Operation Support Specialist - Weekend PM

Simtra BioPharma Solutions•Bloomington, IN

3d•Onsite

About The Position

The Operations Support Specialist is an embedded Operations partner assigned to support manufacturing shifts within an Operations Focus Factory. The Specialist works directly with on-shift Manufacturing and Quality colleagues during operational events to support deviation response, capture critical details, help initiate deviations promptly, and support a safe, compliant return to operations. The role serves as a primary author of manufacturing deviations and is expected to write and close approximately three to four deviations per month, depending on event volume and complexity. The Specialist also owns and drives assigned CAPAs and continuous improvement actions related to manufacturing processes, and oversees CAPA effectiveness after implementation. The assigned shift is 3:00 p.m. to 1:30 a.m., Friday through Monday. The Specialist partners across Manufacturing, QA, Engineering, Maintenance, Validation, and other functions to investigate events, coordinate recovery, and maintain quality and compliance expectations. The role also supports continuous improvement, clear cross-shift communication, coaching on event documentation and GMP practices, and inspection-ready records.

Requirements

Bachelor's degree in Life Sciences, Engineering, or a related field; equivalent relevant experience may be considered in accordance with HR guidance.
Ability to work assigned shift coverage, including second shift, third shift, Weekend AM, or Weekend PM, as assigned by business need.
Strong written communication skills and ability to translate complex manufacturing events into clear, factual, logically structured investigation narratives.
Demonstrated ability to work effectively with Manufacturing, QA, technical subject matter experts, and site support functions in a fast-paced production environment.
Ability to execute multiple investigations and CAPA actions while maintaining attention to detail, compliance, safety, and product quality.
Must wear appropriate personal protective equipment as applicable.
Duties may require overtime, including nights and weekends.
Ability to use hands and fingers to manipulate office equipment.
Position requires sitting for long periods and may involve walking or standing for periods of time.

Nice To Haves

Working knowledge of GMP documentation practices, data integrity principles, deviation investigations, root cause analysis, and CAPA execution.
Experience in sterile, aseptic, pharmaceutical, biotechnology, or other highly regulated manufacturing operations.

Responsibilities

Partner with Manufacturing and QA during operational events to understand what happened, what was impacted, actions taken, and information to preserve for investigation.
Capture timely event details, including timing, equipment state, batch or material identifiers, personnel, process parameters, alarms, documentation status, environmental or area conditions, and containment actions.
Support timely initiation of deviation investigations and clear handoffs when events span shifts or weekends.
Coordinate with Manufacturing, QA, Engineering, Maintenance, Validation, and other partners to support a safe, compliant return to operations.
Serve as a primary author for assigned manufacturing deviations.
Write complete, clear, technically sound investigations, including event chronology, impact assessment input, immediate actions, root cause analysis, corrective and preventive action rationale, and objective evidence.
Use appropriate structured root cause tools, such as 5 Whys, fishbone/Ishikawa, fault tree, process mapping, human performance analysis, and data trending.
Drive assigned deviations to timely closure and coordinate input from relevant subject matter experts and support functions.
Write and close approximately three to four deviations per month, adjusted for complexity, business priorities, and quality system requirements.
Identify recurring event themes, process vulnerabilities, documentation gaps, human-factor contributors, training opportunities, and equipment or workflow issues for continuous improvement actions.
Own and execute assigned CAPA actions related to manufacturing processes and recurring operational issues, as appropriate.
Lead or support continuous improvement actions that improve manufacturing reliability, right-first-time execution, aseptic practice, documentation accuracy, downtime recovery, and batch release readiness.
Build credibility with manufacturing personnel, QA representatives, and technical support functions through visible, responsive, practical floor presence.
Communicate event status, investigation needs, action owners, and next steps across shifts and functions.
Participate in shift handoffs, tier meetings, deviation review routines, CAPA progress reviews, and Focus Factory performance discussions as assigned.
Coach manufacturing colleagues on event detail capture, GDP expectations, deviation readiness, and prevention mindsets without replacing QA decision authority.
Maintain accurate, timely, traceable, inspection-ready investigation and CAPA records, objective evidence, and supporting documentation.
Follow applicable GMP, data integrity, site deviation, CAPA, continuous improvement, change control, training, and document control procedures.
Promptly escalate quality, safety, compliance, or supply risks through established channels.
Perform other duties as assigned.