RIT Solutions, Inc. · 1 day ago
QA Supervisor
United States
Full-time
Remote
Senior Level
5+ years expRIT Solutions, Inc. is a biotech client seeking a highly motivated individual to join their team as a Sr. Specialist in the Quality Assurance (QA) department. This position will be responsible for ensuring quality of cGMP activities at external contract organizations for aseptically produced investigational cell and gene therapy products.
Staffing & Recruiting
Responsibilities
Lead cGMP QA compliance activities at external CxOs for all relevant operations, including raw material testing, GMP manufacturing, QC testing, release, stability, packaging/labeling, lot disposition and clinical supply activities for aseptically produced investigational cell and gene therapy products
Oversee quality aspects for commissioning, qualification and validation activities for equipment, batch record review, deviation handling and quality event processes at external CxOs
Support complex external OOS investigations, manufacturing investigations, change controls and implementation of CAPAs at external CxOs and internally, when applicable
Liaise with external QA representatives and maintain external relationships
Maintain knowledge of current industry standards and trends in best practices for compliance with cGMP regulations
Qualification
Required
Life Sciences-based BSc or advanced degree with a minimum of 5 years' experience in pharma, biopharma or biotech with demonstrated knowledge of relevant cGMP regulations and QA operations in a GMP-regulated environment
Strong knowledge of GMP application to production and QC testing of biologics and aseptic processing, preferably with experience in cell and gene therapy
Strong knowledge of regulations and industry standards, including cGMP and applicable guidance documents, ICH guidance documents, USP, Ph. Eur, ISO and associated global regulations
Ability to support teams in meeting aggressive project timelines and to constructively engage team members in resolving conflicts
Highly adaptable and skilled problem solver with a proactive attitude comfortable with ambiguity
Ability and willingness to work in alternate time zones, if required (ie. early morning, late evening, possibly overnight)
Preferred
If they come from Catalent
Experience working with CxOs and contract testing labs preferred
Company
RIT Solutions, Inc.
Jobdiva Job Portal: https://www1.jobdiva.com/candidates/myjobs/searchjobsdone.jsp?a=xbjdnwgjodtga1y1im2g881fkkeiwd0775lbvq8yqgps8vb2q36w2vj1ga6xxork&compid=-1 Recruitment (contingency search and campus selection).
201-500 employees
H1B Sponsorship
RIT Solutions, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (2)
Funding
Current Stage
Growth StageCompany data provided by crunchbase