Quality Engineer - Osmotica

POSITION DETAILS

Position Title:

Quality Engineer / Sr. Quality Engineer

Function:

Quality

Reports To:

Director of Quality

Location:

Marietta, GA

POSITION OVERVIEW

The Quality Engineer has the quality oversight over all site validation/qualification activities to ensure quality and regulatory requirements (21 CFR 210, 211, and Part 11) are achieved. Validation activities include, but are not limited to, the implementation and maintenance of GxP facilities, utilities, equipment, computerized systems, process validation and cleaning validation. This is accomplished through partnership with the Technical Services Department, Pharmaceutical Sciences Department, IT Department, Operations and system/process owners to ensure validation compliance requirements are defined and followed.

DUTIES AND RESPONSIBILITIES

• Provide oversight for GMP validation/qualification activities
• Represent QA on project teams; leads and/or participates in special projects
• Review and approve validation/qualification protocols and reports
• Determine the acceptability of validation procedures and activities
• Coordinate the development of validation life cycle documentation and tasks to establish systems that meet current regulatory requirements and industry standards
  • Life cycle documentation includes, but is not limited to: validation plans, FAT, SAT, URS, functional and design specifications, risk-analysis, traceability matrices, SOPs, protocols, and summary reports
• Work as part of project teams to evaluate the extent and impact of changes to facilities, utilities, equipment, computerized systems, production processes, and cleaning validation status
• Participate in improvement of validation/qualification processes to ensure quality and adherence to cGMPs
• Serve as the point of contact for administering, processing, and completing validation change control requests
• Conduct, review, and/or approve 21 CFR Part 11 assessments on new and existing computerized systems and GxP software/vendors; review and disposition periodic re-qualification assessments
• Seek out and recommend opportunities for increased quality system efficiencies and operational improvement through modifications to current systems, implementation of new systems, and more efficient use of established system
• Facilitate review and improvement of SOPs associated with the validation compliance
• 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 validation status of systems and processes
• May support, coordinate, and interface with regulatory agencies in support of regulatory agency inspections
• Perform other QA/technology-related activities and responsibilities as assigned by management

EXPERIENCE AND QUALIFICATIONS

• BS in engineering or science discipline
• 3-5 years' work experience in GxP regulations including validation/qualification of facilities, utilities, equipment, computer systems, process validation and cleaning validation processes in a pharmaceutical environment
• Work experience in generating, reviewing, and executing validation and change control documents, authoring SOPs, and providing training on processes.
• Ability to work independently, interpret and assess technical documents, communicate and interact effectively across multiple organizational levels
• Working knowledge of validation lifecycle methodologies
• 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 working with computerized ERP systems (e.g. SAP) and/or QMS (e.g., Track Wise, eCQM, Veeva, Master Control) systems
• Working knowledge of the following:
  • Facility Commissioning and Qualification
  • Utility Systems
  • Process Control Systems
  • Process Equipment and Utilities
  • Laboratory Equipment and Instrumentation
  • Packaging and Labeling Equipment, Serialization
  • FDA's current expectations related to PV/Process Performance Qualification (PPQ)

OTHER REQUIREMENTS

PHYSICAL DEMANDS

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…