What are the responsibilities and job description for the QMS Consultant position at Redbock- an NES Fircroft company?
Our client is a leading T cell receptor (TCR) biotechnology company working to create first-in-class biological therapies to address unmet patient needs in oncology as well as infectious and autoimmune diseases, and they are in immediate need of a Quality Systems Consultant to support QMS and GxP activities.
Responsibilities:
- Manage QMS work, deviations, change controls, CAPAs, SOP writing, and form writing.
- Write, review and manage quality documentation (procedures, protocols, SOPs, etc.)
- Execute routine Document Control activities per SOPs, QMS, and applicable regulatory requirements
Requirements:
- BS Degree minimum
- 3 years experience pharmaceutical or biotechnology industry required
- Must have strong GxP experience, experience in GCP setting are a plus
- Experience with EQMS or EDMS (MasterControl) preferred. Experience with Veeva or Trackwise is acceptable
- Investigation skills are a plus
Job Types: Full-time, Contract
Benefits:
- Dental insurance
- Health insurance
- Life insurance
- Vision insurance
Experience level:
- 3 years
Schedule:
- 8 hour shift
Education:
- Bachelor's (Preferred)
Experience:
- pharma and/or biotech industry: 3 years (Preferred)
- GxP, experience in GCP setting: 3 years (Preferred)
- EQMS or EDMS (MasterControl): 3 years (Preferred)
- Veeva or Trackwise: 3 years (Preferred)
- Quality Investigation: 3 years (Preferred)
Ability to Relocate:
- Conshohocken, PA: Relocate before starting work (Required)
Work Location: Hybrid remote in Conshohocken, PA
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