Principal Operations Quality Engineer

WHAT WE ARE LOOKING FOR

This position is an active principal level position within the QA Compliance department. The position may have direct reports and is required to work cross functionally throughout the plant to ensure compliance levels are maintained and that results are obtained from indirect reports. This person is expected to be a SME (Subject Matter Expert) for site compliance related functions including Exceptions, CAPAs, Complaints, Remediation Enhancements, and Trending.

YOUR ROLE

Primary duties include:

• Lead position in the site execution of external audits from regulatory agencies (i.e SME, Inspection Room Representative). Position will take a lead role in the formulation of inspection responses and commitment completion follow-up.
• Assist in the department completion of trending and metrics (i.e Cost of Poor Quality, Key Performance Indicators, Quality Management Reviews, & Data Trend Analysis)
• Complete department requirements for site Annual Product Quality Reviews (APQRs). Must have the ability to assess shifts and trends, as well as associate CAPA response as it relates to data obtained.
• Ability to write, review and final approve site related complaints, exceptions, and CAPA RCA investigations within a timely manner. When needed, may also perform investigations within each of the compliance quality systems.
• Possess process technical knowledge and writing capabilities.
• Ability to lead site Kaizens or brainstorming initiatives.
• Ability to support site annual or non-routine GMP training.
• Primary designee for Quality Operations Manager in his/her absence.
• Proactively manage and maintain regulatory compliance (US/EU/WHO/Brazilian/Korean standards).
• Providing day to day supervision and oversight of Operations QEs.
• Performs other duties as assigned by management.

Department Specific/Non-Essential Functions:

• Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately.
• Support various information requests from Corporate and other departments. Interact with corporate support groups to drive global continuous improvement validation and supplier management programs.
• Assist QA Compliance Manager with special assignments or projects as directed.
• Seek out and apply best quality assurance methods and practices in support of Quality objectives.
• Performs other duties as assigned by management.

YOUR BACKGROUND

• Education required/ preferred: Minimum BS/BA degree in Life Sciences or Business. MS preferred.
• Experience: Minimum 8-12 years’ experience in a pharmaceutical setting.
• Preferred Skills/Qualifications: ASQ certified inspector/auditor preferred.
• Analytical knowledge of Microbiology and Chemistry is preferred.
• Good documentation skills with eye for details and ability to identify hidden problems within processes and systems.
• Skills/Competencies: Ability to work in a fast-paced environment; Proficient in multi-tasking; Well organized and reliable for consistent decision making
• Other Skills: Strong Technical Writing Skills; Competent with MS Office software environment; Ability to interact with all levels of the organization.

Physical Requirements:

• May be required to sit or stand for extended periods of time.
• May have extended exposure to computer screens.

Cognitive Requirements:

The position routinely interfaces with various personnel from all site departments (Operations, M&D, Engineering, QC and QA), as well as corporate personnel and external suppliers. The position will require independent decisions and personal judgment based on company policies, SOPs, and GMPs.