The opportunity
Under minimal supervision, this position is responsible for the facilitation and handling of product related complex customer complaints and manufacturing investigations including, but not limited to, the effective execution and management of quality investigations in response to pre-market and post-market manufacturing issues for both Company and Partner products. Including tracking and trending of complaint data, manufacturing deviations and generation of reports related to investigation activity. The position requires QA review/approval of investigation reports, change controls, Standard Operating Procedures, Process Validation Protocols/Reports, new and existing methods/procedures, validation/transfer protocols, investigation documentation, and process/facility change control documents. Leads teams using trend and investigational data to identify potential trends and mitigate through process improvements and failure reduction activities. The individual must perform independently to identify failure modes and related process improvements, facilitating teams and working to implement required changes.
This position receives minimal supervision for most assignments. General instructions are provided for non-standard analyses and projects. Data analysis is complex and requires input from multiple sources and innovative problem-solving. Interfaces to negotiate, collaborate and exchange information with all levels of management. Performs other duties as assigned.
How you’ll spend your day
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Interacts closely with Quality Systems, Operations, Process Technology, Supply Chain, and the Quality Control Laboratory to provide an independent Quality Assurance direction to ensure a thorough and timely review and approval of cGMP documents. Any non-essential functions are assumed to be included in other related duties or assignments.
Primary Activities:
• Responsible for executing and managing investigations for pre-market and post-market manufacturing issues for any products manufactured at the Salt Lake City site.
• Responsible for facilitation and maintenance of communication with applicable associates and managers at the Corporate and Partner level(s) regarding complaint detail through closure.
• Responsible to interact with Production, Engineering, Quality Control and other Production support departments to perform root cause analyses and identify corrective/preventive actions.
• Responsible to identify and investigate post market customer complaint trends.
• Responsible for approving records and acting as backup for management out-of-office.
• Responsible for creating and supporting monthly, quarterly and annual trending reports including compiling analyzing and summarizing data from various databases, reports and other sources.
• Responsible for continuous improvement to increase efficiency; accuracy and compliance.
• Responsible to manage and complete critical Deviation Reports.
• Responsible to review and approve non-complex Deviation Reports.
• Responsible to manage and approve Customer Complaint investigations.
• Responsible to support Manufacturing, Quality Control and Packaging investigations, using root cause analysis tools.
• Responsible to review and approve Standard Operating Procedures.
• Responsible to review Cleaning and Process Validation protocols, reports and deviations.
• Responsible to review and approve SOPs Quality Control Methods, Specifications.
• Responsible to complete special reports and risk assessments.
• Responsible to complete Quality Council Slides and Key Performance Indicator metrics
• Responsible to represent the site and provide support during FDA audits.
• Responsible to represent QA management as a decision maker in cross-functional meetings. Serves as back-up to supervisor, manager and associate director.
• Responsible for completing all training requirements and maintaining compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.
