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GMP Technical Writer

Aequor Healthcare Services Saint Joseph, MO Full-Time
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Duration: long-term
Location: St. Joseph Missouri

The basic purpose of this position is to provide investigation into deviation events for products. This position may lead the most complex and abstract investigations of deviations to identify the root cause, impact assessment, and CAPA for the event.
This individual will produce the technical report which details the findings and assessment of the investigation with minimal supervision. The scope of investigations includes but may not be limited to antigen/serum production, central services, blend/fill, packaging/distribution, facility services, QC, QA, calibration and/or validation.
This investigation provides assessment of the quality requirements to comply with USDA, EU, FDA, or GMP regulatory requirements relating to these areas and proposes disposition of the product. This individual may be assigned to or assist with investigational reports not associated local deviations such as TPMQ, complaint, or other facility investigations. This individual may also be assigned to or assist in other quality functions such as Annual Product Review, Documentation Review/Release, Documentation Revision Coordination, Internal Auditing, Change Control, and Inspection Resource Room participant. This individual will be a resource for related technical and compliance information within the Quality and Compliance unit.

1) Investigation and completion of investigation report for products manufactured at/for BIVI. This individual is also responsible for the maintenance of systems associated with the above function.
A) Most complex critical and more abstract investigation reports are completed by due date as identified in procedures.
B) Self tracking of investigation processing.
C) Self prioritization of complex critical investigations.
D) Business critical investigations are completed efficiently to ensure minimal interruption of other business processes.
E) Self prioritization of business critical investigations.
F) Self prioritization of market supply investigations.
G) Individual and group performance is tracked on a weekly/monthly basis through departmental KPI reports.

2) Investigation reports and impact assessments are complete and compliant with regulations.
A) Investigation reports are complete and in compliance with all regulations as well as local procedures.
B) Investigation reports are completed with a high level of decision making and influence of best practice for industry requirements.
C) Large investigations are lead through efficient project management. These projects will have large teams and complex content requiring greater resource requirements.
D) Tracking of investigation and assessment completeness will be evaluated through routine inspection and closeout of deviation records.

3) Serve on assigned internal and external project teams (change controls, process improvements, technology transfer, training, business process excellence, electronic system deployment) as a technical/compliance resource to solve quality related issues.
A) Serve or lead as a QA representative and SME on assigned project teams.
B) Influences the decision making of the project through technical knowledge of industry requirements.
C) Effects the changes developed by the assigned project teams.
D) Communicate new requirements/perform training with QA Investigation team to assure all time-lines are met resulting in successful project completion and new product launches.

4) Assist with internal, regulatory or Corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents.
A) Assist with audit responses and completion of assigned CAPAs by target due dates. Included is the responsibility for making sure QA Investigation areas are "inspection ready " at all times.
B) Influence cross-functional teams to resolve quality issues by referencing appropriate regulations.
C) Manage action items resulting from cross-functional teams by initial target due dates as tracked by internal Quality systems.

5) Performs all company business in accordance with all regulations (e.g. GMP, USDA, FDA, EU, etc.) and Company policy and procedures.
A) Demonstrated high ethical and professional standards with all business contacts in order to maintain BIVI's excellent reputation in the community.
B) When violations are noted or observed, they are immediately reported to management.
C) Successfully completes root cause analysis and annual training on Compliance Modules as assigned by the Company
D) Training completion is monitored on monthly basis through KPI reporting to Quality management.
This position requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source, TrackWise and other relevant electronic applications.
Influencing the understanding of GMP's, root cause analysis, compliance requirements, and regulatory requirements to assess product, procedures, recommended improvements to make quality decisions.
This individual will indirectly lead groups of personnel for projects and teams.
This position is responsible for providing investigations of items with significant direct impact to quality and compliance with high visibility to the company.
This position routinely interacts with internal and well as external departments (QA Technical, Production, Warehouse, QC, Production Planning and Global Supply). This position will frequently interact and influence decisions and effect change plans of personnel of elevated responsibility, both locally and globally. These individuals may include Qualified Persons, site leadership, and department management. Business units interfaced may include production, supply chain, quality assurance, quality control, site services, engineering, or planning.
This position is also required to submit data for weekly/monthly KPI reports.

A BS degree in a relevant scientific discipline plus 8 years relevant experience or MS degree in a relevant scientific discipline plus 5 years relevant experience OR PhD in a relevant scientific discipline plus 3 years relevant experience is required.

-Influencing technical writing skills to provide complete, timely investigation reports.
-Demonstrating logical skills with excellence in written and verbal communication skills.
-Influencing theoretical and practical knowledge of regulated processes and technical disciplines such as root cause analysis, sterilization, aseptic processing, QC testing, quality and compliance, production excellence, and/or maintenance services.
-Able to select, develop, and assess the appropriateness of regulated processes and technical disciplines associated with the manufacture, testing, and verification of products manufactured by BIVI.
-Demonstrating ability to lead and influence large projects and teams.
-Ability to make and influence decisions with minimal supervision regarding the acceptability of product based on investigation provided.
-Technically self-sufficient and proficient in the performance of investigations including root cause analysis, impact assessment, CAPA development, and effectiveness of CAPA plans.
-Excellent attention to detail.
- Fluent reading, writing, and speaking English skills are required for this role.

Recommended skills

Product Quality Assurance
Process Improvements (Business)
Quality Assurance
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