Manufacturing Investigations Specialist II

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

This position is primarily responsible for management and completion of site investigations.  This position is an individual contributor role that works cross-functionally to support manufacturing production activities, ensure compliance with regulations and drives continuous improvement by ensuring through investigation and documentation of facts. Investigation Specialists are responsible for collecting information used to assess impact, identify root cause, and mitigate recurrence through CAPAs. This position requires attention to detail, organization, multi-tasking, and comfort interacting cross-functionally with people who might be junior or senior to the incumbent.  The successful candidate is able to work under the appropriate amount of direction based on level and possesses the ability to work on complex problems by analyzing procedures and data to create solutions.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Owns, leads, authors, and drives site investigations to closure within required timelines.
• Participates in or leads deviation related meetings.
• Cross-functional Triage meetings: to gather facts/data upon event discovery
• Investigation planning meetings: to align on the investigation findings and ensure internal review team and area subject matter experts on an agreed upon investigational path forward.
• Deviation and CAPA Review Board meetings: to update leadership on current status of investigations.
• Specialist actively participate in and occasionally lead Triage meetings and Deviation Review Board meetings.
• Identifies Root Cause by utilizing common and advanced root cause analysis tools such as Control Charts, Fishbone Diagrams, 6Ms and 5 Whys.
• Authors Minor, Major and Critical investigation reports by utilizing robust technical writing skills to communicate moderate to complex technical issues.
• Serves as liaison between multiple teams including Manufacturing, MSAT, Engineering, Quality Control, Supply Chain and Quality Assurance to conduct and complete thorough deviation investigations.
• Ensures appropriate CAPAs are defined to address the identified root cause, and suitable Effectiveness Checks are put into place to proactively ensure the effectiveness of the CAPA.
• Monitors assigned deviations to ensure on time closure.
• Participates in the Quality Risk Management program when requested.
• May support regulatory inspections as a Subject Matter Expert (SME) for Deviations.

QUALIFICATIONS

• Strong knowledge of cGMP regulations and the ability to apply them to commercial manufacturing. Biotech industry experience strongly preferred.
• Knowledge and understanding of Root Cause Analysis processes in a regulated environment.
• Proven technical writing skills within a cGMP manufacturing environment are required. Formal Technical Writing certification is strongly preferred.
• Skilled in effective verbal and written communications.
• Demonstrated ability to work collaboratively to accomplish deadlines and objectives.
• Comfortable asking probing questions and speaking up when complex deviations occur to ensure understanding and alignment.
• Ability to respond quickly to complex inquiries from customers, co-workers, and supervisors regarding deviation details.
• Knowledge of and skill in using computer software and hardware applications. Proficiency with Microsoft applications, including MS Word, MS Excel and Teams (required), and with eQMS applications such as TrackWise (preferred).
• Demonstrates self-awareness regarding personal behaviors that foster a supportive environment, encouraging others to feel comfortable acknowledging and addressing mistakes.
• Ability to perform personnel interviews in an approachable, blame-free manner.
• Demonstrated ability to work in a fast-paced environment, with the ability to manage multiple projects and objectives for on-time event closure.
• Ability to be proactive, detail-oriented, and adapt to changing priorities.

EDUCATION and/or EXPERIENCE

• BS in scientific discipline such as Bioprocess Engineering, Biochemistry, Chemistry, Biology or related discipline.
• Experience with quality management system (MasterControl, TrackWise, etc.) software preferred.
• Experience interacting with clients in a Contract Development and Manufacturing Organization (CDMO) preferred.
• Flexible, have the availability to work 12 hours, 2-2-3 shift schedule necessary to support production and / or maintenance activitie