Calling all QA professionals!
INCOG Biopharma Services is seeking a
Quality Assurance professional to oversee and support
fill/finish activities (e.g. formulation, filing, inspection, packaging) at their state-of-art
CDMO during this exciting time of growth. INCOG is offering the opportunity to contribute towards a better path to market for life-saving drugs. Having recently been voted as one of the
Best Places To Work in Indiana for the second year in a row, INCOG is the perfect place to continue building your career.
WHAT? - Review documentation for compliance and Quality approval (material specifications and release packets, QC test results, equipment records, equipment NCRs/ work orders, facility records (pest control), change control requests, deviations, logbooks, etc.), ensuring data integrity throughout with the use of various paper/automated systems (Veeva, SCADA, BMS, CMMS, etc).
- Perform QA Surveillance walkthroughs through production, labs, warehouse and facilities, as well as AQL Visual Inspections of products, identifying/classifying defects, and performing requalifications.
- Maintain a QA presence on the manufacturing floor, providing process confirmations, and identifying scope/impact of deviations. Provide investigation support, using RCA tools, report writing, and mitigation development.
YOU! The ideal candidate will have a
Bachelor’s degree in a
Science field (Chemistry, Biology,
Biochemistry, Microbiology), as well as a minimum of 2 years experience with
aseptic processes in a
cleanroom/isolator environment. 2 years experience as a performer/
reviewer in
QMS/
DMS,
Deviations/
CAPAs, and
Change Controls. Experience with materials/production movements in SAP, and responding to reports/alarms from BMS/PAS is preferred but not required.
This position may require candidates to work 1st or 2nd shift. So applicants should be prepared to work 3pm - 11pm on occasion. Interested? Send us your resume at
apply@leadcandidate.com or you can find the full job specification here:
INCOG - QA Associate Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself...
Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.