Planet Pharma ยท 16 hours ago
Quality Control Analyst II
Norton, MA
Full-time
Onsite
Mid, Senior Level
$38/hr - $43/hr
4+ years expPlanet Pharma is seeking a Quality Control Analyst II to support their efforts in maintaining high standards of quality and compliance. The role involves executing analytical assays, maintaining laboratory operations, and ensuring adherence to regulatory standards.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Perform routine and non-routine analytical assays, with increasing complexity, to support raw materials, in-process samples, product release, and stability studies, following established SOPs
Maintain up-to-date training records, adhere to the testing schedule, and ensure the timely completion of all assignments to support the seamless operation of QC activities and uphold the department's commitment to meeting project timelines and quality metrics
Assist in the maintenance of laboratory equipment and inventory, including the preparation of reagents and samples to ensure smooth laboratory operations
Ensure data is submitted timely; may qualify as a data reviewer to ensure timely and efficient data availability
Perform role-specific operational assignments (e.g., raw material sampling and testing, environmental monitoring, product testing, etc.)
Contribute to the revision and updating of controlled documents, including SOPs, work instructions, and test methods, to ensure continuous improvement and compliance with requirements
Adhere to internal standards, policies, and SOPs, as well as regulatory and industry standards (e.g., GMP, GLP, ICH guidelines) to maintain the highest levels of quality and compliance
Collaborate with QC and cross-functional teams to ensure seamless quality control operations and to support the collective goals
Pursue ongoing training and development to deepen expertise in QC testing techniques and regulatory compliance
May assist in data verification for regulatory submissions
Participate in inspection readiness activities as well as supporting onsite audits and inspections, as needed
Support continuous improvement initiatives aimed at enhancing QC processes and procedures, increasing laboratory efficiency and effectiveness
Collaborate with other organizational functions including Manufacturing, Materials Management, and Quality Assurance to ensure alignment with overall business goals
Qualification
Required
B.S. in chemistry, biology, or biochemistry, or related scientific field; Associates Degree, Biotech Certificate, or equivalent considered
Pharmaceutical/Biotech industry experience with 4-8 years in a regulated laboratory setting, Quality Control, or equivalent, relevant experience
Ability to work under direction, with attention to detail, in an environment where priorities shift
Good communication and teamwork abilities, capable of working effectively in a collaborative environment
Preferred
Data analysis experience preferred
Knowledge of LIMS, Excel, Word, and PowerPoint is helpful
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