5163 QA Associate I
Main Purpose of the Position:
Solve routine Manufacturing Quality Assurance and Product Release issues limited in scope and complexity following cGMP regulations and the Company standards.
Perform assigned tasks and work to achieve company goals and department objectives.
Follow company policies and procedures.
Maintain a state of inspection readiness.
Provide input to the development of personal performance goals and departmental objectives.
Meet assigned targets and timelines with minimal supervision.
Prioritize assigned tasks within a fast paced environment.
Participate in process improvement and system design teams.
Provide assistance to customers in support of departmental functions.
Work with colleagues to maintain cross-functional and cross-site process and procedural consistency.
Receive specific instruction and work independently to complete tasks.
Apply basic theory and technical principles to address routine problems.
Troubleshoot and assist in the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
Sign documents for activities as authorized and described by the Company’s policies, procedures and job descriptions.
Be accountable for behaviors as described in the Company’s Core, Common, and Critical Competencies.
Perform any other tasks as requested by Management to support Quality oversight activities.
Evaluate and close complex, non-investigational discrepancies.
Initiate discrepancy investigations as required.
Draft and route discrepancy summaries to Discrepancy Management.
Perform Assessor and Evaluation activities defined in the Discrepancy Management System (DMS).
Review and close completed evaluations and perform additional activities as warranted in the Discrepancy Management Systems (DMS).
Review, edit and approve controlled documents.
Assess and summarize complex process deviations.
Collaborate with internal and external departments on MQA and Product Release projects and commitments.
Monitor MQA activities to evaluate trends, and report repetitive anomalies, observations, and discrepancies to Management.
Represent MQA at cross-functional meetings to develop, review, and approve Commercial Quality documents.
Participate in the MQA review audit program and the Raw Material Reconciliation process.
Independently manage daily activities in order to meet standard lead times.
Qualifications: Education, Experience, Knowledge and Skills:
B.A. or B.S. degree (preferably in Life Science) and 0-2 years experience in a related industry.
Knowledge of cGMPs strongly preferred.
Ability to interpret Quality standards for implementation.
Ability to communicate clearly and professionally both in writing and verbally.
Flexibility in problem solving and work hours to meet business objectives.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.