QC Investigations Specialist
San Francisco Metro Area, CA 94949 US
R&D Partners is seeking to hire a QC Investigations Specialist in Novato, CA.
Benefits of this role:
Benefits + 401k
Your main responsibilities as a QC Investigations Specialist:
Lead laboratory investigations (LIRs) for OOS, OOE, OOTs and system suitability failures.
Lead deviation investigations related to QC laboratory, excursions, and adverse trends.
Work with QC team for data gathering, observing processes for investigations, and performance of associate interview.
Build cross-functional workgroups and facilitate identification of the true root cause utilizing root cause analysis tools (fishbone, 5 Why's, etc.).
Assign child records to appropriate groups and provide guidance on investigations to operational staff.
What we are looking for in a QC Investigations Specialist:
B.S. degree, or equivalent, in a biological or biochemical science and at least 4 years of experience in a pharmaceutical laboratory, with at least 2 years as part of a QC organization.
Detailed knowledge of quality management systems, current Good Manufacturing Practices, expertise with QC principles and compliance requirements.
Demonstrated working knowledge and critical thinking with respect to certified functional activities, with subject matter expertise on several technical modules or quality management systems.
Knowledge of various quality tools including fishbone, 5 Why's etc.
Excellent documentation, written and verbal communication skills are essential.
Why Choose R&D Partners?
Refer a Friend bonus
$40.72 - $50.34 (Dependent on Experience)
R&D Partners is a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal opportunity employer.