Planet Pharma · 13 hours ago
Quality Control Analyst
Holly Springs, NC
Full-time
Onsite
Senior Level
5+ years expPlanet Pharma is a company that focuses on pharmaceutical quality assurance, and they are seeking a Quality Control Analyst to support the review of batch documentation and ensure compliance with regulatory requirements. The role involves batch release responsibilities, certification of materials, and development of standard operating procedures.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Batch Release
Responsible for certification and/or rejection of incoming material and manufactured material in compliance with applicable licenses and legal requirements. Ensures compliance with regulatory requirements, internal/external guidelines, SOPs, and specifications related to record review and product release. Ability to identify non-compliances impacting release and report/escalate as appropriate for resolution
Supports the development and implementation of standard operating procedures (SOPs) and supplemental documents governing batch release activities. Authors, reviews, and QA approves Standard Operating Procedures (SOP’s), protocols/reports, work instructions, etc
Creates and maintains QA SAP Master Data builds in support of batch release
Data population and approval of Lot Release Protocols. Supports Lot Release Protocol revisions and GLIMS data builds for LRPs
Additional job responsibilities may be assigned
Qualification
Required
Must have familiarity with SAP; strong preference for candidates who have used SAP for batch release in a prior role
5 years' related experience in Pharma Quality
Strong organization, administrative and data entry skills
Preferred
Experience using Veeva and/or GLIMS
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