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Quality Assurance Associate at Elanco

Posted in General Business 30+ days ago.

Type: Full-Time
Location: Fort Dodge, Iowa





Job Description:

Interested in joining a cause-driven, customer focused company dedicated to positively impacting the health of animals, people and the planet? Search our job listings below.


 

The purpose of this position is to provide administrative coordination and technical direction to persons responsible for Annual Outline Review and internal approval processes for Outlines of Production (OP) and Special Outlines (SO), which are regulated documents with the USDA Center for Veterinary Biologics.

The position interacts with all areas of Manufacturing, Quality and Regulatory Affairs to maintain compliance of operations as stated in the OPs and SOs.  This position will have responsibility for activities at all Est. 196 locations (Fort Dodge, IA and Winslow, ME).

This position shares successful processes and programs with other sites in Elanco network in order to build cross site processes.  

Accountabilities:

Annual Outline Review (AOR) Coordination: 


  • Responsible for providing technical guidance, training and oversight for the overall Est 196 AOR program.

  • Leads, facilitates and enables AOR and internal Outline of Production (OOP) and Standard Outline (SO) approval processes.

  • Revises / updates OOPs / SOs in the interim of Annual Outline Review at both sites.

  • Ensures Est 196 alignment of processes and procedures.

  • Implements applicable Est 196 SOPs to align with current regulations, Elanco Global Quality Standards and Elanco Functional Procedures.

  • Coordinates with departmental managers to strategically drive improvements in AOR process.

  • Ensures the accuracy and compliance of controlled documents against the approved registered OOP / SO

  • Annual Outline Review process operates in an efficient manner, generating quality and timely results within an atmosphere which promotes collaboration and growth.

  • Interim outline updates are completed in a timely manner ensuring availability and accuracy of OOPs and SOs to support production and laboratory operations

  • Network collaboration and alignment with regulatory is achieved during the escalation, investigation and reporting of outline non-compliance.

  • No critical or major regulatory/EGQCA audit findings associated with non-compliance with outlines.

Required Capabilities:

Significant working and theoretical knowledge is required in order to objectively assess procedures and determine the level of compliance, apply appropriate risk assessment and recommend improvements to improve compliance levels.  Thorough and technical correct decision-making skills are required and in constant use in this position.  

Experience in the following is required;


  • Good understanding of the relevant USDA regulations

  • Well versed in all regulatory requirements, inclusive of GMP/GLP and Elanco requirements.

  • Ability to plan, schedule, organize, prioritize, and coordinate project activities in a Team environment.

  • Strong verbal, written, organizational, time management and interpersonal skills with cross-functional groups.

  • Must be self-motivated and of high integrity

  • Demonstrated high ethical and professional standards with all business contacts in order to maintain Elanco's excellent reputation in the community. 

  • Proficiency in relevant computer software programs associated with the area (Veeva RIM, Success Factors).

  • Ability to successfully meet requirements while working remotely.  Approximately 30% travel possible between Fort Dodge and Winslow.  Primary work will be remote.

Minimum Requirements:


  • Bachelor’s Degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, Business Administration, Economics, Engineering or IS/IT.  A BS/BA, or advanced degree is required with a minimum of 5 years in a regulated pharmaceutical /vaccine manufacturing environment. 

  • Must demonstrate ability to work and communicate with diverse groups across the organization at all levels on a routine basis, locally and globally.  Well versed in all regulatory requirements, inclusive of GMP/GLP and Elanco requirements. Interacts with Production, Engineering, Maintenance, Planning. 

  • Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status





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