Operation Support Specialist - Shift 3

Simtra BioPharma Solutions•Bloomington, IN

1d•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 Manufacturing and Quality colleagues during operational events to capture critical details, help initiate deviations promptly, and support a safe, compliant return to operations. The role is a primary author of manufacturing deviations, with an expected workload of approximately three to four deviations written and closed 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 role supports deviation response and investigation authoring, coordinates with cross-functional partners to move investigations toward timely closure, and identifies recurring events and operational vulnerabilities that may warrant corrective actions or process improvements. It also supports compliance, documentation quality, inspection readiness, shift communication, and coaching on event documentation and GMP practices. The assigned shift is 2:30 a.m. to 11:00 a.m., Monday through Friday. Duties may require overtime, including nights and weekends. The role requires use of appropriate personal protective equipment, prolonged sitting, and may involve periods of walking or standing.

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 2nd shift, 3rd 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.
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.
Wear appropriate personal protective equipment as applicable.
Use hands and fingers to manipulate office equipment; sit for long hours, with possible periods of walking or standing.
Duties may require overtime, including nights and weekends.

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 colleagues during operational events to understand what happened, what was affected, what immediate actions were taken, and what information must be preserved.
Capture event details, including timing, equipment state, batch or material identifiers, personnel involved, process parameters, alarms, documentation status, environmental or area conditions, and containment actions.
Support timely initiation of deviation investigations and ensure 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 after incidents.
Author manufacturing deviation investigations, including event chronology, impact assessment input, immediate actions, root cause analysis, corrective/preventive action rationale, and objective evidence.
Use structured root cause tools such as 5 Whys, fishbone/Ishikawa, fault tree, process mapping, human performance analysis, and data trending as appropriate.
Drive assigned deviations to timely closure while coordinating 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 potential continuous improvement actions.
Own and execute assigned CAPA actions related to manufacturing processes, documentation, training, equipment interfaces, behavior-based errors, process controls, and recurring operational issues.
Lead or support continuous improvement actions to improve manufacturing reliability, right-first-time execution, aseptic practice, documentation accuracy, downtime recovery, and batch release readiness.
Build credibility with manufacturing operators, group leaders, supervisors, QA representatives, and technical support functions through visibility, responsiveness, and practical support on the manufacturing floor.
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 records, 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.