Quality Investigation Specialist - Osmotica

POSITION DETAILS

Position Title:

Quality Investigation Specialist / Sr. Specialist

Function:
Quality

Reports To:

Director of Quality

Location:

Marietta, GA

The Investigation Specialist or Sr. Specialist collaborates with Marietta site investigators in conducting and authoring Deviation Investigations to ensure adequate root cause analysis and corrective and preventive actions are implemented, based on quality and regulatory requirements (21 CFR 210 and 211). This is accomplished through partnership with investigation writers from deviation owning departments, such as Production, Analytical Sciences, Engineering, Validation, and Pharmaceutical Sciences.

The Investigation Specialist or Sr. specialist works with the corporate quality team and site departments for writing and resolution of product complaint investigations for the Osmotica site.

• Represent QA on investigation teams
• Conduct investigations into Quality-related non-conformance events
• Act as lead technical writer for Quality
• Leads and/or participates in collaborative triage meetings for Major and Critical Deviations
• Review Events, Deviations, CAPAs, and Issue Reviews, ensuring proper root cause analysis
• Assess risk associated with Events, Deviations (Minor, Major, and Critical) and Issue Reviews
• Determine the acceptability of corrections, corrective actions, and preventive actions, driving prevention of repeat non-conformances
• Assign, launch, and approve Action Items initiated as CAPAs resulting in deviations
• Monitor and track status of all QMS records, conducting weekly status meetings to maintain site visibility to QMS timelines
• Perform product complaint investigations for the Osmotica site in collaboration with the corporate quality team and site departments
• Perform training for site employees involved in writing, review, or approval of deviations, laboratory investigations, CAPA, Issue Review, and other related documents
• Support the development and management of quality metrics to optimize performance, productivity and effective resource planning
• Maintain awareness of current regulatory trends and impact on the site relating to investigations and CAPAs
• May support, coordinate, and interface with regulatory agencies in support of regulatory agency inspections
• Perform other QA activities and responsibilities as assigned by management

• BS in science discipline
• 3-5 years’ work experience in GxP regulations including investigation into non-conformance events in a pharmaceutical environment
• Work experience in conducting and/or reviewing non-conformance investigations and/or procedural deviation records.
• Ability to work independently, interpret and assess technical documents, communicate and interact effectively across multiple organizational levels
• Ability to organize and adapt to organization priority changes and work effectively with minimal supervision with a sense of urgency
• A high level of proficiency in Microsoft Office applications required

Preferred Experience

• Experience with computerized QMS (e.g., Track Wise, eCQM, Veeva, Master Control) systems
• Working knowledge of the following:
  • Technical Writing
  • Root Cause Analysis
  • CAPA
  • Process Control Systems
  • Laboratory Equipment and Instrumentation
  • Packaging and Labeling Equipment, Serialization
  • FDA’s current expectations related to thorough investigations and CAPAs

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the essential duties of this job the employee is frequently required to stand, walk, and reach with hands and arms. The employee is regularly required to sit, use the hands and fingers to type via the use of the PC (Personal Computer). There are no lifting requirements. Periodic/infrequent travel to sister sites may be required. No Personal Protective equipment required, unless entering production areas.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified