goods processes
• Periodically summarize status and progress of assigned activities as requested by Supervisor.
• Function as primary administrator and/or back up for at least one Quality system, to include but not limited to: Document Control process, Quality Training System, and/or the Material Identity Control System (Part number List), etc.
• Draft and/or contribute to QA documentation, including deviation reports, standard operating procedures (SOP), and Quality metrics/trend data.
• Other duties as assigned to facilitate ongoing Eisai Baltimore/Gliadel production and/or operational activities.

Requirements:

• High School Diploma with 3-5 years’ experience; or undergraduate degree in a scientific-related field with 0-2 years of experience in the Pharmaceutical/Biotech industry,
• Experience in a GMP regulated environment preferred.
• The individual also needs to have their own transportation as we will soon begin transferring work back and forth between our current and new site (no public transportation.
• Ability to accurately follow instructions and standard operating procedures.
• Ability to anticipate potential problems and take proactive action to avoid them.
• Ability to anticipate consequences of actions and understand the impact to other areas.
• Ability to independently prioritize, plan and schedule.
• Demonstrates strong organizational skills and the ability to be flexible based on the needs of the organization.
• Ensures the timely follow up to satisfactorily resolve problems.
• Possesses knowledge of CGMPs (relevant laws, guidance, directives and industry practice) and demonstrates ability to apply appropriately and consistently.
• Ability to work and coordinate activities across multiple functional groups with professionalism and a sense of urgency.
• Ability to work in controlled environment and the ability to sit or stand for prolonged periods.
• Possesses excellent written and verbal communication skills.
• Ability to be successful as part of a team and as an individual contributor with minimal supervision.
• Proficient in utilizing standard computer systems (i.e., MS Word and Excel, Outlook).

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.