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Biotech Regulatory Supp Spec, contract, onsite, Santa Ana CA, 33-36/hr w2, no C2C

2 months ago


Santa Ana, United States Integrity Consulting LLC Full time

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