Under minimal supervision, this position is responsible for assisting in managing the review of quality systems and compliance in all areas of technical and clinical operations. This position serves as a resource to operations on quality issues. Participates in performance improvement initiatives through data and process analysis.
DUTIES AND RESPONSIBILITIES:
Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.
Assures quality customer service to all customers.
Maintains good attendance and punctuality per the absence policy.
May assist with coordination of workflow, training, and mentoring of support staff, as required.
Conducts data and process analysis activities including in-depth analysis of deviation and operational performance data. Evaluates data for trends and opportunities for improvement. Facilitates and/or leads improvement initiatives including the use of Six Sigma, Lean, and other improvement tools and methodologies. Serves as an improvement resource to operations.
Leads and participates in process design activities for new and changed processes in identified operational subject matter areas. Participates in the development, evaluation, and launch of Workflow Standards documents. Participates in change implementation and evaluates process changes to include where applicable; planning, pre-implementation, and post-implementation audits.
Supports the internal audit program. Assists operations in evaluating observations, performing investigations, and root cause analysis. Aids in the development of corrective action. Performs follow-up on audit observations. Tracks responses, monitors implementation, and ensures effectiveness of corrective action.
Performs failure mode analysis, risk analysis, risk assessments, and flow analysis of process changes. Conducts analysis on pilot and validation study data. Analyzes process changes. Works with Central Office Performance Improvement and operational staff to evaluate performance improvement needs.
Ensures requests for required regulatory licenses are submitted timely.
Tracks and trends deviations. Identifies areas for improvement and communicates these issues to operations. Ensures all required deviation management reports are accurate and timely. Ensures data entry is performed and events are accurately coded in data management system. Reviews and approves corrective action. Performs effectiveness checks for corrective actions.
Facilitates recalls and market withdrawals.
Hosts external inspections. Assists in facilitating responses to observations. Ensures corrective actions were implemented and effective.
Performs review of documents to ensure processes are within control (e.g., QC data, validations, proficiency testing).
Participates on review team to evaluate nonconforming products, materials, or test results and assesses the impact on external customers. Ensures required actions are implemented.
Assists in the oversight of Clinical Trial Studies.
Performs all other duties, at the discretion of management, as assigned.
Bachelor’s degree or equivalent combination of education and experience required.
Certification as a Medical Technologist or SBB preferred.
Four years related experience in a regulated industry required. To include:
Two years in a quality, regulatory, and/or auditing environment.
Six months supervisory experience preferred.
Must possess the skills and abilities to successfully perform all assigned duties and responsibilities.
Must be able to maintain confidentiality.
Ability to work in a team environment and participate as an active team member.
Must have proficient computer skills.
Must have analytical, statistical, personal organization, and problem solving skills.
Able to organize, prioritize, and execute a variable workload and multiple priorities.
Must have proficient computer skills.
Our organization is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability, please send an e-mail firstname.lastname@example.org or call 1-844-220-2612 to let us know the nature of your request. A representative will respond to accommodation requests within two business days. Please note that this email/phone number is for medical/disability accommodations only and any other inquiries will not receive a response.
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All candidates who receive a conditional written offer of employment will be required to undergo a pre-employment drug test in accordance with the Company’s established guidelines.