Planet Pharma · 20 hours ago
MCS Quality Assurance Specialist
Thousand Oaks, CA
Full-time
Onsite
Mid Level
$36/hr - $46/hrPlanet Pharma is a company focused on Quality Assurance within the ATO Plant Quality Assurance organization. The role involves providing oversight for Commissioning, Qualification, and Validation processes in various GMP areas, ensuring compliance and adherence to quality standards.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Supports Quality Assurance program under the ATO Plant Quality Assurance organization providing oversight of Commissioning, Qualification, and Validation (CQV) processes in Cell Banking, Drug Substance, Drug Product Filling, Drug Product Packaging/Labeling, General Utility, and Quality Control GMP areas
Provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of CQV related processes, procedures, and use of quality systems
Ensures adherence to equipment and computer validation standards and procedures
Participates in CQV design, review of test protocols, analysis of CQV results, and oversight of summary reports
Provides guidance and sets standards in producing quality documentation and serves as an advisor to Engineering, IS and Manufacturing functions
Provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT compliance issues
Executes quality oversight directly in Quality systems
Qualification
Required
Bachelors degree in engineering, Biochemistry, Biology, Chemistry, or related science field
Demonstrated ability to perform or provide oversight of GMP operations including following detailed SOPS, maintaining training, maintaining data integrity principles, and good documentation practices
Experience managing projects through completion while meeting timelines
Evaluating documentation and operations according to company procedures and related regulations
Experience working with Quality Systems
Strong organizational skills and ability to manage multiple tasks at one time
Effective communication skills (both written and verbal)
Demonstrated ability to work as both a team player and independently
Solid understanding and application of aseptic behaviors and principles
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
Founded in 2009
1001-5000 employees
H1B Sponsorship
Planet Pharma 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
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase