Quality Assurance Associate-Document Control (Project Management)
At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of ‘Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better – join our team today!
Your Role: Quality Assurance Associate – Document Control
This vital role serves as the gatekeeper of quality and compliance, ensuring documentation practices meet the highest standards. It ensure that MPRs and batch documentation accurately reflect operational practices and capture all relevant process parameters, quality attributes and process specifications, ensuring alignment with regulatory and GMP requirements (including Outlines of Production, Product Dossiers, Special Outlines, and all applicable quality standards). Collaboration with Manufacturing, Technical Services, Process Engineering, and Process Teams is essential, acting as a champion for quality throughout the production lifecycle.
Your Responsibilities:
Actively engage with Technical Services, Process Engineering and Manufacturing, providing on-floor QA support. Champion quality and compliance through leadership, including observation of production processes to rapidly identify and implement improvements to master production records and batch documentation.
Issue documentation e.g. batch records, logbooks, forms. Perform document review for compliance with Good Documentation Practices, established SOPs/standards, and/or Outline of Production/Special Outline as applicable. Resolve issues found during documentation review (documentation errors, missing information).
Maintain document control area in a state of control and compliance. Ensure documents are archived through the approved retention policy and process records through the site Electronic Documentation Management System as needed. Support site with formatting and routing documents as needed.
Participate in and manage QA projects as needed with minimal supervision. Receive overall project direction from Management but complete most work independently. Assist other Quality Assurance Associate(s) and Quality Assurance Manager(s) as needed.
Perform QA review/approval as needed of executed records (Batch Records, Manufacturing Directions, Solution Records, Autoclave Records, Logbooks, QC Testing), Certificates of Analysis/Compliance for batch release. and local SOPs, Test Specifications, Master Production Record Review, Special Outlines and Outlines of Production with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures/controls.
What You Need to Succeed (minimum qualifications):
Bachelor's degree (scientific discipline preferred) and 3+ years of relevant industry experience or a High School diploma and 5+ years of relevant industry experience (USDA, FDA, ISO, etc.).
Comprehensive knowledge of pharmaceutical cGMPs (US and EU), FDA, USDA, VICH, and EU regulations related to manufacturing and quality activities.
Must be able to work in controlled / clean room environments requiring gowning qualifications.
Exceptional leadership, organizational, and interpersonal skills, combined with meticulous attention to detail.
Demonstrated experience and proficiency with editing documents in Microsoft Word.
What will give you a competitive edge (preferred qualifications):
Demonstrated experience and proficiency with SAP, Veeva Vault, Microsoft Office (Word, Excel, PowerPoint, and Outlook).
Excellent written and verbal communication skills with internal and external customers, peers, and managers. Excellent technical writing skills.
Experience in quality and manufacturing of biological products (e.g., mAbs, recombinant proteins, vaccines).
Experience in Operational Excellence, investigation procedures, materials management, and/or quality control testing for USDA or EU GMP regulated industries.
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
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
