Operation Support Specialist - Weekend AM

Simtra BioPharma Solutions•Bloomington, IN

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 after incidents. The Specialist is 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 role also owns and drives assigned CAPAs and continuous improvement actions related to manufacturing processes, and provides oversight of CAPA effectiveness after implementation. The position works Friday through Monday, 5:00 a.m. to 3:30 p.m. It requires close collaboration across Manufacturing, Quality Assurance, Engineering, Maintenance, Validation, and other functions, as well as accurate, timely, traceable, and inspection-ready records. The Specialist supports GMP, data integrity, safety, quality, and compliance expectations while helping manufacturing return to production after incidents.

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.
Demonstrated ability to work effectively with Manufacturing, QA, technical subject matter experts, and site support functions in a fast-paced production environment.
Ability to manage multiple investigations and CAPA actions while maintaining attention to detail, compliance, safety, and product quality.
Must wear appropriate personal protective equipment as applicable.
Use of hands and fingers to manipulate office equipment is required.
Position requires sitting for long hours and may involve 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 occurred, what was impacted, immediate actions taken, and information to preserve for investigation.
Capture critical 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 clear handoffs when events span shifts or weekends.
Coordinate with Manufacturing, QA, Engineering, Maintenance, Validation, and other partners to support a safe and compliant return to operations.
Serve as a primary author for manufacturing deviations assigned to Operations Support.
Write complete, clear, technically sound investigations covering event chronology, impact assessment input, immediate actions, root cause analysis, corrective and preventive action rationale, and objective evidence.
Apply structured root cause tools as appropriate, including 5 Whys, fishbone/Ishikawa, fault tree, process mapping, human performance analysis, and data trending.
Drive assigned deviations to timely closure by coordinating input from Manufacturing, QA, Engineering, MSAT, Validation, Microbiology, Training, and other subject matter experts.
Complete approximately three to four deviation closures 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 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 clearly 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, and 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.