Planet Pharma ยท 1 month ago
Specialist, QA Validation
Sanford, NC
Contract
Onsite
Mid, Senior Level
$76/hr - $81/hr
3+ years expPlanet Pharma is seeking a Specialist, QA Validation to implement and assess quality systems to support compliant GMP operations. The role involves collaboration with various departments to ensure compliance with quality standards and oversight of QA processes.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance with local and global quality standards, regulatory requirements, and industry guidance
Provide QA review and approval for commissioning/qualification/validation documents
Provide QA review and approval of qualification and validation deviations and discrepancies and support investigation and corrective actions
Author, review and approved controlled documents for the Quality organization including SOPs, specifications, protocols, and reports
Qualification
Required
B.S. degree in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study and 3-5+ years of experience or M.S. degree and 1-3+ years of experience in a QA function in a biologics manufacturing facility
Experience with qualification/validation of process equipment, analytical instruments, clean utilities, automation, sterile filling, and clean facilities
Strong understanding of FDA, EMA, local regulations and guidelines, ICH guidelines, and industry best practices
Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects
Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others
Excellent problem-solving skills and experience with root cause investigations and CAPA determination
Off hours coverage and flexibility may be required
Benefits
Medical
Dental
Vision
401k
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