SUMMARY:
Quality Assurance (QA) is responsible for ensuring that components, intermediates, drug substance, and drug product are of the quality required for their intended use and that quality systems are maintained. With minimal oversight and/or independently, the QA Associate II will perform a variety of duties associated with the Office of Regulatory Affairs and Quality in support of the GMP programs at CLIENT, including, but not limited to, release of products/clinical trial material, assistance with deviations and event management, review of vendor qualifications, analysis of environmental monitoring data, training on GMP requirements, and oversight of component control and disposition. This position will consult with manufacturing operations staff, as applicable/requested, to serve as a resource.
WORK PERFORMED:
With minimal oversight by management or independently:
Provide support and review of change control as it relates to development, modification, and manufacturing process changes.
Represent the Quality Department at project meetings and provide guidance.
Write, revise, and review SOPs.
Assist with continuous improvement projects and initiatives.
Track and trend metrics and identify areas of concern.
Assist in managing quality related matters during inspections.
Review and provide guidance for deviations and investigations.
Collaborate with end users about deviations, issues, and unexpected events that may arise.
Train staff on proper GMP, performing investigations, and root cause analysis.
Review product records for release.
Participate in multiple programs in varying phases of development or that require varying levels of QA involvement.
Conduct Environmental Monitoring of facilities and assist in data analysis.
Conduct audits under the supervision of the Lead Auditor and generate audit reports.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
MINIMUM QUALIFICATION REQUIREMENTS:
Bachelor’s degree
5 years of experience in a GXMP or similar regulated environment
Experience training users on implementing Quality Systems
Prior laboratory experience preferred
Experience in preparing for external audits and/or site visits
Experience in reviewing raw materials, supplies, and manufactured products for acceptability
A Master's or PhD can substitute for experience
Proficient knowledge in GLP, GMP, and/or GTP
Demonstrate leadership, organizational, and time management skills and the ability to handle a multitude of tasks
Have ability to train other staff members effectively
Attention to detail in document review
Team player with sense of urgency to carry out tasks in a timely and accurate manner.
Ability to interact well with employees at all levels.
Strong organizational skills.
Excellent verbal, written, and interpersonal skills. Possess good problem-solving skills.
Adapt to changing priorities effectively.
Able to work effectively independently or in a team environment.
