Planet Pharma · 2 hours ago
Quality Compliance Specialist
Alameda, CA
Full-time
Onsite
Entry, Mid Level
$34/hr - $44/hr
3+ years expPlanet Pharma is seeking a Quality Compliance Specialist to support GxP inspection and audit activities. The role involves maintaining audit records, assisting in inspection readiness, and ensuring data accuracy in various systems.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Responsible for maintaining audit-related records throughout the program lifecycle
Responsible for obtaining and compiling data relevant to risk assessments
Assist with Inspection Readiness activities including the organizational inspection readiness across multiple projects in all stages of development or commercialization
Assist in maintaining and developing standardized templates based on regulatory requirements and procedures
Conduct follow-up activities with internal stakeholders related to the inspection readiness program
Input and maintain inspection ready information in the eQMS and SharePoint
Support internal and external stakeholders for monitoring supplier performance
Assist in tracking and trending of quality metrics related to the supplier qualification, audits and inspection programs
Qualification
Required
BS/B.Sc preferably in the life sciences or STEM disciplines and a minimum of 1-3 years of related experience
Minimum of 3 years experience in biotech, pharmaceutical, or related industry or the equivalent combination of education/training and experience
Must have excellent attention to detail and good investigation, problem solving, and organizational skills
This position requires a knowledge and experience with GxP processes related to managing vendors, partners, and suppliers
Familiarity with FDA Quality System Regulations and Pharmaceutical guidelines, 21 CFR Part 210 & 211, US and EU regulations, ICH guidelines and other industry standards
Administrative experience in organizing and maintaining supplier and audit related records
Proven organizational skills to obtain data across multi-functional groups and present results in a consolidated and clear manner
Keeps Management informed of status of assigned projects
Strong written and oral communication skills
Excellent attention to detail and organizational skills
Ability to influence decision makers and utilizes sound problem solving skills to recommend options and implement effective solutions
Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization
Ability to contribute to the development of company objectives and key performance indicators
Strong user of Microsoft Office applications
Preferred
ISO understanding is a bonus
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
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