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Biotech Regulatory Supp Spec, contract, onsite, Santa Ana CA, 33-36/hr w2, no C2C
3 months ago
Provide investigation support to ensure organization is addressing customer issues appropriately, regardless of origin, for all business lines. This position will perform and execute activities to ensure the company products are fully compliant with all global RA/QA requirements which includes customer inquiries, complaints, CAPAs, Quality Planning and Change requests. Duties include, but not limited to, oversight of the programs, resolving complaints, assessing corrective action, and corrective action preventive action (CAPA), with support from management. May assist with Quality System compliance activities, such as oversee CAPA program by coordinating with individual CAPA owners.
Required Skills:
2 years of experience in GMP Biotech/Pharma environment
2 years of experience with investigations, complaints, regulatory affairs, CAPA or compliance
Strong root cause analysis skills
Proficient in Microsoft Word, Excel, PowerPoint, Outlook
Associate’s degree
Desired Skills:
GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, ISO
ART, Cytogenetics, cell and tissue cultures, Mammalian Cell & Tissue Culture; Biochemistry
Risk management, Failure Mode Effects Analysis (FMEA), Root cause analysis
SAP, SalesForce, Master Control
Experience with Excel, Visio, PowerBI
Bachelors Degree in scientific discipline
