Quality Assurance Associate β Manufacturing Floor (Evening & Night Shift)
Elanco
Quality Assurance Associate β Manufacturing Floor
Responsibilities:
- Provide quality floor support by observing daily processes (statuses, issues/concerns, issuance of cell banks); act as first responder and represent QA on cross-functional process teams.
- Identify, investigate, and resolve complex technical issues; participate in investigation teams, determine next steps, and support closeout/follow-up; make independent decisions and notify management.
- Perform QA review/approval of controlled documents (solution records, batch records, logbooks, autoclave cycles) with strong attention to detail.
- Review change management documentation, deviations, investigations, and CAPA records for completion; write new and revise existing QA documents as needed.
- Participate and manage QA projects with minimal supervision; complete most work independently; assist other QA associates/managers.
Minimum Qualifications:
- BA/BS (or Masterβs) in a Life Science discipline preferred and/or 3 yearsβ experience in a regulated industry (USDA/FDA/ISO, etc.).
- Direct experience with Quality Assurance within a regulated industry.
- Comprehensive knowledge of quality and GMP principles; current understanding of global GMP drug manufacturing regulations.
- Ability to work in controlled/clean room environments requiring gowning.
Preferred Qualifications:
- Familiarity with basic statistics; review/approval of documentation; risk tools; technical writing; writing/reviewing/approving investigations.
- Ability to handle multiple tasks/priorities; strong interpersonal/team skills.
- Demonstrated experience making sound independent decisions.
Additional Information:
- Location: Elwood, KS Manufacturing Site.
- Evening shift: 4:00pmβ12:30am; Night shift: 12amβ8:30am (MonβFri). Rotating weekend schedule every 3rd weekend; 24/7 site.
Benefits and Perks:
- Multiple relocation packages; 8-week parental leave; 9 Employee Resource Groups; annual bonus offering; up to 6% 401(k) matching.