Planet Pharma · 12 hours ago
Quality Assurance Manager, Finished Goods
Cambridge, MA
Full-time
Onsite
Senior Level
$70/hr - $75/hr
5+ years expPlanet Pharma is a company focused on pharmaceutical and biopharmaceutical solutions, and they are seeking a Quality Assurance Manager for Finished Goods. The role involves overseeing quality operations for commercial finished goods, ensuring compliance with internal standards and regulatory requirements, and managing quality records related to packaging and assembly activities.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Serve as QA representative for commercial finished goods and external manufacturing partners
Represent Finished Goods Quality Operations at routine internal meetings and external contract manufacturers and for commercial production
Oversee quality aspects of commercial finished goods specifications, qualification and validation, drawings, artwork, label, serialization, and packaging operations at CMOs for global commercial supply and ensure compliance to internal standards and regulatory requirements for US production
Review and approval of content within manufacturing partner and Alnylam Label and Pack documents, including BOMs, MPRs, Product Specifications, and Variable Data
Ensure proper archival of manufacturing partner documentation in Alnylam’s document management system
Manage Quality Records (deviation, capa, change control, serialization excursions, issue escalation) as it relates to commercial finished good assembly, label, and packaging activities
Recommend continuous improvement opportunities on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business needs
Qualification
Required
Minimum BS degree in life sciences, engineering, or related field
A minimum of 5 years of experience in a pharmaceutical or biopharmaceutical company
Experience with finished goods assembly, labeling, and packaging manufacturing operations at external manufacturers
Excellent organizational, communication (written and verbal), and interpersonal skills
Experience leading, training, and/or implementing root cause analysis and effective investigation practices
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